# Optimizing PrEP adherence in sexual minority men who use stimulants

> **NIH NIH R01** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2021 · $1,042,929

## Abstract

Abstract
Among men who have sex with men (MSM), there is an urgent need to optimize the unprecedented clinical
and public health benefits of pre-exposure prophylaxis (PrEP) to prevent HIV with those who use stimulants
(i.e., methamphetamine, cocaine, and crack-cocaine). Stimulant-using MSM display 3-6 fold faster rates of HIV
seroconversion, and one-in-ten MSM with newly diagnosed HIV infection report recent stimulant use. Findings
from our team and others also demonstrate that stimulant use is a key obstacle to PrEP adherence and
persistence. Stimulant-using MSM have a 3-fold greater rate of disengagement from PrEP care and 5-fold
greater odds of sub-optimal PrEP adherence. The proposed multi-site randomized controlled trial (RCT) will
leverage a promising intervention model of delivering a positive affect intervention during contingency
management (CM), which we have recently demonstrated achieves durable and clinically meaningful
reductions in viral load among HIV+, methamphetamine-using MSM. In the proposed multi-site RCT, we plan
to test whether delivering an Affect Regulation Treatment to Enhance Medication Intervention Success
(ARTEMIS) positive affect intervention during smartphone-based CM for directly observed PrEP doses
achieves more durable reductions in HIV acquisition risk over 12 months. HIV acquisition risk (the primary
outcome) will be operationalized as tenofovir diphosphate (TFV-DP) levels <700 fmol per punchand self-
reported recent condomless anal sex (CAS). Up to 300 MSM on PrEP who report stimulant use and CAS in the
past 3 months as well as any PrEP non-adherence in the past month will be recruited from social networking
applications as well as PrEP clinical services in South Florida and San Francisco. Participants who meet the
inclusion and exclusion criteria at an in-person baseline assessment will provide a dried blood spot (DBS)
specimen that will be stored to measure TFV-DP levels and begin 3-months of smartphone-based CM that
includes financial incentives for completing up to four directly observed PrEP doses per week (48 doses total
over the 3 months). Participants will complete a run-in period (waiting period) where they will complete 4
directly observed smartphone-based CM PrEP doses prior to randomization. At a separate randomization visit,
240 participants (120 South Florida and 120 San Francisco) will be randomized to receive their first individually
delivered ARTEMIS positive affect intervention or attention-control session. All 5 individually delivered
intervention sessions will be delivered during the 3-month CM intervention period. Follow-up assessments will
be conducted at 3, 6, and 12 months after beginning CM, with DBS collected to measure TFV-DP at 6 and 12
months. Consistent with the NIH OAR high priority area of “reducing the incidence of HIV/AIDS,” this clinical
research will meaningfully inform the targeted deployment of limited public health resources to optimize the
unprecedented clinical and publ...

## Key facts

- **NIH application ID:** 10205017
- **Project number:** 5R01DA051848-02
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** Adam Wayne Carrico
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,042,929
- **Award type:** 5
- **Project period:** 2020-07-01 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10205017

## Citation

> US National Institutes of Health, RePORTER application 10205017, Optimizing PrEP adherence in sexual minority men who use stimulants (5R01DA051848-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10205017. Licensed CC0.

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