1.1. Introduction

The human immunodeficiency virus (HIV) pandemic presents a significant challenge to global tuberculosis (TB) control. TB is a leading preventable cause of death among people living with HIV. To mitigate the dual burden of TB/HIV in populations at risk of or affected by both diseases, the Stop TB Department and the Department of HIV/AIDS of the World Health Organization (WHO) published an Interim policy on collaborative TB/HIV activities in 2004 (1). The policy, which provided guidance for Member States and other partners on how to address the HIV-related TB burden, has been one of the most widely accepted policies issued by both departments. Many countries have implemented the policy in a relatively short time; more than 170 countries had reported implementing its components by the end of 2010.

As the evidence base for all the recommendations was not complete at the time the policy was developed in 2003–2004, the term “interim” was applied. In addition to scaling up implementation of the recommended collaborative TB/HIV activities, rapid generation of evidence was emphasized to inform and update the policy. Since then, additional evidence in the field of TB and HIV has been generated from randomized controlled trials, observational studies and operational research. Furthermore, WHO has developed a number of guidelines and policy recommendations to improve the management of TB and HIV. This document updates the 2004 interim policy to reflect current evidence and experience in implementing collaborative TB/HIV activities.

1.2. Scope of the policy

The purpose of the policy is to provide national programmes and stakeholders with guidelines on how to implement and scale-up collaborative TB/HIV activities. It is complementary to and in synergy with the established core activities of TB and HIV prevention, diagnosis, treatment and care programmes. Implementing the interventions recommended in the Stop TB strategy is the core function of national TB control programmes or their equivalents (2). Similarly, the delivery of priority interventions – to provide knowledge of HIV status, prevent transmission of HIV and other sexually-transmitted infections, and provide diagnosis, treatment and care for HIV – forms the basis of the health-sector HIV response and is the core function of national HIV programmes or their equivalents (3). The policy emphasizes the provision of quality-assured, comprehensive and integrated services to prevent, diagnose and treat TB and HIV and provide care for people living with or at risk of HIV and/or TB, their families and communities. It is also aligned with Treatment 2.0, an initiative coordinated by the Joint United Nations Programme on HIV/AIDS (UNAIDS) and WHO, which aims to achieve and sustain universal access to HIV treatment and maximize its preventive benefits through a five-point agenda towards simplification and improved effectiveness and efficiency: optimizing drug regimens, advancing point-of-care and other simplified platforms for diagnosis and monitoring, reducing costs, adapting delivery systems and mobilizing communities (4).

Although the policy promotes strengthened collaboration between national TB-control programmes and HIV programmes or their equivalents, defining effective and pragmatic mechanisms to jointly manage such programmes and deliver integrated services should depend on the epidemiology of TB and HIV as well as context-specific and evidence-based considerations of the health system issues in the country. The policy will be reviewed and updated in five years (2017), in compliance with WHO procedure.

1.3. Target audience

These policy guidelines are intended for decision-makers in the field of health and for managers of TB-control programmes and HIV programmes working at all levels in the health sector, including the private-for-profit sector, as well as donors, development agencies, nongovernmental organizations and other civil society organizations supporting such programmes, and people living with, at risk of or affected by HIV and TB. The recommendations contained in these guidelines also have important implications for the strategic directions and activities of other line ministries working on TB, HIV or harm reduction services, such as ministries responsible for prisons, mining and workplace health services, youth in education facilities, and other stakeholders in maternal and child health programmes.

1.4. Process of updating the policy

The process of updating the policy followed that recommended by the WHO Guidelines Review Committee (GRC). A WHO Steering Group and a Policy Updating Group comprising policy-makers, programme managers, TB and HIV experts, donor agencies, civil society organizations including people living with HIV, and a methodologist in Grading of Recommendations Assessment, Development and Evaluation (GRADE) were established to oversee the process and develop recommendations. The policy guidelines build on the basic framework of the interim policy document that structured collaborative TB/HIV activities under three distinct objectives (establishing and strengthening the mechanisms for delivering integrated TB and HIV services, reducing the burden of TB among people living with HIV, and reducing the burden of HIV among people diagnosed with or presumed to have TB).

Recommendations from the following documents that have been approved by the GRC were used to update the policy:

• Guidelines for intensified case-finding for tuberculosis and isoniazid preventive therapy for people living with HIV in resource-constrained settings, 2010
• Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: towards universal access, recommendations for a public health approach, 2010 version
• Antiretroviral therapy for HIV infection in adults and adolescents, recommendations for a public health approach, 2010 revision
• Treatment of tuberculosis guidelines, fourth edition, 2009
• WHO policy on TB infection control in health-care facilities, congregate settings and households, 2009
• Policy guidelines for collaborative TB and HIV services for injecting and other drug users: an integrated approach, 2009
• A guide to monitoring and evaluation for collaborative TB/HIV activities, 2009 (adjudicated by GRC as a non-guideline)
• Guidelines for surveillance of drug resistance in tuberculosis, fourth edition, 2009 (adjudicated by GRC as a non-guideline)
• Delivering HIV test results and messages for re-testing and counselling in adults, 2010
• Joint WHO/ILO policy guidelines on improving health worker access to prevention, treatment and care services for HIV and TB, 2010
• Guidelines for couples HIV testing and counselling [in press], 2012.

