Recruiting

PrEP Intervention

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06558825

Conditions

Substance Use

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Integrated Intervention to Promote PrEP Uptake

Standard Treatment Condition

Study Details

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.

Conditions

Substance Use

Study ID

NCT06558825

Start date

Oct 1, 2024

Status verified date

Dec, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Mar 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Integrated Intervention to Promote PrEP Uptake

active comparator: Standard Treatment Condition

Interventions

Integrated Intervention to Promote PrEP Uptake

Provision of PrEP information through 3 counseling sessions, prevention navigation, and nurse practitioner-prescribed PrEP in an addiction treatment setting.

Standard Treatment Condition

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

Primary outcome measure

  • Number of participants who uptake PrEP [ Time Frame: 12 weeks post intervention ]

Central Contacts and Locations

Central contacts

Angela M Heads, PhD

(713) 486-2830Angela.M.Heads@uth.tmc.edu

Kaixuan An

(713) 486-2531Kaixuan.An@uth.tmc.edu

Locations

Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

Angela Heads, PhD

(713) 486-2830Angela.M.Heads@uth.tmc.edu

Louis A. Faillace, MD, Department of Psychiatry and Behavioral An, MA

(713) 486-2531Kaixuan.An@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Dec 30, 2024

Last verified

Dec, 2024

Keywords

  • Pre-Exposure Prophylaxis
  • Women
  • HIV Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2024-12-30.