6.4.1. Interventions to ensure timely linkage

6.4.2. CD4 cell count testing at the point of care

6.4.3. Laboratory connectivity

The decentralization of HIV care services to primary-care settings has allowed for expanded access to treatment and improved outcomes. One challenge to delivery of care at peripheral facilities has been to ensure rapid and reliable turnaround of laboratory results. Sample transportation networks can result in delays in or losses of results, which in turn can delay clinical decision-making. While this can be partly overcome through the use of devices at the point of care, in situations where these devices are unavailable, alternative approaches are needed to ensure that delays in turnaround time of essential laboratory results, in particular for EID, are minimized. Early identification of HIV-infected infants is critical to enable timely initiation of ART.

SMS/GSM/GPRS printers represent a potential solution, whereby laboratories can transmit messages to the clinic site in real time via standard telecommunication networks. A number of countries have well-established programmes using SMS/GSM/GPRS printers, including Kenya, Mozambique, Rwanda, South Africa, Zambia and Zimbabwe. Several other countries are in the implementation and pilot phases of SMS/GSM/GPRS printer use.

Background

Poor patient retention undermines programme and patient outcomes, including achieving sustained viral suppression. The global effort to increase the number of people on ART needs to ensure that people taking ART are retained in chronic care for life. Systematic reviews show that retention rates are estimated to be as low as 64% to as high as 94% at 12 months after ART initiation (33,34). Several countries report a lower than 60% retention rate after 3 years on ART, with high loss to follow-up representing unknown outcomes. Retention in ART programmes is a major challenge in all settings and across populations, specifically paediatric and adolescent populations, postpartum women and men. Multiple factors may play a role in loss to follow-up, including distance to health facilities, lack of transport or inability to cover travel expenses, stigma and disclosure-related issues, being too sick and lack of understanding of the need for lifelong care.

Rationale and supporting evidence

A systematic review (35) identified six studies (one randomized controlled trial and five cohort studies) that evaluated community-level interventions to strengthen retention in HIV care: a package of community-based interventions, adherence support clubs and provision of extra care for high-risk patients. A strong recommendation was made despite the overall low quality of evidence due to the balance of benefit greatly outweighing potential harm, the degree of acceptability to people living with HIV and the programmatic benefits of implementing interventions that result in positive patient and programmatic outcomes.

Cost and cost–effectiveness

The cost of implementing community-level interventions varies by setting and depends on whether community-based health programmes are already established. Generally, costs related to training and remunerating lay providers are much less than the cost of care provided at facility level and care provided by health workers. Cost related to community support, peer support and support by patient advocates is often related to training and orienting these cadres and support groups.

Equity and acceptability

A qualitative evidence synthesis (40) highlighted key interventions that were acceptable, related to improving retention in HIV care. These included lay health workers providing support (moderate confidence), particularly if they were also living with HIV; family and friend support (moderate confidence); mobile health (mHealth) interventions (moderate confidence) and developing positive and non-judgemental relationships with those implementing the intervention (moderate confidence).

Population considerations

Implementation considerations

There is no single model of community or peer support that works in all settings, and programmes need to adapt such interventions to the local context. Some patients may choose not to receive services in the community due to concern over stigma and discrimination. Community interventions require linkage with health facilities for smooth transfer and referral of patients, when necessary, and strategic planning and resourcing for sustainability. Community-level programmes still need to be integrated into national health sector plans in many settings.

Research gaps

Implementation research and evaluation of the different models of community-level support in different contexts are necessary to further guide programmes. Innovative approaches and effective strategies are needed to support transitioning across different care-delivery points for men, postpartum women, adolescents and children. Further data on the cost of implementing community-level interventions in different settings will guide national policy.

Background

Adherence to ART is the primary determinant of viral suppression and the risk of transmission, disease progression and death (45–47). Suboptimal adherence is a major challenge worldwide and is associated with a diversity of patient- and programme-related causes. Individual factors may include forgetting doses, being away from home, changes in daily routine, depression or other illness and substance or alcohol use. Adherence to ART may also be challenging in the absence of supportive environments for people living with HIV and in the presence of HIV-related stigma and discrimination. Medication-related factors may include adverse events and the complexity of dosing regimens, such as those for children. Health system factors include distance to health services, long waiting times to receive care and obtain prescription refills, receiving only one month's supply of drugs, pharmacy stock-outs and the burden of direct and indirect costs of care (48,49).

Specific population groups face additional challenges to adherence, and these should be considered when implementing the recommended interventions.

Rationale and supporting evidence

A systematic review and network meta-analysis identified 84 randomized controlled trials of interventions to improve adherence (68). Forty-seven trials reported on overall viral suppression and 71 on adherence. The review found overall moderate-quality evidence to support a range of interventions that demonstrate the benefits of improving adherence and viral suppression. Interventions were grouped by components of similarity, given below:

• Peer counsellors: there is direct evidence of higher levels of adherence compared to standard care.
• Mobile phone text messages: text messages sent to the client's phone one way or two ways. There is direct evidence that text messages result in higher adherence compared to standard care.
• Reminder devices: interventions using calendars, alarms, system devices for disease management assistance and pagers. There is direct evidence that supporters and device reminders result in increased viral suppression.
• Cognitive-behavioural therapy: there is direct evidence of a higher rate of viral suppression compared to standard care.
• Behavioural skills training: provision of training or medication adherence training sessions. These included module-based interventions and those designed to improve life skills, attitudes, behaviour and knowledge.

The benefits significantly outweigh any potential harm for all interventions identified. Peer counsellors are generally considered to be a low-cost intervention and, in some settings, have been highly cost-effective. Interventions such as cognitive-behavioural therapy and behavioural skills training require initial increased investment for training and resources. Reminder devices, telephone interventions and mobile phone text messages are low cost in the majority of low- and middle-income countries. Cost–effectiveness will vary depending on the setting and epidemic context. A strong recommendation was made by the Operational Guideline Development Group, given the potential benefits for patient outcomes, feasibility in a variety of settings and low cost.

Supportive interventions

Several interventions may also be of value in addressing specific challenges that impact on adherence and/or viral suppression. Nutritional assessment, care and support are essential components of HIV care. HIV programmes should ensure that existing national policies on nutritional support are observed to maximize adherence to ART and achieve optimal health outcomes, particularly in food-insecure settings. Nutritional support could include nutritional counselling, cash transfers, subsidizing food costs and/or food vouchers. Studies suggest that providing nutritional support to people receiving ART reduces the risk of non-adherence among food-insecure individuals (69).

