Improving HIV/AIDS Programming through the Translation of Research to Practice 

PEPFAR’s Approach to Promoting Evidence-Based Programming 

The first phase of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) focused on reducing HIV mortality and morbidity as quickly as possible.While basic infrastructure for evaluation and monitoring of programs existed, the main priority of the emergency response was rapid scale-up of service delivery programs.To ensure long-standing, locally owned approaches to sustaining the monu­mental increases in the availability of HIV/AIDS services enabled by PEPFAR’s first phase, the second phase of PEPFAR focuses on increasing the sustainability, cost-effectiveness, and impact of HIV/ AIDS programs in those countries hardest hit by the epidemic. 

In order to accomplish these goals, PEPFAR embraces an “imple­mentation science” framework. Implementation science focuses on how to improve the uptake, translation, and implementation of research into common practices. PEPFAR announced awards for a 3-year, $60 million initiative with potential for additional fund­ing to support implementation science research and evaluation of programs implemented under PEPFAR. These evaluations, funded through collaboration with the U.S, Centers for Disease Control and Prevention (CDC), the National Institutes of Health, and the U.S. Agency for International Development (USAID), will con­tribute to the evidence base for HIV programs and maximize the impact of their investments in programs around the world. Data gathered will help partner countries strengthen their efforts to prevent new infections and save lives.

USAID’s Implementation Science Investment

In August 2011, USAID released the Annual Program Statement (APS) “Implementation Science Research to Support Programs under PEPFAR.” Through the APS, USAID plans to award up to three rounds of studies; the awardees of the APS .first round are described below. Each of the awarded studies will be for a maxi­mum 3-year period of study implementation and with a total study budget of US$3 million or less. The scope of the APS encourages study proposals to address HIV technical-area-specific program areas, as well as how to strengthen the integration of programs across the prevention, care, and treatment continuum. 

USAID’s Partners in Implementation Science 

Coop​erative Agreement Prime Partner: Futures Group International 

• Title: Evaluating the Impact of a Community Savings and Loan Group Model on Child and Household Well-Being
• Subpartners: Institute of Economic and Social Research at the University of Zambia, Catholic Relief Services, and World Vision
• Country of Implementation: Zambia
• Principal Investigators: Dr. Jenifer Chapman, Futures Group International; Dr. Karen Foreit, Futures Group International 

Study Synopsis
Zambia has one of the highest HIV prevalence rates in the world, and as in other countries with high HIV prevalence, Zambia suf­fers from high-poverty rates, high food insecurity, and high child malnutrition.To mitigate these impacts of high HIV prevalence and incidence, the Government of Zambia is committed to improv­ing social support programs for households, specifically  economic strengthening and food security programs. Futures Group will ex­amine the impact of a community savings model, known as savings and internal lending communities (SILC), on child and household well-being in Zambia.The study will assess the impact of caregivers’ participation in SILC on children’s food security and examine how participation in SILC changes household decision-making dynamics, children’s nutritional status, access to health and school services, and household expenditures.The study results will identify effec­tive approaches to implementing savings and loan group models, promoting economic security for orphans and vulnerable children (OVC) households, and improving children’s access to health care, education, and nutrition. 

“We seek to identify what works, what doesn’t, and why, and implement changes in our programs to optimize … that information.”
– USAID Administrator Rajiv Shah – 

• Title: Evaluating Antiretroviral (ARV)-based Prevention in HIV-1 Serodiscordant Couples in Kenya and Uganda 
• Subpartners: Harvard Medical School, Imperial College, Kenyatta National Hospital, Makerere University Kampala, and Kabwohe Clinical Research Center 
• Country of Implementation: Kenya and Uganda 
• Principal Investigator: Dr. Connie Celum, University of Washington 

​Study Synopsis 
In Africa, HIV serodiscordant couples account for a substantial proportion of new HIV infections.  Several studies have shown pre-exposure prophylaxis (PrEP) and initiation of antiretroviral therapy (ART) can significantly reduce HIV transmission. However, some HIV-infected individuals do not want to begin ART until they are symptomatic, and national guidelines for ART typically are based on WHO guidelines for HIV-infected persons with CD4<350. 

