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Behavioral Intervention

PrEP Navigation + Contingency Management for HIV Prevention in Substance Use Disorders

N/A

Recruiting

Led By Cathy J Reback, PhD

Research Sponsored by Friends Research Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare an HIV prevention program with added focus on substance use disorder to a standard HIV prevention program.

Who is the study for?

The ASK-PrEP trial is for HIV-negative trans women and men who have sex with men, over 18 years old, at high risk for HIV, and with a substance use disorder (excluding cannabis only). Participants must have missed multiple PrEP doses or not had PrEP care visits in the past 3 months. They should be willing to consent and comply with study requirements.

What is being tested?

This trial tests a Stepped Care approach versus Standard of Care in preventing HIV. The Stepped Care includes PrEP navigation sessions and weekly text support. Non-responders after three months receive additional focus on their SUD through contingency management.

What are the potential side effects?

While specific side effects are not listed for this behavioral intervention, participants may experience stress or discomfort from frequent communication and adherence monitoring. Any medical interventions like PrEP could carry typical medication-related risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average Cumulative Days of Substance Use

Cost-effectiveness

Rate of PrEP Persistence

Secondary study objectives

Effects of substances, route of administration, severity of SUD, social and structural determinants of health, and differing individual-level characteristics as moderators.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Education and InformationExperimental Treatment1 Intervention

The Standard of Care (SOC) intervention includes a 20-30-minute session of PrEP information and where to access PrEP in Los Angeles. The same session is repeated at the 3-month assessment. Participants randomized to the SOC arm receive 2 educational/informational sessions on PrEP misconceptions, uptake, and adherence. The sessions occur at baseline and the 3-month assessment.

Group II: ASK-PrEPExperimental Treatment2 Interventions

ASK-PrEP is a 5-session PrEP navigation intervention, with text-messaging support, to advance through the PrEP Care Continuum by identifying the individual needs and barriers to PrEP care, including substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Intervention/treatment: PrEP navigation + text messaging Participants receive 5 PrEP navigation sessions within 3 months plus a weekly culturally specific, scripted text message. Participants that do not respond to the ASK-PrEP intervention at the 3-month assessment are re-randomized (1:1) and stepped up to receive ASK-PrEP plus CM or CM alone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard of Care

2017

Completed Phase 4

~4420

Contingency Management

2014

Completed Phase 4

~3440