HIV Risk and Prevention in Women

HIV Clinical Trial

Official title:

Collaborative Biosocial Research on HIV Risk and Prevention in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263391
• Other study ID #: 3878
• Secondary ID: 1R21AA022596-01
• Status: Completed
• Phase: N/A
• First received: September 26, 2014
• Last updated: February 20, 2017
• Start date: March 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2017
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Opt-in or Opt-out testing
Study participants will be offered a health screening onsite.
• Focus Group
Study participants will be invited to participate in a focus group discussion.

Locations

Country	Name	City	State
Russian Federation	St. Petersburg State University	St. Peterburg
United States	University of Oklahoma	Oklahoma City	Oklahoma

Sponsors (5)

Lead Sponsor	Collaborator
University of Oklahoma	National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), Russian Foundation for Basic Research (RFBR), Saint-Petersburg State University

Countries where clinical trial is conducted

United States,  Russian Federation, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	At first visit, an expected average of 1 hour

External Links

•   Information about the study
•   Information about the study
•   Information about the study