# Promoting HIV risk reduction among people who inject drugs: A stepped care approach using contingency management with PrEP navigation

> **NIH NIH R01** · YALE UNIVERSITY · 2020 · $1,217,219

## Abstract

ABSTRACT
People who inject drugs (PWID) often do not receive evidence-based HIV prevention interventions, including
syringe service programs (SSP), medications for opioid use disorder (MOUD) and pre-exposure prophylaxis
(PrEP). This is an urgent problem in Connecticut and Massachusetts. Interventions that address individual and
structural barriers are needed. Furthermore, since PWID often do not receive routine medical care, it is
important to engage them in care in community-based settings. Although contingency management (CM) (i.e.,
use of tangible rewards to incentivize verifiable behavior change) can be effective to address substance use
and infectious disease prevention and treatment, it has not been studied for PrEP among PWID. CM may not
be uniformly effective as some individuals may need additional intervention, such as PrEP navigation, to
overcome individual or structural barriers to receiving HIV prevention interventions. Stepped care strategies
offer a solution as they are adaptive to individuals’ response (e.g. stepped care) to meet individual needs while
optimizing resources. We, therefore, propose a randomized controlled trial of 526 PrEP-eligible PWID in
partnership with opioid treatment programs, a harm reduction agency and AIDS service organization to
evaluate the impact of CM with stepped care as needed to include PrEP navigation (“CM2PN”) vs. treatment
as usual (“TAU”). Participants randomized to CM2PN will receive prize-based CM sessions over 9 sessions to
reward progress towards PrEP initiation adherence, engagement in MOUD and engagement in SSP and other
risk reduction activities. Individuals who do not have high levels of PrEP adherence by week 12 based on self-
report and confirmed by point-of-care urine testing, will be “stepped up” to receive PrEP navigation over 5
sessions. PrEP navigation will be informed by Project INFORM and ARTAS, tailored specifically for PWID and
grounded in motivation interviewing principles. The intervention, CM2PN, will be delivered by trained PrEP
navigators. TAU includes a pamphlet on PrEP and information on ways to access other relevant care (e.g.,
MOUD). The primary outcome will be sustained PrEP adherence assessed by dried blood spot testing to
evaluate cumulative dosing over 6-8 weeks. Our specific aims are to compare the effectiveness of CM2PN
vs. TAU on: 1) on sustained PrEP adherence at 24 weeks; 2) HIV risk behaviors; engagement in opioid use
disorder-related care (SSP, MOUD) and extra-medical opioid use; and (exploratory) STI and HIV acquisition;
and 3) among PrEP navigators, front-line providers and staff, and leadership at each site, conduct an
implementation focused-process evaluation of CM2PN. Our team has expertise in integrating HIV and opioid
use disorder-related care, CM, clinicals trials with adaptive designs, community-engaged research and
implementation science. Innovative aspects include multi-target CM for PWID for PrEP; stepped care design;
academic-community-public hea...

## Key facts

- **NIH application ID:** 10054553
- **Project number:** 1R01DA051871-01
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** E. Jennifer Edelman
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,217,219
- **Award type:** 1
- **Project period:** 2020-07-01 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10054553

## Citation

> US National Institutes of Health, RePORTER application 10054553, Promoting HIV risk reduction among people who inject drugs: A stepped care approach using contingency management with PrEP navigation (1R01DA051871-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10054553. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*