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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Integrated Intervention to Promote PrEP Uptake
  • Behavioral: 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.
Active Comparator
Standard Treatment Condition
  • Other: 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

Recruiting Locations

Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
Houston, Texas 77054
Contact:
Angela Heads, PhD
(713) 486-2830
Angela.M.Heads@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.