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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886561
• Other study ID #: 0126-2005
• Secondary ID: ARX1-2719-YE-06
• Status: Completed
• Phase: Phase 2
• First received: April 22, 2009
• Last updated: November 21, 2013
• Start date: July 2007
• Est. completion date: July 2008

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• HIV Prevention

Intervention

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

Locations

Country	Name	City	State
Armenia	Hope and Help NGO	Yerevan

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	American University of Armenia

Country where clinical trial is conducted

Armenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consistent condom use		3 and 6 months post intervention	No
Secondary	Condom application		3 and 6 months post intervention	No