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

Mental Disorders Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492829
• Other study ID #: GCC#0016-01-04-01-01
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2011
• Last updated: February 15, 2013
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: February 2013
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Women's College Hospital
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Interpersonal Relations
• Mental Disorders
• Psychotic Disorders
• Risk Reduction Behavior

Intervention

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

Locations

Country	Name	City	State
Haiti	NEGES	Leogane

Sponsors (3)

Lead Sponsor	Collaborator
Women's College Hospital	Adelphi University, NEGES Foundation, Leogane, Haiti

Country where clinical trial is conducted

Haiti, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV Knowledge	Brief HIV Knowledge Questionnaire (Carey & Schroder, 2002)	8 weeks	No
Secondary	Sexually Transmitted Infection Knowledge	Measured using Sexually Transmitted Disease Knowledge Questionnaire (Jaworski & Carey, 2007)	8 weeks	No
Secondary	Condom use	Measured using a self-report of frequency of condom use with regular, casual and paid sex sexual partners	8 weeks	No
Secondary	Substance use	Measured using self-reported frequency of drug/alcohol use	8 weeks	No
Secondary	Depression	Measured using Patient Health Questionnaire 2 (PHQ-2)	8 weeks	No
Secondary	Social support	Measured using Multi-dimensional scale of perceived social support (Zimet et al., 1988)	8 weeks	No
Secondary	resilient coping	Measured using Brief Resilient Coping Scale (Sinclair & Wallston, 2004)	8 weeks	No
Secondary	Relationship Control	Sexual Relationship Power Scale (Pulerwitz, Gortmaker & DeJong, 2000)	8 weeks	No

External Links

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