HIV Risk and Prevention in Women
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 44 |
| Updated: | 4/2/2016 |
| Start Date: | March 2014 |
| End Date: | December 2015 |
| Contact: | Tatiana Balachova, PhD |
| Email: | Tatiana-Balachova@ouhsc.edu |
Collaborative Biosocial Research on HIV Risk and Prevention in Women
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.
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.
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.
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.
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