Assessing the Impact of an Intervention to Prevent Intimate Partner Violence and HIV in Uganda

NCT02050763 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11451

Last updated 2014-10-15

No results posted yet for this study

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.

Conditions

  • HIV
  • Physical Abuse of Adult (If Focus of Attention is on Victim)
  • Sexual Abuse of Adult (If Focus of Attention is on Victim)
  • Risk Reduction Behavior

Interventions

BEHAVIORAL

The SHARE Project

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.

Sponsors & Collaborators

  • Rakai Health Sciences Program

    collaborator OTHER
  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Jennifer Wagman, PhD · University of California, San Diego

  • Ronald H Gray, MD · Johns Hopkins Bloomberg School of Public Health

  • David Serwadda, MMed · Makerere University

  • Heena Brahmbhatt, PhD · Johns Hopkins Bloomberg School of Public Health

  • Fred Nalugoda, MHS · Rakai Health Sciences Program

  • Joseph Kagaayi, MD · Rakai Health Sciences Program

  • Gertrude Nakigozi, MD · Rakai Health Sciences Program

  • Jacquelyn Campbell, PhD · Johns Hopkins School of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02050763 on ClinicalTrials.gov