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PrEP Adherence Intervention for Women with Substance Use Disorders

This study is testing a new way to help women with substance use disorders (SUD) use PrEP (Pre-exposure Prophylaxis) effectively. PrEP is a medication that can prevent HIV infection. The study will compare an intervention that provides PrEP information through counseling sessions, prevention navigation, and nurse practitioner-prescribed PrEP in an addiction treatment setting, to standard care. Standard care involves getting information and referrals to a community partner for PrEP evaluation. Researchers want to see if the new intervention helps more women start and continue using PrEP. You may be able to join if you are a Black/African American or Hispanic/Latina cisgender woman, aged 18-60, diagnosed with SUD, HIV-negative, sexually active with an opposite-sex partner, and not currently using PrEP. The study aims to enroll 60 participants.

Study design
This is an interventional study comparing two approaches to PrEP uptake and adherence. It plans to enroll 60 women.
What's involved
Participants will receive PrEP information through 4 counseling sessions, prevention navigation, and nurse practitioner-prescribed PrEP in an addiction treatment setting.
Compensation
Not stated in the trial record.
Follow-up
PrEP uptake will be measured at 12 weeks post intervention.

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NCT06158607

Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women with Substance Use Disorders

Recruiting
NAAges 18–60InterventionalPrevention
The University of Texas Health Science Center, Houston
~60 participants
Updated 2024-12-30 on ClinicalTrials.gov
What's tested:Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use DisordersStandard of care treatment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PrEP uptake
Measured over 12 weeks post intervention

Conditions

Substance Use

Explore related trials

Substance use disorder

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Angela Heads, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Angela Heads, PhD
[email protected]
(713) 486-2830
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Black/African American and Hispanic/Latina cisgender women
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

be concurrently participating in another SUD behavioral treatment program
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).

What this trial measures

  • PrEP uptake12 weeks post intervention

    Filling the PrEP prescription and taking at least one dose of the medication by two weeks following their visit with the PrEP provider