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Using MOST to Optimize an HIV Care Continuum Intervention for Vulnerable Populations (HTH2-MOST)

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ClinicalTrials.gov Identifier: NCT02801747
Recruitment Status : Active, not recruiting
First Posted : June 16, 2016
Last Update Posted : February 11, 2020
Sponsor:
Collaborators:
Penn State University
Binghamton University
Information provided by (Responsible Party):
Marya Gwadz, New York University

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Heart to Heart2 (HTH2) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 512 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Using MOST to Optimize an HIV Care Continuum Intervention for Vulnerable Populations
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Condition 1
Receives a core intervention session and the navigation intervention component (long duration; that is, up to 6 months).
Behavioral: Heart to Heart2 (HTH2)
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.

Experimental: Condition 2
Receives a core intervention session, the focused support group component, and the navigation intervention component (short duration, that is, up to 3 months).
Behavioral: Heart to Heart2 (HTH2)
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.

Experimental: Condition 3
Receives a core intervention session, the peer mentorship component, and the navigation intervention component (short duration, that is, up to 3 months).
Behavioral: Heart to Heart2 (HTH2)
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.

Experimental: Condition 4
Receives a core intervention session, the peer mentorship component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months).
Behavioral: Heart to Heart2 (HTH2)
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.

Experimental: Condition 5
Receives a core intervention session, the pre-adherence preparation component, and the navigation intervention component (short duration, that is, up to 3 months).
Behavioral: Heart to Heart2 (HTH2)
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.

Experimental: Condition 6
Receives a core intervention session, the pre-adherence preparation component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months).
Behavioral: Heart to Heart2 (HTH2)
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.

Experimental: Condition 7
Receives a core intervention session, the pre-adherence preparation component, the peer mentorship component, and the navigation intervention component (long duration, that is, up to 6 months).
Behavioral: Heart to Heart2 (HTH2)
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.

Experimental: Condition 8
Receives a core intervention session, the pre-adherence preparation component, the peer mentorship component, and the navigation intervention component (short duration, that is, up to 3 months).
Behavioral: Heart to Heart2 (HTH2)
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.

Experimental: Condition 9
Receives a core intervention session, the Motivational Interviewing sessions component, and the navigation intervention component (short duration, that is, up to 3 months).
Behavioral: Heart to Heart2 (HTH2)
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.

Experimental: Condition 10
Receives a core intervention session, the Motivational Interviewing sessions component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months).
Behavioral: Heart to Heart2 (HTH2)
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.

Experimental: Condition 11
Receives a core intervention session, the Motivational Interviewing sessions component, the peer mentorship component, and the navigation intervention component (long duration, that is, up to 6 months).
Behavioral: Heart to Heart2 (HTH2)
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.

Experimental: Condition 12
Receives a core intervention session, the Motivational Interviewing sessions component, the peer mentorship component, the focused support group component, and the navigation intervention component (short duration, that is, up to 3 months).
Behavioral: Heart to Heart2 (HTH2)
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.

Experimental: Condition 13
Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, and the navigation intervention component (long duration, that is, up to 6 months).
Behavioral: Heart to Heart2 (HTH2)
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.

Experimental: Condition 14
Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, the focused support group component, and the navigation intervention component (short duration, that is, up to 3 months).
Behavioral: Heart to Heart2 (HTH2)
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.

Experimental: Condition 15
Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, the peer mentorship component, and the navigation intervention component (short duration, that is, up to 3 months).
Behavioral: Heart to Heart2 (HTH2)
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.

Experimental: Condition 16
Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, the peer mentorship component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months).
Behavioral: Heart to Heart2 (HTH2)
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.




Primary Outcome Measures :
  1. Change in HIV viral suppression [ Time Frame: Assessed at 4 month follow up (FU), 12 month FU ]
    Blood will be drawn and viral load will be assessed via laboratory report (Bioreference Lab, HIV-1,RNA,PCR,ULTRA). Participants will not have viral suppression at baseline. Change in viral suppression, that is, whether viral suppression has been achieved, will be coded as present if viral load levels are < 20 ppml. Viral suppression will be assessed at both FU periods. Participants may achieve this primary endpoint, or not, at one or both FU periods.


Secondary Outcome Measures :
  1. Absolute HIV viral load (log10) [ Time Frame: Assessed at baseline, 4 month follow up (FU), 12 month FU ]
    Blood will be drawn and viral load will be assessed via laboratory report (Bioreference Lab, HIV-1,RNA,PCR,ULTRA).

  2. Adherence to antiretroviral therapy [ Time Frame: 4 month follow up (FU), 8 month FU, 12 month FU ]
    Hair samples will be tested for average adherence to antiretroviral therapy

  3. Engagement in HIV primary care [ Time Frame: 4 month follow up (FU), 12 month FU ]
    Assessed with a Medical Report Form completed by the health care provider. "Engagement in HIV care" is operationalized as 3 visits a year (two of them at least 90 days apart) and < 2 missed visits/year



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • African American/Black or Latino/Hispanic race/ethnicity
  • HIV diagnosed for at least 6 months (HIV status confirmed with medical documentation)
  • Has not taken antiretroviral therapy (ART) in the past 6 weeks (the period of time assessed by hair assay, and a reasonable period of time not on ART for the present study)
  • Sub-optimal engagement in HIV care (assessed from the medical record, defined as less than 1 visit in every 4-mo. period in the past year [two of them at least 90 days apart], pro-rated for those diagnosed less than a year ago) or > 2 missed visits (without prior cancellation) in the past year
  • Reside in the New York City (NYC) metropolitan area
  • Not planning to leave the NYC metropolitan area in next year
  • Not actively psychotic based on screening instrument
  • Not a participant in the preliminary pilot HTH R34 study
  • Able to conduct research activities in English or Spanish
  • Willing to provide hair sample (if possible), blood samples (to assess CD4, VL), and Medical Report Form ([MRF]; to assess health care attendance) at screening
  • Willing to participate in a Core intervention session and be randomly assigned to 1-5 intervention components.

Exclusion Criteria:

NONE SEE ABOVE


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801747


Locations
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United States, New York
New York University Silver School of Social Work
New York, New York, United States, 10003
Sponsors and Collaborators
New York University
Penn State University
Binghamton University
  Study Documents (Full-Text)

Documents provided by Marya Gwadz, New York University:
Informed Consent Form  [PDF] March 8, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marya Gwadz, Senior Research Scientist, New York University
ClinicalTrials.gov Identifier: NCT02801747    
Other Study ID Numbers: i15-01480
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marya Gwadz, New York University:
HIV care continuum
antiretroviral therapy
engagement in HIV care
Multiphase Optimization Strategy (MOST)