NCT01492829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

5 months

First QC Date

December 13, 2011

Last Update Submit

February 15, 2013

Conditions

Risk Reduction BehaviorInterpersonal RelationsMental Disorders

Keywords

HIV preventionsexually transmitted infection preventionHIV knowledgerelationship powerdepressioncopingsocial supportinternally displaced personscommunity health workerHIV/STI educational videosubstance usewomen's health

Outcome Measures

Primary Outcomes (1)

  • HIV Knowledge

    Brief HIV Knowledge Questionnaire (Carey \& Schroder, 2002)

    8 weeks

Secondary Outcomes (7)

  • Sexually Transmitted Infection Knowledge

    8 weeks

  • Condom use

    8 weeks

  • Substance use

    8 weeks

  • Depression

    8 weeks

  • Social support

    8 weeks

  • +2 more secondary outcomes

Interventions

individual and group-based, community health worker deliveredBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • and over
  • capable of providing informed consent
  • internally displaced (living in tent or camp)
  • female

You may not qualify if:

  • male
  • under 18 years old
  • not able to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NEGES

Léogâne, Haiti

Location

Related Publications (3)

  • Logie CH, Daniel C, Wang Y. Factors associated with consistent condom use among internally displaced women in Leogane, Haiti: results from a cross-sectional tablet-based survey. Sex Transm Infect. 2016 Nov;92(7):520-524. doi: 10.1136/sextrans-2015-052400. Epub 2016 Mar 31.

    PMID: 27034426DERIVED

  • 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.

    PMID: 24587068DERIVED

  • Logie CH, Daniel C, Newman PA, Loutfy MR. An HIV/STI prevention intervention for internally displaced women in Leogane, Haiti: study protocol for an N-of-1 pilot study. BMJ Open. 2012 Jul 18;2(4):e001634. doi: 10.1136/bmjopen-2012-001634. Print 2012.

    PMID: 22815471DERIVED

MeSH Terms

Conditions

Risk Reduction BehaviorMental DisordersDepressionSubstance-Related Disorders

Condition Hierarchy (Ancestors)

BehaviorBehavioral SymptomsChemically-Induced Disorders

Study Officials

  • Carmen H Logie, PhD

    Women's College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doctoral Fellow

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 15, 2011

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

February 20, 2013

Record last verified: 2013-02

Locations

HA(1)