Summary of recommendations

The following table presents all recommendations and good practice statements included in these guidelines.

The ★ symbol represents recommendations or good practice statements developed between 2020 and 2021.

Chapter 2.

HIV testing and diagnosis

2.4.

HIV testing service delivery approaches

2.4.1.

Facility-based HIV testing services

High-HIV-burden settings

HIV testing should be offered to all populations and in all services (for example, services for sexually transmitted infections, hepatitis, TB, children under five, immunization, malnutrition, antenatal care and all services for key populations) as an efficient and effective way to identify people with HIV.

Low-HIV-burden settings

HIV testing should be offered for:

• adults, adolescents or children who present in clinical settings with signs and symptoms or medical conditions that could indicate HIV infection, including TB, viral hepatitis and sexually transmitted infections;
• HIV-exposed children and symptomatic infants and children;
• key populations and their partners; and
• all pregnant women.

2.4.2.

Facility-based HIV testing services for infants and children

High-HIV-burden settings

In settings with a high burden of HIV infection, infants and children with unknown HIV status who are admitted for inpatient care or attending malnutrition clinics should be routinely tested for HIV (strong recommendation, low-certainty evidence).

High-HIV-burden settings

In settings with a high burden of HIV infection, infants and children with unknown HIV status should be offered HIV testing in outpatient or immunization clinics (conditional recommendation, low-certainty evidence).

Good practice statement

In all settings, the biological children of a parent living with HIV (or who may have died from HIV) should be routinely offered HIV testing services and, if found to be either infected or at high risk of infection through breastfeeding, should be linked to services for treatment or prevention and offered a broader package of voluntary provider-assisted referral.

2.4.3.

Community-based HIV testing services

High-HIV-burden settings

Community-based HIV testing services are recommended, with linkage to prevention, treatment and care services, in addition to routine facility-based testing, for all populations, particularly key populations (strong recommendation, low-certainty evidence).

High-HIV-burden settings

Community-based HIV testing services are recommended for key populations, with linkage to prevention, treatment and care services, in addition to routine facility-based testing (strong recommendation, low-certainty evidence).

2.4.4.

HIV self-testing

HIV self-testing should be offered as an approach to HIV testing (strong recommendation, moderate-certainty evidence).

Remarks

• Providing HIV self-testing service delivery and support options is desirable.
• Communities need to be engaged in developing and adapting HIV self-testing models.
• HIV self-testing does not provide a definitive HIV-positive diagnosis. Individuals with a reactive test result must receive further testing from a trained tester using the national testing algorithm.

2.4.5.

HIV partner services

Provider-assisted referral should be offered to people with HIV as part of a comprehensive package of testing and care (strong recommendation, moderate-certainty evidence).

Social network–based approaches can be offered as an HIV testing approach for key populations as part of a comprehensive package of care and prevention (conditional recommendation, very-low-certainty evidence).

Good practice statement

In all settings, biological children with a parent living with HIV (or who may have died from HIV) should be routinely offered HIV testing services and, if found to be either infected or at high risk of infection through breastfeeding, should be linked to services for treatment or prevention and offered a broader package of voluntary provider-assisted referral.

Note: Partner services include partner notification, contact tracing, index testing and family-based index case testing for reaching the partners of people living with HIV. These guidelines define partner services as encompassing a range of partner services packages and approaches, including social network–based approaches.

2.6.7.

Priority populations

Infants and children

Addition of nucleic acid testing (NAT) at birth to existing early infant diagnosis testing approaches can be considered to identify HIV infection among HIV-exposed infants (conditional recommendation, low-certainty evidence).

In settings with a high burden of HIV infection, infants and children with unknown HIV status who are admitted for inpatient care or attending malnutrition clinics should be routinely tested for HIV (strong recommendation, low-certainty evidence).

In settings with a high burden of HIV infection, infants and children with unknown HIV status should be offered HIV testing in outpatient or immunization clinics (conditional recommendation, low-certainty evidence).

Point-of-care nucleic acid testing should be used to diagnose HIV among infants and children younger than 18 months of age (strong recommendation, high-certainty evidence).

Rapid diagnostic tests for HIV serology can be used to assess HIV exposure among infants younger than four months of age. HIV-exposure status among infants and children 4–18 months of age should therefore be ascertained by HIV serological testing the mother (conditional recommendation, low-certainty evidence).

Rapid diagnostic tests for HIV serology can be used to diagnose HIV infection among children older than 18 months following the national testing strategy (strong recommendation, moderate-certainty evidence).

An indeterminate range of viral copy equivalents should be used to improve the accuracy of all nucleic acid–based early infant diagnosis assays (strong recommendation, moderate-certainty evidence).

Good practice statements

National regulatory agencies are encouraged not to delay the adoption of point-of-care early infant diagnosis by conducting further evaluations but instead to adopt a rapid and streamlined registration and national approval process for immediate implementation.

In all settings, biological children with a parent living with HIV (or who may have died of HIV) should be routinely offered HIV testing services and, if found to be either infected or at high risk of infection through breastfeeding, should be linked to services for treatment or prevention and offered a broader package of voluntary provider-assisted referral.

Adolescents

HIV testing services, with linkages to prevention, treatment and care, are recommended for adolescents from key populations (strong recommendation, very-low-certainty evidence).

Adolescents should be counselled about the potential benefits and risks of disclosing their HIV-positive status and empowered and supported to determine whether, when, how and to whom to disclose (conditional recommendation, very-low-certainty evidence).

Settings with a high burden of HIV infection

In settings with a high burden of HIV infection, HIV testing services, with linkage to prevention, treatment and care, are recommended for all adolescents (strong recommendation, very-low-certainty evidence).

Settings with a low burden of HIV infection

HIV testing services, with linkage to prevention, treatment and care, should be accessible to adolescents in low and concentrated epidemics¹ (conditional recommendation, very-low-certainty evidence).

Good practice statement

Governments should revisit age-of-consent policies, considering the need to uphold adolescents’ rights to make choices about their own health and well-being (with consideration for different levels of maturity and understanding).

Infants and children

HIV testing services should be routinely offered to all key populations both in the community and in facility-based settings. Community-based HIV testing, with linkage to prevention, treatment and care, should be offered, in addition to routinely offering testing in facilities, for key populations in all settings (strong recommendation, low-certainty evidence).

Social network–based approaches can be offered as an HIV testing approach for key populations as part of a comprehensive package of care and prevention (conditional recommendation, very-low-certainty evidence).

Pregnant women, couples and partners

All pregnant women should be tested for HIV, syphilis and hepatitis B surface antigen (HBsAg)² at least once and as early as possible (syphilis: strong recommendation, moderate-certainty evidence; HBsAg²: strong recommendation, low-certainty evidence).

Dual HIV and syphilis rapid diagnostic tests can be the first test in HIV testing strategies and algorithms in antenatal care.

Provider-assisted referral should be offered to all people with HIV as part of a voluntary comprehensive package of testing and care (strong recommendation, moderate-certainty evidence).

Couples and partners should be offered voluntary HIV testing services with support for mutual disclosure (strong recommendation, low-certainty evidence).

Women who disclose any form of violence by an intimate partner (or other family member) or sexual assault by any perpetrator should be offered immediate support. Health-care providers should, as a minimum, offer first-line support when women disclose violence. If health-care providers are unable to provide first-line support, they should ensure that someone else (within their health-care setting or another that is easily accessible) is immediately available to do so (strong recommendation, indirect evidence).

Health-care providers should ask about exposure to intimate partner violence when assessing conditions that may be caused or complicated by intimate partner violence, to improve diagnosis and identification and subsequent care (strong recommendation, indirect evidence).

Good practice statement

Mandatory or coercive testing is never warranted. In consultation with the client, the provider should assess the risk of harm, the most appropriate approach for couple and partner testing, including more supportive options such as provider assistance, and situations that make couple or partner testing inadvisable.

2.6.

Strategies to make HIV testing services accessible

Task sharing

Lay providers who are trained and supervised to use rapid diagnostic tests can independently conduct safe and effective HIV testing services (strong recommendation, moderate-certainty evidence).

2.7.

Maintaining the accuracy and reliability of HIV diagnosis

Western blotting

Western blotting and line immunoassays should not be used in national HIV testing strategies and algorithms (strong recommendation, low-certainty evidence).

HIV testing strategy and algorithm

WHO recommends that all HIV testing algorithms achieve at least 99% positive predictive value and use a combination of tests with ≥99% sensitivity and ≥98% specificity.

The first test in an HIV testing strategy and algorithm should have the highest sensitivity, followed by a second and third test of the highest specificity.

Countries should consider moving to a three-test strategy as HIV positivity within national HIV testing service programmes falls below 5% – meaning all people presenting for HIV testing services should have three consecutive reactive test results in order to receive an HIV-positive diagnosis.

