Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women with Substance Use Disorders
NCT ID: NCT06158607
Last Updated: 2024-12-30
Study Results
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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RECRUITING
NA
60 participants
INTERVENTIONAL
2022-06-07
2025-05-30
Brief Summary
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• If the integrated intervention increase PrEP uptake and adherence compared to standard treatment
Participants will
* receive provision of PrEP information through 4 counseling sessions
* prevention navigation
* receive nurse practitioner prescribed PrEP in an addiction treatment setting
Researchers will compare intervention group with standard treatment to see if the integrated intervention help increase PrEP uptake and adherence
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention
Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders
Provision of PrEP information through 4 counseling sessions, prevention navigation, and nurse practitioner prescribed PrEP in an addiction treatment setting.
Standard of care treatment
Standard of care treatment
Participants in substance use 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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Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders
Provision of PrEP information through 4 counseling sessions, prevention navigation, and nurse practitioner prescribed PrEP in an addiction treatment setting.
Standard of care treatment
Participants in substance use 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
Eligibility Criteria
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Inclusion Criteria
* diagnosed with a Substance use disorder (SUD) per Diagnostic and Statistical Manual of Mental Illnesses (DSM)-5 criteria
* 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
* able to speak, read, and write in English; and
* own or have regular access to a smart phone.
Exclusion Criteria
* unable to provide informed consent for participation (e.g., 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
* be ineligible for PrEP based on Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP based on substance use and sexual risk
* have medical contraindications for PrEP (e.g., known renal impairment which can be exacerbated by PrEP use).
18 Years
60 Years
FEMALE
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Angela M Heads
Associate Professor
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
Countries
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Central Contacts
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Facility Contacts
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Angela Heads
Role: primary
Kaixuan An
Role: backup
References
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Heads AM, Santa Maria D, Hill MJ, Suchting R, Evans KN, Gaul Z, Yammine L, de Dios C, Schmitz JM. Development and Pilot Testing of an Addiction Clinic-Based Pre-Exposure Prophylaxis Uptake and Adherence Intervention for Women with Substance Use Disorders: Protocol for a Pilot Randomized Trial. JMIR Res Protoc. 2025 May 23;14:e64961. doi: 10.2196/64961.
Other Identifiers
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HSC-MS-21-0451
Identifier Type: -
Identifier Source: org_study_id