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

BMC Public Health

Study Protocol

Mallory O. Johnson¹  John A. Sauceda¹  Natasha Ludwig-Barron¹  Torsten B. Neilands¹  Rogelio Covarrubias²  David Gomez³  Jorge Puentes⁴  Julia Lechuga⁴  Jorge Salazar⁵  Katerina A. Christopoulos⁵  David Montelongo⁶  Maria Elena Ramos⁶  Joselyn Hernandez⁶  Alejandro Ortiz⁶  Itzia Avila⁶  Julian Rojas⁶  Luisa Ramos⁶  Marya V. Gwadz⁷ 

[1] Center for AIDS Prevention Studies, Department of Medicine, University of California, San Francisco, 550 16th Street, 94158, San Francisco, CA, USA;Centro Ambulatorio para la prevención y Atención de SIDA y de las Enfermedades de Transmisión Sexual (CAPASITS), Cuidad Juárez, Avenue Paseo Triunfo de la Republica 3530, 32330, Partido Escobedo, Chihuahua, México;Centro de Integración Juvenil (CIJ), Cuidad Juárez, Blvd Ing Bernardo Norzagaray, 32130, Cazatecas, Chihuahua, México;College of Health Sciences, Department of Public Health Sciences, University of Texas at El Paso, 1851 Wiggins Rd., 79968, El Paso, TX, USA;Division of HIV, Infectious Diseases and Global Medicine, University of California, San Francisco, 996 Potrero Avenue, Building 80, 6th Floor, 94110, San Francisco, CA, USA;Program Compañeros, Cuidad Juárez, Avenue de la Raza 2661, Silvias, Chihuahua, México;Silver School of Social Work, New York University, 1 Washington Square N, 10003, New York, NY, USA;

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

DOI  :  10.1186/s12889-023-15172-2

 received in 2022-11-04, accepted in 2023-01-31,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPeople 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.MethodsThe 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 24 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.DiscussionWe 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 registrationThis project was registered at clinicaltrials.gov (NCT05377463) on May 17th, 2022.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 2