Dual HIV/syphilis rapid diagnostic tests can be the first test in HIV testing strategies and algorithms in antenatal care.

WHO suggests using a testing strategy for HIV diagnosis that is suitable for HIV diagnosis during surveillance and routinely returning HIV test results to participants.

Retesting prior to ART initiation

All people newly diagnosed with HIV should be retested to verify their HIV status prior to starting ART, using the same testing strategy and algorithm as the original diagnosis.

Retesting among people with HIV who already know their status, including those on treatment, is not recommended as it can provide incorrect results if the person with HIV is on ART.

2.8.

HIV diagnosis among infants and children

2.8.1.

Timing of virological testing

The addition of nucleic acid testing (NAT) at birth to existing early infant diagnosis testing approaches can be considered to identify HIV infection in HIV-exposed infants (conditional recommendation, low-certainty evidence).

2.8.3.

Technologies to use for infant testing ★

Point-of-care nucleic acid testing should be used to diagnose HIV among infants and children younger than 18 months of age (strong recommendation, high-certainty evidence).

2.8.4.

Rapid diagnostic tests for HIV serology

Rapid diagnostic tests for HIV serology can be used to assess HIV exposure among infants younger than four months of age. HIV-exposure status among infants and children four to 18 months of age should therefore be ascertained by undertaking HIV serological testing in the mother (conditional recommendation, low-certainty evidence).

Rapid diagnostic tests for HIV serology can be used to diagnose HIV infection among children older than 18 months following the national testing strategy (strong recommendation, moderate-certainty evidence).

2.8.5.

Minimizing false-positive results by introducing an indeterminate range for infant diagnosis when using NAT

An indeterminate range³ of viral copy equivalents should be used to improve the accuracy of all nucleic acid–based early infant diagnosis assays (strong recommendation, moderate-certainty evidence).

Chapter 3.

HIV prevention

3.2.

Pre-exposure prophylaxis for preventing the acquisition of HIV

3.2.1.

Oral pre-exposure prophylaxis for preventing the acquisition of HIV

Oral pre-exposure prophylaxis (PrEP) containing TDF should be offered as an additional prevention choice for people at substantial risk of HIV infection⁴ as part of combination HIV prevention approaches (strong recommendation, high-certainty evidence).

3.2.2.

PrEP using the dapivirine vaginal ring ★

The dapivirine vaginal ring may be offered as an additional prevention choice for women⁵ at substantial risk of HIV infection as part of combination prevention approaches (conditional recommendation, moderate-certainty evidence).

3.3.

Post-exposure prophylaxis

Overall

An HIV post-exposure prophylaxis (PEP) regimen with two ARV drugs is effective, but three drugs are preferred (conditional recommendation, low-certainty evidence).

Adults and adolescents

TDF + 3TC (or FTC) is recommended as the preferred backbone regimen for HIV PEP (strong recommendation, low-certainty evidence).

DTG is recommended as the preferred third drug for HIV PEP (strong recommendation, low-certainty evidence).

When available, ATV/r, DRV/r, LPV/r and RAL may be considered as alternative third drug options for PEP (conditional recommendation, low-certainty evidence).

Children⁶

AZT + 3TC is recommended as the preferred backbone regimen for HIV PEP for children 10 years and younger. ABC + 3TC or TDF + 3TC (or FTC) can be considered as alternative regimens (strong recommendation, low-certainty evidence).

DTG is recommended as the preferred third drug for HIV PEP with approved DTG dosing (strong recommendation, low-certainty evidence).

When available, ATV/r, DRV/r, LPV/r and RAL may be considered as alternative third drug options for PEP (conditional recommendation, low-certainty evidence).

3.4.

Infant prophylaxis

Good practice statement

ART should be initiated urgently among all pregnant and breastfeeding women living with HIV, even if they are identified late in pregnancy or postpartum, because the most effective way to prevent HIV vertical transmission is to reduce maternal viral load.⁷

Infants born to mothers with HIV who are at high risk of acquiring HIVb should receive dual prophylaxis with daily AZT and NVP for the first six weeks of life, whether they are breastfed or formula fed (strong recommendation, moderate-certainty evidence).

Breastfed infants who are at high risk of acquiring HIV⁸, including those first identified as exposed to HIV during the postpartum period, should continue infant prophylaxis for an additional six weeks (total of 12 weeks of infant prophylaxis) using either AZT and NVP or NVP alone (conditional recommendation, low-certainty evidence).

Infants of mothers who are receiving ART and are breastfeeding should receive six weeks of infant prophylaxis with daily NVP. If infants are receiving replacement feeding, they should be given four to six weeks of infant prophylaxis with daily NVP (or twice-daily AZT) (strong recommendation, moderate-certainty evidence for breastfeeding infants; strong recommendation, low-certainty evidence for infants receiving only replacement feeding).

Chapter 4.

ART for people living with HIV

4.4.

When to start ART

All populations

ART should be initiated for all people living with HIV regardless of WHO clinical stage and at any CD4 cell count.

• Adults (strong recommendation, moderate-certainty evidence)
• Pregnant and breastfeeding women (strong recommendation, moderate-certainty evidence)
• Adolescents (conditional recommendation, low-certainty evidence)
• Children living with HIV one year old to less than 10 years old (conditional recommendation, low-certainty evidence)
• Infants diagnosed in the first year of life (strong recommendation, moderate-certainty evidence)

4.5.

Timing of ART

4.5.1.

Rapid ART initiation

Rapid ART initiation⁹ should be offered to all people living with HIV following a confirmed HIV diagnosis and clinical assessment (strong recommendation: high-certainty evidence for adults and adolescents; low-certainty evidence for children).

ART initiation should be offered on the same day to people who are ready to start (strong recommendation: high-certainty evidence for adults and adolescents; low-certainty evidence for children).

Good practice statement

ART initiation should follow the overarching principles of providing people-centred care. People-centred care should be focused and organized around the health needs, preferences and expectations of people and communities, upholding individual dignity and respect, especially for vulnerable populations, and should promote engaging and supporting people and families to play an active role in their own care by informed decision-making. People should be encouraged but not coerced to start ART immediately and should be supported in making an informed choice regarding when to start ART and what ARV drug regimen to use.

4.5.2.

Timing of ART for adults, adolescents and children being treated for HIV-associated TB ★

ART should be started as soon as possible within two weeks of initiating TB treatment, regardless of CD4 cell count, among people living with HIV.¹⁰

Adults and adolescents (strong recommendation, low- to moderate-certainty evidence)

Children and infants (strong recommendation, very-low-certainty evidence)

4.5.3.

Timing of ART for people living with HIV and cryptococcal meningitis

Immediate ART initiation is not recommended for adults, adolescents and children living with HIV who have cryptococcal meningitis because of the risk of increased mortality and should be deferred by 4–6 weeks from the initiation of antifungal treatment (strong recommendation, low-certainty evidence for adults and very-low-certainty evidence for children and adolescents).

4.5.4.

Timing of ART for people living with HIV and histoplasmosis ★

ART should be initiated as soon as possible among people with disseminated histoplasmosis for whom central nervous system involvement is not suspected or proven (conditional recommendation, very-low-certainty evidence).

4.6.

What to start

4.6.1.

First-line ART

Preferred regimen

1. DTG in combination with an NRTI backbone is recommended as the preferred first-line regimen for people living with HIV initiating ART.¹¹

• Adults and adolescents (strong recommendation, moderate-certainty evidence)
• Infants and children with approved DTG dosing¹² (conditional recommendation, low-certainty evidence)

Alternative regimen (adults and adolescents)

2. EFV at low dose (400 mg) in combination with an NRTI backbone is recommended as the alternative first-line regimen for adults and adolescents living with HIV initiating ART¹³ (strong recommendation, moderate-certainty evidence).

Preferred regimen (neonates)

3. An RAL-based regimen may be recommended as the preferred first-line regimen for neonates (conditional recommendation, very-low-certainty evidence).

4.6.2.

Second-line ART

Non-DTG-based regimens

DTG in combination with an optimized nucleoside reverse-transcriptase inhibitor backbone may be recommended as a preferred second-line regimen for people living with HIV for whom non-DTG-based regimens are failing.

• Adults and adolescents (conditional recommendation, moderate-certainty evidence)
• Children with approved DTG dosing (conditional recommendation, low-certainty evidence)

DTG-based regimens

Boosted protease inhibitors in combination with an optimized nucleoside reverse-transcriptase inhibitor backbone are recommended as a preferred second-line regimen for people living with HIV for whom DTG-based regimens are failing (strong recommendation, moderate-certainty evidence).

4.6.3.

