Expansion to Interdisciplinary HIV Prevention in Women

HIV Clinical Trial

Official title:

Preventing FAS/ARND in Russian Children/Expansion to Interdisciplinary HIV Prevention in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994603
• Other study ID #: 1590
• Secondary ID: 3R01AA016234-05S
• Status: Completed
• Phase: N/A
• First received: October 23, 2013
• Last updated: January 13, 2016
• Start date: December 2012
• Est. completion date: September 2015

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• AIDS
• Alcohol Related Neurodevelopmental Disorder
• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome
• HIV
• Mental Disorders Diagnosed in Childhood

Intervention

Behavioral:
• Opt-in or Opt-out testing
Study participants will be offered a health screening onsite.
• Focus Group
Study participants will be invited to participate in a focus group discussion.

Locations

Country	Name	City	State
Russian Federation	St. Petersburg State University	St. Peterburg
United States	University of Oklahoma	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

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