Clinical trial NCT02263391: HIV Risk and Prevention in Women
Official title: Collaborative Biosocial Research on HIV Risk and Prevention in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: transmission
prevention
women
childbearing age
HIV testing
testing strategy
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Russian Foundation for Basic Research (RFBR)
name: Saint Petersburg State University, Russia
First posted: 2014-10-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of participants who accepted a rapid health screening/HIV test
timeFrame: At first visit, an expected average of 1 hour
measure: Number of participants who accepted the health screening/HIV test after a focus group
timeFrame: After completing a focus group discussion, an expected average of 4 weeks
Secondary outcomes:
measure: Brief survey to assess reasons for being tested
timeFrame: At first visit, an expected average of 1 hour
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: St. Peterburg
country: Russian Federation
facility: St. Petersburg State University
Study officials:
affiliation: University of Oklahoma
name: Tatiana Balachova, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Facility: St. Petersburg State University St. Peterburg, Russian Federation
name: Alla Shaboltas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.