CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11,451 enrolled
Drug / intervention
The SHARE Projectbehavioral
Likely dose
Not stated in record
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Search/NCT02050763
NCT02050763N/ACompleted

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

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Jan 31, 2014·Updated Oct 15, 2014

In Brief

A clinical study evaluating The SHARE Project for HIV and 3 related conditions. Completed, enrolled 11,451 participants across 1 site.

Detailed Summary

Intimate partner violence (IPV) is a precursor to and consequence of HIV infection. Few interventions combining HIV and IPV prevention have been evaluated and none has significantly decreased both outcomes. A cluster-randomized trial was conducted in Rakai, Uganda. Four intervention arm clusters (N=5,339) received an IPV prevention intervention (the Safe Homes and Respect for Everyone (SHARE) Project), enhanced HIV testing and treatment and routine HIV services provided by Rakai Health Sciences Program (RHSP). Seven control arm clusters (N=6,112) received standard of care HIV services alone. Baseline and two follow-up visits were conducted via the Rakai Community Cohort Study between 2005 and 2009. Primary outcomes were past year emotional, physical and sexual IPV and HIV incidence. Secondary outcomes included past year intimate partner rape/forced sex, number of total and extra-marital sex partners, alcohol use surrounding sex, condom use, discussion about condom use, partner's disclosure of HIV status and respondent's disclosure of HIV status. Analysis was by intention-to-treat. Modified Poisson regression was used to estimate prevalence risk ratios (PRR) to detect the impact of the intervention on IPV and secondary outcomes. Poisson regression was used to estimate incidence rate ratios (IRR) of HIV acquisition per 100 person years (py). Our study had three research aims and related hypotheses. Aim 1 was to assess the impact of SHARE + RHSP community services on report of victimization from and perpetration of physical and/or sexual IPV in the past 12 months, compared to the impact of RHSP community services alone. Hypothesis 1(a): SHARE intervention will reduce women's reports of IPV victimization in intervention vs. control arms. Hypothesis 1(b): SHARE intervention will reduce men's reports of IPV perpetration in intervention vs. control arms. Aim 2 was to assess the impact of SHARE + RHSP services on report of sexual risk behaviors among men and women compared to the impact of RHSP community services alone. Hypothesis 2(a): SHARE intervention will reduce selected sexual risk behaviors in the intervention vs. control arms. Aim 3 was to assess the impact of SHARE + RHSP services on HIV incidence compared to the impact of RHSP community services alone. Hypothesis 3(a): Incidence of HIV will be lower in the intervention vs. control arms.

Study Details

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 31, 2014
Enrollment StartFeb 1, 2005
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 12.4 years ago

Interventions

The SHARE Projectbehavioral

SHARE aimed to reduce IPV and used methodologies from two proven successful violence prevention frameworks: Stepping Stones (Welbourn, 1995) and the Resource Guide for Mobilizing Communities to Prevent Domestic Violence (Michau \& Naker, 2003). SHARE promoted a process of social change based on the Transtheoretical Model's Stages of Change Theory (Prochaska \& DiClemente, 1983; Prochaska \& Velicer, 1997) which posits that although people realize they need to make changes in their life, they do it in stages instead of one major life change. There are five main stages of change: (1) pre-contemplation, (2) contemplation, (3) preparation for action, (4) action and (5) maintenance. We hypothesized that repeated exposure to the ideas included in SHARE would encourage men and women to begin a process of change that results in preventive behavior.