AIDS, Alcohol Related Neurodevelopmental Disorder, Fetal Alcohol Syndrome, HIV
Conditions
Keywords
Prevention, HIV, AIDS, Fetal Alcohol Syndrome (FAS), Alcohol Related Neurodevelopmental Disorder (ARND)
Brief summary
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.
Detailed description
A mixed methods research design combining qualitative and quantitative data collection methods will be used to increase the understanding of barriers to HIV testing, identify promising strategies to increase testing, generate research hypotheses, and design a future randomized clinical trial to evaluate HIV prevention targeted to at-risk women in the general population in Russia. The qualitative methods include structured interviews and a focus group participation to assess women's reasons for being the tested and possible prevention strategies. The quantitative methods include observation/recording of women's testing behaviors.
Interventions
BEHAVIORALOpt-in or Opt-out testing
Study participants will be offered a health screening onsite.
BEHAVIORALFocus Group
Study participants will be invited to participate in a focus group discussion.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who completed HIV test | First 1: at initial contact, an expected average of 15 minutes | A brief survey completed over the phone. Participants asked when the last HIV test was completed and her reasons for taking the test. |
| Number of participants who accepted a rapid health screening/HIV test | Phase 2: an expected average of 2 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief survey to assess reasons for being tested | Phase 2: at time of completing HIV testing | Participants who accepted a rapid health screening/HIV test are asked about reasons for taking the test at this time |
Countries
Russia, United States
Outcome results
None listed