Clinical trial NCT01994603: Expansion to Interdisciplinary HIV Prevention in Women
Official title: Preventing FAS/ARND in Russian Children/Expansion to Interdisciplinary HIV Prevention in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
AIDS
Fetal Alcohol Syndrome
Alcohol Related Neurodevelopmental Disorder
Keywords: Prevention
HIV
AIDS
Fetal Alcohol Syndrome (FAS)
Alcohol Related Neurodevelopmental Disorder (ARND)
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2013-11-26
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who completed HIV test
timeFrame: First 1: at initial contact, an expected average of 15 minutes
measure: Number of participants who accepted a rapid health screening/HIV test
timeFrame: Phase 2: an expected average of 2 hours
Secondary outcomes:
measure: Brief survey to assess reasons for being tested
timeFrame: Phase 2: at time of completing HIV testing
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: St. Peterburg
country: Russian Federation
facility: St. Petersburg State University
Study officials:
affiliation: University of Oklahoma
name: Tatiana Balachova
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Petersburg State University, Russia
name: Alla Shaboltas, PhD
role: PRINCIPAL_INVESTIGATOR
References: