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Clinical Trials/NCT00886561
NCT00886561CompletedPhase 2

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

Emory University1 site in 1 country120 target enrollmentStarted: July 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
120
Locations
1
Primary Endpoint
Consistent condom use

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

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

Arms & Interventions

HIV risk reduction intervention

Experimental

Behavioral intervention designed to reduce HIV risk behaviors and enhance enhance HIV-preventive behaviors among female sex workers (FSWs) in Armenia

Intervention: HIV risk reduction intervention (Behavioral)

Wait list control

Active Comparator

Will receive behavioral intervention after completion of study upon request.

Intervention: HIV risk reduction intervention (Behavioral)

Outcomes

Primary Outcomes

Consistent condom use

Time Frame: 3 and 6 months post intervention

Secondary Outcomes

  • Condom application(3 and 6 months post intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ralph J. DiClemente

Principal Investigator

Emory University

Study Sites (1)

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