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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
  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:


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:
    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
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Women's College Hospital

Additional 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
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 November 27, 2014