Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: A study protocol

Marya Viorst Gwadz, Linda M. Collins, Charles M. Cleland, Noelle R. Leonard, Leo Wilton, Monica Gandhi, R. Scott Braithwaite, David C. Perlman, Alexandra Kutnick, Amanda S. Ritchie

Research output: Contribution to journalArticle

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Abstract

Background: More than half of persons living with HIV (PLWH) in the United States are insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART), mainly African Americans/Blacks and Hispanics. In the proposed project, a potent and innovative research methodology, the multiphase optimization strategy (MOST), will be employed to develop a highly efficacious, efficient, scalable, and cost-effective intervention to increase engagement along the HIV care continuum. Whereas randomized controlled trials are valuable for evaluating the efficacy of multi-component interventions as a package, they are not designed to evaluate which specific components contribute to efficacy. MOST, a pioneering, engineering-inspired framework, addresses this problem through highly efficient randomized experimentation to assess the performance of individual intervention components and their interactions. We propose to use MOST to engineer an intervention to increase engagement along the HIV care continuum for African American/Black and Hispanic PLWH not well engaged in care and not taking ART. Further, the intervention will be optimized for cost-effectiveness. A similar set of multi-level factors impede both HIV care and ART initiation for African American/Black and Hispanic PLWH, primary among them individual- (e.g., substance use, distrust, fear), social- (e.g., stigma), and structural-level barriers (e.g., difficulties accessing ancillary services). Guided by a multi-level social cognitive theory, and using the motivational interviewing approach, the study will evaluate five distinct culturally based intervention components (i.e., counseling sessions, pre-adherence preparation, support groups, peer mentorship, and patient navigation), each designed to address a specific barrier to HIV care and ART initiation. These components are well-grounded in the empirical literature and were found acceptable, feasible, and promising with respect to efficacy in a preliminary study. Methods/design: Study aims are: 1) using a highly efficient fractional factorial experimental design, identify which of five intervention components contribute meaningfully to improvement in HIV viral suppression, and secondary outcomes of ART adherence and engagement in HIV primary care; 2) identify mediators and moderators of intervention component efficacy; and 3) using a mathematical modeling approach, build the most cost-effective and efficient intervention package from the efficacious components. A heterogeneous sample of African American/Black and Hispanic PLWH (with respect to age, substance use, and sexual minority status) will be recruited with a proven hybrid sampling method using targeted sampling in community settings and peer recruitment (N = 512). Discussion: This is the first study to apply the MOST framework in the field of HIV prevention and treatment. This innovative study will produce a culturally based HIV care continuum intervention for the nation's most vulnerable PLWH, optimized for cost-effectiveness, and with exceptional levels of efficacy, efficiency, and scalability. Trial registration: ClinicalTrials.gov, NCT02801747, Registered June 8, 2016.

Original languageEnglish (US)
Article number383
JournalBMC Public Health
Volume17
Issue number1
DOIs
StatePublished - May 4 2017

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Continuity of Patient Care
Vulnerable Populations
HIV
Hispanic Americans
African Americans
Cost-Benefit Analysis
Primary Health Care
Research Design
Patient Navigation
Therapeutics
Social Stigma
Motivational Interviewing
Costs and Cost Analysis
Mentors
Self-Help Groups
Fear
Counseling

All Science Journal Classification (ASJC) codes

  • Public Health, Environmental and Occupational Health

Cite this

Gwadz, Marya Viorst ; Collins, Linda M. ; Cleland, Charles M. ; Leonard, Noelle R. ; Wilton, Leo ; Gandhi, Monica ; Scott Braithwaite, R. ; Perlman, David C. ; Kutnick, Alexandra ; Ritchie, Amanda S. / Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations : A study protocol. In: BMC Public Health. 2017 ; Vol. 17, No. 1.
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Gwadz, MV, Collins, LM, Cleland, CM, Leonard, NR, Wilton, L, Gandhi, M, Scott Braithwaite, R, Perlman, DC, Kutnick, A & Ritchie, AS 2017, 'Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: A study protocol', BMC Public Health, vol. 17, no. 1, 383. https://doi.org/10.1186/s12889-017-4279-7

Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations : A study protocol. / Gwadz, Marya Viorst; Collins, Linda M.; Cleland, Charles M.; Leonard, Noelle R.; Wilton, Leo; Gandhi, Monica; Scott Braithwaite, R.; Perlman, David C.; Kutnick, Alexandra; Ritchie, Amanda S.

In: BMC Public Health, Vol. 17, No. 1, 383, 04.05.2017.

Research output: Contribution to journalArticle

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AU - Collins, Linda M.

AU - Cleland, Charles M.

AU - Leonard, Noelle R.

AU - Wilton, Leo

AU - Gandhi, Monica

AU - Scott Braithwaite, R.

AU - Perlman, David C.

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AU - Ritchie, Amanda S.

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N2 - Background: More than half of persons living with HIV (PLWH) in the United States are insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART), mainly African Americans/Blacks and Hispanics. In the proposed project, a potent and innovative research methodology, the multiphase optimization strategy (MOST), will be employed to develop a highly efficacious, efficient, scalable, and cost-effective intervention to increase engagement along the HIV care continuum. Whereas randomized controlled trials are valuable for evaluating the efficacy of multi-component interventions as a package, they are not designed to evaluate which specific components contribute to efficacy. MOST, a pioneering, engineering-inspired framework, addresses this problem through highly efficient randomized experimentation to assess the performance of individual intervention components and their interactions. We propose to use MOST to engineer an intervention to increase engagement along the HIV care continuum for African American/Black and Hispanic PLWH not well engaged in care and not taking ART. Further, the intervention will be optimized for cost-effectiveness. A similar set of multi-level factors impede both HIV care and ART initiation for African American/Black and Hispanic PLWH, primary among them individual- (e.g., substance use, distrust, fear), social- (e.g., stigma), and structural-level barriers (e.g., difficulties accessing ancillary services). Guided by a multi-level social cognitive theory, and using the motivational interviewing approach, the study will evaluate five distinct culturally based intervention components (i.e., counseling sessions, pre-adherence preparation, support groups, peer mentorship, and patient navigation), each designed to address a specific barrier to HIV care and ART initiation. These components are well-grounded in the empirical literature and were found acceptable, feasible, and promising with respect to efficacy in a preliminary study. Methods/design: Study aims are: 1) using a highly efficient fractional factorial experimental design, identify which of five intervention components contribute meaningfully to improvement in HIV viral suppression, and secondary outcomes of ART adherence and engagement in HIV primary care; 2) identify mediators and moderators of intervention component efficacy; and 3) using a mathematical modeling approach, build the most cost-effective and efficient intervention package from the efficacious components. A heterogeneous sample of African American/Black and Hispanic PLWH (with respect to age, substance use, and sexual minority status) will be recruited with a proven hybrid sampling method using targeted sampling in community settings and peer recruitment (N = 512). Discussion: This is the first study to apply the MOST framework in the field of HIV prevention and treatment. This innovative study will produce a culturally based HIV care continuum intervention for the nation's most vulnerable PLWH, optimized for cost-effectiveness, and with exceptional levels of efficacy, efficiency, and scalability. Trial registration: ClinicalTrials.gov, NCT02801747, Registered June 8, 2016.

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