# Sequential Strategies to Reach and Reengage Individuals after Lapses from HIV Care in Zambia

> **NIH NIH R01** · WASHINGTON UNIVERSITY · 2024 · $662,604

## Abstract

ABSTRACT
Treatment lapses remain one of the most enduring challenges to viral suppression in Africa. These individuals
have higher rates of viremia (~70%), morbidity, and mortality, and now represent the majority of those
hospitalized with advanced HIV. Even among those who return to care, 30-50% have repeat lapses due to
ongoing challenges with care such competing obligations, travel/mobility, clinic-based, or psychosocial barriers.
Effective strategies for durably reengaging individuals with treatment lapses must address two steps: they must
first be brought back into care, but after return, person-centered strategies are needed to prevent repeat lapses
and keep them reengaged long-term. Navigation (NAV) and community-based medication delivery (CB-Med)
are strategies that have been found to improve outcomes among those newly initiating or stable on ART, and
our preliminary data indicates their complementary mechanisms hold promise to address key challenges at both
the return and reengage stages. NAV offers a flexible approach to tailor outreach, care coordination, and
psychosocial support to match individuals' unique barriers to care. Leveraging navigators to provide ongoing
CB-Med efficiently adds instrumental support to further reduce challenges with medication access. Still, rigorous
evidence on the use, timing, and optimal combinations of NAV and CB-Med after treatment lapses is lacking.
For example, offering NAV+CB-Med may improve rates of ART re-initiation, but this may not translate to better
longer-term outcomes if it is stopped after return and individuals then receive the same care that previously
failed. We propose a sequential multiple assignment randomized trial (SMART) among 1270 individuals who are
>30 days late for an appointment to assess different sequential combinations of return to care and reengagement
strategies. We randomize participants in the first-stage to receive (1) routine phone outreach only (standard of
care [SOC]) or (2) NAV+CB-Med for rapid ART re-initiation in the community and reentry support. Among those
who return to care, we re-randomize them in the second-stage to: (1) routine care and counseling after return
(RCC [SOC]), (2) NAV only after return, or (3) NAV+CB-Med after return. In Aim 1a, we compare phone outreach
only vs. NAV+CB-Med on time to ART re-initiation and return to care. In Aim 1b, among individuals who return,
we compare RCC, NAV alone, and NAV+CB-Med on retention in care after return (time to missing a pharmacy
refill by >14 days). In Aim 2, we assess the overall effectiveness and cost-effectiveness of the six sequential
combination return-and-reengage strategies embedded within the SMART design on viral suppression at 18-
months after initial randomization (primary outcome). Lastly, in Aim 3 we conduct a mixed-methods evaluation
to understand implementation (e.g., reach, adoption, fidelity, acceptability), mechanisms of action, and potential
for sustainability among diverse stakeholders (e....

## Key facts

- **NIH application ID:** 10839696
- **Project number:** 1R01MH135819-01
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** Aaloke Mody
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $662,604
- **Award type:** 1
- **Project period:** 2024-08-09 → 2029-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10839696

## Citation

> US National Institutes of Health, RePORTER application 10839696, Sequential Strategies to Reach and Reengage Individuals after Lapses from HIV Care in Zambia (1R01MH135819-01). Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/grant/nih/10839696. Licensed CC0.

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