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

February 15, 2013 updated by: Carmen Logie, Women's College Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Haiti
      • Leogane, Haiti
        • NEGES

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's College Hospital

Collaborators

Adelphi University
NEGES Foundation, Leogane, Haiti

Investigators

  • Principal Investigator: Carmen H Logie, PhD, Women's College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

December 14, 2011

First Posted (Estimate)

December 15, 2011

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 15, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCC#0016-01-04-01-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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