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Behavioural Intervention

PrEP Adherence Intervention for Substance Use Disorders

N/A
Recruiting
Led By Angela Heads, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Not using PrEP for HIV prevention at the time of screening
Be between 18 and 65 years old
Must not have
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 medical contraindications for PrEP (e.g., known renal impairment which can be exacerbated by PrEP use)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post prep initiation
Awards & highlights

Summary

This trial tests an integrated addiction treatment/PrEP intervention to see if it helps increase PrEP uptake & adherence among high-risk women. Researchers compare it to standard treatment.

Who is the study for?
This trial is for Black/African American and Hispanic/Latina cisgender women with substance use disorders, who are HIV negative, sexually active, not currently using PrEP, speak English, and have smartphone access. It's not for those in other SUD programs, unable to consent or participate fully due to cognitive or psychological issues, ineligible for PrEP by CDC criteria or with medical contraindications.
What is being tested?
The study tests a behavioral intervention aimed at increasing uptake and adherence to PrEP among women with high-risk sexual behaviors and problematic substance use. The intervention includes counseling sessions on PrEP information, prevention navigation services, and prescription of PrEP within an addiction treatment setting.
What are the potential side effects?
While the side effects aren't detailed here as it focuses on behavioral interventions rather than medication side effects per se; generally speaking about PrEP: potential side effects can include nausea, headaches, stomach pain and weight loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not using HIV prevention medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am able to understand and consent to participate in the study.
Select...
I cannot take PrEP due to kidney problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days post prep initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post prep initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PrEP uptake
Secondary study objectives
Daily PrEP adherence as assessed by the levels of tenofovir (TFV) urine concentrations
Intervention acceptability as assessed by the Client satisfaction questionnaire

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: Standard of care treatmentActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
934 Previous Clinical Trials
333,748 Total Patients Enrolled
1 Trials studying Substance Abuse
7,500 Patients Enrolled for Substance Abuse
Angela Heads, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
60 Total Patients Enrolled
~14 spots leftby May 2025
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