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

NCT ID: NCT06558825

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Substance Use

Keywords

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Pre-Exposure Prophylaxis Women HIV Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Integrated Intervention to Promote PrEP Uptake

Group Type EXPERIMENTAL

Integrated Intervention to Promote PrEP Uptake

Intervention Type BEHAVIORAL

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

Standard Treatment Condition

Group Type ACTIVE_COMPARATOR

Standard Treatment Condition

Intervention Type 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

Interventions

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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.

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Angela M Heads

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angela Heads, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Angela M Heads, PhD

Role: CONTACT

Phone: (713) 486-2830

Email: [email protected]

Kaixuan An

Role: CONTACT

Phone: (713) 486-2531

Email: [email protected]

Facility Contacts

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Angela Heads, PhD

Role: primary

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

Role: backup

Other Identifiers

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1R34DA055496-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-MS-21-0544

Identifier Type: -

Identifier Source: org_study_id