Third-line ART

National programmes should develop policies for third-line ART (conditional recommendation, low-certainty evidence).

Third-line regimens should include new drugs with minimal risk of cross-resistance to previously used regimens, such as INSTIs and second-generation NNRTIs and PIs (conditional recommendation, low-certainty evidence).

People receiving a failing second-line regimen with no new ARV drug options should continue with a tolerated regimen (conditional recommendation, very low-certainty evidence).

4.7.

Monitoring the response to ART

Preferred monitoring approach

Viral load is recommended as the preferred monitoring approach to diagnose and confirm treatment failure¹⁴ (strong recommendation, low-certainty evidence).

Point-of-care viral load testing may be used to monitor treatment among people living with HIV receiving ART¹⁵ (conditional recommendation, moderate-certainty evidence). ★

Timing of treatment monitoring ★

Routine viral load monitoring can be carried out by six months, at 12 months and then every 12 months thereafter if the person is established on ART to synchronize with routine monitoring and evaluation reporting (conditional recommendation, very-low-certainty evidence).

See Fig. 4.2 for an updated treatment monitoring algorithm.

Role of CD4 cell count monitoring

In settings in which routine viral load monitoring is available, CD4 cell count¹⁶ monitoring can be stopped for individuals who are established on ART¹⁷ (conditional recommendation, low-certainty evidence).

In settings where viral load is not routinely available

If viral load testing is not routinely available, CD4 count and clinical monitoring should be used to diagnose treatment failure (strong recommendation, moderate-certainty evidence).

Use of dried blood spot specimens

Dried blood spot specimens using venous or capillary whole blood can be used to determine HIV viral load. A threshold of 1000 copies/mL can be used to determine virological failure when using dried blood spot samples, as defined for testing in plasma¹⁸ (conditional recommendation, low-certainty evidence).

4.9.

ARV drug resistance

For people initiating first-line ART with pretreatment HIV drug resistance to NNRTIs, a NNRTI-containing regimen should be avoided (conditional recommendation, low-certainty evidence).

Consensus statement

In countries in which the prevalence of pretreatment HIV drug resistance to NNRTIs among people initiating first-line ART is equal to or greater than 10%, NNRTI-based ART should be avoided.

Chapter 5.

Advanced HIV disease

5.3.

Providing a package of care

A package of interventions including screening, treatment and/or prophylaxis for major opportunistic infections, rapid ART initiation and intensified adherence support interventions should be offered to everyone presenting with advanced HIV disease (strong recommendation, moderate-certainty evidence).

5.4.

Overview of clinical management of cryptococcal disease

A package of interventions including screening, treatment and/or prophylaxis for major opportunistic infections, rapid ART initiation and intensified adherence support interventions should be offered to everyone presenting with advanced HIV disease (strong recommendation, moderate-certainty evidence).

Diagnosis of cryptococcal meningitis

For adults, adolescents and children living with HIV suspected of having a first episode of cryptococcal meningitis, prompt lumbar puncture with measurement of CSF opening pressure and rapid cryptococcal antigen assay is recommended as the preferred diagnostic approach (strong recommendation, moderate-certainty evidence for adults and adolescents).

The following diagnostic approaches are recommended, according to the context:

Settings with ready access to and no contraindication for lumbar puncture

1. If both access to a cryptococcal antigen assay (either lateral flow assay or latex agglutination assay) and rapid results (less than 24 hours) are available: lumbar puncture with rapid CSF cryptococcal antigen assay is the preferred diagnostic approach (strong recommendation, moderate-certainty evidence for adults and adolescents).
2. If access to a cryptococcal antigen assay is not available and/or rapid results are not available: lumbar puncture with CSF India ink test examination is the preferred diagnostic approach (strong recommendation, moderate-certainty evidence for adults and adolescents).

Settings without immediate access to lumbar puncture or when lumbar puncture is clinically contraindicated such as significant coagulopathy or suspected space-occupying lesion based on focal nervous system signs or recurrent seizures

1. If both access to a cryptococcal antigen assay and rapid results (less than 24 hours) are available: rapid serum, plasma or whole-blood cryptococcal antigen assays are the preferred diagnostic approaches (strong recommendation, moderate-certainty evidence for adults and adolescents).
2. If a cryptococcal antigen assay is not available and/or rapid access to results is not ensured: prompt referral for further investigation and treatment as appropriate (strong recommendation, moderate-certainty evidence for adults and adolescents).

Prevention and screening

Screening for cryptococcal antigen followed by pre-emptive antifungal therapy among cryptococcal antigen–positive people to prevent the development of invasive cryptococcal disease are recommended before initiating or reinitiating ART for adults and adolescents living with HIV who have a CD4 count <100 cells/mm³(strong recommendation, moderate-certainty evidence).

This may be considered at a higher CD4 cell count threshold of <200 cells/mm³ (conditional recommendation, moderate-certainty evidence).

All people living with HIV with a positive cryptococcal antigen result on screening should be carefully evaluated for signs and symptoms of meningitis and undergo a lumbar puncture, if feasible, with CSF examination and India ink or CSF cryptococcal antigen assay to exclude active cryptococcal disease. India ink has low sensitivity, and a negative result on India ink should be confirmed by CSF cryptococcal antigen testing. When cryptococcal antigen screening is not available, fluconazole primary prophylaxis should be given to adults and adolescents living with HIV who have a CD4 count <100 cells/mm³ (strong recommendation, moderate-certainty evidence).

This may be considered at a higher CD4 cell count threshold of <200 cells/mm³ (conditional recommendation, moderate-certainty evidence).

Treatment

The following is recommended as the preferred induction regimen.

For adults, adolescents and children, a short-course (one-week) induction regimen with amphotericin B deoxycholate (1.0 mg/kg per day) and flucytosine (100 mg/kg per day, divided into four doses per day) is the preferred option for treating cryptococcal meningitis among people living with HIV (strong recommendation, moderate-certainty evidence for adults).

The following induction regimens are recommended as alternative options.

• Two weeks of fluconazole (1200 mg daily, 12 mg/kg per day for children and adolescents) + flucytosine (100 mg/kg per day, divided into four doses per day) (strong recommendation, moderate-certainty evidence).
• Two weeks of amphotericin B deoxycholate (1.0 mg/kg per day) + fluconazole (1200 mg daily, 12 mg/kg per day for children and adolescents up to a maximum of 800 mg daily) (strong recommendation, moderate-certainty evidence).

Consolidation

Fluconazole (400–800 mg daily for adults or 6–12 mg/kg per day for children and adolescents up to a maximum of 800 mg daily) is recommended for the consolidation phase (for eight weeks following the induction phase) (strong recommendation, low-certainty evidence).

Maintenance (or secondary prophylaxis)

Fluconazole (200 mg daily for adults or 6 mg/kg per day for adolescents and children) is recommended for the maintenance phase (strong recommendation, high-certainty evidence).

Using adjunctive systemic corticosteroids in treating cryptococcal meningitis

Routine use of adjunctive corticosteroid therapy during the induction phase is not recommended in treating adults, adolescents and children who have HIV-associated cryptococcal meningitis (strong recommendation, high-certainty evidence for adults and adolescents).

Timing of ART

Immediate ART initiation is not recommended among adults, adolescents and children living with HIV who have cryptococcal meningitis because of the risk of increased mortality and should be deferred 4–6 weeks from the initiation of antifungal treatment (strong recommendation, low-certainty evidence for adults).

5.5.

Overview of clinical management of histoplasmosis

Diagnosis of disseminated histoplasmosis among people living with HIV ★

Among people living with HIV, disseminated histoplasmosis should be diagnosed by detecting circulating Histoplasma antigens (conditional recommendation, low-certainty evidence).

Induction therapy ★

Treating people living with HIV for severe or moderately severe histoplasmosis: liposomal amphotericin B, 3.0 mg/kg, for two weeks is recommended. In settings in which liposomal amphotericin B is unavailable, deoxycholate amphotericin B, 0.7–1.0 mg/kg, is recommended for two weeks (conditional recommendation, very-low-certainty evidence).

Good practice statements

As a good practice for people with renal failure, or at risk of renal injury, measures to prevent or treat toxicity are recommended.

Induction therapy should be given for two weeks. Since deoxycholate amphotericin B may be associated with renal toxicity, therapy may need to be shorter than two weeks based on the clinical assessment of how the person responds to treatment. Involvement of the central nervous system may require extending induction therapy or increasing dosage.

Treating people living with HIV for mild to moderate histoplasmosis: itraconazole 200 mg three times daily for three days and then 200 mg twice daily is recommended (conditional recommendation, very-low-certainty evidence).

Maintenance therapy ★

Itraconazole 200 mg twice daily for 12 months is recommended (conditional recommendation, very-low-certainty evidence).

Less than 12 months of therapy can be considered when the person is clinically stable, receiving ART, has suppressed viral load and the immune status has improved (conditional recommendation, very-low-certainty evidence).

Timing of ART ★

ART should be initiated as soon as possible among people with disseminated histoplasmosis for whom central nervous system involvement is not suspected or proven (conditional recommendation, very-low-certainty evidence).

TB therapy for people coinfected with TB, HIV and histoplasmosis ★

People living with HIV who also have TB and histoplasmosis coinfection should receive TB therapy according to WHO treatment guidelines (conditional recommendation, very-low-certainty evidence).

Chapter 6.

Coinfections and comorbidities

6.2.

General care for people living with HIV

Children and adolescents

Children and adolescents should do at least an average of 60 minutes per day of moderate- to vigorous-intensity, mostly aerobic, physical activity, across the week (strong recommendation, moderate-certainty evidence).

Vigorous-intensity aerobic activities, as well as those that strengthen muscle and bone, should be incorporated at least three days a week (strong recommendation, moderate-certainty evidence).

Children and adolescents should limit the amount of time spent being sedentary, particularly the amount of recreational screen time (strong recommendation, low-certainty evidence).

Adults (18–64 years old) and older adults (65 years and older), including those with chronic conditions

All adults should undertake regular physical activity (strong recommendation, moderate-certainty evidence).

Adults should do at least 150–300 minutes of moderate-intensity aerobic physical activity; or at least 75–150 minutes of vigorous intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week, for substantial health benefits (strong recommendation, moderate-certainty evidence).

Adults should also do muscle strengthening activities at moderate or greater intensity that involve all major muscle groups on two or more days a week, since these provide additional health benefits (strong recommendation, moderate-certainty evidence).

Adults may increase moderate-intensity aerobic physical activity to more than 300 minutes; or do more than 150 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week for additional health benefits (conditional recommendation, moderate-certainty evidence).

Adults should limit the amount of time spent being sedentary. Replacing sedentary time with physical activity of any intensity (including light intensity) provides health benefits (strong recommendation, moderate-certainty evidence).

To help reduce the detrimental effects of high levels of sedentary behaviour on health, adults should aim to do more than the recommended levels of moderate- to vigorous-intensity physical activity (strong recommendation, moderate-certainty evidence).

Additional recommendation for older adults (65 years and older)

As part of their weekly physical activity, older adults should do varied multicomponent physical activity that emphasizes functional balance and strength training at moderate or greater intensity, on three or more days a week, to enhance functional capacity and to prevent falls (strong recommendation, moderate-certainty evidence).

6.3.

Co-trimoxazole prophylaxis

Co-trimoxazole prophylaxis is recommended for adults (including pregnant women) with severe or advanced HIV clinical disease (WHO stage 3 or 4) and/or with CD4 cell count ≤350 cells/mm³ (strong recommendation, moderate-certainty evidence).

In settings where malaria and/or severe bacterial infections are highly prevalent, co-trimoxazole prophylaxis should be initiated regardless of CD4 cell count or WHO stage (conditional recommendation, moderate-certainty evidence).

Co-trimoxazole prophylaxis may be discontinued for adults (including pregnant women) with HIV who are clinically stable on ART, with evidence of immune recovery and viral suppression (conditional recommendation, low-certainty evidence).

In settings where malaria and/or severe bacterial infections are highly prevalent, co-trimoxazole prophylaxis should be continued regardless of CD4 cell count or WHO clinical stage (conditional recommendation, moderate-certainty evidence).

Co-trimoxazole prophylaxis is recommended for infants, children and adolescents with HIV, regardless of clinical and immune conditions. Priority should be given to all children younger than five years old regardless of CD4 cell count or clinical stage and children with severe or advanced HIV clinical disease (WHO clinical stage 3 or 4) and/or those with CD4 cell count ≤350 cells/mm³(strong recommendation, high-certainty evidence).

In settings where malaria and/or severe bacterial infections are highly prevalent, co-trimoxazole prophylaxis should be continued until adulthood whether or not ART is being taken (conditional recommendation, moderate-certainty evidence).

In settings of low prevalence for both malaria and bacterial infections, co-trimoxazole prophylaxis may be discontinued for children five years of age and older who are clinically stable and/or virally suppressed on ART for at least six months and CD4 cell count >350 cells/mm³ (strong recommendation, very-low-certainty evidence).

Co-trimoxazole prophylaxis is recommended for HIV-exposed infants from four to six weeks of age and should be continued until HIV infection has been excluded by an age-appropriate HIV test to establish final diagnosis after complete cessation of breastfeeding (strong recommendation, very-low-certainty evidence).

Routine co-trimoxazole prophylaxis should be given to all people living with HIV with active TB disease regardless of CD4 cell count (strong recommendation, high-certainty evidence).

6.4.

Tuberculosis

6.4.1.

Screening and diagnosis

Systematic screening for TB among people living with HIV ★

People living with HIV should be systematically screened for TB disease at each visit to a health facility (strong recommendation, very-low-certainty evidence).

Tools for screening for TB among people living with HIV ★

Among adults and adolescents living with HIV, systematic screening for TB disease should be conducted using the WHO-recommended four-symptom screen, and those who report any one of the symptoms of current cough, fever, weight loss or night sweats may have TB and should be evaluated for TB and other diseases (strong recommendation, moderate-certainty evidence).

Among children younger than 10 years who are living with HIV, systematic screening for TB disease should be conducted using a symptom screen including any one of the symptoms of current cough, fever, poor weight gain or close contact with a person with TB disease (strong recommendations, low-certainty evidence for test accuracy).

Among adults and adolescents living with HIV, C-reactive protein with a cut-off of >5 mg/L may be used to screen for TB disease (conditional recommendation, low-certainty evidence for test accuracy).

Among adults and adolescents living with HIV, chest X-ray may be used to screen for TB disease (conditional recommendation, moderate-certainty evidence for test accuracy).

Among individuals aged 15 years and older in populations in which TB screening is recommended, computer-aided detection software programmes may be used in place of human readers for interpreting digital chest X-rays for screening and triage for TB disease (conditional recommendation, low-certainty evidence).

Among adults and adolescents living with HIV, molecular WHO-recommended rapid diagnostic tests may be used to screen for TB disease (conditional recommendation, moderate-certainty evidence for test accuracy).

Adult and adolescent inpatients with HIV in medical wards where the TB prevalence is >10% should be tested systematically for TB disease with a molecular WHO-recommended rapid diagnostic test (strong recommendation, moderate-certainty evidence for test accuracy).

6.4.3.

Treatment

Treatment of people with drug-resistant TB ★

WHO recommends ART for all people with HIV and drug-resistant TB, requiring second-line anti-TB drugs irrespective of CD4 cell count, as early as possible (within the first eight weeks) following initiation of anti-TB treatment (strong recommendation, very-low-certainty evidence).

Identifying populations for latent TB infection testing and TB preventive treatment ★

Adults and adolescents

Adults and adolescents living with HIV who are unlikely to have active TB should receive TB preventive treatment as part of a comprehensive package of HIV care. Treatment should also be given to those receiving ART, to pregnant women and to those who have previously been treated for TB, irrespective of the degree of immunosuppression and even if latent TB infection testing is unavailable (strong recommendation, high-certainty evidence).

Infants aged <12 months

Infants aged <12 months living with HIV who are in contact with a person with TB and who are unlikely to have active TB on an appropriate clinical evaluation or according to national guidelines should receive TB preventive treatment (strong recommendation, moderate-certainty evidence)

Children aged ≥12 months

Children aged ≥12 months living with HIV who are considered unlikely to have active TB on an appropriate clinical evaluation or according to national guidelines should be offered TB preventive treatment as part of a comprehensive package of HIV prevention and care if they live in a setting with high TB transmission, regardless of contact with a person with TB (strong recommendation, low-certainty evidence).

All children

All children living with HIV who have successfully completed treatment for TB disease may receive TB preventive treatment (conditional recommendation, low-certainty evidence).

Algorithms to rule out active TB disease ★

Adults and adolescents living with HIV should be screened for TB according to a clinical algorithm. Those who do not report any of the symptoms of current cough, fever, weight loss or night sweats are unlikely to have active TB and should be offered preventive treatment, regardless of their ART status (strong recommendation, moderate-certainty evidence).

Adults and adolescents living with HIV who are screened for TB according to a clinical algorithm and who report any of the symptoms of current cough, fever, weight loss or night sweats may have active TB and should be evaluated for TB and other diseases and offered preventive treatment if active TB is excluded (strong recommendation, moderate-certainty evidence).

Chest radiography may be offered to people living with HIV receiving ART and TB preventive treatment given to those with no abnormal radiographic findings (conditional recommendation, low-certainty evidence).

Infants and children living with HIV who have poor weight gain, fever or current cough or who have a history of contact with a person with TB should be evaluated for TB and other diseases that cause such symptoms. If TB disease is excluded after an appropriate clinical evaluation or according to national guidelines, these children should be offered TB preventive treatment, regardless of their age (strong recommendation, low-certainty evidence).

The absence of any symptoms of TB and the absence of abnormal chest radiographic findings may be used to rule out active TB disease among HIV-negative household contacts aged ≥5 years and other risk groups before TB preventive treatment (conditional recommendation, very-low-certainty evidence).

Testing for latent TB infection ★

Either a tuberculin skin test or interferon-gamma release assay can be used to test for latent TB infection (strong recommendation, very-low-certainty evidence).

TB preventive treatment options ★

The following options are recommended for the treatment of latent TB infection regardless of HIV status: six or nine months of daily isoniazid, or a three-month regimen of weekly rifapentine plus isoniazid, or a three-month regimen of daily isoniazid plus rifampicin (strong recommendation, moderate- to high-certainty evidence in the estimates of effect).

A one-month regimen of daily rifapentine plus isoniazid or four months of daily rifampicin alone may also be offered as alternatives (conditional recommendation, low- to moderate-certainty evidence).

In settings with high TB transmission, adults and adolescents living with HIV who have an unknown or a positive latent TB infection test and are unlikely to have active TB disease should receive at least 36 months of daily isoniazid preventive therapy. Daily isoniazid preventive therapy for 36 months should be given whether or not the person is receiving ART and irrespective of the degree of immunosuppression, history of previous TB treatment and pregnancy in settings considered to have high TB transmission as defined by national authorities (conditional recommendation, low-certainty evidence).

6.5.

Hepatitis B and C

6.5.2.

Testing for chronic HBV infection

General population testing

In settings with a ≥2% or ≥5%¹⁹ HBsAg seroprevalence in the general population, it is recommended that all adults and adolescents have routine access to and be offered HBsAg serological testing with linkage to prevention, care and treatment services. General population testing approaches should make use of existing community- or health facility–based testing opportunities or programmes such as at antenatal clinics, HIV or TB clinics (conditional recommendation, low-certainty evidence).

Routine testing in pregnant women

In settings with a ≥2% or ≥5%%¹⁹ HBsAg seroprevalence in the general population, it is recommended that HBsAg serological testing be routinely offered to all pregnant women in antenatal clinics,²⁰ with linkage to prevention, care and treatment services. Couples and partners in antenatal care settings should be offered HBV testing services (strong recommendation, low-certainty evidence).

Focused testing in most affected populations

In all settings (and regardless of whether delivered through facility- or community-based testing), it is recommended that HBsAg serological testing and linkage to care and treatment services be offered to the following individuals:

• adults and adolescents from populations most affected by HBV infection²¹ (who either are part of a population with high HBV seroprevalence or have a history of exposure and/or high-risk behaviour for HBV infection);
• adults, adolescents and children for whom chronic viral hepatitis²² is clinically suspected (through symptoms, signs or laboratory markers);
• sexual partners, children and other family members and close household contacts of those with HBV infection;²³ and
• health-care workers: in all settings, it is recommended that HBsAg serological testing be offered and HBV vaccination given to all health-care workers who have not been vaccinated previously (adapted from existing guidance on HBV vaccination) (strong recommendation, low-certainty evidence).

Blood donors

In all settings, screening of blood donors should be mandatory with linkage to care, counselling and treatment for those who test positive.

6.5.2.

Testing for chronic HCV infection

Focused testing in most affected populations

In all settings (and regardless of whether delivered through facility- or community-based testing), it is recommended that serological testing for HCV antibody²⁴ be offered with linkage to prevention, care and treatment services to the following individuals:

• adults and adolescents from populations most affected by HCV infection²⁵ (who are either part of a population with high HCV seroprevalence or have a history of exposure to and/or high-risk behaviour for HCV infection); and
• adults, adolescents and children for whom chronic viral hepatitis is clinically suspected²⁶ (through symptoms, signs or laboratory markers) (strong recommendation, low-certainty evidence).

General population testing

In settings with a ≥2% or ≥5%²⁷ HCV antibody seroprevalence in the general population, it is recommended that all adults have access to and be offered HCV serological testing with linkage to prevention, care and treatment services. General population testing approaches should make use of existing community- or facility-based testing opportunities or programmes such as HIV or TB clinics, drug treatment services and antenatal clinics²⁸ (conditional recommendation, low-certainty evidence).

Birth cohort testing

This approach may be applied to specific identified birth cohorts of older people at higher risk of infection²⁹ and morbidity within populations that have an overall lower general prevalence (conditional recommendation, low-certainty evidence).

6.5.5.

Preventing mother-to-child transmission of HBV infection

Routinely testing pregnant women for HIV, HBV and syphilis

All pregnant women should be tested for HIV, syphilis and HBsAg at least once and as early as possible in the pregnancy (HIV standing recommendation since 2007; syphilis: strong recommendation, moderate-certainty evidence; HBsAg: strong recommendation, low-certainty evidence).

Immunization

All infants should receive their first dose of HBV vaccine as soon as possible after birth, preferably within 24 hours. Delivery of HBV vaccine within 24 hours of birth should be a performance indicator for all immunization programmes, and reporting and monitoring systems should be strengthened to improve the quality of data on the birth dose. The birth dose should be followed by two or three doses to complete the primary series.

Tenofovir prophylaxis

Women coinfected with HIV and HBV should be receiving TDF-based ART, which will provide prophylaxis to prevent the mother-to-child transmission of HBV. This is in addition to three-dose HBV vaccination for all infants, including timely birth dose (conditional recommendation, moderate-certainty evidence).

6.6.

Malaria

Good practice statement ★

For people who have HIV and uncomplicated Plasmodium falciparum malaria, avoid artesunate + sulfadoxine-pyrimethamine if they are being treated with co-trimoxazole and avoid artesunate + amodiaquine if they are being treated with efavirenz or zidovudine.

6.8.

Leishmaniasis

People coinfected with visceral leishmaniasis and HIV in eastern Africa ★

Liposomal amphotericin B + miltefosine regimen

Liposomal amphotericin B (up to a total of 30 mg/kg at 5 mg/kg on days 1, 3, 5, 7, 9 and 11) + miltefosine (100 mg/day for 28 days) (conditional recommendation, very-low-certainty evidence)

People coinfected with visceral leishmaniasis and HIV in South-East Asia ★

Liposomal amphotericin B + miltefosine regimen

Liposomal amphotericin B (up to a total of 30 mg/kg at 5 mg/kg on days 1, 3, 5, 7, 9 and 11) + miltefosine (100 mg/day for 14 days) (conditional recommendation, very-low-certainty evidence).

Provide secondary prophylaxis after the first episode of visceral leishmaniasis for all people coinfected with visceral leishmaniasis and HIV (conditional recommendation, very-low-certainty evidence). ★

6.9.

Cervical cancer

Screening and treatment recommendations to prevent cervical cancer for women living with HIV ★

WHO recommends using HPV DNA detection as the primary screening test rather than visual inspection of the cervix with acetic acid (VIA) or cytology in screening and treatment approaches among women living with HIV (strong recommendation, moderate-certainty evidence).

Remarks: Existing programmes with quality-assured cytology as the primary screening test should be continued until HPV DNA testing is operational; existing programmes using VIA as the primary screening test should transition rapidly because of the inherent challenges with quality assurance.

WHO suggests using an HPV DNA primary screening test with triage rather than without triage to prevent cervical cancer among women living with HIV (conditional recommendation, moderate-certainty evidence).

In a screen, triage and treat approach using HPV DNA detection as the primary screening test, WHO suggests using partial genotyping, colposcopy, VIA or cytology to triage women living with HIV after a positive HPV DNA test (conditional recommendation, moderate-certainty evidence).

Remarks: The benefits, harm and programmatic costs of the triage options are similar; therefore, the choice of triage method will depend on feasibility, training, programme quality assurance and resources in countries. HPV16/18 genotyping could be integrated into the HPV DNA test.

When HPV DNA testing is provided, WHO suggests using either samples taken by a health-care provider or self-collected samples (conditional recommendation, low-certainty evidence).

WHO suggests starting regular cervical cancer screening at the age of 25 years among women living with HIV (conditional recommendation, low-certainty evidence).

Remarks: Moderate-certainty evidence found that few women living with HIV younger than 25 years are likely to have cervical cancer. This recommendation applies to women living with HIV regardless of when they first tested positive for HIV.

After the age of 50 years, WHO suggests that screening be stopped after two consecutive negative screening results, consistent with the recommended regular screening intervals among women living with HIV (conditional recommendation, very-low-certainty evidence).

