Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Intervention for Women With Trauma-related Conditions
NCT Number: NCT06558825
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Substance Use
Interventions: BEHAVIORAL: Integrated Intervention to Promote PrEP Uptake|OTHER: Standard Treatment Condition
Sponsor: The University of Texas Health Science Center, Houston
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2025-06-30
Locations: Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston, Houston, Texas, 77054, United States

Summary:
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.

Primary Outcome Measures: Number of participants who uptake PrEP, PrEP uptake is defined as obtaining a prescription and taking the first dose., 12 weeks post intervention
Secondary Outcome Measures: Number of Participants who adhere to PrEP, PrEP adherence is lab confirmed and is defined as having adequate levels of tenofovir (TFV) (\>1000ng/ml)., 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., 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., 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., at the time of enrollment|Intervention feasibility as assessed by number of sessions attended by participants, 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., 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., 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., 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., 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., 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., baseline, 15 weeks post enrollment