Expansion to Interdisciplinary HIV Prevention in Women

January 13, 2016 updated by: University of Oklahoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • St. Peterburg, Russian Federation, 199034
        • St. Petersburg State University
  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First 1: at initial contact, an expected average of 15 minutes
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.
Phase 2: an expected average of 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Phase 2: at time of completing HIV testing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Tatiana Balachova, University of Oklahoma
  • Principal Investigator: Alla Shaboltas, PhD, Saint Petersburg State University, Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 26, 2013

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1590
  • 3R01AA016234-05S1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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