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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

PRIME 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.Check my eligibility

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.See study design

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.

PRIME Trial 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.

PRIME Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

TFV-DP levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots

Tenofovir diphosphate (TFV-DP) levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots

Secondary outcome measures

ARCH-IDU Score

Qualitative interview data describing participant experiences taking PrEP, with Integrated Next-Step Counseling, and among those randomized to the VDOT-CM arm, experience with VDOT-CM

SexPro score

PRIME 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

San Francisco Department of Public HealthLead Sponsor

35 Previous Clinical Trials

34,211 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,469 Previous Clinical Trials

2,619,269 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

Frequently Asked Questions

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

What is the participant limit for this medical experiment?

"Affirmative. According to clinicaltrials.gov, this medical research program is still accepting individuals for enrollment and first opened on April 30th 2021. The latest update was made May 3rd 2022 with the aim of recruiting 140 patients from one centre."

Answered by AI

Has this investigation begun to accept new participants?

"As evidenced by clinicaltrials.gov, this clinical trial is actively seeking participants and was first made public on April 30th 2021 with updates concluding May 3rd 2022."

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Does this clinical research include elderly individuals beyond the age of eighty?

"The lower limit for patient enrollment is 18 and the upper limit is 65 years old, in accordance with this trial's inclusion criteria."

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Could I be a potential candidate for this investigation?

"For eligibility in this clinical trial, individuals must have a HIV infection and be between 18 to 65 years old. 140 people are being accepted into the study."

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To what extent can Video directly observed therapy with contingency management be harmful to participants?

"The safety of Video Directly Observed Therapy with Contingency Management is rated at a 3, as it has achieved FDA clearance and completed Phase 4 trials."

Answered by AI