Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Intervention for Women with Trauma-related Conditions

NCT06558825 | Recruiting

• 2 other identifiers: HSC-MS-21-05441R34DA055496-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Pre-Exposure Prophylaxis; Women; HIV Prevention

Outcome Measures

Primary Outcomes (1)

• Number of participants who uptake PrEP

  PrEP uptake is defined as obtaining a prescription and taking the first dose.

  12 weeks post intervention

Secondary Outcomes (11)

• Number of Participants who adhere to PrEP

  12 weeks post PrEP initiation

• PrEP adherence as assessed by proportion of videos uploaded

  from the time of PrEP initiation to 12 weeks post PrEP initiation

• PrEP adherence as assessed by proportion of self-reported daily adherence

  from the time of PrEP initiation to 12 weeks post PrEP initiation

• Intervention feasibility as assessed by number of participants enrolled

  at the time of enrollment

• Intervention feasibility as assessed by number of sessions attended by participants

  15 weeks post enrollment

Study Arms (2)

Integrated Intervention to Promote PrEP Uptake

EXPERIMENTAL

Behavioral: Integrated Intervention to Promote PrEP Uptake

Standard Treatment Condition

ACTIVE COMPARATOR

Other: Standard Treatment Condition

Interventions

Integrated Intervention to Promote PrEP Uptake BEHAVIORAL

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

Integrated Intervention to Promote PrEP Uptake

Standard Treatment Condition OTHER

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

Standard Treatment Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

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

Houston, Texas, 77054, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Angela Heads, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela M Heads, PhD

CONTACT

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

Kaixuan An

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 19, 2024
• Study Start: October 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)