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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
  Purpose

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


Condition Intervention Phase
HIV Prevention
HIV Infections
Behavioral: HIV risk reduction intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Consistent condom use [ Time Frame: 3 and 6 months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Condom application [ Time Frame: 3 and 6 months post intervention ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: July 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: HIV risk reduction intervention
Education intervention designed to reduce HIV risk behaviors and enhance HIV prevention behaviors among female sex workers in Armenia
Active Comparator: Wait list control
Will receive behavioral intervention after completion of study upon request.
Behavioral: HIV risk reduction intervention
Education intervention designed to reduce HIV risk behaviors and enhance HIV prevention behaviors among female sex workers in 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886561

Locations
Armenia
Hope and Help NGO
Yerevan, Armenia
Sponsors and Collaborators
Emory University
American University of Armenia
Investigators
Principal Investigator: Ralph J DiClemente, PhD Emory University
  More Information

No publications provided

Responsible Party: Ralph J. DiClemente, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00886561     History of Changes
Other Study ID Numbers: 0126-2005, ARX1-2719-YE-06
Study First Received: April 22, 2009
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
HIV prevention, female sex workers
HIV seronegativity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 23, 2014