# A SMART trial evaluating phased implementation of text messaging, cell phone support, and contingency management in youth nonadherent to antiretroviral medication

> **NIH NIH U19** · FLORIDA STATE UNIVERSITY · 2020 · $168,904

## Abstract

In the United States, it is estimated that one-third of all new HIV diagnoses are among people less
than 25 years of age. There is strong evidence that adherence to ART is a primary determinant of
virological suppression, disease progression, and mortality. However, a recent review and metaanalysis
of research on youth with HIV found an average ART adherence rate of 53% in North
America, the lowest adherence rate globally. Intensive and/or in-person adherence intervention
models have been problematic for youth with HIV. Interventions requiring multiple visits, even with
brief, in-person sessions, have been difficult for youth to complete. These models have largely failed
to promote long-term, sustained medication adherence (and sustained viral load below detection),
and are commonly cost prohibitive for use in real world settings regardless of efficacy. Given these
issues, one possibility for sustainable, yet individualized intervention delivery is through mobile
health/technology-based approaches. This proposal directly addresses the urgent need for culturally
acceptable, youth-friendly ART adherence interventions that can be rapidly implemented in clinical
settings. We plan to conduct a clinical trial comparing two promising youth-friendly intervention
strategies: weekday cell phone support (CPS) and daily text messaging (SMS). In pilot studies, both
have demonstrated significant improvements in medication adherence. Participants who received
CPS showed significant reductions in HIV viral load during the 24 week intervention; moreover,
effects persisted for 24 weeks post intervention. The proposed research moves beyond a traditional
clinical trial by utilizing a “SMART” (Sequential Multiple Assignment Randomized Trial) design as a
cost-effective and methodologically rigorous way to explore additional questions to optimize the
interventions and maximize clinical utility and real-world implementation. This SMART design will
allow us to identify the most effective and cost efficient sequence of SMS and/or CPS, utilizing
incentives strategically, and tapering to sustain the impact of the intervention. We hypothesize that
youth randomized to CPS will have significantly greater viral load suppression (primary outcome)
and self-reported medication adherence (secondary outcome) than those in the SMS group. The
proposed research brings together a team of skilled HIV clinical and behavioral researchers with
decades of experience with clinical care and adherence research with youth, including numerous
collaborations within the NIH-funded Adolescent Trials Network. This research will be conducted at
five clinical sites with decades of experience conducting trials and that have a track record of
excellence in recruiting, retaining, and collecting data from youth living with HIV.

## Key facts

- **NIH application ID:** 9980432
- **Project number:** 5U19HD089875-06
- **Recipient organization:** FLORIDA STATE UNIVERSITY
- **Principal Investigator:** MARVIN E BELZER
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $168,904
- **Award type:** 5
- **Project period:** — → 2022-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9980432

## Citation

> US National Institutes of Health, RePORTER application 9980432, A SMART trial evaluating phased implementation of text messaging, cell phone support, and contingency management in youth nonadherent to antiretroviral medication (5U19HD089875-06). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9980432. Licensed CC0.

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