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

NCT ID: NCT00886561

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-07-31

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.

Conditions

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HIV Prevention HIV Infections

Keywords

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HIV prevention, female sex workers HIV seronegativity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

HIV risk reduction intervention

Intervention Type BEHAVIORAL

Education intervention designed to reduce HIV risk behaviors and enhance HIV prevention behaviors among female sex workers in Armenia

Wait list control

Will receive behavioral intervention after completion of study upon request.

Group Type ACTIVE_COMPARATOR

HIV risk reduction intervention

Intervention Type BEHAVIORAL

Education intervention designed to reduce HIV risk behaviors and enhance HIV prevention behaviors among female sex workers in Armenia

Interventions

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HIV risk reduction intervention

Education intervention designed to reduce HIV risk behaviors and enhance HIV prevention behaviors among female sex workers in Armenia

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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American University of Armenia

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Ralph J. DiClemente

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ralph J DiClemente, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Hope and Help NGO

Yerevan, Yerevan, Armenia

Site Status

Countries

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Armenia

Other Identifiers

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ARX1-2719-YE-06

Identifier Type: OTHER

Identifier Source: secondary_id

0126-2005

Identifier Type: -

Identifier Source: org_study_id