HIV Risk and Prevention in Women

University of Oklahoma200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

200

Conditions

HIV

Interventions

Opt-in or Opt-out testingBEHAVIORAL

Study participants will be offered a health screening onsite.

Focus GroupBEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 44 Years

Medical Language ↔ Plain English

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.

Locations (2)

University of Oklahoma

Oklahoma City, Oklahoma, United States

St. Petersburg State University

Saint Peterburg, Russia

Outcomes

Primary Outcomes

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.

Time frame: 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.

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

Secondary Outcomes

Brief survey to assess reasons for being tested

Participants who accepted a rapid health screening/HIV test are asked about reasons for taking the test at this time.

Time frame: At first visit, an expected average of 1 hour

Data from ClinicalTrials.gov

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