Financial support can reduce the risk of non-adherence (70). Programmes and care providers should consider a broader programmatic approach to reducing the costs of care for people living with HIV. This includes avoiding out-of-pocket payments at the point of care (such as drugs, diagnostics and clinical services), supporting transport costs, decentralizing care and reducing the frequency of health facility visits. Programmes need to consider the ethical and equity implications of providing financial support and non-monetary incentives for people living with HIV. Standardized criteria for supporting people receiving ART may need to be developed based on national income levels.

Equity and acceptability

A qualitative evidence review (71) of the acceptability of interventions to improve adherence identified intervention-specific themes. These included educational programmes for individuals and families (high confidence), mobile phone text messages (high confidence), health worker outreach (moderate confidence) and complex interventions (low confidence). Confidentiality and privacy and strengthening social networks were identified as cross-cutting themes from a total of 31 studies. Interventions may be more acceptable if they consider local cultural customs and religious beliefs. Peer-based interventions are generally well accepted, in particular among adolescents, who find that hearing experiences and learning from others facing the same challenges is critical for supporting adherence and engagement in care (72).

Implementation considerations – monitoring adherence

Effective monitoring of adherence requires a combination of approaches based on human and financial resource capacity, acceptability to people with HIV and health workers and an understanding of the local context.

Pharmacy refill records

Pharmacy refill records provide information on when people pick up their ARV drugs (74,75). Pharmacy records are more reliable than self-reporting (76) and are already a part of national monitoring and evaluation frameworks in many settings.

Self-reporting

Self-reported data are easy to collect and can be a useful adjunct to estimating non-adherence but are subject to recall bias (77). Counselling on the importance of remembering ART doses and an environment that promotes and enables honest reporting of non-adherence are critical components of monitoring adherence to ART in routine care settings.

Pill counts

Counting the remaining pills in bottles may help to assess adherence. Pill counts usually take place at routine health-care visits. However, some people discard tablets prior to health-care visits, leading to overestimated adherence. Counting pills also requires health-care personnel to invest significant time and may not be feasible in routine care settings. Pill count has been found to perform better when combined with self-reported adherence (78).

Research gaps

Further research is needed to determine:

• optimal ways to proactively monitor adherence and identify through simple triage those patients in greatest need of adherence support;
• interventions to support adherence in populations at heightened risk of suboptimal adherence (children and adolescents, pregnant women, men who have sex with men, people who inject drugs);
• potential synergistic effects of combining two or more interventions that could impact individual, social support and health system factors; and
• the effectiveness of long-acting ART in improving adherence and viral suppression.

Background

In the early period of ART scale-up in low- and middle-income settings, the majority of people seeking HIV care presented with advanced disease, often requiring intensive clinical management (79). This led to the typical practice of monthly visits to health facilities for clinical review (80). As guidelines now recommend treatment at earlier stages of the disease, there is a growing appreciation that, with effective ART and good adherence, people can have a near-normal life expectancy (81–83). HIV programmes are providing ART to increasing numbers of people who are stable on ART, and there is a need to rationalize the delivery of care to reduce the burden on health systems, particularly in countries with a high HIV prevalence. Frequent clinical visits also place a burden on people taking ART, and the opportunity and financial costs of travelling to the clinic have been associated with an increased risk of poor adherence and poor retention in care (84). Correspondingly, approaches to reducing the frequency of clinical visits, including community ART dispensing, have been associated with improved retention (85,86).

Rationale and supporting evidence

Because clinical visits and medication pickup are often linked, both were assessed in a combined systematic review that found eight studies (one cluster randomized controlled trial, two randomized controlled trials and five cohort studies) from Kenya, Malawi, South Africa, Uganda and the United States, providing comparative data on the impact of reduced frequency of clinical visits. Overall, the review found that reduced frequency of clinical visits among stable individuals was associated with significantly better retention, with no difference in mortality outcomes. The same review identified three studies from Malawi, South Africa and Spain, which reported that reduced frequency of ART refills was also associated with improved retention in care. The studies also reported a positive trend towards improved adherence (87). There was no evidence that reduced frequency of ART refills led to additional complications or disengagement from care.

The strong recommendation to reduce the frequency of clinical visits and drug refills is supported by the expanding availability of ART and the fact that people are presenting to care earlier and require less intensive clinical care. This trend is expected to continue as countries move towards initiating ART for all people living with HIV regardless of CD4 cell count. In addition, there is substantial cost to people and health services of monthly clinical visits for those who are stable on ART. Reducing the frequency of clinical and ART pickup visits will be cost saving for both patients and health services. All cost analyses conducted within the systematic review point towards reduced cost per patient with reduced visits.

Equity and acceptability

Implementation of these recommendations is likely to improve equity as it relieves the burden placed on people to attend for frequent clinical assessments and to pick up drugs. This burden is greatest on people in rural areas (distance to travel) and those with very low income (costs associated with time off work). This recommendation is supported by the reported acceptability by young people and adults, citing increased convenience and fewer interruptions of daily schedules.

Implementation considerations

Reduced frequency of clinical and ART pickup visits has already been implemented for HIV and other chronic diseases in a variety of low- and middle-income settings. In implementing these recommendations, programmes need to consider coordinating routine clinical consultations with planned medicine pickup to reduce visit frequency. ARV drug procurement and supply management should be strengthened to ensure availability of ARV drugs and prevent stock-outs in the context of less frequent medication pickup (see section 6.10 “Integrating and linking services”).

In some settings, consideration is being given to implementing even less frequent (i.e. annual) clinical visits for people who are stable on ART. While there is currently no published evidence to support this approach as a formal recommendation in these guidelines, it is recognized that this may be a reasonable approach in certain contexts and for certain populations.

Population considerations

Research gaps

Further evidence of the feasibility and benefits of increasingly spaced clinical visits and medication pickup (greater than 6 months) is needed, and this should be studied across various patient populations.

Background

The number of available health workers remains inadequate in many settings with a high burden of HIV. Task shifting and task sharing involve the redistribution of tasks within health workforce teams. Specific tasks are reassigned to health workers with shorter training and fewer qualifications to optimize the available human resources. Although increasing the number of health-care personnel is also crucial, clinical tasks need to be shared and shifted to ensure that enough health workers are available.

In 2013, WHO made recommendations on task shifting relating to initiation, maintenance and dispensing of ART. These recommendations are supported by a systematic review of four randomized controlled trials and six observational studies (88). Overall, the data showed no difference in mortality and some evidence of reduced rates of loss to follow-up when nurses or non-physician clinicians initiated or maintained people on ART or when community health workers maintained people on ART relative to physicians performing these tasks. The quality of care in these studies was ensured by providing training, mentoring and supervision for nurses, non-physician clinicians and community health workers, clear referral pathways and effective monitoring and evaluation systems (88).

