Objective

We identify complexities encountered, including unanticipated crossover between trial arms and inadequate 'standard of care' violence services, during a cluster randomized trial (CRT) of a community-level intimate partner violence (IPV) and HIV prevention intervention in Uganda.

Methods

Concepts in public health ethics - beneficence, social value of research, fairness, standard of care, and researcher responsibilities for post-trial benefits - are used to critically reflect on lessons learned and guide discussion on practical and ethical challenges of violence intervention CRTs.

Results

Existing ethical guidelines provide incomplete guidance for responding to unexpected crossover in CRTs providing IPV services. We struggled to balance duty of care with upholding trial integrity, and identifying and providing appropriate standard of care. While we ultimately offered short-term IPV services to controls, we faced additional challenges related to sustaining services beyond the 'short-term' and post-trial.

Conclusion

Studies evaluating community-level violence interventions, including those combined with HIV reduction strategies, are limited yet critical for developing evidence-based approaches for effectively preventing IPV. Although CRTs are a promising design, further guidance is needed to implement trials that avoid introducing tensions between validity of findings, researchers' responsibilities to protect participants, and equitable distribution of CRT benefits.

The World Health Organization recommends that HIV counseling and testing (HCT) programs implement strategies to address how intimate partner violence (IPV) influences women's ability to protect themselves from and seek care and treatment for HIV infection. We discuss the process used to adapt a screening and brief intervention (SBI) for female clients of HCT services in Rakai, Uganda-a setting with high prevalence of both HIV and IPV. By outlining our collaborative process for adapting and implementing the SBI in Rakai and training counselors for its use, we hope other HCT programs will consider replicating the approach in their settings.

Intimate partner violence (IPV) has a bidirectional relationship with HIV infection. Researchers from the Rakai Health Sciences Program (RHSP), an HIV research and services organization in rural Uganda, conducted a combination IPV and HIV prevention intervention called the Safe Homes and Respect for Everyone (SHARE) Project between 2005 and 2009. SHARE was associated with significant declines in physical and sexual IPV and overall HIV incidence, and its model could be adopted as a promising practice in other settings. In this article we describe how SHARE's IPV-prevention strategies were integrated into RHSP's existing HIV programming and provide recommendations for replication of the approach.

The Safe Homes And Respect for Everyone (SHARE) intervention introduced an intimate partner violence (IPV) prevention approach into Rakai Health Sciences Program, an established HIV research and service organization in Uganda. A trial found exposure to SHARE was associated with reductions in IPV and HIV incidence. This mixed methods process evaluation was conducted between August 2007 and December 2009, with people living in SHARE intervention clusters, to assess awareness about/participation in SHARE, motivators and barriers to involvement, and perceptions of how SHARE contributed to behavior change. Surveys were conducted with 1407 Rakai Community Cohort Study participants. Qualitative interviews were conducted with 20 key informants. Most (77%) were aware of SHARE, among whom 73% participated in intervention activities. Two-thirds of those who participated in SHARE felt it influenced behavior change related to IPV. While some felt confident to take part in new IPV-focused activities of a well-established program, others were suspicious of SHARE's motivations, implying awareness raising is critical. Many activities appealed to the majority (e.g., community drama) while interest in some activities was limited to men (e.g., film shows), suggesting multiple intervention components is ideal for wide-reaching programming. The SHARE model offers a promising, acceptable approach for integrating IPV prevention into HIV and other established health programs in sub-Saharan Africa.