Substance Use
Conditions
Keywords
Pre-Exposure Prophylaxis, Women, HIV Prevention
Brief summary
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
Interventions
BEHAVIORALAddiction 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.
OTHERStandard 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
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP uptake | 12 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Enrollment rate as assessed by the number of participants that signed the consent form | 12 weeks post intervention | — |
| Daily PrEP adherence as assessed by the levels of tenofovir (TFV) urine concentrations | 90 days post PrEP initiation | levels of tenofovir (TFV) urine concentrations (\>1000ng/ml) detected in urine shows higher adherence |
| 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 | 12 weeks post intervention | This is a 15 item questionnaire and each is cored from 1(not at all true)-9( absolutely true), higher number indicating more satisfaction |
| Number of sessions attended by participants | 12 weeks post enrollment | — |
Countries
United States
Contacts
Primary ContactAngela Heads, PhD
Backup ContactKaixuan An
Outcome results
None listed