Providing PrEP to the HIV-negative partner as a bridge until the HIV-infected partner initiates ART and achieves viral suppression could be an effective method to prevent HIV transmission in HIV serodiscordant couples.This study looks to examine the feasibility and effectiveness of bridging PrEP to ART in decreasing HIV trans­mission among HIV serodiscordant couples. The primary objec­tives are to identify high-risk HIV serodiscordant couples in Kenya and Uganda based on an empiric risk score and the factors that affect the successful implementation of PrEP as a bridge to ART. Other objectives include measuring the proportion of individuals who achieve sustained adherence to ART and PrEP, and determine the impact of the bridging strategy on HIV transmission and cost­effectiveness.This project will study how to translate the efficacy of antiretrovirals for prevention of HIV transmission into a public health delivery model focused on HIV serodiscordant couples. 

• Title: Combination Intervention Package to Enhance Antiretrovi­ral Therapy Uptake and Retention during TB Treatment in Lesotho 
• Subpartners: National University of Lesotho, Lesotho’s Ministry of Health and Social Welfare, Lesotho Red Cross, and Christian Health Association of Lesotho 
• Country of Implementation: Lesotho 
• Principal Investigator: Dr.Andrea Howard, ICAP

Study Synopsis 
Tuberculosis (TB) morbidity and mortality among HIV-infected patients remain a major problems in Africa. In Lesotho, HIV preva­lence is the world’s third highest (23 percent), and the TB incidence rate is the world’s sixth highest (633 cases per 100,000 popula­tion). Fortunately, effective treatments exist for individuals infected by both HIV and TB. Provision of ART among those being treated for TB reduces mortality risk by 64 percent to 95 percent and is associated with a reduction in recurrent TB. Despite substantial evi­dence of the benefits of early ART initiation of HIV-infected TB pa­tients, implementation and uptake have been suboptimal.This study looks to evaluate the effectiveness and acceptability of a combina­tion of interventions to improve early ART initiation and reten­tion during TB treatment, as well as TB treatment success among HIV-infected TB patients in Lesotho. Researchers will examine the evidence-to-program gap between the barriers that prevent early ART implementation in high-burden, resource-limited settings. 

Cooperative Agreement Prime Partner: Elizabeth Glaser Pediatric AIDS Foundation (EGPAF)

• Title: The Kabeho Study-Assessing the Implementation of Revised HIV and Infant Feeding Guidelines and the Effect on Nutrition, Growth and HIV-Free Survival among Children Born to HIV-Positive Mothers in Kigali, Rwanda
• Subpartners: National University of Rwanda, School of Public Health, and Rwanda Ministry of Health
• Country of Implementation: Rwanda
• Principal Investigators: Dr. Emily Bobrow, EGPAF; Dr.Anita Asi­imwe, Rwanda Biomedical Center 

Study Synopsis 
In 2010, the World Health Organization released a series of guidelines for the prevention of mother-to-child transmission of HIV (PMTCT). These guidelines highlighted effective infant feeding practices and emphasized the use of ARVs to make extended breast feeding a safe option for HIV-positive women and children.The Government of Rwanda took these guidelines a step further and ini­tiated all HIV-positive women on lifetime ARV therapy in addition to infant feeding counseling and support programs to reduce pediatric HIV and allow for safe breast feeding practices. However, there are large evidence gaps on how to carry out effectively national PMTCT programs to eliminate pediatric HIV in resource-limited countries. The challenges of PMTCT program scale-up include adherence to long drug regimens and regular attendance at prenatal and postnatal clinics for safe breast feeding practices.This prospective cohort study will examine the effectiveness and feasibility of universal ART for HIV-positive pregnant women coupled with infant feeding counsel­ing and food support on 18-month HIV-free survival of HIV-ex­posed children in Kigali, Rwanda. Other objectives include determin­ing factors associated with optimal infant growth and adherence to the ART regimen.This study addresses the lack of evidence that exists in how to effectively scale up ARV therapy and infant feeding counseling and support for PMTCT efforts in low-resource coun­tries, and how effective these programs are in reducing mother-to-­child transmission (MTCT). 

