# PRIME: PrEP Intervention for people who Inject MEthamphetamine

> **NIH NIH R01** · PUBLIC HEALTH FOUNDATION ENTERPRISES · 2024 · $738,862

## Abstract

Project Summary/Abstract
Notwithstanding a substantial effort of “getting to zero”, new HIV infections among people who inject drugs are
increasing. Methamphetamine is a primary driver of that increase, as methamphetamine use has been
extensively demonstrated to increase both sexual and injection-related HIV transmission. Methamphetamine
use is also associated with poor medication adherence, such that people with HIV who use methamphetamine
are less likely to be virally suppressed. The most powerful tool for prevention of HIV available today, in addition
to aggressive treatment of people living with HIV to ensure viral suppression, is pre-exposure prophylaxis
(PrEP) with emtricitabine plus a tenofovir product (e.g. FTC/TAF). PrEP has been extensively demonstrated to
reduce HIV infection when taken in sufficient amounts, generally defined as ≥4 doses per week. The Centers
for Disease Control and other health agencies recommend PrEP for people who inject drugs, yet there has
been precious little attention to this population in PrEP clinical trials, implementation studies, and
demonstration projects. Two major reasons for this lack of attention are (1) that syringe access programs,
where available, are powerful tools to lower HIV transmission by injection, and (2) that people who inject drugs
– and in particular people who use methamphetamine – are likely to struggle with medication adherence. In the
context of expanding methamphetamine use – as the next wave of the opioid crisis – and a national effort to
eliminate HIV transmission, syringe access programs are unlikely to be sufficient to prevent the remaining
infections that occur. In this study, “PrEP Intervention for people who Inject Methamphetamine” (PRIME), we
propose to address the second concern by testing a combined adherence intervention. PRIME is a two-arm
trial comparing standardized counseling to video directly-observed treatment with real-time contingency
management (VDOT-CM) for adherence to once-daily emtricitabine/tenofovir alafenamide (FTC/TAF) PrEP
among people who inject methamphetamine. We will randomize 140 adults who inject methamphetamine, are
HIV-negative, and have recently engaged in HIV risk behaviors to VDOT-CM or counseling alone for 24 weeks.
Both groups will receive PrEP and counseling to support PrEP adherence; the intervention condition will also
receive a mobile phone app that video records daily PrEP use and a nominal contingency management
incentive to complete the observed PrEP dosing. We will compare adherence to PrEP in both arms by testing
dried blood spots for tenofovir disphosphate (TFV-DP) levels of ≥ 950 fmol/punch, corresponding to ≥4 doses
per week. We will assess acceptability of PrEP in this population through qualitative interviews and survey
items. Finally, we will compare injection and sexual risk behaviors prior to PrEP to those while on PrEP, to
evaluate for risk compensation. Study results will provide critical data for intensive adherence suppo...

## Key facts

- **NIH application ID:** 10877124
- **Project number:** 5R01DA051850-05
- **Recipient organization:** PUBLIC HEALTH FOUNDATION ENTERPRISES
- **Principal Investigator:** PHILLIP O COFFIN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $738,862
- **Award type:** 5
- **Project period:** 2020-08-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10877124

## Citation

> US National Institutes of Health, RePORTER application 10877124, PRIME: PrEP Intervention for people who Inject MEthamphetamine (5R01DA051850-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10877124. Licensed CC0.

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