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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Prevention, HIV Infections

Intervention / Treatment
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* Behavioral: HIV risk reduction intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV risk reduction intervention<br>Behavioral intervention designed to reduce HIV risk behaviors and enhance enhance HIV-preventive behaviors among female sex workers (FSWs) in Armenia | Behavioral: HIV risk reduction intervention<br>* Education intervention designed to reduce HIV risk behaviors and enhance HIV prevention behaviors among female sex workers in Armenia<br>|
| Active Comparator: Wait list control<br>Will receive behavioral intervention after completion of study upon request. | Behavioral: HIV risk reduction intervention<br>* Education intervention designed to reduce HIV risk behaviors and enhance HIV prevention behaviors among female sex workers in Armenia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistent condom use |  | 3 and 6 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Condom application |  | 3 and 6 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV prevention, female sex workers, HIV seronegativity