Over the past decade, tremendous progress has been made in addressing the HIV epidemic in low- and middle-income countries, with expanded access to antiretroviral therapy (ART) in many countries, and advances in key areas, such as prevention of mother-to-child transmission and voluntary medical male circumcision.1 However, many gaps remain, with limited coverage for care and treatment in many countries1 and ongoing challenges for epidemic control. As countries and donors work to expand access to critical HIV prevention, care and treatment services in an era of declining funding and multiple competing needs, programs will need to determine strategic priorities, identifying and implementing interventions that demonstrate the greatest impact on key outcomes.
The US President's Emergency Plan for AIDS Relief (PEPFAR), which supports HIV programs in 36 countries and regions in Africa, Asia, Eastern Europe, Central America, and the Caribbean, is currently engaged in such a process, re-examining overall priorities with the goal of controlling the epidemic and achieving an AIDS-free generation. As outlined in PEPFAR 3.0: Controlling the epidemic: Delivering on the promise of an AIDS-free generation,2 PEPFAR is in the process of realigning geographic and programmatic focus, emphasizing strategic investments to scale up effective evidence-based interventions in high HIV prevalence areas and populations to maximize impact on the epidemic. As part of this focus on impact, efficiency, and sustainability, PEPFAR is reassessing programmatic priorities both within and across program areas. PEPFAR-supported programs are engaged in a similar prioritization process at the country/regional level.
An internal US government (USG) group of HIV care and support experts from across several agencies was charged with assisting PEPFAR country teams to reassess care and support priorities within the programs they support. As defined by PEPFAR, care and support services consist of key non-ART interventions for people living with HIV (PLHIV), including clinical (eg, prevention and treatment of opportunistic infections) and nonclinical (eg, social and preventive) services3 (listed in Table 1). In considering priorities, there was agreement that priority interventions should be identified based on evidence of effectiveness in addressing critical needs and demonstrable public health impact on key health outcomes. This approach is consistent with recommendations from the recent US Institute of Medicine evaluation of PEPFAR,4 which called on PEPFAR to prioritize care and support interventions based on their impact on key outcomes. Key outcomes identified by the USG experts included mortality, morbidity, retention in care, quality of life, and prevention of ongoing HIV transmission. A detailed review of the evidence was conducted for individual care and support interventions, examining available evidence on the impact of each intervention on the outcomes listed above. Further information on the methodology of the review and findings for individual interventions is provided in the Introduction5 and other articles in this supplement.
After careful review of the evidence for each intervention, and consideration of the impact of each intervention on the outcomes listed above, a framework was developed to help PEPFAR country teams to determine priority interventions within their care and support programs.
THE PEPFAR CARE AND SUPPORT FRAMEWORK: IDENTIFYING PEPFAR CARE AND SUPPORT PRIORITIES
Based on the evidence, some interventions were deemed necessary for all PLHIV, in all settings. However, the need for other interventions may vary depending on the country context. Thus, the framework groups care and support interventions into two categories—universal and contextual.
This category includes interventions that are expected to have the greatest impact on morbidity and mortality, which are supported by a strong evidence base and are universally applicable—in every country, for every PLHIV. This category includes the following interventions:
- Regular clinical and laboratory monitoring, including World Health Organization (WHO) staging, and if possible, CD4 count and/or viral load, per country guidelines.
- Screening for active tuberculosis (TB) (intensified case finding), with referral for diagnosis and treatment as appropriate.
- Cotrimoxazole (CTX) prophylaxis for those who are eligible, per country guidelines.
- Evidence-based interventions (both clinical and nonclinical) to optimize retention in care and adherence to ART, which address local gaps and barriers.
The rationale for inclusion of these activities as universal interventions is described here. Clinical and laboratory (CD4 and/or viral load) monitoring, although not specifically examined in the evidence review, are necessary for appropriate follow-up of all patients in all settings.6 Clinical and laboratory monitoring, as defined, are vital to determine eligibility for ART and need for other interventions (eg, screening and prophylaxis for opportunistic infections); they are also key to assessing response to ART and potential need for alternative regimens. TB screening (intensified case finding), with referral for TB diagnosis and treatment as appropriate, and CTX prophylaxis are the two non-ART interventions known to have the greatest impact on morbidity and mortality in both ART and pre-ART patients, and thus are also considered universally applicable.7,8 Finally, given the critical importance of retention in care and adherence to ART, evidence-based interventions (clinical and nonclinical, facility and community based) that are expected to improve retention and adherence in the local context are also included as universal interventions.6
Interventions to address retention and adherence are not specifically defined, as these may vary depending on the local context. In selecting appropriate interventions to address retention and adherence, PEPFAR-supported programs need to understand local gaps and barriers and identify interventions that address them. It is important to emphasize that interventions to improve retention and adherence should be supported by evidence, ideally from the published literature, or in-country data.
The interventions listed above are also highlighted in PEPFAR's recently implemented Monitoring, Evaluation and Reporting system. Specifically, there are Monitoring, Evaluation and Reporting indicators addressing clinical and laboratory monitoring, TB screening, and retention on ART, as well as a new site-level quality indicator that will assess whether 80% of PLHIV in care are receiving clinical and/or laboratory monitoring, TB screening and if eligible, CTX. In addition, these interventions are also addressed within PEPFAR's new Site Improvement through Monitoring System, a system-wide approach to improving quality across PEPFAR-supported sites, with core essential elements that address ART eligibility (based on WHO staging or CD4 count), TB screening, CTX, patient tracking to optimize retention in care, and ART adherence.