These guidelines provide a new recommendation for trained and supervised lay providers to distribute ART to adults, adolescents and children living with HIV. Several high HIV-burden settings are experiencing a critical shortage of pharmacy personnel to undertake this task. Apart from the absolute shortage of such staff, pharmacy personnel tend to be concentrated in urban settings, large hospitals and private pharmacies, accentuating shortages in rural and primary-care settings (89–91). Community distribution of ART for stable individuals can ease the burden of care on people with HIV and health services by reducing the frequency of clinical consultation and drug pick-up visits. Additionally, retrospective cohort studies from Uganda, the United Republic of Tanzania and Zambia demonstrate that community ARV distribution results in significantly less patient attrition than health facility-based services (92).

Rationale and supporting evidence

Indirect evidence from a systematic review comparing dispensing of ARV drugs by non-pharmacists compared to pharmacists identified two cluster randomized trials that compared the outcomes of community-based HIV care with clinic-based care (93). The first trial evaluated patient outcomes (viral load, CD4 count, opportunistic infections and change in ART regimen) when ART was provided in community settings by community care counsellors living with HIV compared to clinic-based ART delivery where care was provided by health professionals. In the community-based settings, ART was distributed by community care counsellors who were trained and mentored for patient triaging, referral when necessary and distribution of ARV drugs prefilled by pharmacy personnel. People receiving community-based care had been on ART for more than six months and had no clincial conditions and high levels of self-reported adherence to treatment (94). People in the standard-of-care arm visited health facilities on a monthly basis, picked up their ARV drugs from a health facility pharmacy and were provided care by health workers. The second trial evaluated virological failure among those accessing ART from lay providers in the community compared to the standard ART care delivery by health professionals at health facilities (95).

The meta-analysis identified no difference in mortality and virological failure between people who received care from a community-based team and those who received care from health professionals at a health facility. Fewer people were lost to follow-up in the community-based care group. Both groups demonstrated high levels of self-reported medication adherence, with no statistical differences between the groups. The overall quality of evidence is low. The lay providers were also part of a wider community-based intervention with additional confounders that supported the success of the intervention, not solely the distribution of ART.

A strong recommendation was made that trained and supervised lay providers can distribute ART to adults, adolescents and children living with HIV despite the low quality of evidence, considering existing programme experience of trained and supervised community health workers and lay workers providing and performing other tasks within the HIV testing, treatment and care continuum. Additionally, there are important examples within the broader health sector where community health workers, with minimal training, are entrusted to provide curative and preventive care in maternal and child health services, malaria diagnosis and treatment and TB care.

Potential benefits and harm

The public health benefits of lay providers distributing ART are an overall increase in the number of providers to overcome the shortage of facility personnel, reduced clinic congestion and services provided closer to communities, which support retention in care. Where ARV drug supply and stock management are not reliable, distributing ARV drugs outside health facilties may increase distribution sites and potentially aggravate stock-outs. Neither of the two studies in the systematic review included people with comorbidities or children. While the recommendation is relevant to these populations, necessary dose adjustments, as the child grows, can be safely done during clinic visits, with maintenance treatment provided at the community level.

Cost and cost–effectiveness

There may be initial increased costs for training and other costs associated with introduction of community ART distribution. However, studies report substantial costs to patients when they are required to travel to centralized health services to collect medication. A study from Uganda reported that the cost to people receiving hospital-based care was three times higher than for people who received home-based care (95).

Equity and acceptability

A qualitative evidence synthesis identified that task shifting can enhance linkage to care and treatment adherence and assists HIV programmes to cope with shortages of professional health workers (18). Strengthened relationships between people with HIV and local communities can empower individuals. In Malawi, people from the community were hired as pharmacy attendants to pre-package and distribute ARV drugs to enhance the capacity of pharmaceutical services, an approach that has facilitated visit spacing and reduced waiting times and health providers' workload at health facilities (96).

Implementation considerations

Both initial and ongoing training and mentoring, supportive supervision and administrative planning have been critical to the success of programmes that have implemented task shifting. Programmes adopting these recommendations need to train and establish a system for routine supportive supervision of health workers, including lay providers. Adopting task shifting and sharing strategies often requires the revision of regulatory frameworks and national policies so that new cadres of health workers can perform new tasks. WHO recommends that all health workers, including lay providers, should be adequately remunerated (97), and programme experience indicates that it is difficult to sustain health services based on volunteerism alone. National regulatory bodies, professional associations and other stakeholders need to be involved when addressing the scope of practice, roles and responsibilities of health workers.

It is important that the local supply chain system take into account task shifting and sharing responsibilities, and community models of ARV drug delivery to ensure adequate stock. The supply management logistic information system needs to incorporate all ARV drug distribution outlets, including community lay providers' distribution sites (see section 6.13 “Procurement and supply management systems for HIV health products”).

WHO recommends that trained and supervised lay providers be used to provide safe and effective HIV testing services using rapid diagnostic tests (see section 2.3.1 “Pre- and post-test services: overview). A systematic review (98) was conducted to evaluate the outcomes of shifting tasks of finger-prick specimen collection for HIV-related diagnostic tests to non-laboratory staff (i.e. clinicians, nurses and midwives) and lay providers compared to laboratory professionals doing the same task. The review identified 27 studies (observational and technical evaluations), the majority based in sub-Saharan Africa (88%). The study results were inconsistent due to various cadres of health workers, test types utilized and the outcomes assessed. All of the studies reported a high degree of acceptability by clients and health workers, which was consistent with findings from the qualitative evidence synthesis on the acceptability of task shifting (see recommendations for task shifting). The inconsistent study results, high risk of bias and limitations of the reported data reduce the ability to make definitive conclusions from the systematic review alone.

A good practice statement was developed on task shifting for conducting blood samples by finger-prick testing, due to the overall benefits outweighing any potential harm. Nurses, midwives and clinicians readily perform HIV testing and are involved in EID sample collection and CD4 point-of-care testing in many settings, which form the basis of this good practice statement. Expanding finger-prick testing to lay providers will support increased access to essential diagnostics and decentralization of HIV care. In several settings, trained and supervised lay providers are already conducting HIV testing and performing sample collection using the finger-prick method. No harm was identified from this approach; however, a system of quality assurance is necessary for effective and safe implementation. The WHO Consolidated guidelines on HIV testing services provide additional considerations and key steps for successful implementation related to performing testing and sample collection by lay providers (http://www.who.int/hiv/pub/guidelines/hiv-testing-services/en).

