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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
60
Provision of PrEP information through 4 counseling sessions, prevention navigation, and nurse practitioner prescribed PrEP in an addiction treatment setting.
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
Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGPrEP uptake
Filling the PrEP prescription and taking at least one dose of the medication by two weeks following their visit with the PrEP provider
Time frame: 12 weeks post intervention
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
Time frame: 90 days post PrEP initiation
Daily PrEP adherence as assessed by the proportion of videos uploaded
Time frame: 12 weeks post PrEP initiation
Daily PrEP adherence as assessed by the proportion of self reported daily adherence
Time frame: 12 weeks post PrEP initiation
Enrollment rate as assessed by the number of participants that signed the consent form
Time frame: 12 weeks post intervention
Number of sessions attended by participants
Time frame: 12 weeks post enrollment
Study retention as assessed by the number of participants that completed the study
Time frame: 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
Time frame: 12 weeks post intervention
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