HIV Clinical Trial
Official title:
Preventing FAS/ARND in Russian Children/Expansion to Interdisciplinary HIV Prevention in Women
Verified date | January 2016 |
Source | University of Oklahoma |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This trial will pilot test intervention strategies to increase utilization of HIV testing and gain knowledge for designing a clinical trial to evaluate prevention strategies to reduce HIV sexual transmission in the general population in Russia. The study will assess whether external (cost, convenience) or internal factors (low perception of own risk, reluctance to identify a partner as at-risk, fear of stigma) drive Russian women's reluctance to be tested and if peer support impacts their decision. A randomized experimental manipulation, comparing opt-in vs. bundled opt-out testing approaches, followed by focus group discussions, followed by a second-chance testing offer will be used to inform these questions. The answers will enable the international research team to engineer and then test an HIV testing promotion strategy in Russia. The project will collect preliminary data for a larger study to develop an evidence-based program to reduce the HIV transmission in this high risk population.
Status | Completed |
Enrollment | 41 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility |
Inclusion Criteria: - A parent study participants who completed HIV risk survey and - Reported two or more partners in the last 12 months and no or inconsistent condom use in the last 3 months and no HIV testing in the last 12 months - Or reported any sexually-transmitted disease and no HIV testing in the last 12 months Exclusion Criteria: - A parent study participants who declined to be contacted for participating in future research studies |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Russian Federation | St. Petersburg State University | St. Peterburg | |
United States | University of Oklahoma | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States, Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants who completed HIV test | A brief survey completed over the phone. Participants asked when the last HIV test was completed and her reasons for taking the test. | First 1: at initial contact, an expected average of 15 minutes | No |
Primary | Number of participants who accepted a rapid health screening/HIV test | Women's decision to take/not take a health screening test/HIV test is recorded. If a woman chooses to be tested, she will be asked a few questions to assess her reasons for being tested. She will be provided with the results of the testing. If a woman's test is positive for HIV (or other health risks in the bundled opt-out condition), counseling with a trained study nurse, physician or psychologist will be available on-site and a referral for additional testing, counseling, and appropriate medical care will be provided. | Phase 2: an expected average of 2 hours | No |
Secondary | Brief survey to assess reasons for being tested | Participants who accepted a rapid health screening/HIV test are asked about reasons for taking the test at this time | Phase 2: at time of completing HIV testing | No |
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