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Using MOST to Optimize an HIV Care Continuum Intervention for Vulnerable Populations

NCT02801747 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2022-11-03

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Penn State University

    collaborator OTHER

  • Binghamton University

    collaborator OTHER

  • New York University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2022-07-15
Completion
2022-07-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02801747 on ClinicalTrials.gov