Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: a study protocol
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,...
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2017-05-01
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Online Access: | http://link.springer.com/article/10.1186/s12889-017-4279-7 |
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Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
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 |
spellingShingle |
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 Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: a study protocol BMC Public Health HIV care continuum Antiretroviral initiation HIV care Multiphase optimization strategy MOST African American |
author_facet |
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 |
author_sort |
Marya Viorst Gwadz |
title |
Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: a study protocol |
title_short |
Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: a study protocol |
title_full |
Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: a study protocol |
title_fullStr |
Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: a study protocol |
title_full_unstemmed |
Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: a study protocol |
title_sort |
using the multiphase optimization strategy (most) to optimize an hiv care continuum intervention for vulnerable populations: a study protocol |
publisher |
BMC |
series |
BMC Public Health |
issn |
1471-2458 |
publishDate |
2017-05-01 |
description |
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. |
topic |
HIV care continuum Antiretroviral initiation HIV care Multiphase optimization strategy MOST African American |
url |
http://link.springer.com/article/10.1186/s12889-017-4279-7 |
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doaj-93aa316b1d7a415daca5ea811609f9012020-11-24T21:33:54ZengBMCBMC Public Health1471-24582017-05-0117112010.1186/s12889-017-4279-7Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: a study protocolMarya Viorst Gwadz0Linda M. Collins1Charles M. Cleland2Noelle R. Leonard3Leo Wilton4Monica Gandhi5R. Scott Braithwaite6David C. Perlman7Alexandra Kutnick8Amanda S. Ritchie9Center for Drug Use and HIV Research, Rory Meyers College of Nursing, New York UniversityThe Methodology Center and Department of Human Development and Family Studies, Pennsylvania State UniversityCenter for Drug Use and HIV Research, Rory Meyers College of Nursing, New York UniversityCenter for Drug Use and HIV Research, Rory Meyers College of Nursing, New York UniversityDepartment of Human Development, State University of New York at BinghamtonDivision of HIV, Infectious Diseases, and Global Medicine, School of Medicine, University of California San FranciscoDepartment of Population Health, New York University School of MedicineDepartment of Infectious Diseases, Mount Sinai Beth IsraelCenter for Drug Use and HIV Research, Rory Meyers College of Nursing, New York UniversityCenter for Drug Use and HIV Research, Rory Meyers College of Nursing, New York UniversityAbstract 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.http://link.springer.com/article/10.1186/s12889-017-4279-7HIV care continuumAntiretroviral initiationHIV careMultiphase optimization strategyMOSTAfrican American |