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Behavioral Intervention
PrEP Navigation + Contingency Management for HIV Prevention in Substance Use Disorders
Phase 2
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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Cumulative Days of Substance Use
Cost-effectiveness
Rate of PrEP Persistence
Secondary outcome measures
Effects of substances, route of administration, severity of SUD, social and structural determinants of health, and differing individual-level characteristics as moderators.
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
2003
Completed Phase 2
~3220
Find a Location
Who is running the clinical trial?
Friends Research Institute, Inc.Lead Sponsor
52 Previous Clinical Trials
20,358 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,055 Previous Clinical Trials
1,316,045 Total Patients Enrolled
University of California, Los AngelesOTHER
1,532 Previous Clinical Trials
10,265,018 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I missed taking my PrEP medication 4 or more times a week in the last month.I have been consistently taking PrEP and attended all PrEP care visits in the last 3 months.I am HIV positive.I identify as a transgender woman or a man who has sex with men.My kidney and liver function is good enough for PrEP use.I am younger than 18 years old.I do not identify as a transgender woman or a man who has sex with men.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: ASK-PrEP
- Group 2: Education and Information
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are actively participating in this research endeavor?
"That is correct. According to the information posted on clinicaltrials.gov, enlistment for this trial commenced on May 11th 2023 and was recently updated on June 28th 2023. The study seeks to enrol 250 patients from a single medical centre."
Answered by AI
Are individuals currently being welcomed to partake in this medical trial?
"According to clinicaltrials.gov, this trial is still actively recruiting patients; the advertisement was initially posted on May 11th 2023 and most recently amended on June 28th 2023."
Answered by AI
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