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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01492829
Date of registration: 13/12/2011
Prospective Registration: Yes
Primary sponsor: Women's College Hospital
Public title: A Community-health Worker Delivered HIV/STI Prevention Intervention for Internally Displaced Women in Leogane, Haiti FASY
Scientific 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
Date of first enrolment: January 2012
Target sample size: 200
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01492829
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention  
Phase:  Phase 1
Countries of recruitment
Haiti
Contacts
Name:     Carmen H Logie, PhD
Address: 
Telephone:
Email:
Affiliation:  Women's College Hospital
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Mental Disorders
Interpersonal Relations
Risk Reduction Behavior
Intervention(s)
Behavioral: individual and group-based, community health worker delivered
Primary Outcome(s)
HIV Knowledge [Time Frame: 8 weeks]
Secondary Outcome(s)
resilient coping [Time Frame: 8 weeks]
Condom use [Time Frame: 8 weeks]
Depression [Time Frame: 8 weeks]
Relationship Control [Time Frame: 8 weeks]
Sexually Transmitted Infection Knowledge [Time Frame: 8 weeks]
Social support [Time Frame: 8 weeks]
Substance use [Time Frame: 8 weeks]
Secondary ID(s)
GCC#0016-01-04-01-01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Adelphi University
NEGES Foundation, Leogane, Haiti
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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