Remarks: VIA and ablation treatment are not suitable for screening women for whom the transformation zone is not visible. Inadequate visualization is typical after menopause.

Good-practice statement

Priority should be given to screening women living with HIV 25–49 years old. When tools are available to manage postmenopausal women, women living with HIV 50–65 years old who have never been screened should also be given priority.

WHO suggests a regular screening interval of every 3–5 years when using HPV DNA detection as the primary screening test among women living with HIV (conditional recommendation, low-certainty evidence).

Where HPV DNA testing is not yet operational, WHO suggests a regular screening interval of every three years when using VIA or cytology as the primary screening test among women living with HIV (conditional recommendation, low-certainty evidence).

Good-practice statement

While transitioning to a programme with a recommended regular screening interval, screening even just twice in a lifetime is beneficial.

WHO suggests that women living with HIV who have screened positive on an HPV DNA primary screening test and then negative on a triage test be retested with HPV DNA testing in 12 months and, if negative, move to the recommended screening interval (conditional recommendation, low-certainty evidence).

WHO suggests that women living with HIV who have screened positive on a cytology primary screening test and then have normal results on colposcopy be retested with HPV DNA testing in 12 months and, if negative, move to the recommended regular screening interval (conditional recommendation, low-certainty evidence).

WHO suggests that women living with HIV who have been treated for histologically confirmed CIN2/3 or adenocarcinoma in situ or treated as a result of a positive screening test be retested in 12 months with HPV DNA testing when available rather than with cytology or VIA or co-testing, and, if negative, be retested again at 12 months and, if negative again, move to the recommended screening interval (conditional recommendation, low-certainty evidence).

Good-practice statement

As programmes introduce HPV DNA testing, use this test when rescreening women living with HIV regardless of the test that was used at the previous screening. In existing programmes with cytology or VIA as the primary screening test, rescreening with the same test should be continued until HPV DNA testing is operational.

General population and women living with HIV ★

Good practice statement

Once a decision to treat a woman is made, treating as soon as possible within six months is good practice to reduce losses to treatment. However, for women who are pregnant, good practice includes deferral until after pregnancy.

In circumstances when treatment is not provided within this time frame, evaluating the woman before treatment is good practice.

WHO suggests large loop excision of the transformation zone or cold-knife conization for women who have histologically confirmed adenocarcinoma in situ (conditional recommendation, low-certainty evidence for effects).

Remarks: Loop excision may be preferred for women of reproductive age, in settings with greater availability of large loop excision of the transformation zone and by providers with greater expertise performing large loop excision of the transformation zone. Cold-knife conization may be preferred when interpretation of the margins of the histological specimen is imperative.

6.10.

Noncommunicable diseases

Assessment and management of cardiovascular risk should be provided for all individuals living with HIV according to standard protocols recommended for general population (conditional recommendation, very-low-certainty evidence).³⁰

Good practice statement

Strategies for the prevention and risk reduction of cardiovascular diseases by addressing modifiable factors such as blood pressure, smoking, obesity status, unhealthy diet and lack of physical activity should be applied to all people living with HIV.

6.11.

Mental health among people living with HIV

Assessment and management of depression should be included in the package of HIV care services for all individuals living with HIV (conditional recommendation, very-low-certainty evidence).

6.13.

Sexually transmitted infections

For men who have sex with men and transgender people

Men who have sex with men and transgender people with symptomatic sexually transmitted infections should seek and be offered syndromic management and treatment.

Offering periodic testing for asymptomatic urethral and rectal N. gonorrhoeae and C. trachomatis infections using NAAT is suggested over not offering such testing for men who have sex with men and transgender people (conditional recommendation, low-certainty evidence).

Not offering periodic testing for asymptomatic urethral and rectal N. gonorrhoeae infections using culture is suggested over offering such testing for men who have sex with men and transgender people (conditional recommendation, low-certainty evidence).

Offering periodic serological testing for asymptomatic syphilis infection to men who have sex with men and transgender people is strongly recommended over not offering such screening (strong recommendation, moderate-certainty evidence).

For sex workers and their clients in low- and middle-income countries

WHO suggests offering periodic screening for asymptomatic sexually transmitted infections to female sex workers (conditional recommendation, low-certainty evidence).

WHO suggests offering female sex workers, in settings with high prevalence and limited clinical services, periodic presumptive treatment for asymptomatic sexually transmitted infections (conditional recommendation, moderate- to high-certainty evidence).

For sex workers and their clients in low- and middle-income countries

The WHO sexually transmitted infection guideline recommends screening all pregnant women for syphilis during the first antenatal care visit (strong recommendation, moderate-certainty evidence).

This recommendation applies to all settings, including settings with high or low prevalence of syphilis.

Management of urethral discharge ★

For people who present with urethral discharge from the penis, management is recommended to be based on the results of quality-assured molecular assays. However, in settings with limited or no molecular tests or laboratory capacity, WHO recommends syndromic treatment to ensure treatment on the same day of the visit (strong recommendation, moderate-certainty evidence).

Management of vaginal discharge ★

For people who present with vaginal discharge, WHO recommends treatment for N. gonorrhoeae and/or C. trachomatis and/or T. vaginalis on the same visit. WHO suggests treatment based on the results of quality-assured molecular assays for N. gonorrhoeae and/or C. trachomatis and/or T. vaginalis. In settings in which treatment based on the results of molecular assay in the same visit is not feasible or that have limited or no molecular testing, WHO suggests treatment based on testing with quality-assured rapid point-of-care tests or on syndromic treatment (strong recommendation, moderate-certainty evidence).

WHO suggests treating for bacterial vaginosis if vaginal discharge is present (for example, tenacious or thin) or based on the results of microscopy, if available (conditional recommendation low-certainty evidence).

WHO suggests treating for candidiasis, where indicated by type of discharge (such as curd-like with vaginal itching) or by the results of microscopy, if available (conditional recommendation low-certainty evidence).

For management of women with lower abdominal pain ★

For sexually active women who present with lower abdominal pain, WHO suggests assessing for pelvic inflammatory disease and treating syndromically.

WHO suggests the following.

• Treat for pelvic inflammatory disease on the same visit.
• Test for infection with N. gonorrhoeae and C. trachomatis and, if available, Mycoplasma genitalium, to support partner management when tests are available (conditional recommendation, low-certainty evidence).

Management of genital ulcer disease, including anorectal ulcers ★

For people who present with genital ulcers (including anorectal ulcers), WHO recommends treatment based on quality-assured molecular assays of the ulcer. However, in settings with limited or no molecular tests or laboratory capacity, WHO recommends syndromic treatment to ensure treatment on the same day of the visit (strong recommendation, moderate-certainty evidence).

Management of anorectal discharge ★

For people who present with anorectal discharge and report receptive anal sex, WHO recommends management based on the results of quality-assured molecular assays. However, in settings with limited or no molecular tests or laboratory capacity, WHO recommends syndromic treatment to ensure treatment on the same day of the visit (strong recommendation, moderate-certainty evidence).

Good practice for men includes:

• taking a medical and sexual history and assessing risk for sexually transmitted infections;
• performing a physical examination of the genital and anal areas;
• offering HIV and syphilis testing and other preventive services as recommended in other guidelines;
• if symptoms persist at review, good practice includes checking partner notification and treatment history; and
• for people with recurrent or persistent urethral discharge, referring people to a centre with laboratory capacity to diagnose infection with N. gonorrhoeae, C. trachomatis, M. genitalium and T. vaginalis and to test for antimicrobial-resistant N. gonorrhoeae and M. genitalium.

Good practice for women includes:

• taking a medical and sexual history and assessing risk for sexually transmitted infections;
• performing a physical examination, including abdominal and pelvic examination to assess for pelvic inflammatory disease, surgical conditions or pregnancy and external vulvo-vaginal examination to visualize any lesions, overt genital discharge or vulval erythema and excoriations;
• bimanual digital examination of the vagina to (1) assess for cervical motion tenderness or pain with palpation of the pelvic area to exclude pelvic inflammatory disease; and (2) assess for the presence of vaginal discharge and the colour and consistency of the discharge on the glove;
• offering HIV and syphilis testing and other preventive services as recommended in other guidelines; and
• for people with recurrent or persistent vaginal discharge, referring to a centre with laboratory capacity to diagnose infection with N. gonorrhoeae, C. trachomatis, M. genitalium, T. vaginalis and bacterial vaginosis and to test for antimicrobial-resistant N. gonorrhoeae and M. genitalium (if there is a test) or for a specialist’s assessment (sexually transmitted infection expert and physician or a gynaecologist), when no such testing is available in primary health care centres.

6.16.1.

