Using MOST to Optimize an HIV Care Continuum Intervention for Vulnerable Populations
Condition: HIV
Study type: Interventional

Summary: 
      The present study targets the large population of persons living with HIV/AIDS (PLHA) in the
      U.S. who are both insufficiently engaged in HIV primary care and not taking antiretroviral
      therapy (ART), who are mainly African American/Black and Latino. NIH has emphasized the
      urgent need for new research approaches to advance intervention science, and the proposed
      project employs a new, potent, and innovative research methodology, the Multiphase
      Optimization STrategy (MOST), a framework for developing highly efficacious, efficient,
      scalable, and cost-effective interventions. The proposed study has the highest public health
      significance: it addresses a vulnerable population of PLHA, including the critically
      important subpopulations of men who have sex with men (MSM) and substance users; will develop
      an efficient and cost effective intervention to increase engagement along the HIV care
      continuum for these vulnerable groups; and addresses two areas highlighted in the August 2015
      notice on research priorities from the NIH Office of AIDS Research (NOT-OD-15-137), namely,
      engaging PLHA in prevention/treatment services, and reducing HIV/AIDS-related racial/ethnic
      disparities.
    

Detailed description: 
      More than half of persons living with HIV/AIDS (PLHA) in the U.S. are insufficiently engaged
      in HIV primary care and not taking antiretroviral therapy (ART), mainly African Americans and
      Latinos. In the proposed project, two experienced and productive behavioral scientists will
      employ a potent and innovative research methodology, the Multiphase Optimization STrategy
      (MOST), to develop a highly efficacious, efficient, scalable, and cost-effective intervention
      to increase engagement along the HIV care continuum. Whereas randomized controlled trials
      (RCTs) 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. The investigators propose to use MOST to engineer an
      intervention to increase engagement along the HIV care continuum for African American and
      Latino PLHA not well engaged in care and not taking ART. Further, the intervention will be
      optimized for cost-effectiveness. This efficiency and cost-effectiveness are critical in a
      time of constrained resources, and will also increase the intervention's future scalability.
      NIH has signaled its interest in MOST, and this is the first study to apply it in the field
      of adult HIV treatment. A similar set of multi-level factors impede both HIV care and ART
      initiation for African American and Latino PLHA, 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,
      the study will evaluate 5 distinct intervention components (i.e., Motivational Interviewing
      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. Study aims are: 1)
      using a highly efficient experimental design, identify which of 5 components contribute
      meaningfully to improvement in viral suppression, and secondary outcomes of ART adherence and
      engagement in HIV primary care; 2) identify mediators and moderators of 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 and Latino PLHA (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). This highly innovative and significant study, which
      addresses a high-priority research area (NIH NOT-OD-15-137), will produce an HIV care
      continuum intervention for the nation's most vulnerable PLHA, optimized for
      cost-effectiveness, and with exceptional levels of efficacy, efficiency, and scalability.
    

Intervention name(s): Heart to Heart2 (HTH2)
Intervention type(s): Behavioral
Intervention description(s): The present study uses a fractional factorial design to evaluate the efficacy of five distinct culturally appropriate intervention components on the primary outcome, HIV viral suppression.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: HIV care continuum; antiretroviral therapy; engagement in HIV care; Multiphase Optimization Strategy (MOST)