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

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ClinicalTrials.gov Identifier: NCT01492829
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : February 20, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Risk Reduction Behavior Interpersonal Relations Mental Disorders Behavioral: individual and group-based, community health worker delivered Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2012
Primary Completion Date : June 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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

Outcome Measures

Primary Outcome Measures :
  1. HIV Knowledge [ Time Frame: 8 weeks ]
    Brief HIV Knowledge Questionnaire (Carey & Schroder, 2002)


Secondary Outcome Measures :
  1. Sexually Transmitted Infection Knowledge [ Time Frame: 8 weeks ]
    Measured using Sexually Transmitted Disease Knowledge Questionnaire (Jaworski & Carey, 2007)

  2. Condom use [ Time Frame: 8 weeks ]
    Measured using a self-report of frequency of condom use with regular, casual and paid sex sexual partners

  3. Substance use [ Time Frame: 8 weeks ]
    Measured using self-reported frequency of drug/alcohol use

  4. Depression [ Time Frame: 8 weeks ]
    Measured using Patient Health Questionnaire 2 (PHQ-2)

  5. Social support [ Time Frame: 8 weeks ]
    Measured using Multi-dimensional scale of perceived social support (Zimet et al., 1988)

  6. resilient coping [ Time Frame: 8 weeks ]
    Measured using Brief Resilient Coping Scale (Sinclair & Wallston, 2004)

  7. Relationship Control [ Time Frame: 8 weeks ]
    Sexual Relationship Power Scale (Pulerwitz, Gortmaker & DeJong, 2000)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013

Keywords provided by Carmen Logie, 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 Spectrum and Other Psychotic Disorders