Building human resource capacity

As HIV treatment and care have been scaled up in the past decade, in-service training has assumed a key role in rapidly upgrading the competencies of health-care providers. All health workers, including community health workers and lay providers, need to be regularly trained, mentored and supervised to ensure high-quality care and timely implementation of updated national policies. Given the rapidly evolving knowledge on HIV care and treatment, countries need to consider a system for supporting health workers' continuing education, including through clinical mentoring and regular supportive supervision (99). The use of new technologies, such as computer-based self-learning, distance education, online courses and phone-based consultation, may supplement classroom in-service training and enable efficient use of health workers' time and other resources. It is equally important to strengthen the HIV treatment and care components of existing pre-service courses for health workers graduating and receiving certification in a range of disciplines. Health-care workers also need to be equipped to manage HIV as a chronic condition, work in a team and implement new national guidelines and protocols.

Programme managers should also support the development and implementation of policies to create a suitable environment for recruiting, retaining, remunerating and motivating health workers in rural or remote areas, where turnover and attrition may be considerably higher than in urban settings.

In many countries, people living with HIV, community workers and volunteers are involved in delivering HIV testing, counselling, care, treatment and social support services. People with HIV are also involved in training health workers as expert trainers. Involving people living with HIV in both training health workers and delivering HIV services may have the additional benefit of overcoming HIV-related stigma and discrimination.

Research gaps

Research is needed to determine the feasibility and safety of further task shifting to improve access to treatment, including initiation and maintenance of ART at the community level, with spaced clinical visits to a health facility.

High-quality evidence is lacking for the initiation of second-line ART by trained non-physician clinicians, midwives and nurses. Further research in this area would identify the benefits and harm of implementing this approach in settings where there are clinician shortages.

Background

The rapid scale-up of ART programmes has posed significant challenges to health systems in high-burden, resource-limited settings. In many settings with a high burden of HIV infection, clinics have long waiting times due to the volume of patients needing care. Decentralizing HIV treatment and care reduces waiting times for people receiving care in facilities and brings HIV services closer to people's homes. Decentralizing HIV treatment and care also strengthens community engagement by linking community-based interventions with health facilities and can optimize access to services, care-seeking behaviour and retention in care. People living with HIV, affected communities and community-based interventions play a key role in providing HIV testing, treatment, care and support.

Rationale and supporting evidence

This recommendation, made in 2013, is supported by a systematic review identifying 16 studies (two cluster randomized trials and 14 cohort studies) assessing models of decentralized HIV treatment and care. The review provides evidence that decentralization of HIV care, either from hospitals to health centres or from health centres to community-based care, improves patient access and retention in care without compromising clinical outcomes. All but one of the studies was carried out in sub-Saharan Africa, and the benefits of decentralization may differ in different contexts (100).

Implementation considerations

The optimal model for ART decentralization (partial or full) depends on the local context, including the burden of HIV infection and the health-care delivery system. Programmes should determine which clinical and laboratory services will be available at what level of the health-care delivery system.

Programme managers should consider the values and preferences of those receiving care, the number of people likely to attend decentralized settings and whether decentralization brings services closer to people who would otherwise travel long distances to receive ART.

Decentralization should be accompanied by efforts to strengthen linkage and referral systems. Community-based treatment programmes should be linked with regular care at health facilities and with adequate laboratory facilities, diagnostics, monitoring and evaluation and drug and supply management systems.

Standards of care should be defined for each level of the health system. The role of each level should match its capacity, and the lines of authority and accountability should be clear and well understood. In many settings, decentralizing ART requires task shifting to ensure an appropriate mix of health workers at peripheral facilities. An appropriate regulatory framework (laws, regulations, policies and guidelines) is needed to allow tasks to be performed by different cadres of health workers.

Adaptations may be needed for specific populations. HIV care and treatment services for pregnant and postpartum women and HIV-exposed and -infected children can be provided in decentralized settings and is a preferred option where the HIV burden is high and a large number of women and children access health services in primary care settings. In settings with a low HIV burden, a centralized service delivery model with community linkage may be more appropriate. Some groups, such as adolescents and key populations, may choose to receive HIV services in a facility that is not close to their homes due to stigma and disclosure-related concerns. In such settings, programme managers should incorporate the values and preferences of their clients in designing appropriate service delivery models.

6.10.1. Delivering ART in maternal and child health-care settings

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

6.10.3. ART in settings providing opioid substitution therapy

6.10.4. STI and family planning services in HIV care settings

6.10.5. Care transition

An effective continuum of HIV care ensures that patients are retained as they transition between different health-care services and providers. Care transitions may be negatively affected by stigma and discrimination, fear of disclosure to new providers and anxiety or inconvenience resulting from changes in providers, their practice style and location. Examples of such changes include adolescents transitioning from paediatric care to adult care; pregnant and postpartum women transitioning from maternal and child health services to HIV care; patients transitioning from hospitals to primary care facilities; patients transitioning from facility-based to community-based services; and patients in correctional facilities transitioning to general outpatient care. Effective planning and support for patients are needed to ensure that these transitions occur as smoothly as possible.

Background

These guidelines recommend ART initiation in all adolescents (10–19 years old) living with HIV, regardless of CD4 count or clinical stage of disease (see section 4.3.3 “When to start ART in adolescents (10–19 years of age)”). There is a growing cohort of adolescents living with HIV, which includes those infected from birth and those who have acquired HIV later in childhood and adolescence. While there is still a lack of health outcome data for this age group, emerging evidence indicates that adolescents living with HIV are underserved by current HIV services and have significantly worse access to and coverage of ART (139). Adolescents are at high risk of loss to follow-up both before and after ART initiation; people aged 15–24 years and those attending services for the PMTCT of HIV are particularly at risk (140–146).

Rationale and supporting evidence

All adolescents, including those living with HIV, face significant barriers to accessing health services, due to inadequate health literacy, limited ability to navigate health systems, legal requirements for parental or caregiver consent, and insufficient resources to pay direct and associated service costs (147,148). Adolescents face significant levels of stigma and discrimination, particularly those from key populations, among whom criminalization of behaviour such as sex work, drug use and same-sex activity further perpetuates social exclusion and hinders access to health and support services (149,150).

Poor quality of services also limits adolescent engagement in health care. Adolescents often perceive health services as unacceptable due to concerns about confidentiality and negative health provider attitudes (150,151,153). Services are often not organized to accommodate adolescent needs and routines and have inconvenient service schedules, inflexible appointments and unwelcoming environments (150,151). Without sufficient consideration and support, adolescents can be lost between paediatric and adult services. The rapid developmental and social changes that occur during adolescence exacerbate the impact of such barriers and can have a profound impact on the way adolescents engage with health services (151).

