A Cluster Randomized Trial of the Impact of an Intimate Partner Violence and HIV Prevention Intervention on Emotional, Physical and Sexual Abuse, Sexual Risk Behaviors and HIV Incidence in Rakai, Uganda

Research Team: Rakai Health Sciences Program Data collection for the proposed dissertation analysis was done by the research teams and investigators from Rakai Health Sciences Program (RHSP) which was established in 1988 with a focus on HIV/AIDS research, including evaluation of health education and condom promotion. Over time activities have increased in nature and volume and expanded to include laboratory and clinical research, randomized trials of new prevention strategies, health professional training, expanded community services including HIV voluntary testing and counseling, provision of HIV antiretroviral therapy (ART), general and HIV-related medical care, prevention of mother-to-child transmission of HIV (PMTCT), and family planning services. In 2002, the Rakai Program became an International Center for Excellence in Research (ICER), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The core of the RHSP is the 18-year community-based longitudinal Rakai Community Cohort Study (RCCS), within which the RHSP has implemented multiple interdisciplinary studies. Over 150 peer-reviewed papers have been generated from the RCCS and its nested studies.

Data Source: Rakai Community Cohort Study All data for the proposed analysis were derived from the Rakai Community Cohort Study (RCCS) which conducts survey interviews every 12-18 months with all consenting people aged 15-49 in ~5,000 households in 47-50 communities throughout Rakai. These 47-50 communities represent 7% of the 720 communities situated in Rakai District. The RCCS includes participants residing in trading centers and agrarian villages, representative of rural southwestern Uganda. Each RCCS participant receives a unique, life-long study identification number used to link data over time and between RHSP studies. RCCS written informed consent forms cover study participation, sample archiving for future assays including genetic testing, linkage of RCCS data to other RHSP databases, and permission to re-contact participants for other studies.

Trial Design The SHARE intervention trial used a cluster randomized controlled design where study regions rather than individuals were selected to receive (or not receive) exposure to the intervention, with all consenting adults in the community being offered treatment (intervention). The community-based approach was selected because offering a partner violence prevention intervention to individuals without involving their intimate partners would not achieve holistic results. IPV involves both members of the couple and its prevention must likewise target both.

The SHARE intervention trial was done via the Rakai Community Cohort Study (RCCS) which operates in ~50 communities which were aggregated into 11 study regions (categorized as rural or semi-urban) for a prior trial of sexually transmitted disease control and HIV transmission prevention conducted between 1994 and 1999. A previous FP outreach trial (1999 and 2002) had randomized these communities,35 and the SHARE study built on this prior randomization whereby the SHARE intervention was implemented in 4 regions (Buyamba, Kabira, Kalisizo, Katana) of the total 11 RCCS research areas. . For the current trial, four of the six FP intervention clusters were randomly assigned to the IPV intervention arm.

The process used to select regions for exposure to the SHARE trial built on a previous cluster randomized trial (CRT) that was conducted between 1999 and 2002 to assess the impact of family planning outreach via social marketing in Rakai. For the family planning CRT, 5 clusters were randomly selected to receive standard family planning services while 6 clusters were assigned to the intervention arm and received additional family planning information, counseling, and contraceptive methods from government service providers and community-based volunteer agents using social marketing and other strategies. Condom use was promoted in both control and intervention areas. Findings indicated family planning outreach via social marketing can significantly increase hormonal contraceptive use and decrease pregnancy rates. No differentials were found, however, in condom use between study arms.