HIV Risk and Prevention in Women

NCT02263391 | Completed DMC

• 2 other identifiers: 38781R21AA022596-01
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 2

Brief Summary

This study gathers information about HIV testing utilization and influences on HIV testing decisions among young, general population Russian women at-risk of HIV exposure. The study compares HIV testing acceptance across two types of low-barrier testing strategies (opt-in vs. opt-out) and conducts one of the first randomized experimental comparisons of these strategies. The overarching goal is to gain knowledge that can be used to increase utilization of HIV testing among at-risk young women and offer gender-specific strategies for improving prevention.

Conditions

HIV

Keywords

transmission; prevention; women; childbearing age; HIV testing; testing strategy

Outcome Measures

Primary Outcomes (2)

• 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.

  At first visit, an expected average of 1 hour

• Number of participants who accepted the health screening/HIV test after a focus group

  participating in a focus group in which participants who have not accepted HIV testing (non-accepters) and those who accepted (accepters) will be asked to discuss their health beliefs related to HIV prevention, barriers and reasons for testing/not testing; then (5) after the focus group is complete, privately offer another testing opportunity to non-accepters, under the same opt-in or opt-out strategy to which they previously were randomized.

  After completing a focus group discussion, an expected average of 4 weeks

Secondary Outcomes (1)

• Brief survey to assess reasons for being tested

  At first visit, an expected average of 1 hour

Study Arms (2)

Opt-in testing

EXPERIMENTAL

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). The research assistant will say: "There is voluntary HIV testing available to all study participants if you wish to do it. It is free, private, it is only a finger stick, and you will learn your HIV results in just minutes." 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.

Behavioral: Opt-in or Opt-out testing; Behavioral: Focus Group

Opt-out testing

EXPERIMENTAL

Participants will be informed that a routine health test bundle is available on a voluntary basis to study participants, and the participant may elect to decline all or any individual part of the testing. The assistant will say: "We are offering a voluntary panel of routine health screening test today for study participants. It includes blood sugar, cholesterol, and HIV. We recommend all of them for everyone, but you can choose to decline any or all of them. This is free, private, it is only a finger stick, and you will learn your results for all the tests in just minutes." 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.

Behavioral: Opt-in or Opt-out testing; Behavioral: Focus Group

Interventions

Opt-in or Opt-out testing BEHAVIORAL

Study participants will be offered a health screening onsite.

Opt-in testing; Opt-out testing

Focus Group BEHAVIORAL

Study participants will be invited to participate in a focus group discussion.

Opt-in testing; Opt-out testing

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The participant's sexual risk behaviors (i.e., a) two or more partners in the last 12 months, or her partner's HIV risk (e.g., HIV positive, no HIV testing and a diagnosis of sexually transmitted diseases in last 12 months, multiple partners, blood transmission, male partners, served in prison, or drug use) and no or inconsistent condom use in the last 3 months, and no HIV testing in the last 12 months, or b) any sexually-transmitted disease and no HIV testing in the last 12 months).

You may not qualify if:

• Does not speak Russian, are currently pregnant, have a condition that might preclude a finger-stick procedure, or have tested HIV positive in the past.

Sponsors & Collaborators

• University of Oklahoma: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Russian Foundation for Basic Research (RFBR): collaborator
• Saint Petersburg State University, Russia: collaborator

Study Sites (2)

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

St. Petersburg State University

Saint Peterburg, 199034, Russia

Location

Related Publications (1)

• Balachova TN, Batluk JV, Bryant KJ, Shaboltas AV. International collaboration in HIV prevention research: evidence from a research seminar in Russia. AIDS Res Hum Retroviruses. 2015 Feb;31(2):163-72. doi: 10.1089/AID.2014.0078. Epub 2014 Dec 31.

  PMID: 25430518 BACKGROUND

MeSH Terms

Interventions

Focus Groups

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tatiana Balachova, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

• Alla Shaboltas, PhD

  Facility: St. Petersburg State University St. Peterburg, Russian Federation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 13, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

RU (1); US (1)