Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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
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.


Options:
A: Inclusion criteria:

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

Exclusion criteria:

1. Younger than 15 years and older than 49 years;
2. Did not consent to participation;
3. Non-resident in study community;
4. Not enrolled in RCCS between 2005-06;
5. Not yet sexually active or not sexually active during year prior to baseline;
6. Incomplete follow up information on variables of interest;
7. HIV positive at baseline
B: Inclusion Criteria:

* Caregivers of children aged 2 months to 10 years who present for well-child care visit at a pediatric clinic

Exclusion Criteria:

* Non-English speaking
* Foster parents
* Previously enrolled parent
* No access to telephone
C: Inclusion:

* female clients
* ages 16-29
* English or Spanish speaking
* able to provide their own consent
* plan to be in area for the next 12 months
* willing to be contacted for follow up survey and able to provide additional contact information

Exclusion Criteria:

* female clients not of the specified age range
* neither English nor Spanish speaking
* clients who are intoxicated or otherwise not able to provide their own consent
D: Inclusion Criteria:

* Pregnant women 31 weeks or less gestation, over age 18, with a history of intimate partner violence within the past 2 years, and who are willing to participate in the home visit program

Exclusion Criteria:

Age 17 or less. History of partner violence beyond 2 years. Not participating in home visit program. Does not speak English

Answer: A