A factorial experiment grounded in the multiphase optimization strategy to promote viral suppression among people who inject drugs on the Texas-Mexico border: a study protocol.

Publisher: BioMed Central Country of Publication: England NLM ID: 100968562 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2458 (Electronic) Linking ISSN: 14712458 NLM ISO Abbreviation: BMC Public Health Subsets: MEDLINE

Original Publication: London : BioMed Central, [2001-

HIV Infections*/psychology ; Drug Users*; Humans ; Texas ; Mexico ; Counseling ; Randomized Controlled Trials as Topic

Background: People who inject drugs living with HIV (PWIDLH) suffer the lowest rates of HIV viral suppression due to episodic injection drug use and poor mental health coupled with poor retention in HIV care. Approximately 44% of PWIDLH along the US-Mexico border are retained in care and only 24% are virally suppressed. This underserved region faces a potential explosion of transmission of HIV due to highly prevalent injection drug use. This protocol describes an optimization trial to promote sustained viral suppression among Spanish-speaking Latinx PWIDLH.
Methods: The multiphase optimization strategy (MOST) is an engineering-inspired framework for designing and building optimized interventions and guides this intervention. The primary aim is to conduct a 2 ⁴ factorial experiment in which participants are randomized to one of 16 intervention conditions, with each condition comprising a different combination of four behavioral intervention components. The components are peer support for methadone uptake and persistence; behavioral activation therapy for depression; Life-Steps medication adherence counseling; and patient navigation for HIV care. Participants will complete a baseline survey, undergo intervention, and then return for 3-,6-,9-, and 12-month follow-up assessments. The primary outcome is sustained viral suppression, defined as viral loads of < 40 copies per mL at 6-,9-, and 12-month follow-up assessments. Results will yield effect sizes for each component and each additive and interactive combination of components. The research team and partners will make decisions about what constitutes the optimized multi-component intervention by judging the observed effect sizes, interactions, and statistical significance against real-world implementation constraints. The secondary aims are to test mediators and moderators of the component-to-outcome relationship at the 6-month follow-up assessment.
Discussion: We are testing well-studied and available intervention components to support PWIDLH to reduce drug use and improve their mental health and engagement in HIV care. The intervention design will allow for a better understanding of how these components work in combination and can be optimized for the setting.
Trial Registration: This project was registered at clinicaltrials.gov (NCT05377463) on May 17th, 2022.
(© 2023. The Author(s).)

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P30 MH062246 United States MH NIMH NIH HHS; R01 DA053659 United States DA NIDA NIH HHS; R25 DA028567 United States DA NIDA NIH HHS

Keywords: ART adherence; Behavioral activation therapy (BAT); Factorial experiment; HIV care continuum; HIV viral load suppression; Life-steps; Medication-assisted treatment (MAT); Multiphase optimization strategy (MOST); Patient navigation; U.S.-Mexico Border

ClinicalTrials.gov NCT05377463

Date Created: 20230211 Date Completed: 20230214 Latest Revision: 20240923

20240923

PMC9921633

10.1186/s12889-023-15172-2

36765309