NCT02263391

HIV Risk and Prevention in Women

Collaborative Biosocial Research on HIV Risk and Prevention in Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Opt-in or Opt-out testing	Study participants will be offered a health screening onsite.
BEHAVIORAL	Focus Group	Study participants will be invited to participate in a focus group discussion.

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-10-13
• Last updated: 2017-02-23

Locations

2 sites across 2 countries: United States, Russia