In addition, the following four questions (three clinical and one programmatic) that were not covered by the aforementioned documents were identified by the Steering Group and a comprehensive systematic review of the available scientific evidence was conducted to formulate the related recommendations.

1. What are the benefits of HIV testing and counselling among patients with presumptive TB (that is, patients with signs and symptoms of TB or suspected TB) and diagnosed TB, and the partners and family members of those found to be HIV-positive?
2. Does the administration of routine co-trimoxazole preventive therapy, as compared with no co-trimoxazole preventive therapy, reduce the number of illness episodes and deaths in TB patients living with HIV?
3. Can earlier initiation of antiretroviral therapy at higher CD4 counts (more than 350 cells/mm³) be used to prevent active TB in people living with HIV?
4. What models are available to deliver integrated TB and HIV services for people living with HIV?

Systematic literature reviews of studies related to these four questions were conducted using PubMed, MEDLINE, EMBASE and various other databases using combinations of different keywords to search for studies related to each question. A search was also conducted for abstracts presented at conferences on TB and lung diseases organized by the International Union Against Tuberculosis and Lung Disease (The Union) and the International AIDS Society. Investigators of large-scale HIV clinical trials were also asked for information, especially about the role of earlier initiation of ART to prevent TB. All retrieved titles and abstracts were reviewed for their relevance to the topic in question. The reference lists of the retrieved studies were also reviewed to identify further studies that met the eligibility criteria. In addition, recognized experts in the field were contacted to identify any unpublished studies that did not appear in the initial electronic search for each question. Details on evidence retrieval and quality assessment for the three clinical questions are described in the annexes, which are available online. Details of the other recommendations can be found in the guidelines listed above and in the references section.

1.5. Quality of evidence and strength of recommendation

The quality of evidence and the strength of each recommendation were assessed using the GRADE methodology for the three clinical questions (1–3 above). In the GRADE assessment process, the quality of a body of evidence is defined as the extent to which one can be confident that the reported estimates of effect (desirable or undesirable) available from the evidence are close to the actual effects of interest. The usefulness of an estimate of the effect (of the intervention) depends on the level of confidence in that estimate. The higher the quality of evidence, the more likely a strong recommendation can be made; however, the decision regarding the strength of the evidence also depends on other factors. Although the GRADE evidence assessment process was used for the clinical questions, it was not always possible to complete GRADE profiles for all the questions because there was a lack of data and information to calculate the necessary risk ratios.

In the GRADE profiles, the following levels of assessment of the evidence were used:

The strength of evidence and recommendation is presented for the three clinical questions that were specifically reviewed for the development of this policy. The strength of evidence and recommendation from the other documents approved by the GRC are also presented when possible. However, given the lack of the data necessary to calculate risk ratios, and as they largely represent programmatic processes, the strength of evidence for the activities included in section A of the collaborative TB/HIV activities and for the programmatic question (4 above) is not presented.

The rationale for strong and conditional recommendations is presented in the table below.

The draft document, including the population/intervention/comparison/outcome (PICO) questions, was prepared by a WHO Steering Group, representing the WHO HIV/AIDS and Stop TB departments, and then circulated to the members of the Policy Updating Group for feedback. The group discussed the overall structure of the policy through email-based discussion, assessed the evidence along with the risks and benefits of the three clinical questions, and determined the recommendations and their strengths. A telephone conference call was organized among members of the Policy Updating Group to further discuss issues that were not clarified during the email-based discussions. The policy was revised based on feedback obtained from emails and telephone conference discussion and reviewed again by the Policy Updating Group before consensus was reached. The policy was then circulated to 34 internal and external peer reviewers. Comments from internal and external peer reviewers were discussed among the WHO Steering Group, and the document was finalized by the coordinators of the process.

1.6. Adaptation of the policy

The interim policy on collaborative TB/HIV activities has been widely implemented since its publication in 2004. National programmes and other stakeholders should use the experiences garnered over the years to adapt their policies with the update to best suit their local circumstances. Factors should include the epidemiology of TB and HIV and the health-care delivery system specific to individual countries. The adaptation process should include national-level policy and programmatic decisions to determine the best country-specific programme management mechanism for providing integrated TB and HIV services. The ultimate goal of the adaptation should be scaled up nationwide coverage of collaborative TB/HIV activities to reduce HIV-associated TB mortality and morbidity depending on the epidemiology of TB and HIV.