All other care and support interventions (those not defined as “universal” above) fall into this category, requiring further consideration based on the country context to determine appropriate prioritization (Table 1). PEPFAR-supported programs should consider evidence for each intervention, prioritizing interventions expected to have the greatest impact on morbidity and mortality based on the individual country context. The articles included in this supplement provide an overview and assessment of the evidence base for these interventions. In assessing interventions, PEPFAR-supported programs may also want to consider in-country data, particularly data examining the impact of interventions on key outcomes, such as morbidity and mortality.
In addition to weighing evidence for impact of each intervention, a number of country contextual and programmatic factors should be considered in assessing whether to implement care and support interventions, including the following:
- Scope and impact of problem within each country for PLHIV (eg, prevalence of cryptococcal disease, cervical cancer, etc. among PLHIV; public health burden, including morbidity and mortality among PLHIV; and anticipated public health impact of designated interventions addressing the problem).
- Complexity of systems and infrastructure needed to address the issue (eg, equipment, commodities, implications for supply chain; need for laboratory, pharmacy, or referral systems; human resource requirements, including staff and training; implications for data collection and reporting and information systems; need for systems to assure quality, including supervision, site monitoring, quality assurance/improvement).
- Level of investment and adequacy of existing systems and infrastructure (eg, ability to build on existing systems and leverage previous investments).
- Availability of other non-PEPFAR support (eg, funding from other USG agencies, other donors, or national governments might reduce the need for PEPFAR support).
- Level of host government commitment and prioritization (eg, availability of a national policy, strategy, guidelines; degree to which government has committed resources, including funding, staff, space; degree of government engagement and support), as activities not prioritized by host country governments are unlikely to be sustainable.
- Engagement of other stakeholders, particularly in-country stakeholders (eg, civil society, PLHIV groups).
- Potential for sustainability.
- Cost and cost-effectiveness.
Because many of these contextual factors vary significantly from country to country, PEPFAR-supported programs will need to weigh these contextual considerations, along with the evidence base, to determine how to prioritize each of the interventions in the “contextual” group.
THE PEPFAR CARE AND SUPPORT FRAMEWORK: IMPLICATIONS FOR PEPFAR-SUPPORTED PROGRAMS
Based on the considerations outlined above, PEPFAR has issued recommendations for PEPFAR-supported programs, summarized in this article. The recommendations state that PEPFAR-supported programs should use the Care and Support Framework described above, along with available evidence (including evidence cited in this supplement, and in-country data as appropriate), to help determine care and support priorities within the country context, identifying interventions that are critical to saving lives, preventing new infections, and controlling the epidemic—regardless of funding source. Then, considering PEPFAR's role within the context of overall support from governments and other donors, PEPFAR programs will need to determine which interventions PEPFAR should support.
Implications for Prioritization
Because these interventions are deemed universally applicable and critical to saving lives, PEPFAR-supported programs should support these interventions, unless they are adequately supported by governments or other donors with high-quality programming and evidence of impact.
In considering contextual interventions, PEPFAR-supported programs should weigh the evidence for each intervention, prioritizing interventions expected to have the greatest impact on morbidity and mortality based on the individual country context. Weighing the strength of evidence and the potential impact of each intervention in a given country context, and considering the need for PEPFAR support in the context of overall support from government and other donors, PEPFAR-supported programs should determine how to prioritize and whether to support each contextual intervention.
It is important to note that many care and support interventions may have the potential for significant impact on morbidity and mortality, but may not be universally applicable, or may not have as strong a body of evidence to support impact, and so may not fall into the universal category. However, these may still be very important interventions with the potential for significant public health impact within the context of an individual country. Thus, many care and support interventions that are not defined as “universal” may still be considered priority interventions that PEPFAR-supported programs choose to support based on the country context.
Thus, all PEPFAR-supported country or regional programs would be expected to support the universal interventions listed above, unless these interventions are adequately supported by governments or other donors and of high quality, with evidence of impact. Programs should then assess the remaining contextual care and support interventions to determine how to prioritize and whether to support each of these interventions, based on the considerations above.
The PEPFAR Care and Support Framework described in this article provides a systematic approach for PEPFAR-supported programs to build on available evidence as well as country contextual considerations to help determine key care and support priorities. The accompanying articles in this supplement provide an assessment of evidence for individual interventions, focusing particularly on their impact on key outcomes. This approach is aligned with PEPFAR's emphasis on impact, sustainability, and efficiency.2 However, this approach may also be of value beyond PEPFAR programs, as other countries and donors consider how to prioritize interventions. The authors hope that this framework, and the accompanying articles assessing the evidence for care and support interventions, will provide useful resources to help countries and donors prioritize HIV care and support interventions to maximize impact on the epidemic.
The authors thank Jonathan E. Kaplan from the Division of Global HIV/AIDS, Center for Global Health, Centers for Disease Control and Prevention (CDC) for helpful discussion and comments on the article; Douglas Shaffer from the Office of the US Global AIDS Coordinator and Health Diplomacy for review of the article; and Rebecca Kahn, also from the Office of the US Global AIDS Coordinator and Health Diplomacy, for logistical support.