Due to their unique needs, adolescents living with HIV require quality comprehensive services and care to support access, retention and adherence. This includes psychosocial support, SRH and mental health care (151,152). The WHO quality-of-care framework provides a useful working definition of adolescent-friendly health services (Box 6.1) (153,154). Additionally, global standards for quality health-care services for adolescents have been developed to support implementation (Box 6.2) (155).

Box 6.1

WHO-defined characteristics of adolescent-friendly health services. Equitable: all adolescents, not just certain groups, are able to obtain the health services they need. Accessible: adolescents are able to obtain the services that are provided.

Box 6.2

Global standards for quality of health-care services for adolescents.

A systematic review (156) was conducted to assess the effectiveness of adolescent-friendly health services for adolescents living with HIV compared to standard care. Due to the limited evidence available, the review was expanded to include the general adolescent population and young people up to and including 24 years of age. Adolescent-friendly health services were defined according to the WHO characteristics and the global standards for quality health-care services for adolescents. Eleven randomized control trials (157–167) and eight observational studies (168–175) from four of the six WHO regions were identified. Four studies focused on adolescents living with HIV; the remainder focused on SRH, HIV prevention, mental health, diabetes, general health and smoking cessation. All studies included two or more of the WHO characteristics, and global standards for quality health-care services for adolescents. Only one study included all WHO characteristics and no study addressed all global standards.

Young people engaged in adolescent-friendly health services compared to standard care showed small but significant improvements in various outcomes, including health outcomes (lower pregnancy rates); health-care utilization (presentation at a clinic for mental health, HIV counselling and testing and outpatient visits); uptake (HIV testing); knowledge (HIV and STI acquisition, pregnancy prevention and sexual health); attitudes (towards sex and HIV testing); sexual risk-reduction behaviour (condom use); self-efficacy (condom use or diabetes management); and service acceptability. No differences were seen with respect to healthy lifestyle or quality of life outcomes. Among HIV-positive young people exposed to adolescent-friendly health services compared to the standard care, there were small but significant improvements with respect to short-term viral load reduction and long-term ART adherence. The overall quality of evidence is low. A strong recommendation was made despite low-quality data, citing the promising improvement in outcomes, the existing programme experience, and evidence of feasibility and acceptability by the end users.

Cost and cost–effectiveness

No studies have assessed the resource requirements or cost–effectiveness of adolescent-friendly health services within HIV service settings. However, a cost modelling study and a retrospective cost analysis for adolescent-friendly health services in low- and middle-income countries reported that, although additional resources are required to ensure delivery of quality adolescent-friendly health services, investments to implement and scale up these services – in particular, services providing multiple interventions – appear to have value and impact for adolescents (176,177).

Equity and acceptability

Adolescent-friendly approaches aim to ensure that all adolescents obtain the health services that they need, that policies and procedures are in place to facilitate provision of health services to adolescents and that all health service providers treat adolescents with equal care and respect, regardless of HIV status, behaviour or other characteristics.

A global consultation of 470 young people living with HIV and a situational analysis of over 200 facilities in the WHO African Region was undertaken to prepare for the development of these guidelines (150,178). Additional inputs were also considered from two unpublished, multicountry longitudinal qualitative studies with 147 adolescents living with HIV (179).

Key acceptability themes and suggested strategies for improving service delivery focused on empowered and solution-oriented information and support; opportunities for open and honest discussion; skills development on SRH and HIV disclosure from an early age; comprehensive care that addresses issues beyond HIV, including support for adolescents from key populations; flexible scheduling of clinic visits to accommodate school hours; free services closer to home and community-based services; dedicated hours and spaces for adolescents; peer-led interventions and services; and an adolescent-competent workforce.

Feasibility

The programmatic and facility-level feasibility of adolescent-friendly health services was explored. The situational analysis of facilities assessed the availability of appropriate HIV treatment services for adolescents (181). Thirty-five per cent of facilities reported that adolescent patients were attended to separately from adult and/or paediatric patients through the use of dedicated schedules, staff or spaces. A case study of a government ART clinic in KwaZulu-Natal province in South Africa found that it is feasible to provide adolescent-friendly health service approaches in an HIV service setting. Although financial costs were low, consideration needs to be given to ensure engagement of stakeholders, including adolescents, adolescent-specific training, minimal provider rotation and adequate time for planning of restructured services. A survey of HIV programme managers highlighted the lack of appropriately trained health service providers and the need for greater preparation of health-care services as key challenges in delivering HIV services to adolescents (180).

Experience in Zimbabwe has identified several requirements for scaling up adolescent-friendly HIV services. These include a national, multisectoral, coordinated response; adolescent-sensitive policies and guidelines; meaningful involvement of adolescents; training and sustained mentorship of health service providers; community systems strengthening; linking community interventions with health facilities; and a national monitoring and evaluation framework with disaggregation and clear indicators for adolescents.

Implementation considerations

The global standards for quality health-care services for adolescents provide an approach to implementing health-care services for adolescents (Box 6.2) (152). The standards outline the desired level of care and what needs to be done for the standards to be achieved.

Further actions to implement the standards at the national, district and facility levels are outlined within the implementation guide (158). These standards and actions are relevant to HIV services for adolescents.

HIV-specific implementation considerations include the following:

• aligning approaches for HIV service delivery with WHO and national adolescent-friendly health service standards, protocols and activities;
• including implementation of adolescent-friendly approaches in HIV health service supervisory and monitoring systems;
• ensuring training, research and personal development opportunities for health service providers on adolescent HIV treatment and care;
• engaging service providers, adolescents and other key stakeholders to identify acceptable and feasible activities;
• implementing adolescent-friendly health service approaches in all HIV services used by adolescents, including antenatal care for pregnant adolescents living with HIV;
• establishing linkages and referral pathways to ensure a comprehensive continuum of care, especially for the transition from paediatric to adult HIV services; and
• addressing the needs and vulnerabilities of adolescents from key populations (181).

Additional guidance

Adolescent HIV testing, counselling and care: implementation guidance for health providers and planners. Geneva: World Health Organization; 2014. (http://www.who.int/maternal_child_adolescent/documents/hiv-testing-counselling/en).

HIV and adolescents: guidance for HIV testing and counselling and care for adolescents living with HIV. Geneva: World Health Organization; 2013. (http://www.who.int/hiv/pub/guidelines/adolescents/en) [PubMed: 25032477].

Global standards for quality health-care services for adolescents: a guide to implement a standards-driven approach to improve the quality of health-care services for adolescents. Geneva: World Health Organization; 2015. (http://www.who.int/maternal_child_adolescent/documents/global-standards-adolescent-care/en).

Interagency Working Group on Key Populations: technical brief series on young key populations (http://www.who.int/hiv/pub/toolkits/hiv-young-msm/en).

Research gaps

Research should contribute to a better understanding of how to implement adolescent-friendly health services at a programmatic level and the cost–effectiveness of these approaches in HIV services in low- and middle-income countries. Research on the service delivery needs of adolescents living with HIV should examine the minimum package of care; models of delivery at different service levels, including for key populations and pregnant adolescents living with HIV; the integration of SRH in ART services for adolescents; interventions to support safe disclosure; treatment literacy; interventions to address mental health; and the impact of provider training and peer interventions.

Background

This section provides brief guidance for programme managers and health-care providers on improving the quality of HIV care services. It focuses on key principles, approaches and interventions, highlighting QA and quality improvement (QI) practices based on implementation and programme experience. HIV programmes should also be innovative in addressing local challenges and aim to strengthen programme monitoring and the routine use of programme data to improve the quality of services. Quality of care emphasizes that services should be effective in achieving desired health outcomes and that health-care practices should be people-centred and safe (182). The WHO global strategy on people-centred and integrated health services outlines the strategy and provides an overview of evidence and good practices (183,184). Strategies to improve the quality of HIV care services are needed both at the programme management level and at health facility and community levels where HIV care services are provided (185). If an intervention is to achieve the desired health outcomes, it needs to be evidence based, of high quality and achieve a level of coverage that brings desired outcomes at the population level.

Rationale for strengthening the quality of HIV care services

Quality care means that people living with HIV receive the care they require to maintain their health and quality of life. For HIV programmes and health-care providers, quality HIV care optimizes programme effectiveness and efficiency. For policy-makers and funding agencies, quality care is an important requirement for maintaining health at the population level and ensuring the optimal use of available resources.

HIV programmes should plan to provide quality HIV care services from the outset by incorporating quality in the national policy, strategic plan, strategic information framework and operational and service delivery plans. Quality of care should not be seen as an additional activity to routine HIV services or a short-term project to redress implementation issues and gaps; it should be incorporated into daily activities at all levels, from service delivery to national programme management.

WHO, the participants of a scoping consultation on strengthening quality of HIV clinical services and members of the Operational Guideline Development Group developed the following good practice statements for HIV care services that are reflective of the broader WHO global strategy on people-centred and integrated health services (187).

Components of quality assurance and quality improvement

QI is the process of improving services and care through the routine use of patient and programme data. Several contextual factors, such as leadership and teamwork, also have a bearing on the quality of HIV care. Programme managers and health-care providers need to continuously monitor the quality of HIV care services (Fig. 6.2). This can be done by comparing implementation against set standards, analysis and use of routinely collected data at facility level and consultation with service users or community networks on the needs, values and preferences related to HIV care services that they receive. Some quality interventions require broader system-level interventions to ensure sustained improvement. For example, the delivery of community ART, triaging patients to reduce clients' waiting time for clinical consultation and use of lay providers in patient education and counselling all require a supportive programme and resources for sustained implementation. Lessons from the QI process in HIV care service delivery and management should feed back into subsequent policy and programme formulation and planning processes.

Fig. 6.2

Key enablers of quality HIV care services.

Enablers of quality improvement

HIV programmes should provide a national framework for strengthening the quality of HIV care services. The framework should also facilitate accountability and resource mobilization at different levels of the health-care delivery system. Integration of quality HIV care in national policies and strategic plans can also facilitate partnership with other health programmes and stakeholders, including professional associations, funding agencies, research institutions, communities and networks of people living with HIV. A national framework should also highlight the needs of marginalized people or groups, address resource needs to reach underserved populations and address health worker capacity to bridge gaps in quality. Comprehensive quality-of-care activities should include both QA and QI activities. Fig. 6.2 summarizes enablers for delivering high-quality HIV care services.

Several key considerations for integrating QI of HIV care into national policies, programmes and strategic plans are given below.

• Ensure involvement of stakeholders, including networks of people with HIV, communities and health-care workers, for building a common understanding on strengthening quality HIV care services and efficient use of resources.
• Identify elements of national policies and strategies to address the quality of HIV care services and HIV-related stigma and its impact on accessing HIV care services.
• Prioritize strategies for QA and QI of HIV care (Fig. 6.3).
• Identify nationally harmonized key indicators and reporting requirements for monitoring the quality of HIV care.
• Define roles and responsibilities of stakeholders at different levels of the health-care delivery system in strengthening the quality of HIV care services.
• Allocate resources for the development of mechanisms to support QI; for management and information systems that report, monitor and improve the quality of HIV care services; and for alignment of performance with implementation of evidence-based good practices.
• Include high-quality, people-centred HIV care service delivery in the principles, values and strategies of national polices and the HIV strategic plan.
• Set standards for evidence-based HIV care through national guidelines by defining the package of HIV care services to be offered, including at what level of the health-care delivery system and for which population or geographical location.
• Provide a national monitoring framework for continuous QI of HIV care services and assure that the practice of care adheres to national, evidence-based guidelines and standards.

Fig. 6.3

Process of building a strategy for continuous quality improvement.

6.13.1. Overview

This section provides operational guidance on procurement and supply management (PSM), with a focus on how PSM systems can respond to new recommendations in these guidelines. Comprehensive advice on the general management of PSM systems is readily available in existing publications and training materials. References to relevant publications and materials are provided at the end of this section.

The overarching objective of PSM systems is to support national policy with the adequate and continuous availability of the most effective, heat-stable, fixed-dose, quality-assured ARV drug formulations, diagnostics and other consumables at service delivery sites, in the right quantities, at the lowest possible cost and in a timely manner.

The new recommendation that ART should be initiated in all people living with HIV regardless of CD4 cell count will require an integrated national strategic response that considers the resources available and enables strong PSM systems at all levels of the health system. In addition, the fact that all people living with HIV need to be on ART will accelerate the scaling up of ART programmes. Procurement managers and ART programme managers will need to work together to ensure that the national supply system is forecasting, procuring and distributing the quantities of ARV drug and other health commodities required to meet the increasing national demand and the 90–90–90 target.

While there are no major changes in the ART regimens recommended in these guidelines, new drugs are recommended as components of alternative regimen choices, with potentially important implications for PSM.

6.13.2. Implementation considerations

Most national HIV programmes will need to plan a phased approach to the adoption of the new recommendations, notably the expansion of ART to all people living with HIV and the introduction of pre-exposure prophylaxis (PrEP) for groups at substantial risk of HIV infection. Where programme resources are already stretched, unplanned adoption of these new recommendations with the associated increase in demand for drugs and diagnostics may lead to stock-outs and imbalances.

Challenges and opportunities associated with implementing new WHO recommendations include the following:

• product selection;
• quantification and demand forecast;
• procurement planning and execution, including delivery and timeliness of orders;
• the ability of global supply to cope with the increasing global demand;
• storage and distribution, including logistics constraints;
• monitoring of consumption and demand changes;
• frequency of ARV drug pickup;
• information flow between stakeholders at different levels;
• costs and opportunities for cost saving;
• shelf-life of ARV drugs;
• risk of stock-outs if procurement does not meet demand; and
• risk of expired health products if the quantities procured have been overestimated.

National HIV programmes should consider establishing a stakeholder working group to develop a plan to address these issues, with participation by health policy-makers, implementers, PSM specialists and representatives from central medical stores management and the finance ministry.

6.13.3. Special considerations for adult and adolescent ART regimens

The preferred first-line ART regimen remains tenofovir (TDF) in combination with lamivudine and efavirenz, or TDF in combination with FTC and efavirenz (EFV), preferably as fixed-dose combinations (see section 4.4 “What to start: first-line ART”). Regimens containing nevirapine (NVP) are retained in the guidelines as an alternative option where clinically required for patients who cannot tolerate or have contraindications to TDF or EFV.

Key changes compared to 2013 are:

• dolutegravir (DTG) and EFV 400 mg/day are recommended as alternative first-line agents;
• darunavir/ritonavir (DRV/r) (as part of a heat-stable fixed-dose combination [FDC]) and DTG are recommended as alternative second-line options (see section 4.8.1 “Second-line ART for adults and adolescents”); and
• DTG and raltegravir (RAL) are recommended as potential third-line options (see section 4.8.3 “Third-line ART”).

Four key challenges for the supply chain arise as a result of the recommended ARV drug regimens.

• The currently approved suppliers of preferred first-line FDC formulations are expected to have sufficient production capacity to satisfy the increased demand for these formulations as the number of patients on treatment increases, provided that increases are carefully phased to avoid sudden spikes in demand. However, short-term supply constraints may arise, highlighting the need for proper planning and maintenance of buffer stocks at the national level.
• Delivery lead times for the recommended first-line drugs may become extended during peak periods of demand. PSM managers should be aware of current lead times and plan their orders and deliveries accordingly.
• Purchasers and implementing partners who are distributing zidovudine (AZT)-based and NVP-based regimens to patients and have stocks and orders in process should consider how to manage their stocks to avoid stock-outs or wastage due to expiry of usable products from overstocking.
• There may initially be limited demand for alternative first-line, second-line or third-line regimens, particularly those containing the newer medicines DTG, DRV/r and RAL. Pooling orders from several buyers is recommended to increase the volumes to be ordered and ensure that suppliers can deliver and adequately respond to the demand.

6.13.4. Special considerations for paediatric ART

These guidelines make no changes to the first-line paediatric ART regimen recommended in 2013 (see section 4.4.4 “First-line ART for children three to ten years of age” and section 4.4.5 “First-line ART for children younger than three years of age”). RAL is newly recommended in second-line paediatric ART for children younger or older than 3 years after failure of a first-line regimen containing LPV/r (see section 4.8.3 “Third-line ART”).

6.13.5. Checklist for introducing new products and phasing out old ones

These guidelines recommend new ARV drug formulations for adults and adolescents as well as for paediatric ART. Introduction of new medicinal or diagnostic products is one of the most complex and unpredictable activities in any HIV programme and, as such, presents a heightened challenge for policy-makers, PSM managers and manufacturers. When planning the introduction of new products, the following PSM-related factors should be taken into account.

• Is the product subject to patent or other intellectual property protection that would restrict access to generic formulations of the product in your country? In many middle-income countries, access to generic versions of ARV drugs is restricted. Should this be the case, advice is available from the Public Health, Innovation and Intellectual Property Team of the WHO Department of Essential Medicines and Health Products.
• Is the product registered for use in your country? If not, consider obtaining a temporary waiver and, in the meantime, accelerate the official registration processes for future procurement. This information should be available from the national drug regulatory authority. While it is the responsibility of the manufacturer to arrange registration, registering a drug can be a lengthy and expensive process.
• What is the forecasted demand for the product, including the anticipated pace of adoption? The pace of adoption is very difficult to forecast accurately, and ordering and delivery schedules must take into account this unpredictability. Faster adoption may lead to stock-outs if the procurement plan has not taken this into account, whereas a slower pace could lead to expiry of stocks if the procurement plan assumed a faster adoption. PSM managers will need to monitor consumption closely and have risk mitigation strategies in place. In case of faster adoption, suppliers should be asked to be prepared to respond to urgent orders. In case of slower adoption, suppliers should be asked to deliver quantities gradually according to country requests until all the quantities ordered are consumed. Ordering in large volumes has the advantage of economies of scale, but suppliers should be flexible enough to send deliveries according to national demand to prevent wastage by expiry. PSM managers are encouraged to work with HIV programme managers in formulating risk mitigation plans to account for the difficulty of accurate forecasting of demand and the pace of adoption.
• How will introduction of the new product impact the use of existing medicines or diagnostics? Unless it is recommended that a product be stopped due to severe toxicity or other reasons, PSM managers should always plan to optimize the use of existing stocks and orders before a full switchover to new products, in order to avoid wastage.
• How will purchase of the new product affect procurement budgets? PSM managers may wish to consult with major global purchasers to gauge the expected price so that quantities of existing and new products can be accommodated within the available budget. In some cases, lack of sufficient funds has delayed a full transition to new products that were more expensive or led to stock-outs of existing products.
• What is the shelf-life of the product and how might this affect the procurement strategy and the in-country distribution of the product? The “first expiry, first out” principle should be applied in stock management and distribution. Products with a shorter shelf-life should be distributed to treatment sites and dispensed as quickly as possible to allow their consumption before their expiry.
• Does the new product require any special handling or storage, such as temperature control? Consider adjusting the capacity and storage conditions of current facilities.
• What is the production status of the new product? What minimum order will the supplier accept and what is the anticipated lead time from order placement to delivery? In the case of products in lower demand, manufacturers may be willing to only commit to production once they are assured of commercially viable orders.
• If small volumes of new products are required, PSM managers should consider collaborating with neighbouring countries or global pooled procurement mechanisms to reach total order volumes that are viable for the manufacturers. This strategy may be particularly appropriate for second- and third-line formulations and for paediatric ARVs.
• Policy-makers and PSM managers may wish to consult with global purchasers and other knowledgeable entities to gain market intelligence on new formulations while they develop strategies to introduce these new formulations through national procurement.

6.13.6. Useful PSM resources

This document does not cover all technical issues related to PSM. The PSM Toolbox contains PSM tools that can be searched by technical area and by publishing organization: http://psmtoolbox.org/en.

