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Expansion to Interdisciplinary HIV Prevention in Women

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ClinicalTrials.gov Identifier: NCT01994603
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : January 14, 2016
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Oklahoma

Tracking Information
First Submitted Date  ICMJE October 23, 2013
First Posted Date  ICMJE November 26, 2013
Last Update Posted Date January 14, 2016
Study Start Date  ICMJE December 2012
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
  • Number of participants who completed HIV test [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01994603 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
Brief survey to assess reasons for being tested [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Expansion to Interdisciplinary HIV Prevention in Women
Official Title  ICMJE Preventing FAS/ARND in Russian Children/Expansion to Interdisciplinary HIV Prevention in Women
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV
  • AIDS
  • Fetal Alcohol Syndrome
  • Alcohol Related Neurodevelopmental Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2016)
41
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2013)
100
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994603
Other Study ID Numbers  ICMJE 1590
3R01AA016234-05S1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oklahoma
Study Sponsor  ICMJE University of Oklahoma
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Tatiana Balachova University of Oklahoma
Principal Investigator: Alla Shaboltas, PhD Saint Petersburg State University, Russia
PRS Account University of Oklahoma
Verification Date January 2016

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