Cooperative Agreement Prime Partner: Population Services International 

• Title: Randomized Evaluation of Family Planning and HIV Ser­vice Linkage and Integration Models for Implementation at Scale in Zambia
• Subpartners: Population Services International-Zambia and  Population Council
• Country of Implementation: Zambia
• Principal Investigators: Dr. Paul C. Hewett, Population Council; Mr. Nicholas Shiliya, Society for Family Health 

Cooperative Agreement Prime Partner:The Aurum Institute 

• Title: Accelerating Entry into Care Following HIV Diagnosis
• Subpartners: South African Department of Health
• Country of Implementation: South Africa
• Principal Investigator: Dr. Salome Charalambous 

Study Synopsis 
Late initiation of ART of newly diagnosed HIV-positive patients contributes to the high HIV, associated mortality, and HIV inci­dence in South Africa. Even after raising the CD4 count threshold to initiate therapy, late entry to ART remains a prevalent problem in South Africa. One purposed reason for late entry is the failure to connect people who test positive for HIV into immediate care. This has led to increased HIV associated mortality and contributed to HIV transmission.This study looks to examine how to increase effectively and efficiently the timely entry into care among people recently diagnosed as HIV-positive. One of the main objectives will be to examine barriers and facilitators to entry of care among people testing HIV-positive.The principal investigator will exam­ine four different strategies on entry into care by 6 months. Each strategy tested addresses key barriers to timely initiation of ART; health perceptions, personal barriers, and structural barriers. Other factors that will be examined include the time to initiate ART among those eligible, retention in care 6 months from entry, cost-effectiveness, and impact on mortality and HIV transmission. 

• Title: Situkilwane Lesiphephile-Safe Generations: Improving Ap­proaches to ARV Therapy for HIV+ Pregnant Women
• Subpartners: Swaziland Ministry of Health and Social Welfare, University of Cape Town, National Emergency Response Council on HIV/AIDS, and Elizabeth Glaser Pediatric AIDS Foundation
• Country of Implementation: Kingdom of Swaziland
• Principal Investigator: Dr. Elaine Abrams, Columbia University 

Study Synopsis 
Mother-to-child transmission of HIV is attributable to 90 percent of new pediatric HIV infections worldwide, yet evidence shows that initiating ARV therapy during pregnancy can effectively reduce MTCT. When it comes to PMTCT, there are barriers to scal­ing up effectively ARV therapy into effective PMTCT programs. Many factors, from diagnosis of maternal HIV to initiation of ARV, have prevented effective PMTCT efforts. Several PEPFAR prior­ity countries provide a suitable context to study how to translate effectively proven PMTCT techniques into effective programs.This study will evaluate the feasibility and cost-effectiveness of provid­ing all HIV-positive pregnant women lifelong triple ARV therapy, regardless of CD4 count, in the Kingdom of Swaziland. All enrolled women and their infants will be comprehensively followed up to determine outcomes.The goal of the study is to show that a single, streamlined approach to ARV therapy for HIV-positive pregnant women will lead to more effective PMTCT. 

Cooperative Agreement Prime Partner:  ICAP at Columbia University 

• Title: Combination Intervention Strategies for Linkage and Retention
• Subpartners: Eduardo Mondlane University, Ministry of Health Mozambique, Mozambican National Institute of Health, and Center for Collaboration in Health
• Country of Implementation: Mozambique
• Principal Investigator: Dr. Batya Elul 

Study Synopsis 
Effective linkage from HIV testing to HIV care remains an obstacle in many PEPFAR priority countries. From initial diagnosis to reten­tion in ART, only about one-third of patients who test HIV-positive are linked with HIV treatment after 1 year. Previous research has failed to address the multiple concurrent barriers newly diagnosed HIV patients face in the linkage from HIV testing to HIV care. In ad­dition, most previous research has examined retention in HIV care instead of identifying weaknesses in linkage.This site-randomized study in Mozambique will compare the effectiveness of a combina­tion of interventions, versus the current standard of care, on link­age and retention of newly diagnosed HIV patients. Patients will be followed from initial testing to retention in care 1 year later. In ad­dition, investigators will look at the incremental effect of providing non-cash financial incentives in conjunction with the combination of interventions compared to just the combination of interventions alone. Researchers hope to show that a combination of interven­tions of linkage and retention will be more effective in mitigating the multiple barriers HIV-positive patients face when moving from diagnosis to treatment.

USAID’s Ongoing Support for Implementation Science 

In early 2013, USAID plans to release the second round of the “Implementation Science Research to Support Programs under PEPFAR” APS.To ensure USAID supports the broadest possible range of program issues under the APS, USAID will emphasize in the second round those program-specific and cross-cutting issues that were not addressed by the studies supported under the first round of the APS. 

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