Despite 20 years of considerable HIV prevention efforts in Sub Saharan Africa the epidemic continues to have devastating impacts. The advent of expansion of treatment and care for AIDS in the region has provided important and lifesaving services, but has also added complexity to coordination and service delivery across prevention and care efforts. How to best combine intervention strategies (prevention, treatment, care, behavioral, biomedical) is a pressing question in the field. We believe that the best way to combine interventions is based on synergy, with intervention components directly reinforcing one another, not just whether programs occur simultaneously. In addition, needs are great and services limited. To achieve the maximum population-level reduction in HIV incidence it is important that those at greatest risk of transmitting and acquiring HIV receive more intensive interventions. We propose to conduct a prospective observational study of 1700 couples aged 18-45 years in Kisarawe, Tanzania who will be provided an intervention that offers: (1) HIV self-testing kits and pre-test counseling provided at the household, (2) linkage to a counseling and referral center for those who test positive, (3) facilitated enrollment to care and treatment for couples with confirmed HIV infection; and (4) access to pre-exposure prophylaxis for the negative partner in a HIV sero-discordant couple. A baseline and 18- month survey will be administered to all 1700 couples (3400 individuals), with a HIV and test conducted at 18-months. Positive partners who engaged in care as a dyad will have a CD4 and viral load test conducted at 18 months. All HIV sero-discordant couples identified through self-testing and entering care (estimated to be 50 couples) will also be administered an additional 6- and 12-month survey, and we will collect ongoing clinical data from each clinic visit. Biometric data (fingerprint) will be collected at enrollment, and all encounters with the counseling and referral center, and HIV treatment center, to allow linking of utilization of services with survey data. The study will position the project to advance to an appropriately powered randomized controlled trial should compelling efficacy be found, and safety and acceptance be established.

Public Health Relevance

To maximize the public health benefit of expenditures on HIV prevention, treatment and care in Sub Saharan Africa programs are needed that synergistically combine intervention strategies, target the intensity of interventions to attributable risk, suppor couples to reduce their risk of HIV transmission within the partnership, and facilitate safe and acceptable uptake of available treatment and prevention services. The goal of this study is to advance methodological innovations in the support of cost- effective combination HIV prevention programs. The study will develop reliable indicators for intervention exposure using biometric identifiers, develop indicators that capture dynamic multi- component risk reduction strategies, establish proof of concept for the combination and scalability of proven HIV intervention components never before brought to scale (HIV self-testing, PrEP for discordant couples), carefully assess the safety and acceptance of the strategy, and examine important operational issues related to comparative cost and efficiency of competing strategies. The study will be conducted in Kisarawe, Tanzania. The intervention, if found efficacious, would provide needed program and policy guidance highly significant to public health. In addition, if these strategies being explored are proven to be effective it could lead to substantial savings to US programs that support global AIDS control and treatment.

National Institute of Health (NIH)
National Institute of Mental Health (NIMH)
Research Project (R01)
Project #
Application #
Study Section
Behavioral and Social Consequences of HIV/AIDS Study Section (BSCH)
Program Officer
Stirratt, Michael J
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Medical University of South Carolina
Schools of Medicine
United States
Zip Code
O'Reilly, Kevin R; d'Aquila, Erica; Fonner, Virginia et al. (2017) Can Policy Interventions Affect HIV-Related Behaviors? A Systematic Review of the Evidence from Low- and Middle-Income Countries. AIDS Behav 21:626-642