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PrEP Adherence Intervention for HIV Prevention (PRIME Trial)

Phase 4
Recruiting
Led By Phillip Coffin
Research Sponsored by San Francisco Department of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Reports condomless sero-unknown/discordant anal sex with a person assigned male sex at birth or of male gender in the past 12 months
Age 18-65 years inclusive
Must not have
Contraindication to tenofovir or emtricitabine-containing products
On PrEP for more than 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in sexpro score from baseline at 24 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will assess if using video directly observed therapy with real-time contingency management (VDOT-CM) may help people assigned male sex at birth who have sex with men (MSM) who inject methamphetamine adhere to PrEP.

Who is the study for?
This trial is for males aged 18-65 who inject substances, use methamphetamine, and are at risk of HIV. They must be HIV-negative with recent risky sexual behavior and have access to a computer. It's not for those on PrEP over 6 months or with certain health conditions like kidney issues or hepatitis B.
What is being tested?
The study tests if video observed therapy with rewards (VDOT-CM) improves adherence to PrEP medication compared to counseling alone in preventing HIV. Participants will either receive VDOT-CM or just counseling for six months and their adherence and attitudes towards PrEP will be monitored.
What are the potential side effects?
Potential side effects from the interventions may include discomfort from daily medication intake, privacy concerns due to video recording, and possible stress related to adhering to the treatment regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had unprotected sex with a male or someone assigned male at birth in the last year.
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I am between 18 and 65 years old.
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I was assigned male at birth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take medications containing tenofovir or emtricitabine.
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I have been taking PrEP for over 6 months.
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My kidney function is low, with a creatinine clearance of 30 mL/min or less.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in sexpro score from baseline at 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in sexpro score from baseline at 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
ARCH-IDU Score
SexPro score

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Video directly observed therapy with contingency managementExperimental Treatment2 Interventions
Video directly observed therapy with contingency management, in addition to Integrated Next-Step Counseling.
Group II: Integrated Next-Step CounselingPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

San Francisco Department of Public HealthLead Sponsor
37 Previous Clinical Trials
35,904 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,582 Previous Clinical Trials
3,326,900 Total Patients Enrolled
Phillip CoffinPrincipal Investigator - San Francisco Department of Public Health
San Francisco Department of Public Health

Media Library

Video directly observed therapy with contingency management Clinical Trial Eligibility Overview. Trial Name: NCT04523519 — Phase 4
Human Immunodeficiency Virus Infection Research Study Groups: Video directly observed therapy with contingency management, Integrated Next-Step Counseling
Human Immunodeficiency Virus Infection Clinical Trial 2023: Video directly observed therapy with contingency management Highlights & Side Effects. Trial Name: NCT04523519 — Phase 4
Video directly observed therapy with contingency management 2023 Treatment Timeline for Medical Study. Trial Name: NCT04523519 — Phase 4
~15 spots leftby May 2025
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