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

Abstract

BackgroundMore 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/designStudy 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).DiscussionThis 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 ...

A scoping review of social‐behaviour change techniques applied in complementary feeding interventions

“…One promising approach in the field of behavioural intervention research that enables such testing is the Multiphase Optimization Strategy (Collins, Murphy, Nair, & Strecher, ). This approach has been applied, for example, in the fields of HIV (Collins, Kugler, & Gwadz, ; Gwadz et al, ), smoking cessation (Baker et al, ; Collins et al, ), and to develop optimized behavioural interventions.…”

An international, Delphi consensus study to identify priorities for methodological research in behavioral trials in health research

“…NB. Weights were calculated as follows: first priority = 5; second priority = 4; third priority = 3; fourth priority = 2; fifth priority = 1 human immunodeficiency virus (HIV) care [16], smoking cessation [44] and remotely delivered intensive lifestyle treatment for obesity [42]. The SMART design allows evaluation of adaptive interventions in which the type or dose of treatment is individually tailored based on the patient's needs [2,37].…”

Understanding long-term HIV survivorship among African American/Black and Latinx persons living with HIV in the United States: A qualitative exploration through the lens of symbolic violence

“…First, low SES appears to account for at least some of these observed racial/ethnic disparities in HIV outcomes (8,13). Low SES creates complex competing priorities and tangible structural barriers to engagement, including unstable or low-quality housing (14,15). Social-level barriers include complex stigma and a lack of social support (16,17), and, at the individual level, primary barriers include medical distrust, unemployment, and substance and mental health problems (6,18,19).…”

“…The eligibility criteria for Study 2 included diagnosed with HIV, age 18-65 years, African American/Black or Latinx race/ethnicity, sub-optimal adherence to ART, non-suppressed HIV viral load based on a lab report, and sub-optimal engagement in HIV care. A total of 512 participants were enrolled in Study 2, described in detail elsewhere (14). For the present study, 2-4 participants from each of the 16 intervention conditions were randomly selected to participate in semi-structured in-depth qualitative interviews 3-4 months postenrollment.…”