Back to resultsHIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia
Primary Purpose
HIV Prevention, HIV Infections
Status
Completed
Phase
Phase 2
Locations
Armenia
Study Type
Interventional
Intervention
HIV risk reduction intervention
Sponsored by
About this trial
This is an interventional prevention trial for HIV Prevention focused on measuring HIV prevention, female sex workers, HIV seronegativity
Eligibility Criteria
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
Sites / Locations
- Hope and Help NGO
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HIV risk reduction intervention
Wait list control
Arm Description
Behavioral intervention designed to reduce HIV risk behaviors and enhance enhance HIV-preventive behaviors among female sex workers (FSWs) in Armenia
Will receive behavioral intervention after completion of study upon request.
Outcomes
Primary Outcome Measures
Consistent condom use
Secondary Outcome Measures
Condom application
Full Information
NCT ID
NCT00886561
First Posted
April 22, 2009
Last Updated
November 21, 2013
Sponsor
Emory University
Collaborators
American University of Armenia
1. Study Identification
Unique Protocol Identification Number
NCT00886561
Brief Title
HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia
Official Title
HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
American University of Armenia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Prevention, HIV Infections
Keywords
HIV prevention, female sex workers, HIV seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIV risk reduction intervention
Arm Type
Experimental
Arm Description
Behavioral intervention designed to reduce HIV risk behaviors and enhance enhance HIV-preventive behaviors among female sex workers (FSWs) in Armenia
Arm Title
Wait list control
Arm Type
Active Comparator
Arm Description
Will receive behavioral intervention after completion of study upon request.
Intervention Type
Behavioral
Intervention Name(s)
HIV risk reduction intervention
Intervention Description
Education intervention designed to reduce HIV risk behaviors and enhance HIV prevention behaviors among female sex workers in Armenia
Primary Outcome Measure Information:
Title
Consistent condom use
Time Frame
3 and 6 months post intervention
Secondary Outcome Measure Information:
Title
Condom application
Time Frame
3 and 6 months post intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph J DiClemente, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hope and Help NGO
City
Yerevan
Country
Armenia
12. IPD Sharing Statement
Learn more about this trial
HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia
We'll reach out to this number within 24 hrs