A cluster randomized trial of the impact of an intimate partner violence (IPV) and HIV prevention intervention on emotional, physical and sexual abuse,

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A cluster randomized trial of the impact of an intimate partner violence (IPV) and HIV prevention intervention on emotional, physical and sexual abuse, sexual risk and HIV incidence in Rakai, Uganda ____________________________________________ Wagman JA, Gray RH, Campbell J, Thoma M, Ndyanabo A, Ssekasanvu J, Nalugoda Fred, Kagaayi J, Nakigozi G, Serwadda, Brahmbhatt H 24 July 2014 ~ AIDS 2014

Background The relationship between IPV and HIV  IPV is a cause & consequence of HIV infection  Direct mechanisms Rape  Indirect mechanisms High HIV risk behaviors among IPV victims and perpetrators Limited capacity to self-protect  Several IPV/HIV prevention intervention studies have been conducted but none has successfully reduced both IPV and HIV infection

Introduction to study  An CRT in in Rakai, Uganda by RHSP via Rakai Community Cohort Study (RCCS) Objective  Evaluate the impact of IPV prevention intervention (the Safe Homes and Respect for Everyone (SHARE) Project) on IPV and HIV incidence.

Methods: Data Parent study: Rakai Community Cohort Study (RCCS)  50 communities organized in 11 study regions (clusters)  All consenting adults aged years  Annual surveys and biological samples Data from 3 rounds of RCCS – Used for in the CRT  Baseline (16 months: Feb 2005–Jun 2006)  Follow-up 1 (19 months: Aug 2006–Apr 2008)  Follow-up 2 (18 months: Jun 2008–Nov 2009) Trail registered with ClinicalTrials.gov- NCT

Randomization and Exposure by arm Allocation and baseline sample: Intervention = 4 clusters (n=5,337) Control = 7 clusters (6,111)

Data analysis: IPV & risk behaviors  Measures  IPV: Emotional, physical and sexual IPV-conflict tactic scale  Risk behaviors: spousal rape, total/extra-marital partners, alcohol use at sex, condom use, disclosure of HIV status  “Modified” Poisson regression models used to estimate prevalence risk ratios (PRRs)  Adjusted models controlled for baseline IPV measure of interest and covariates correlated with the violence outcomes and/or found to differ (at p<0.05 level) between trial arms at baseline

Data analysis: HIV incidence  HIV incidence/100 py assessed by cumulatively over 3 rounds  Poisson regression models fitted to estimate IRRs of HIV acquisition  Univariate and multivariate analysis to estimate the IRR in intervention vs. control communities over 4.5 year period.

Baseline characteristics

Results: Impact of SHARE on IPV at final FUP Women Men Adjusted for baseline age, education, marital status, experience of IPV victimization (women) or perpetration (men) (according to type), and # of non- marital sex partners.

Results: Impact of SHARE on spousal rape, risk factors and HIV incidence SHARE was associated with:  Reduced spousal rape (aPRR=0.80; 95% CI: )  Increased HIV results disclosure in all categories  Reduced HIV incidence:  In population (aIRR=0.64; 95% CI: , P=0.028)  Among men (aIRR=0.63, 95% CI: , P=0.049)  Among women (aIRR=0.69; 95% CI: , P=0.088)  SHARE was not associated with changes in number of partners, alcohol use surrounding sex, or condom use.

Conclusions and Implications  SHARE reduced women’s experiences of IPV and overall HIV incidence, possibly by reduction of rape and increased disclosure of HIV results.  HIV prevention programs should integrate IPV prevention into existing protocols.  SHARE approach could be effective for IPV prevention in other settings in Uganda and region  More comprehensive research needed to understand how trauma/physiology related to forced sex might increase risk for HIV infection.

Acknowledgements Funders  RCCS  Bill & Melinda Gates Foundation ( )  National Institutes of Health (U1AI51171)  Training support: The Fogarty International Center (5D43TW and 2D43TW AITRP)  SHARE impact measurement: World Health Organization (WHO# A55085).  SHARE intervention: President's Emergency Program For AIDS Relief (PEPFAR# CoAg GH000817)  Analysis of evaluation data  National Institute of Mental Health (NRSA, F31MH095649)  National Institute on Drug Abuse (T32DA023356). Insightful reviews and guidance on manuscript and abstract development  Dr. Lawrence Moulton, JHBSPH  Dr. David Celentano, JHBSPH Special thanks  Rakai Health Sciences Program for their efforts in study design, implementation, data collection and management  SHARE intervention team for their dedication to successful roll out of the violence prevention project  Study participants for providing extensive information for this research.