Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Feb 14:12:e42691.
doi: 10.2196/42691.

Leveraging mHealth and Patient Supporters for African Americans' and Latinxs' Engagement in HIV Care (LEAN): Protocol for a Randomized, Controlled, Effectiveness-Implementation Trial

Joyce Jones  1 , Jane McKenzie-White  1 , Ronald Saxton  1 , Suzanne M Grieb  1 , Bareng Nonyane  2 , Cadeesha Graham  1 , Anthony Cano  1 , Sheridan Johnson  1   3 , Lanisha Childs  3 , Adena Greenbaum  3 , Colin Flynn  4 , Marcia Pearlowitz  4 , Shivaun Celano  1 , Larry W Chang #  1 , Kathleen R Page #  1
Affiliations

Leveraging mHealth and Patient Supporters for African Americans' and Latinxs' Engagement in HIV Care (LEAN): Protocol for a Randomized, Controlled, Effectiveness-Implementation Trial

Joyce Jones et al. JMIR Res Protoc. .

Abstract

Background: Despite substantial investments in ending the HIV epidemic, disparities in HIV care persist, and there is an urgent need to evaluate novel and scalable approaches to improving HIV care engagement and viral suppression in real-world settings.

Objective: This paper aims to describe a study protocol for a pragmatic type II hybrid effectiveness-implementation randomized controlled trial comparing existing standard of care clinic HIV linkage, adherence, and retention (LAR) protocols to a mobile health (mHealth)-enhanced linkage, adherence, and retention (mLAR) intervention.

Methods: The study will enroll 450 participants from clinics in Baltimore City. Eligibility criteria include being ≥18 years of age, having a new HIV diagnosis or being HIV-positive and out of care, or being HIV-positive and deemed by clinic staff as someone who could benefit from linkage and retention services. Participants randomized to the intervention receive mHealth-supported patient navigation for 12 months. Participants in the control group receive the referring clinic's standard of care patient support. The primary outcome is HIV virologic suppression at 12 months. A subset of participants will be interviewed at 12 months to learn about their HIV care experiences and, for those in the intervention arm, their experiences with the mLAR intervention. This protocol was developed in collaboration with the Baltimore City Health Department (BCHD) and the Maryland Department of Health (MDH) and with input from a community advisory board.

Results: Enrollment began on February 25, 2020. As of August 11, 2022, 411 of the 450 target participants had been enrolled.

Conclusions: Pragmatic implementation science trials designed with input from key stakeholders, including health departments and community members, can help evaluate the evidence for mHealth interventions to reduce HIV health disparities.

Trial registration: ClinicalTrials.gov NCT03934437; https://clinicaltrials.gov/ct2/show/NCT03934437.

International registered report identifier (irrid): DERR1-10.2196/42691.

Keywords: HIV continuum of care; HIV linkage to care; HIV virologic suppression; adherence; implementation; mHealth.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: Under a licensing agreement between emocha Mobile Health and the Johns Hopkins University, LWC, KRP, and JM-W are entitled to royalties on an invention described in this article. LWC and JM-W are also consultants to emocha Mobile Health. This arrangement has been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies.

Figures

Figure 1
Figure 1
LEAN (Leveraging mHealth and Patient Supporters for African Americans and Latinxs in HIV Care) study design. BCHD: Baltimore City Health Department; LAR: linkage, adherence, and retention; mLAR: mobile health–enhanced linkage, adherence, and retention.
Figure 2
Figure 2
The situated Information-Motivation-Behavioral Skills (sIMB) Model of Adherence conceptual framework.
Figure 3
Figure 3
Patient view of NxtSTEP app.
Figure 4
Figure 4
Patient supporter view of NxtSTEP app.
See this image and copyright information in PMC

References

    1. Fauci AS, Lane HC. Four Decades of HIV/AIDS - Much Accomplished, Much to Do. N Engl J Med. 2020 Jul 02;383(1):1–4. doi: 10.1056/NEJMp1916753. - DOI - PubMed
    1. Fauci AS, Marston HD. Ending the HIV-AIDS Pandemic--Follow the Science. N Engl J Med. 2015 Dec 03;373(23):2197–9. doi: 10.1056/NEJMp1502020. - DOI - PubMed
    1. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data: United States and 6 dependent areas. CDC. 2019. [2022-12-23]. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveil... .
    1. Rao S, Seth P, Walker T, Wang G, Mulatu MS, Gilford J, German EJ. HIV Testing and Outcomes Among Hispanics/Latinos - United States, Puerto Rico, and U.S. Virgin Islands, 2014. MMWR Morb Mortal Wkly Rep. 2016 Oct 14;65(40):1099–1103. doi: 10.15585/mmwr.mm6540a2. doi: 10.15585/mmwr.mm6540a2. - DOI - DOI - PubMed
    1. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR, HPTN 052 Study Team Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493–505. doi: 10.1056/NEJMoa1105243. https://europepmc.org/abstract/MED/21767103 - DOI - PMC - PubMed

Associated data

LinkOut - more resources