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
  Purpose

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.


Condition Intervention
HIV
AIDS
Fetal Alcohol Syndrome
Alcohol Related Neurodevelopmental Disorder
Behavioral: Opt-in or Opt-out testing
Behavioral: Focus Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Preventing FAS/ARND in Russian Children/Expansion to Interdisciplinary HIV Prevention in Women

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. "
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-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.
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.

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

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994603

Locations
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Russian Federation
St. Petersburg State University
St. Peterburg, Russian Federation, 199034
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Tatiana Balachova University of Oklahoma
Principal Investigator: Alla Shaboltas, PhD St. Petersburg State University
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01994603     History of Changes
Other Study ID Numbers: R01AA016234-SUPL, 3R01AA016234-05S1
Study First Received: October 23, 2013
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Prevention
HIV
AIDS
Fetal Alcohol Syndrome (FAS)
Alcohol Related Neurodevelopmental Disorder (ARND)

Additional relevant MeSH terms:
Syndrome
Fetal Alcohol Spectrum Disorders
Disease
Pathologic Processes
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on October 16, 2014