Clinical trial NCT06558825: Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Intervention for Women with Trauma-related Conditions
Official title: Development and Pilot Testing of a Mental Health Clinic-Based PrEP Uptake and Adherence Intervention for Women in Treatment for Trauma-Related Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use
Keywords: Pre-Exposure Prophylaxis
Women
HIV Prevention
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-08-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Currently undergoing mental health treatment;
* Have a history of trauma;
* HIV negative;
* Sexually active with an opposite sex partner within the past 6 months;
* Not using PrEP for HIV prevention at the time of screening;
* Eligible for PrEP based on having at least one Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP;
* Fluent in English;
* Own or have regular access to a smart phone.

Exclusion Criteria:

* HIV positive;
* Concurrently participating in another HIV prevention program;
* Have severe cognitive impairment that would interfere with their ability to consent, understand study procedures and/or effectively participate in therapy;
* Have psychological distress that would prohibit them from participating in the study;
* Be unable or unwilling to meet study requirements.

Primary outcomes:
measure: Number of participants who uptake PrEP
timeFrame: 12 weeks post intervention
Secondary outcomes:
measure: Number of Participants who adhere to PrEP
timeFrame: 12 weeks post PrEP initiation
measure: PrEP adherence as assessed by proportion of videos uploaded
timeFrame: from the time of PrEP initiation to 12 weeks post PrEP initiation
measure: PrEP adherence as assessed by proportion of self-reported daily adherence
timeFrame: from the time of PrEP initiation to 12 weeks post PrEP initiation
measure: Intervention feasibility as assessed by number of participants enrolled
timeFrame: at the time of enrollment
measure: Intervention feasibility as assessed by number of sessions attended by participants
timeFrame: 15 weeks post enrollment
measure: Intervention feasibility as assessed by study retention
timeFrame: 15 weeks post enrollment
measure: Intervention acceptability as assessed by score on a satisfaction questionnaire
timeFrame: 15 weeks post enrollment
measure: Change in PrEP Anticipated Stigma as assessed by the PrEP Anticipated Stigma Scale
timeFrame: baseline, 15 weeks post enrollment
measure: Change in perceived HIV risk as assessed by Perceived Risk of HIV Scale
timeFrame: baseline, 15 weeks post enrollment
measure: Change in PrEP knowledge as assessed by PrEP Knowledge Questionnaire
timeFrame: baseline, 15 weeks post enrollment
measure: Change in PrEP attitudes as assessed by PrEP Attitudes Measure
timeFrame: baseline, 15 weeks post enrollment
Other outcomes:
Locations:
city: Houston
country: United States
facility: Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Angela Heads, PhD
role: PRINCIPAL_INVESTIGATOR
References: