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

NCT02050763 | Completed DMC

• 2 other identifiers: 1F31MH095649-01A1WIRB Protocol # 20031318
• Study Type: interventional
• Target: 11,451
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV; Intimate partner violence; Community based prevention intervention; Uganda; Cluster randomized trial

Outcome Measures

Primary Outcomes (1)

• Intimate partner violence

  Physical violence was measured by asking female participants, "In the past 12 months has your current partner done any of the following to you: Pushed, pulled, slapped, or held you down? Punched you with fist or with something that could hurt you? Kicked you or dragged you? Tried to strangle you or burn you? Threatened you with a knife, gun or other type of weapon? Attacked you with knife, gun, or other weapon?" (Yes/No) Sexual IPV was measured by asking female participants, "In the past 12 months has your current partner done any of the following to you: Used verbal threats to force you to have sex when you did not want to? Physically forced you to have sex when you did not want to? Forced you to perform other sexual acts when you did not want to?" (Yes/No) Emotional intimate partner violence was measured by asking female participants, "In the past 12 months, has your current partner verbally abused or shouted at you?" (Yes/No).

  One year

Secondary Outcomes (10)

• HIV incidence

  One year

• Non-marital partnerships

  One year

• Condom use

  One year

• Alcohol use

  One year

• Circumcision status

  One year

Study Arms (2)

Intervention arm

EXPERIMENTAL

Intervention arm clusters (n=4) received an IPV prevention intervention (the Safe Homes and Respect for Everyone (SHARE) Project), enhanced HIV testing and treatment and routine HIV services.

Behavioral: The SHARE Project

Control arm

NO INTERVENTION

Control arm clusters (n=7) received standard of care HIV services alone.

Interventions

The SHARE Project BEHAVIORAL

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.

Intervention arm

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between the ages of 15-49 years;
• Consent to participation;
• Resident of at least 6 months in study community;
• Enrollment into RCCS at baseline (2005-06);
• Report of sexual activity or being in a partnership in the year prior to the baseline interview;
• Provision of follow-up information on variables of interest.
• For HIV incidence, only participants with initial HIV-negative serostatus at their baseline visit were included in the analyses.

You may not qualify if:

• Younger than 15 years and older than 49 years;
• Did not consent to participation;
• Non-resident in study community;
• Not enrolled in RCCS between 2005-06;
• Not yet sexually active or not sexually active during year prior to baseline;
• Incomplete follow up information on variables of interest;
• HIV positive at baseline

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Rakai Health Sciences Program: collaborator

Study Sites (1)

Rakai Health Sciences Program

Kalisizo, Rakai, Uganda

Location

Related Publications (4)

• Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38.

  PMID: 10170434 BACKGROUND

• Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983 Jun;51(3):390-5. doi: 10.1037//0022-006x.51.3.390. No abstract available.

  PMID: 6863699 BACKGROUND

• Wagman JA, Namatovu F, Nalugoda F, Kiwanuka D, Nakigozi G, Gray R, Wawer MJ, Serwadda D. A public health approach to intimate partner violence prevention in Uganda: the SHARE Project. Violence Against Women. 2012 Dec;18(12):1390-412. doi: 10.1177/1077801212474874.

  PMID: 23419276 BACKGROUND

• Wagman JA, Gray RH, Campbell JC, Thoma M, Ndyanabo A, Ssekasanvu J, Nalugoda F, Kagaayi J, Nakigozi G, Serwadda D, Brahmbhatt H. Effectiveness of an integrated intimate partner violence and HIV prevention intervention in Rakai, Uganda: analysis of an intervention in an existing cluster randomised cohort. Lancet Glob Health. 2015 Jan;3(1):e23-33. doi: 10.1016/S2214-109X(14)70344-4. Epub 2014 Nov 28.

  PMID: 25539966 DERIVED

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jennifer Wagman, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Ronald H Gray, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• David Serwadda, MMed

  Makerere University

  STUDY DIRECTOR

• Heena Brahmbhatt, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Fred Nalugoda, MHS

  Rakai Health Sciences Program

  STUDY DIRECTOR

• Joseph Kagaayi, MD

  Rakai Health Sciences Program

  PRINCIPAL INVESTIGATOR

• Gertrude Nakigozi, MD

  Rakai Health Sciences Program

  PRINCIPAL INVESTIGATOR

• Jacquelyn Campbell, PhD

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 31, 2014
• Study Start: February 1, 2005
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: October 15, 2014

Record last verified: 2014-01

Locations

UG (1)