A Community-health Worker Delivered HIV/STI Prevention Intervention for Internally Displaced Women in Leogane, Haiti (FASY)
This study has been completed.
Sponsor:
Women's College Hospital
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Risk Reduction Behavior Interpersonal Relations Mental Disorders |
Behavioral: individual and group-based, community health worker delivered |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Depression
HIV/AIDS
Mental Disorders
Psychotic Disorders
Sexually Transmitted Diseases
U.S. FDA Resources
Further study details as provided by Women's College Hospital:
Primary Outcome Measures:
- HIV Knowledge [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Brief HIV Knowledge Questionnaire (Carey & Schroder, 2002)
Secondary Outcome Measures:
- 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)
| Enrollment: | 200 |
| Study Start Date: | January 2012 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492829
Locations
| Haiti | |
| NEGES | |
| Leogane, Haiti | |
Sponsors and Collaborators
Women's College Hospital
NEGES Foundation, Leogane, Haiti
Adelphi University
Investigators
| Principal Investigator: | Carmen H Logie, PhD | Women's College Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Carmen Logie, Post-doctoral Fellow, Women's College Hospital |
| ClinicalTrials.gov Identifier: | NCT01492829 History of Changes |
| Other Study ID Numbers: | GCC#0016-01-04-01-01 |
| Study First Received: | December 13, 2011 |
| Last Updated: | February 15, 2013 |
| Health Authority: | Canada: Women's College Hospital |
Keywords provided by Women's College Hospital:
|
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 |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on March 07, 2013