6.14.1. Overview

Implementing recommendations in these guidelines will require increased access to laboratory and diagnostic services.

To ensure that diagnostic services are accurate and reliable, relevant QA systems need to be developed and strengthened. Within a country, a multiplicity of diagnostic settings may exist, such as laboratories, maternal and child health clinics, HIV testing and counselling sites and community-based testing. A multipronged and networked approach to selecting diagnostics and laboratory systems should therefore be planned and adopted. Because many new diagnostic tests and point-of-care systems are entering the market, the use of only high-quality diagnostics and equipment needs to be ensured. Strategic planning for proper placement and harmonization of testing platforms should be carried out to ensure appropriate use and cost–effectiveness.

Effective laboratory and diagnostic services require sound leadership and governance to enable the following activities (188):

• strengthening and expanding laboratory and diagnostic services;
• supporting a dedicated specimen referral system;
• appropriate availability of CD4 count testing;
• increased access to HIV viral load testing for all people on ART, for monitoring purposes;
• supporting the expansion of diagnostic services to include testing at the point of care;
• training and certifying health-care workers who perform testing;
• ensuring high-quality diagnostics and plans for implementing these, including QA; and
• ensuring appropriate deployment of diagnostic technologies to increase their efficient and optimal use.

WHO and the United States Centers for Disease Control and Prevention (CDC) have developed a handbook on QA approaches to point-of-care testing and for laboratories in low- and middle-income countries (188). Figure 6.4 shows the three-phase approach to QA of laboratory programmes.

Fig. 6.4

Three phases of laboratory quality assurance. Source: WHO US CDCImproving the quality of HIV-related point-of-care testing: ensuring the reliability and accuracy of test results Geneva World Health Organization2015(http://www.who.int/hiv/pub/toolkits/handbook-point-of-care-testing/en). (more...)

6.14.2. Strengthening and expanding laboratory and diagnostic services

The following areas are important for strengthening the network of laboratory and diagnostic services in order to implement the recommendations in these guidelines:

• national laboratory strategic plans and policies;
• evaluating diagnostics for their performance and operational characteristics to validate testing algorithms (with backup options) before introduction;
• carrying out strategic planning in order to properly place and harmonize testing platforms to ensure appropriate use and cost–effectiveness;
• expanding current laboratory networks to support and monitor the decentralization and integration of testing services and to provide access to testing when diagnostic services are unavailable at service delivery sites;
• allocating appropriate resources to ensure the availability of testing services, including human and financial resources; and
• guidance on operations and service delivery.

6.14.3. Supporting a dedicated specimen referral system

Laboratory referral systems and procedures for collecting and processing specimens need to be strengthened to increase access to viral load and other testing (e.g. CD4 testing at the point of care and EID). Providing for and strengthening a dedicated, efficient, safe and cost-effective specimen referral system requires reliable specimen transport with adequate conditions for whole blood, plasma and dried blood spot specimens as well as for rapidly and dependably reporting test results back to the referring site with linkage to care. Rapid reporting of results is essential for timely care.

6.14.4. Increasing access to HIV viral load testing

These guidelines recommend the use of viral load testing to monitor treatment response and diagnose treatment failure and the use of dried blood spot samples for viral load testing. This will require ongoing strengthening of existing laboratory services and phased expansion of monitoring services in peripheral facilities. It may involve:

• strengthening and leveraging existing EID networks;
• ensuring that laboratories have adequate infrastructure, technical expertise and QA and QI programmes;
• ensuring an appropriate mix of high-volume centralized laboratory testing and testing at the point of care for facilities in remote locations; and
• use of dried blood spot specimens to increase access to viral load testing.

6.14.5. Planning for appropriate use of CD4 count testing as access to viral load testing increases

As countries move to eliminate CD4 count-dependent treatment initiation thresholds and viral load monitoring replaces monitoring with CD4 cell count, it is anticipated that the demand for CD4 count testing will decrease. As this transition takes place, programme, laboratory and PSM staff should take into account the following programmatic considerations.

• As demand decreases, reductions in CD4 count testing capacity can be staged through several strategies based on site-level demand, age of the instrument and failure rates.
• Although sample referral networks for CD4 cell count and viral load testing may overlap, the sample types require different transport capabilities. Programmes need to ensure adequate network capability for sample referral for viral load testing prior to scaling down CD4 count testing.
• Programme planning should include a realistic transition of financial support from CD4 count testing to viral load monitoring. Cost savings may not be evident immediately, as the cost per test for CD4 count testing will increase as volumes decrease.
• Quantification and forecasting (active supply planning) will be essential to account for commodity shifts. This is particularly important in the early phases of the transition when historical data will not reflect current commodity needs. Supply chain needs, including cold-chain transport and storage, must also be considered during the transition.
• Even in settings with full access to viral load testing, CD4 cell count testing capability will continue to be needed as part of HIV programmes for baseline risk and other clinical assessments. Depending on the context, as the transition to viral load monitoring from CD4 count testing for initiation and monitoring progresses, programmes may wish to consider centralizing the continued use of CD4 count testing.

6.14.6. Expanding diagnostic services to point-of-care settings

Decentralizing laboratory and diagnostic services requires that all aspects of testing be in place before services are implemented. This includes:

• using only high-quality, evaluated and reliable diagnostic tests;
• supervising and monitoring point-of-care testing for quality and reliability;
• implementing a strategy for managing the supply chain and equipment service;
• establishing data management systems for timely identification of quality issues; and
• regional and national data reporting.

6.14.7. Ensuring appropriate deployment of diagnostic technologies

The WHO diagnostic use survey demonstrated that several technologies are available in the countries that reported their diagnostic usage. Their utilization is lower than 50% of their capacity for several reasons:

• Deployment of high-throughput instruments in low-volume settings with no appropriate plan for sample transportation: CDC and WHO have produced a strategic planning manual since the Maputo Declaration on Strengthening of Laboratory Systems to ensure that equipment is deployed in a tiered laboratory network based on the volume of tests at the testing sites (Table 6.3).
• Frequent stock-out of reagents: WHO has developed a manual for efficient procurement of essential equipment and laboratory commodities to support national programme managers when they are estimating their procurement (http://apps.who.int/iris/bitstream/10665/180980/1/9789241509183_eng.pdf?ua=1).
• Lack of maintenance and repair needs: maintenance should be embedded in the contractual agreement with the manufacturers supplying diagnostics.
• Lack of installation of purchased equipment due to lack of trained personnel or adequate space for the size of the equipment: prior strategic planning is essential to ensure that appropriate space and a trained laboratory technician are ready when the procured equipment is delivered for use in the country.

Table 6.3

Tiered laboratory network at various levels of the health-care delivery system.