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

This study has been completed.
Sponsor:
Collaborator:
American University of Armenia
Information provided by (Responsible Party):
Ralph J. DiClemente, Emory University
ClinicalTrials.gov Identifier:
NCT00886561
First received: April 22, 2009
Last updated: November 21, 2013
Last verified: November 2013

April 22, 2009
November 21, 2013
July 2007
July 2008   (final data collection date for primary outcome measure)
Consistent condom use [ Time Frame: 3 and 6 months post intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00886561 on ClinicalTrials.gov Archive Site
Condom application [ Time Frame: 3 and 6 months post intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia
HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Prevention
  • HIV Infections
Behavioral: HIV risk reduction intervention
Education intervention designed to reduce HIV risk behaviors and enhance HIV prevention behaviors among female sex workers in Armenia
  • Experimental: 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
    Intervention: Behavioral: HIV risk reduction intervention
  • Active Comparator: Wait list control
    Will receive behavioral intervention after completion of study upon request.
    Intervention: Behavioral: HIV risk reduction intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Armenia
 
NCT00886561
0126-2005, ARX1-2719-YE-06
No
Ralph J. DiClemente, Emory University
Emory University
American University of Armenia
Principal Investigator: Ralph J DiClemente, PhD Emory University
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP