# Stepped Care, Peer-Delivered Intervention to Improve ART Adherence and SUD in Primary Care

> **NIH NIH R01** · UNIV OF MARYLAND, COLLEGE PARK · 2022 · $684,566

## Abstract

Significance: This proposal is for a type 2 hybrid effectiveness-implementation trial to test an intervention and
implementation strategy of a peer-delivered, stepped care approach for integrating HIV and substance use
(SU) services in a resource-limited primary care setting. Globally, a SU treatment gap exists, with only 1-4% of
individuals who need treatment in the most resource-limited contexts receiving minimally adequate treatment.
Given the impact of untreated SU on poor HIV outcomes along the care continuum, efforts are needed to
sustainably integrate behavioral interventions into primary care settings to reach individuals at highest risk for
poor ART adherence and SU outcomes. This gap in care in resource-limited settings will be met through
implementing a peer-delivered, stepped care intervention, which has been successfully piloted in Cape Town,
South Africa in the PI’s K23 award (“Khanya”). Preliminary work: Our team has developed and adapted the
Khanya peer-delivered intervention based on key stakeholder feedback to improve ART adherence among
PLWH with SU in primary care in South Africa. Khanya integrates Life-Steps, a single-session problem solving
and motivational intervention for ART adherence, with brief behavioral skills to reduce SU (i.e., behavioral
activation, mindfulness, relapse prevention). The PI’s K23 award included a pilot Type 1 hybrid effectiveness-
implementation trial that demonstrated initial feasibility, acceptability, and preliminary effectiveness of Khanya
for improving ART adherence compared to enhanced standard of care (ESOC). At post-treatment, adherence
in Khanya was M=60.3% days vs. M=26.5% in ESOC. Methods: Guided by RE-AIM, the current study aims to
test in a Type 2 hybrid effectiveness-implementation trial the effectiveness and implementation of a stepped-
care Khanya intervention for PLWH at highest risk for ongoing ART nonadherence and HIV transmission. A
stepped care approach is appealing in a resource-limited context, as the least resource intensive part of an
intervention is delivered first, and only individuals who do not respond receive the more resource intensive part
of the intervention. 150 PLWH with SU will be recruited from an integrated primary care site and randomized to
ESOC (i.e., facilitated referral to public SU treatment) or Khanya. Khanya begins with Life-Steps + ESOC, and
only those who continue to demonstrate ART nonadherence (i.e., detected using real-time electronic
adherence monitoring; ≥3 missed doses in a 2-week period) will step up to receive the full intervention. Based
on our pilot data, we anticipate Life-Steps + ESOC alone will be sufficient for ~44% of patients to overcome
barriers to ART adherence, but the other ~56%, particularly those with more severe SU, will require the full
intervention. Participants will be followed for 12 months on: ART adherence (Wisepill, DBS concentrations, and
self-report), SU (urinalysis, PEth, and self-report), implementation (reach and upta...

## Key facts

- **NIH application ID:** 10462094
- **Project number:** 1R01DA056102-01
- **Recipient organization:** UNIV OF MARYLAND, COLLEGE PARK
- **Principal Investigator:** Jessica F Magidson
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $684,566
- **Award type:** 1
- **Project period:** 2022-08-01 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10462094

## Citation

> US National Institutes of Health, RePORTER application 10462094, Stepped Care, Peer-Delivered Intervention to Improve ART Adherence and SUD in Primary Care (1R01DA056102-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10462094. Licensed CC0.

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