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

NCT03358927 | Completed DMC

• 1 other identifier: R34MH114739
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief 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

HIV/AIDS

Keywords

HIV/AIDS; Fast-track care; Behavioral economics; Differentiated care

Outcome Measures

Primary Outcomes (1)

• Viral Suppression; cut-off <200 copies/ml

  HIV-1 RNA \<200 copies/ml

  48 weeks after enrollment

Secondary Outcomes (9)

• Viral Suppression; cut-off <50 copies/ml

  48 weeks after enrollment

• Viral Suppression; cut-off <1000 copies/ml

  48 weeks after enrollment

• Adherence by pharmacy refill records

  48 weeks after enrollment

• Cost-effectiveness

  48 weeks after enrollment

• Connectedness to Treatment Setting Scale

  Day of enrollment, and 24 weeks and 48 weeks after enrollment

Study Arms (2)

Standard Group

ACTIVE COMPARATOR

Deferred fast-track care

Behavioral: Deferred Fast-Track Care

Immediate Fast-Track Group

EXPERIMENTAL

Immediate fast-track care

Behavioral: Immediate Fast-Track Care

Interventions

Immediate Fast-Track Care BEHAVIORAL

Eligible for fast-track care at enrollment

Immediate Fast-Track Group

Deferred Fast-Track Care BEHAVIORAL

Eligible for fast-track care after 6 months on ART

Standard Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women of ≥18 years of age
• Ability and willingness to give written informed consent
• Documentation of positive HIV status (test conducted at GHESKIO), and initiation of same-day ART prior to enrollment
• Physician-confirmed WHO Stage 1 or 2 disease
• Acceptance of HIV diagnosis, defined as affirmative responses to two questions: "I believe that HIV and AIDS exist" and "I believe that the results of my HIV test show that I am infected".
• Access to a phone, or able to provide a contact person with a phone (this does not require disclosure of HIV status to the contact person)
• Agreement to provide a contact phone number and address, and to accept home visits from a CHW.

You may not qualify if:

• Any use of ART in the past
• Pregnancy or breastfeeding at the screening visit
• WHO Stage 3 or 4 disease
• Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician
• Score of \<3 for any of the 7 questions on the ART readiness survey
• Planning to transfer care to another clinic during the study period

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic: collaborator
• Weill Medical College of Cornell University: collaborator
• Duke University: collaborator
• Florida International University: collaborator
• Analysis Group, Inc.: collaborator

Study Sites (1)

GHESKIO

Port-au-Prince, Haiti

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Serena Koenig, MD

  Brigham and Women's Hospital/GHESKIO

  PRINCIPAL INVESTIGATOR

• Jean Pape, MD

  GHESKIO; Weill Medical College of Cornell University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Model Details: Patients will be randomized in a 1:1 ratio

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: November 27, 2018
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available at the time of publication of the primary study results.
• Access Criteria: Information will be posted online.

Locations

HA (1)