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

This study has been completed.

Sponsor:

Collaborators:

NEGES Foundation, Leogane, Haiti

Adelphi University

Information provided by (Responsible Party):

Carmen Logie, Women's College Hospital

ClinicalTrials.gov Identifier:

NCT01492829

First received: December 13, 2011

Last updated: February 15, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 13, 2011

Last Updated Date

February 15, 2013

Start Date ^ICMJE

January 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HIV Knowledge [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Brief HIV Knowledge Questionnaire (Carey & Schroder, 2002)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01492829 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sexually Transmitted Infection Knowledge [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Measured using Sexually Transmitted Disease Knowledge Questionnaire (Jaworski & Carey, 2007)
Condom use [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Measured using a self-report of frequency of condom use with regular, casual and paid sex sexual partners
Substance use [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Measured using self-reported frequency of drug/alcohol use
Depression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Measured using Patient Health Questionnaire 2 (PHQ-2)
Social support [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Measured using Multi-dimensional scale of perceived social support (Zimet et al., 1988)
resilient coping [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Measured using Brief Resilient Coping Scale (Sinclair & Wallston, 2004)
Relationship Control [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Sexual Relationship Power Scale (Pulerwitz, Gortmaker & DeJong, 2000)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Risk Reduction Behavior
Interpersonal Relations
Mental Disorders

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

July 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Haiti

Administrative Information

NCT Number ^ICMJE

NCT01492829

Other Study ID Numbers ^ICMJE

GCC#0016-01-04-01-01

Has Data Monitoring Committee

Responsible Party

Carmen Logie, Women's College Hospital

Study Sponsor ^ICMJE

Women's College Hospital

Collaborators ^ICMJE

NEGES Foundation, Leogane, Haiti
Adelphi University

Investigators ^ICMJE

Principal Investigator:

Carmen H Logie, PhD

Women's College Hospital

Information Provided By

Women's College Hospital

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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