Please select the arm or intervention descriptions that belong 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: Arm Label: Intervention arm; Type: EXPERIMENTAL; Interventions: Behavioral: The SHARE Project | Arm Label: Control arm; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: The SHARE Project; Assigned to Arm(s): Intervention arm
B: Intervention Type: BEHAVIORAL; Name: Prompting (survey instrument/resources list) (behavior); Assigned to Arm(s): N/A
C: Arm Label: Clinics trained in brief intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Family Planning-based Partner Violence Intervention | Arm Label: Control sites providing standard of care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Family Planning-based Partner Violence Intervention; Assigned to Arm(s): Clinics trained in brief intervention
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Public Health Nurse Home Visit | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Intimate Partner Violence (IPV) Protocol | Intervention Type: BEHAVIORAL; Name: Public Health Nurse Home Visit; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Intimate Partner Violence (IPV) Protocol; Assigned to Arm(s): 2

Answer: A