Infant feeding in the context of HIV

Mothers living with HIV should breastfeed for at least 12 months and may continue breastfeeding for up to 24 months or longer (similar to the general population) while being fully supported for ART adherence (see Chapter 7 for interventions to optimize adherence) (strong recommendation, low-certainty evidence for 12 months; very-low-certainty evidence for 24 months).³¹

Remarks

The Guideline Development Group agreed that this recommendation should be framed as follows. In settings in which health services provide and support lifelong ART, including adherence counselling, and promote and support breastfeeding among women living with HIV, the duration of breastfeeding should not be restricted. Further, mothers living with HIV (and whose infants are HIV uninfected or of unknown HIV status) should exclusively breastfeed their infants for the first six months of life, introducing appropriate complementary foods thereafter and continue breastfeeding. Breastfeeding should then only stop once a nutritionally adequate and safe diet without breast-milk can be provided.

This recommendation updates the component of the 2010 recommendation on which breastfeeding practices and for how long related to the duration of breastfeeding. The components of the 2010 recommendation on breastfeeding practices and stopping breastfeeding remain unchanged and valid.

When mothers living with HIV do not exclusively breastfeed

Good practice statement

Mothers living with HIV and health-care workers can be reassured that ART reduces the risk of postnatal HIV transmission in the context of mixed feeding. Although exclusive breastfeeding is recommended, practising mixed feeding is not a reason to stop breastfeeding in the presence of ARV drugs.

When mothers living with HIV do not plan to breastfeed for 12 months

Good practice statement

Mothers living with HIV and health-care workers can be reassured that shorter durations of breastfeeding of less than 12 months are better than never initiating breastfeeding at all.

Chapter 7.

Service delivery

7.2.

Linkage from HIV testing to enrolment in care

Following an HIV diagnosis, a package of support interventions should be offered to ensure timely linkage to care for all people living with HIV (strong recommendation, moderate-certainty evidence).

The following interventions have demonstrated benefit in improving linkage to care following an HIV diagnosis:

• streamlined interventions to reduce time between diagnoses and engagement in care including (i) enhanced linkage with case-management; (ii) support for HIV disclosure; (iii) tracing; (iv) training staff to provide multiple services, and (v) streamlined services (moderate-certainty evidence);
• peer support³² & navigation approaches for linkage (moderate-certainty evidence); and
• quality improvement approaches using data to improve linkage (low-certainty evidence).

Good practice statement

ART initiation should follow the overarching principles of providing people-centred care. People-centred care should be focused and organized around the health needs, preferences and expectations of people and communities, upholding individual dignity and respect, especially for vulnerable populations. It should promote the engagement and support of people and families to play an active role in their own care through informed decision-making.

Good practice statement

All people newly diagnosed with HIV should be retested to verify their HIV status before starting ART, using the same testing strategy and algorithm as the initial test. To minimize the risk of misdiagnosis, this approach should be maintained in settings in which rapid ART initiation is being implemented.

Good practice statement

The introduction of the “treat all” recommendation (ART for all people living with HIV regardless of CD4 cell count) supports the rapid initiation of ART, including the offer of same-day initiation where there is no clinical contraindication.

Good practice statement

People with no contraindication to rapid ART initiation should be fully informed of the benefits of ART and offered rapid ART initiation, including the option of same-day initiation. Rapid start of ART is especially important for people with very low CD4 cell counts, among whom the risk of death is high. People should not be coerced to start immediately and should be supported in making an informed choice regarding when to start ART.

7.4.

People-centred care

Good practice statement ★

Health systems should invest in people-centred practices and communication, including ongoing training, mentoring, supportive supervision and monitoring health-care workers, to improve the relationships between patients and health-care providers

Good practice statement

HIV programmes should:

• provide people-centred care that is focused and organized around the health needs, preferences and expectations of people and communities, upholding individual dignity and respect, especially for vulnerable populations, and engage and support people and families to play an active role in their own care by informed decision-making;
• offer safe, acceptable and appropriate clinical and non-clinical services in a timely fashion, aiming to reduce morbidity and mortality associated with HIV infection and to improve health outcomes and quality of life in general; and
• promote the efficient and effective use of resources.

7.5.

Initiating and maintaining treatment

7.5.1.

Initiating ART outside the health facility

ART initiation may be offered outside the health facility (conditional recommendation, low- to moderate-certainty evidence). ★

This recommendation is additional to the routine offer of ART initiation at the health facility.

7.5.2.

Rapid initiation of ART, including same-day start

Rapid ART initiation³³ should be offered to all people living with HIV following a confirmed HIV diagnosis and clinical assessment (strong recommendation: high-certainty evidence for adults and adolescents; low-certainty evidence for children).

ART initiation should be offered on the same day to people who are ready to start (strong recommendation: high-certainty evidence for adults and adolescents; low-certainty evidence for children).

Good practice statement ★

The offer of same-day ART initiation should include approaches to improve uptake, treatment adherence and retention such as tailored patient education, counselling and support.

7.5.3.

Frequency of clinical visits and ART pick-up ★

People established on ART should be offered clinical visits every 3–6 months, preferably every six months if feasible³⁴ (strong recommendation, moderate-certainty evidence).

People established on ART should be offered refills of ART lasting 3–6 months, preferably six months if feasible³⁵ (strong recommendation, moderate- to low-certainty evidence).

7.5.4.

Adherence support

Adherence support interventions should be provided to people on ART (strong recommendation, moderate-certainty evidence).

The following interventions have demonstrated effectiveness in improving adherence and virological suppression:

• peer counsellors (moderate-certainty evidence);
• mobile phone text messages (moderate-certainty evidence);
• reminder devices (moderate-certainty evidence);
• cognitive behavioural therapy (moderate-certainty evidence);
• behavioural skills training or medication adherence training (moderate-certainty evidence); and
• fixed-dose combinations and once-daily regimens (moderate-certainty evidence).

7.5.5.

Monitoring adherence to ART in routine programme and care settings

Good practice statement

Viral load for treatment monitoring should be complemented with non-judgemental, tailored approaches to assessing adherence.

7.6.

Continuity of care

7.6.1.

Retention in care

Programmes should provide community support for people living with HIV to improve retention in HIV care (strong recommendation, low-certainty evidence).

The following community-level interventions have demonstrated benefit in improving retention in care:

• package of community-based interventions³⁶ (children: low-certainty evidence; adults: very-low-certainty evidence);
• adherence clubs³⁷ (moderate-certainty evidence); and
• extra care for high-risk people (very-low-certainty evidence).

7.6.2.

Tracing and re-engagement in care ★

HIV programmes should implement interventions to trace people who have disengaged from care and provide support for re-engagement (strong recommendation, low-certainty evidence).

7.7.

Task sharing

7.7.1.

Task sharing for initiation and maintenance of ART

These recommendations apply to all adults, adolescents and children living with HIV

Trained non-physician clinicians, midwives and nurses can initiate first-line ART (strong recommendation, moderate-certainty evidence).

Trained non-physician clinicians, midwives and nurses can maintain ART (strong recommendation, moderate-certainty evidence).

Trained and supervised community health workers can dispense ART between regular clinical visits (strong recommendation, moderate-certainty evidence).

Trained and supervised lay providers can distribute ART (strong recommendation, low-certainty evidence).

7.7.2.

Task sharing of specimen collection and point-of-care testing ★

Task sharing of specimen collection and point-of-care testing with non-laboratory personnel should be implemented when professional staffing capacity is limited (strong recommendation, moderate-certainty evidence).

7.8.

Decentralization

Decentralization of ART care should be considered as a way to increase access and improve retention in care. The following approaches have demonstrated effectiveness in improving access and retention:

• initiation of ART in hospitals with maintenance of ART in peripheral health facilities (strong recommendation, low-certainty evidence);
• initiation and maintenance of ART in peripheral health facilities (strong recommendation, low-certainty evidence); and
• initiation of ART at peripheral health facilities with maintenance at the community level³⁸ (strong recommendation, moderate-certainty evidence).

7.9.

Integrating services

7.9.1.

Delivering ART in maternal and child health-care settings

In generalized epidemic settings, ART should be initiated and maintained in pregnant and postpartum women and in infants at maternal and child health care settings, with linkage and referral to ongoing HIV care and ART, where appropriate (strong recommendation, very-low-certainty evidence).

7.9.2.

Delivering ART in TB treatment settings and TB treatment in HIV care settings

In settings with a high burden of HIV and TB, ART should be initiated in TB treatment settings, with linkage to ongoing HIV care and ART (strong recommendation, very-low-certainty evidence).

In settings with a high burden of HIV and TB, TB treatment may be provided for people living with HIV in HIV care settings where a TB diagnosis has also been made (strong recommendation, very-low-certainty evidence).

