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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

December 13, 2011
February 15, 2013
January 2012
June 2012   (final data collection date for primary outcome measure)
HIV Knowledge [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Brief HIV Knowledge Questionnaire (Carey & Schroder, 2002)
Same as current
Complete list of historical versions of study NCT01492829 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
A Community-health Worker Delivered HIV/STI Prevention Intervention for Internally Displaced Women in Leogane, Haiti
Development and Evaluation of a Community Health Worker Delivered HIV/STI Prevention Intervention for Women Living in Internally Displaced Persons Camps in Leogane, Haiti

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.

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.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Risk Reduction Behavior
  • Interpersonal Relations
  • Mental Disorders
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
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
July 2012
June 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Haiti
 
NCT01492829
GCC#0016-01-04-01-01
No
Carmen Logie, Women's College Hospital
Women's College Hospital
  • NEGES Foundation, Leogane, Haiti
  • Adelphi University
Principal Investigator: Carmen H Logie, PhD Women's College Hospital
Women's College Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP