Expansion to Interdisciplinary HIV Prevention in Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01994603
First received: October 23, 2013
Last updated: November 19, 2013
Last verified: November 2013

October 23, 2013
November 19, 2013
December 2012
November 2013   (final data collection date for primary outcome measure)
  • Number of participants who completed HIV test [ Time Frame: First 1: at initial contact, an expected average of 15 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Phase 2: an expected average of 2 hours ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01994603 on ClinicalTrials.gov Archive Site
Brief survey to assess reasons for being tested [ Time Frame: Phase 2: at time of completing HIV testing ] [ Designated as safety issue: No ]
Participants who accepted a rapid health screening/HIV test are asked about reasons for taking the test at this time
Same as current
Not Provided
Not Provided
 
Expansion to Interdisciplinary HIV Prevention in Women
Preventing FAS/ARND in Russian Children/Expansion to Interdisciplinary HIV Prevention in Women

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • HIV
  • AIDS
  • Fetal Alcohol Syndrome
  • Alcohol Related Neurodevelopmental Disorder
  • Behavioral: Opt-in or Opt-out testing
    Study participants will be offered a health screening onsite.
  • Behavioral: Focus Group
    Study participants will be invited to participate in a focus group discussion.
  • Experimental: Opt-in testing
    Participants will be scheduled for a two-hour appointment to complete the written consent procedure, enroll in the study, and participate in the study activities, testing and a focus group. Opt-in: Common barriers to HIV screening testing will be removed as much as possible (i.e., providing rapid testing, results shortly available, testing on-site, confidentiality). "There is voluntary HIV testing available to all study participants if you wish to do it. "
    Interventions:
    • Behavioral: Opt-in or Opt-out testing
    • Behavioral: Focus Group
  • Experimental: Opt-out testing
    Participants will be scheduled for a two-hour appointment to complete the written consent procedure, enroll in the study, and participate in the study activities, testing and a focus group. Opt-out multicomponent testing. Participants will be informed that a bundled routine health test is available on a voluntary basis to study participants, and the participant may elect to decline all or part of the testing.
    Interventions:
    • Behavioral: Opt-in or Opt-out testing
    • Behavioral: Focus Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
Not Provided
November 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 44 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation,   United States
 
NCT01994603
R01AA016234-SUPL, 3R01AA016234-05S1
Yes
University of Oklahoma
University of Oklahoma
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Tatiana Balachova University of Oklahoma
Principal Investigator: Alla Shaboltas, PhD St. Petersburg State University
University of Oklahoma
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP