A Community-health Worker Delivered HIV/STI Prevention Intervention for Internally Displaced Women in Leogane, Haiti

Study Overview
=================
Brief Summary
-----------------
The investigators will develop, deliver and evaluate a solar powered tablet-based individual and group focused HIV/STI prevention intervention with internally displaced women in Leogane, Haiti. Internally displaced women will be trained as community health workers to deliver the HIV/STI prevention intervention to other internally displaced women.

Detailed Description
-----------------
We will develop and field test a multi-component intervention that includes (1) solar-powered tablets with brief video-based educational messages and (2) 6 weekly peer-group sessions. The tablet will be programmed to analyze the data and to indicate incorrect HIV knowledge responses so the community health worker can immediately provide correct responses. This intervention involves 6 weekly women's health meetings that will cover a variety of issues pertinent to women's sexual health: HIV/AIDS, sexually transmitted infections, interpersonal relationships, communication and decision making, mental health and coping, creating social change.

Official Title
-----------------
Development and Evaluation of a Community Health Worker Delivered HIV/STI Prevention Intervention for Women Living in Internally Displaced Persons Camps in Leogane, Haiti

Conditions
-----------------
Risk Reduction Behavior, Interpersonal Relations, Mental Disorders

Intervention / Treatment
-----------------
* Behavioral: individual and group-based, community health worker delivered


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 and over capable of providing informed consent internally displaced (living in tent or camp) female Exclusion Criteria: male under 18 years old not able to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: individual and group-based, community health worker delivered|Pre-test will be individual, tablet-based; participants will receive correct information for incorrect HIV/STI knowledge responses and will watch a brief HIV/STI educational video. This will be followed by participants attending 6 weeks of group educational sessions focused on: HIV, STI, interpersonal relationships, communication and decision-making, mental health and coping, creating social change|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Knowledge | Brief HIV Knowledge Questionnaire (Carey & Schroder, 2002) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexually Transmitted Infection Knowledge | Measured using Sexually Transmitted Disease Knowledge Questionnaire (Jaworski & Carey, 2007) | 8 weeks | 
| Condom use | Measured using a self-report of frequency of condom use with regular, casual and paid sex sexual partners | 8 weeks | 
| Substance use | Measured using self-reported frequency of drug/alcohol use | 8 weeks | 
| Depression | Measured using Patient Health Questionnaire 2 (PHQ-2) | 8 weeks | 
| Social support | Measured using Multi-dimensional scale of perceived social support (Zimet et al., 1988) | 8 weeks | 
| resilient coping | Measured using Brief Resilient Coping Scale (Sinclair & Wallston, 2004) | 8 weeks | 
| Relationship Control | Sexual Relationship Power Scale (Pulerwitz, Gortmaker & DeJong, 2000) | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
social support, HIV prevention, sexually transmitted infection prevention, HIV knowledge, relationship power, depression, coping, internally displaced persons, community health worker, HIV/STI educational video, substance use, women's health