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New treatment option for Substance Use
Official title Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women with Substance Use Disorders
ClinicalTrials.gov ID: NCT06158607
What this study is testing
- What it's testing
- The goal of this clinical trial is to test an addiction-clinic based behavioral intervention for increasing PrEP uptake and adherence among women who engage in high-risk sexual behaviors and problematic substance use. The main question it aims to answer is: 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only
You may be able to join if
- 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
You likely can't join if
- 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...
- 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).
See the full eligibility criteria
- 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.