7.9.3.

Integrating sexual and reproductive health services, including contraception, within HIV services

Sexually transmitted infection (STI) and family planning services can be integrated within HIV care settings (conditional recommendation, very-low-certainty evidence).

Sexual and reproductive health services, including contraception, may be integrated within HIV services (conditional recommendation, very-low-certainty evidence). ★

7.9.4.

Integrating diabetes and hypertension care with HIV care ★

Diabetes and hypertension care may be integrated with HIV services (conditional recommendation, very-low-certainty evidence).

7.9.5.

ART in settings providing opioid substitution therapy ★

ART should be initiated and maintained in people living with HIV at care settings where opioid substitution therapy (OST) is provided (strong recommendation, very-low-certainty evidence).

7.9.6.

Diagnostic integration

Good practice statement

Disease programmes, especially HIV and TB, should actively work towards balanced integration of diagnostic services.

7.11.

Service delivery for adolescents

7.11.1.

Delivering quality HIV services to adolescents

Adolescent-friendly services should be implemented in HIV services to ensure engagement and improved outcomes (strong recommendation, low-certainty evidence).

Community-based approaches can improve treatment adherence and retention in care of adolescents living with HIV (conditional recommendation, very-low-certainty evidence).

Training of health-care workers can contribute to treatment adherence and improvement in retention in care of adolescents living with HIV (conditional recommendation, very-low-certainty evidence).

Adolescents should be counselled about the potential benefits and risks of disclosure of their HIV status to others and empowered and supported to determine if, when, how and to whom to disclose (conditional recommendation, very-low-certainty evidence).

7.11.2.

Psychosocial interventions for adolescents and young adults living with HIV ★

Psychosocial interventions should be provided to all adolescents and young adults living with HIV (strong recommendation, moderate-certainty evidence).

7.15.

Laboratory connectivity

Electronic communication can be considered to transfer test results and reduce delays in acting on the results of infant diagnosis and other essential laboratory tests (conditional recommendation, low-certainty evidence).

Footnotes

1

Now referred to as settings with a low burden of HIV infection.

2

Particularly in settings with a ≥2% HBsAg seroprevalence in the general population.

3

Indeterminate range: a range of viral copy equivalents that would be too low to be accurately diagnosed as HIV infected. The indeterminate range suggested is currently estimated to be approximately equivalent to a cycle threshold of 33 on the Roche COBAS® Ampliprep/COBAS® TaqMan® HIV-1 Qualitative Test v2.0 assay.

4

See Box 3.2 for reflections on the definition of substantial risk of HIV infection.

5

For the recommendation on the dapivirine vaginal ring, the term women applies to cisgender women, meaning women assigned female at birth. There is no research at this time to support the dapivirine vaginal ring for other populations.

6

The choice of ARV drugs for children will depend on the availability of approved dosing and age-appropriate formulations for children.

7

Whenever possible, all efforts should be made to identify HIV-infected pregnant women early enough to avoid the need for enhanced prophylaxis.

8

High-risk infants are defined as those:

• born to women with established HIV infection who have received less than four weeks of ART at the time of delivery; or
• born to women with established HIV infection with viral load >1000 copies/mL in the four weeks before delivery, if viral load is available; or
• born to women with incident HIV infection during pregnancy or breastfeeding; or
• born to women identified for the first time during the postpartum period, with or without a negative HIV test prenatally.

9

Rapid initiation is defined as within seven days from the day of HIV diagnosis; people with advanced HIV disease should be given priority for assessment and initiation.

10

Except when signs and symptoms of meningitis are present.

11

In settings or populations in which DTG is not accessible or unsuitable because of toxicity and national levels of pretreatment HIV drug resistance are ≥10%, PI/r-based ARV drugs should be used in first-line ART. The choice of PI/r will depend on the programmatic characteristics. Alternatively, and if feasible, HIV drug resistance testing can be considered to guide the selection of first-line ART regimen (see Section 4.9 and Table 4.3).

12

As of July 2021, the United States Food and Drug Administration and the European Medicines Agency have approved DTG for infants and children older than four weeks and weighing at least 3 kg.

13

In settings in which pretreatment HIV drug resistance to NNRTIs is ≥10%, EFV-based ART should be avoided. EFV should also be avoided for people initiating or reinitiating first-line regimens with previous ARV drug exposure, regardless of the national prevalence of pretreatment drug resistance. See section 4.9 on HIV drug resistance considerations, Table 4.3 and Fig. 4.3.

14

Plasma specimens are preferred for viral load testing. Dried blood spot specimens are recommended in settings in which logistical, infrastructural or operational barriers prevent routine viral load monitoring using plasma specimens.

15

See section 4.7 on using point-of-care viral load testing.

16

The timing and use of CD4 remains the same as in the 2016 WHO consolidated guidelines.

17

Being established on ART includes suppressed viral loads (see section 7.3).

18

Plasma specimens are preferred for viral load testing. Dried blood spot specimens are recommended in settings in which logistical, infrastructural or operational barriers prevent routine viral load monitoring using plasma specimens.

19

A threshold of ≥2% or ≥5% seroprevalence was based on several published thresholds of intermediate or high seroprevalence. The threshold used will depend on other country considerations and the epidemiological context.

20

Many countries have chosen to adopt routine testing in all pregnant women, regardless of seroprevalence in the general population, and especially if the seroprevalence ≥2%. A full vaccination schedule including birth dose should be completed for all infants, in accordance with the WHO position paper on HBV vaccines.

21

Includes those who are either part of a population with higher seroprevalence (such as some mobile or migrant populations from high- or intermediate-endemic countries and certain indigenous populations) or have a history of exposure to or high-risk behaviour for HBV infection (such as people who inject drugs; people in prisons and other closed settings; gay men and other men who have sex with men; sex workers; people living with HIV; and partners, family members and children of people with HBV infection).

22

Features that may indicate underlying chronic HBV infection include clinical evidence of existing liver disease, such as cirrhosis or hepatocellular carcinoma, or unexplained liver disease, including abnormal liver function tests or liver ultrasound.

23

In all settings, it is recommended that HBsAg serological testing with HBV vaccination of those who are HBsAg negative and not previously vaccinated be offered to all children with parents or siblings diagnosed with HBV infection or with clinical suspicion of hepatitis, through community- or facility-based testing.

24

This may include fourth-generation combined antibody or antigen assays.

25

Includes those who are either part of a population with higher seroprevalence (such as some mobile or migrant populations from high- or intermediate-endemic countries and certain indigenous populations) or have a history of exposure to or high-risk behaviour for HCV infection (such as people who inject drugs; people in prisons and other closed settings; gay men and other men who have sex with men; sex workers; people living with HIV; and the children of mothers with chronic HCV infection, especially if HIV-coinfected).

26

Features that may indicate underlying chronic HCV infection include clinical evidence of existing liver disease, such as cirrhosis or hepatocellular carcinoma or unexplained liver disease, including abnormal liver function tests or liver ultrasound.

27

Features that may indicate underlying chronic HCV infection include clinical evidence of existing liver disease, such as cirrhosis or hepatocellular carcinoma or unexplained liver disease, including abnormal liver function tests or liver ultrasound.

28

Routine testing of pregnant women for HCV infection is currently not recommended.

29

Because of historical exposure to unscreened or inadequately screened blood products and/or poor injection safety.

30

The WHO Package of Essential Noncommunicable (PEN) disease interventions for primary health care in low-resource settings targets the following populations for cardiovascular disease screening: age older than 40 years, smokers, people with known hypertension or diabetes, waist circumference (>90 cm for women and >110 cm for men) and family history of diabetes or premature cardiovascular disease.

31

WHO-recommended breastfeeding is defined as: (1) initiating breastfeeding within the first hour of life; (2) exclusive breastfeeding for the first six months of life (that is, the infant only receives breast-milk without any additional food or drink, not even water); followed by (3) continued breastfeeding for up to two years of age or beyond (with the introduction of appropriate complementary foods at six months); and (4) breastfeeding on demand – that is, as often as the child wants, day and night.

32

Includes peer counselling.

33

Rapid initiation is defined as within seven days from the day of HIV diagnosis; people with advanced HIV disease should be given priority for assessment and initiation.

34

When routine clinical consultations are due, they should be coordinated with planned medicine pickups to reduce visit frequency.

35

ARV supply management should be strengthened to ensure availability of ARV medicine and prevent stock-outs in the context of less frequent medication pickups.

36

Patient advocates, treatment and peer support interventions providing adherence and psychosocial support in the community.

37

Peer support, distribution of ARV drugs and assessment by non-clinical or lay providers.

38

Community level includes external outreach sites, health posts, home-based services or community-based organizations. Frequency of clinic visits will depend on health status.