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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post prep initiation
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PrEP uptake
Secondary outcome measures
Daily PrEP adherence as assessed by the levels of tenofovir (TFV) urine concentrations
Daily PrEP adherence as assessed by the proportion of self reported daily adherence
Daily PrEP adherence as assessed by the proportion of videos uploaded
+4 more

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
904 Previous Clinical Trials
320,900 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for new participants in this clinical research?

"Affirmative. The information on clinicaltrials.gov attests that this investigation, which was initially uploaded to the website on June 7th 2022, is presently enrolling candidates. 60 volunteers are needed for the trial at one particular site."

Answered by AI

Can elderly persons participate in this clinical experiment?

"In accordance with the criteria for inclusion, this medical trial necessitates that all participants are over 18 years of age and no older than 60."

Answered by AI

How many participants are being included in the current research?

"Affirmative. Clinicaltrials.gov has information revealing that this clinical trial is actively seeking participants, which was initially advertised on June 7th 2022 and last edited November 27th 2023. In total, 60 patients are needed at a singular site for the study to succeed."

Answered by AI

Does my profile qualify me for participation in this clinical venture?

"Candidates between the ages of 18 and 60 who are struggling with substance abuse can apply to take part in this medical trial. The study is currently looking for a total of sixty participants."

Answered by AI

Who else is applying?

What site did they apply to?
Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I wanting to be able to help others and also myself.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women With Substance Use Disorders
Angela M Heads 2022. "Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women With Substance Use Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06158607.
~22 spots leftby May 2025
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