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Immediate Fast-Track Versus Standard Care for Persons Living With HIV in Haiti

NCT03358927 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2021-04-09

No results posted yet for this study

Summary

In the proposed R34 grant, the investigators will develop and test a strategy of immediate fast-track care. The study population will include adult patients with early HIV infection. Participants will be randomized to immediate fast-track or standard (deferred fast-track) care. All participants will receive same-day HIV testing and ART initiation prior to study enrollment. The intervention group will receive immediate fast-track care, which is conditional upon timely visits, and after 24 weeks in care, an undetectable viral load (HIV-1 RNA \<200 copies/ml). The standard group will be eligible to start fast-track care at 24 weeks, if they are on time for that visit and have an undetectable viral load. Participants in either group who are \>3 days late for any fast-track visit will lose fast-track care for that visit; those in either group with detectable viremia on their 24-week viral load test will be evaluated by a physician, with follow-up visits every 4 weeks until they have an undetectable viral load. Participants will be followed for 48 weeks. With the proposed pilot study, the investigators aim to conduct the formative work that is necessary to successfully implement a future clinical trial with the same primary outcome. The investigators hypothesize that immediate fast-track care will result in higher retention with viral suppression.

Conditions

Interventions

BEHAVIORAL

Immediate Fast-Track Care

Eligible for fast-track care at enrollment

BEHAVIORAL

Deferred Fast-Track Care

Eligible for fast-track care after 6 months on ART

Sponsors & Collaborators

  • Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • Florida International University

    collaborator OTHER

  • Analysis Group, Inc.

    collaborator INDUSTRY

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Serena Koenig, MD · Brigham and Women's Hospital/GHESKIO

  • Jean Pape, MD · GHESKIO; Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-27
Primary Completion
2021-04-01
Completion
2021-04-01

Countries

  • Haiti

Study Locations

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Entities

Diseases
Companies

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 NCT03358927 on ClinicalTrials.gov