HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia
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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 |
- Consistent condom use [ Time Frame: 3 and 6 months post intervention ] [ Designated as safety issue: No ]
- 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
|
|
No Intervention: Wait list control
Wait list control arm
|
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 |
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
More Information
No publications provided
| Responsible Party: | Ralph DiClemente, Emory University |
| ClinicalTrials.gov Identifier: | NCT00886561 History of Changes |
| Other Study ID Numbers: | ARX1-2719-YE-06 |
| Study First Received: | April 22, 2009 |
| Last Updated: | May 14, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
HIV prevention, female sex workers HIV seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on June 18, 2013