An interventional study of Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders and Standard of care treatment in Substance Use, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Prevention
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:
Participants will
Researchers will compare intervention group with standard treatment to see if the integrated intervention help increase PrEP uptake and adherence
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's planned enrollment of 60 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders
Other: Standard of care treatment
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
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
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
Plan to share: No
No publications or documents are linked to this record.
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The University of Texas Health Science Center, Houston