The investigators have previously developed an integrated bio-behavioral intervention to promote PrEP uptake and adherence in cisgender women who are undergoing treatment for trauma-related mental health conditions and who are at a higher risk for HIV. The intervention is delivered within the mental health treatment setting and integrates knowledge, behavioral skills, and motivation to engage in and adhere to PrEP care. The purpose of this study is to assess the preliminary efficacy, feasibility, and acceptability of this intervention. The hypothesis is that, compared to standard treatment, the intervention will be feasible, acceptable, and associated with greater PrEP uptake and adherence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
60
Provision of PrEP information through 3 counseling sessions, prevention navigation, and nurse practitioner-prescribed PrEP in an addiction treatment setting.
Participants in trauma treatment will be given information and referral to a community partner who will evaluate them to determine if they could benefit from PrEP for HIV prevention
Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGNumber of participants who uptake PrEP
PrEP uptake is defined as obtaining a prescription and taking the first dose.
Time frame: 12 weeks post intervention
Number of Participants who adhere to PrEP
PrEP adherence is lab confirmed and is defined as having adequate levels of tenofovir (TFV) (\>1000ng/ml).
Time frame: 12 weeks post PrEP initiation
PrEP adherence as assessed by proportion of videos uploaded
In the intervention arm, participants are asked to take a video of themselves taking PrEP. Videos are uploaded through an app, which is offered in the intervention arm only (and not the standard treatment arm). Data will be reported as the number of days a video is uploaded divided by the number of days of the intervention period.
Time frame: from the time of PrEP initiation to 12 weeks post PrEP initiation
PrEP adherence as assessed by proportion of self-reported daily adherence
In both arms, participants are sent a questionnaires weekly in which they record the number of days they took PrEP over the past seven days. Data will be reported as the number of days PrEP is taken divided by the number of days of the intervention period.
Time frame: from the time of PrEP initiation to 12 weeks post PrEP initiation
Intervention feasibility as assessed by number of participants enrolled
The number enrolled is the number of participants who signed the consent form.
Time frame: at the time of enrollment
Intervention feasibility as assessed by number of sessions attended by participants
Time frame: 15 weeks post enrollment
Intervention feasibility as assessed by study retention
Study retention is assessed by the the number of participants who completed the study.
Time frame: 15 weeks post enrollment
Intervention acceptability as assessed by score on a satisfaction questionnaire
This is a 15 item questionnaire and each item is scored from 1 (not at all true) to 9 (absolutely true). Total score ranges from 15 to 135, with a higher score indicating greater satisfaction.
Time frame: 15 weeks post enrollment
Change in PrEP Anticipated Stigma as assessed by the PrEP Anticipated Stigma Scale
Total score ranges from 8 to 32, with a higher score indicating greater stigma.
Time frame: baseline, 15 weeks post enrollment
Change in perceived HIV risk as assessed by Perceived Risk of HIV Scale
Total score ranges from 10 to 40, with a higher score indicating a greater perceived HIV risk.
Time frame: baseline, 15 weeks post enrollment
Change in PrEP knowledge as assessed by PrEP Knowledge Questionnaire
Total score ranges from 0 to 6, with a higher score indicating a greater knowledge about PrEP.
Time frame: baseline, 15 weeks post enrollment
Change in PrEP attitudes as assessed by PrEP Attitudes Measure
Total score ranges from 5.2 to 26, with a higher score indicating a better attitude toward PrEP.
Time frame: baseline, 15 weeks post enrollment
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