HIV Risk and Prevention in Women

NCT ID: NCT02263391

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-01-31

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.

Detailed Description

The study uses an adaptive design. That is, the procedures and phases of the study experienced by a participant depend to some extent on their responses to earlier phases. Ultimately, this design yields a number of practice relevant pathways and endpoints, each of which has a testing rate associated with it.

Phase-I is initial screening for risk status, collecting background data, and ascertaining whether there has been recent independent HIV testing. If there has been independent testing, information about the independent testing is collected and the participant's involvement is complete.

Those who are not independent testers enter Phase-II. Phase II will include: randomization to opt-in vs. opt-out conditions; a survey asking about reasons for acceptance or non-acceptance; 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. The design was selected in order simultaneously answer a number of questions that we believe will be important for engineering a testing and prevention strategy suitable for testing in a subsequent study: (1) identify key attitudes, beliefs and knowledge (survey); (2) contrast opt-in and opt-out strategies (randomized trial); (3) generate qualitative data about reasons for decisions in the women's own words (focus group); and (4) identify any incremental benefit related to peer discussion.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Opt-in testing

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.

Group Type: EXPERIMENTAL

Opt-in or Opt-out testing

Intervention Type: BEHAVIORAL

Study participants will be offered a health screening onsite.

Focus Group

Intervention Type: BEHAVIORAL

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

Opt-out testing

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.

Group Type: EXPERIMENTAL

Opt-in or Opt-out testing

Intervention Type: BEHAVIORAL

Study participants will be offered a health screening onsite.

Focus Group

Intervention Type: BEHAVIORAL

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

Interventions

Opt-in or Opt-out testing

Study participants will be offered a health screening onsite.

Intervention Type: BEHAVIORAL

Focus Group

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Russian Foundation for Basic Research (RFBR)

UNKNOWN

Sponsor Role: collaborator

Saint Petersburg State University, Russia

OTHER

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tatiana Balachova, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Alla Shaboltas, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

University of Oklahoma

Oklahoma City, Oklahoma, United States

St. Petersburg State University

Saint Peterburg, , Russia

Countries

United States; Russia

References

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.

Reference Type: BACKGROUND

PMID: 25430518 (View on PubMed)

Other Identifiers

1R21AA022596-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3878

Identifier Type: -

Identifier Source: org_study_id