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

Primary Purpose

Risk Reduction Behavior, Interpersonal Relations, Mental Disorders

Status

Completed

Phase

Phase 1

Locations

Haiti

Study Type

Interventional

Intervention

individual and group-based, community health worker delivered

About this trial

This is an interventional prevention trial for Risk Reduction Behavior focused on measuring HIV prevention, sexually transmitted infection prevention, HIV knowledge, relationship power, depression, coping, social support, internally displaced persons, community health worker, HIV/STI educational video, substance use, women's health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

NEGES

Outcomes

Primary Outcome Measures

HIV Knowledge

Brief HIV Knowledge Questionnaire (Carey & Schroder, 2002)

Secondary Outcome Measures

Sexually Transmitted Infection Knowledge

Measured using Sexually Transmitted Disease Knowledge Questionnaire (Jaworski & Carey, 2007)

Condom use

Measured using a self-report of frequency of condom use with regular, casual and paid sex sexual partners

Substance use

Measured using self-reported frequency of drug/alcohol use

Depression

Measured using Patient Health Questionnaire 2 (PHQ-2)

Social support

Measured using Multi-dimensional scale of perceived social support (Zimet et al., 1988)

resilient coping

Measured using Brief Resilient Coping Scale (Sinclair & Wallston, 2004)

Relationship Control

Sexual Relationship Power Scale (Pulerwitz, Gortmaker & DeJong, 2000)

Full Information

NCT ID

NCT01492829

First Posted

December 13, 2011

Last Updated

February 15, 2013

Sponsor

Women's College Hospital

Collaborators

NEGES Foundation, Leogane, Haiti, Adelphi University

1. Study Identification

Unique Protocol Identification Number

NCT01492829

Brief Title

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

Acronym

FASY

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Women's College Hospital

Collaborators

NEGES Foundation, Leogane, Haiti, Adelphi University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Risk Reduction Behavior, Interpersonal Relations, Mental Disorders

Keywords

HIV prevention, sexually transmitted infection prevention, HIV knowledge, relationship power, depression, coping, social support, internally displaced persons, community health worker, HIV/STI educational video, substance use, women's health

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

individual and group-based, community health worker delivered

Intervention Description

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

Primary Outcome Measure Information:

Title

HIV Knowledge

Description

Brief HIV Knowledge Questionnaire (Carey & Schroder, 2002)

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Sexually Transmitted Infection Knowledge

Description

Measured using Sexually Transmitted Disease Knowledge Questionnaire (Jaworski & Carey, 2007)

Time Frame

8 weeks

Title

Condom use

Description

Measured using a self-report of frequency of condom use with regular, casual and paid sex sexual partners

Time Frame

8 weeks

Title

Substance use

Description

Measured using self-reported frequency of drug/alcohol use

Time Frame

8 weeks

Title

Depression

Description

Measured using Patient Health Questionnaire 2 (PHQ-2)

Time Frame

8 weeks

Title

Social support

Description

Measured using Multi-dimensional scale of perceived social support (Zimet et al., 1988)

Time Frame

8 weeks

Title

resilient coping

Description

Measured using Brief Resilient Coping Scale (Sinclair & Wallston, 2004)

Time Frame

8 weeks

Title

Relationship Control

Description

Sexual Relationship Power Scale (Pulerwitz, Gortmaker & DeJong, 2000)

Time Frame

8 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carmen H Logie, PhD

Organizational Affiliation

Women's College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

NEGES

City

Leogane

Country

Haiti

12. IPD Sharing Statement

Citations:

PubMed Identifier

27034426

Citation

Logie CH, Daniel C, Wang Y. Factors associated with consistent condom use among internally displaced women in Leogane, Haiti: results from a cross-sectional tablet-based survey. Sex Transm Infect. 2016 Nov;92(7):520-524. doi: 10.1136/sextrans-2015-052400. Epub 2016 Mar 31.

Results Reference

derived

PubMed Identifier

24587068

Citation

Logie CH, Daniel C, Newman PA, Weaver J, Loutfy MR. A psycho-educational HIV/STI prevention intervention for internally displaced women in Leogane, Haiti: results from a non-randomized cohort pilot study. PLoS One. 2014 Feb 28;9(2):e89836. doi: 10.1371/journal.pone.0089836. eCollection 2014.

Results Reference

derived

PubMed Identifier

22815471

Citation

Logie CH, Daniel C, Newman PA, Loutfy MR. An HIV/STI prevention intervention for internally displaced women in Leogane, Haiti: study protocol for an N-of-1 pilot study. BMJ Open. 2012 Jul 18;2(4):e001634. doi: 10.1136/bmjopen-2012-001634. Print 2012.

Results Reference

derived

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

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