HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia

Phase 2

Completed

• Conditions: HIV Infections; HIV Prevention
• Interventions: Behavioral: HIV risk reduction intervention

• Registration Number: NCT00886561
• Lead Sponsor: Emory University

Brief Summary

This pilot study will test the efficacy of a behavioral intervention in reducing HIV related risk behaviors among sex workers in Yerevan, Armenia.

Detailed Description

The purpose of this pilot study is to evaluate the efficacy of an intervention to reduce sexual risk behaviors and enhance HIV-preventive behaviors among female sex workers (FSWs) in Yerevan, Armenia. The study design is a randomized controlled trial of 120 FSWs aged 18 and over recruited through Hope and Help NGO. Participants will complete an interviewer administered questionnaire collected at baseline, 3- and 6-month follow-up.

Subsequently, participants will be randomly assigned to either the intervention condition or a wait-list control. Those randomized to the intervention condition will receive a 2-hour one-on-one intervention session emphasizing HIV knowledge, self-efficacy, and condom use behaviors. They will also receive a 10-15 minute booster session at 3-month follow-up. The comparison condition is wait-listed, but have the choice of participating in the intervention program upon completion of the study.

The main outcome measure includes consistent condom use, defined as condom use during every episode of vaginal intercourse with clients. Other outcome measures are condom application by FSW and HIV- preventive behaviors such as condom use self-efficacy, knowledge of HIV transmission dynamics,perceived barriers to condom use and condom use errors.

Results from this pilot study are expected to inform a larger trial to be implemented with FSWs in Armenia, in an effort to devise gender and culturally relevant intervention programs to prevent HIV transmission in this vulnerable population.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• 18 years and older
• traded sex for money in the past 7 days
• cognitive ability to participate in assessment and intervention

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Exclusion Criteria

• younger than 18 years of age
• did not trade sex for money in the past 7 days
• cognitively unable to participate in assessment and intervention

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV risk reduction intervention	HIV risk reduction intervention	Behavioral intervention designed to reduce HIV risk behaviors and enhance enhance HIV-preventive behaviors among female sex workers (FSWs) in Armenia
Wait list control	HIV risk reduction intervention	Will receive behavioral intervention after completion of study upon request.

Primary Outcome Measures

Name	Time	Method
Consistent condom use	3 and 6 months post intervention

Secondary Outcome Measures

Name	Time	Method
Condom application	3 and 6 months post intervention

Trial Locations

Locations (1)

Hope and Help NGO; 🇦🇲 Yerevan, Armenia