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

Study Overview
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Brief Summary
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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

Official Title
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Development and Pilot Testing of an Addiction Clinic-Based PrEP Adherence Intervention for Women With Substance Use Disorders

Conditions
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Substance Use

Intervention / Treatment
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* Behavioral: Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders
* Other: Standard of care treatment


Participation Criteria
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Eligibility Criteria
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Inclusion 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders<br>* Provision of PrEP information through 4 counseling sessions, prevention navigation, and nurse practitioner prescribed PrEP in an addiction treatment setting.<br>|
| Active Comparator: Standard of care treatment<br> | Other: Standard of care treatment<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP uptake | Filling the PrEP prescription and taking at least one dose of the medication by two weeks following their visit with the PrEP provider | 12 weeks post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily PrEP adherence as assessed by the proportion of videos uploaded |  | 12 weeks post PrEP initiation | 
| Daily PrEP adherence as assessed by the proportion of self reported daily adherence |  | 12 weeks post PrEP initiation | 
| Daily PrEP adherence as assessed by the levels of tenofovir (TFV) urine concentrations | levels of tenofovir (TFV) urine concentrations (>1000ng/ml) detected in urine shows higher adherence | 90 days post PrEP initiation | 
| Enrollment rate as assessed by the number of participants that signed the consent form |  | 12 weeks post intervention | 
| Number of sessions attended by participants |  | 12 weeks post enrollment | 
| Study retention as assessed by the number of participants that completed the study |  | 12 weeks post enrollment | 
| Intervention acceptability as assessed by the Client satisfaction questionnaire | This is a 15 item questionnaire and each is cored from 1(not at all true)-9( absolutely true), higher number indicating more satisfaction | 12 weeks post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-Exposure Prophylaxis, Women, HIV Prevention