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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2021
• Main ID: NCT03358927
• Date of registration: 27/11/2017
• Prospective Registration: Yes
• Primary sponsor: Brigham and Women's Hospital
• Public title: Immediate Fast-Track Versus Standard Care for Persons Living With HIV in Haiti
• Scientific title: Immediate Fast-Track Versus Standard Care for Persons Living With HIV in Haiti: A Randomized Pilot Study
• Date of first enrolment: November 27, 2018
• Target sample size: 149
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03358927
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Haiti

Contacts

• Name: Serena Koenig, MD
• Affiliation: Brigham and Women's Hospital/GHESKIO

• Name: Jean Pape, MD
• Affiliation: GHESKIO; Weill Medical College of Cornell University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV/AIDS

Intervention(s)

Behavioral: Immediate Fast-Track Care

Behavioral: Deferred Fast-Track Care

Primary Outcome(s)

Viral Suppression; cut-off <200 copies/ml [Time Frame: 48 weeks after enrollment]

Secondary Outcome(s)

Connectedness to Treatment Setting Scale [Time Frame: Day of enrollment, and 24 weeks and 48 weeks after enrollment]

Cost-effectiveness [Time Frame: 48 weeks after enrollment]

Social Provisions Scale [Time Frame: Day of enrollment, and 24 and 48 weeks after enrollment]

Patient Satisfaction Survey [Time Frame: Weeks 2, 24, and 48 after enrollment]

Viral Suppression; cut-off <50 copies/ml [Time Frame: 48 weeks after enrollment]

Coping Survey [Time Frame: Weeks 2, 24, and 48 after enrollment]

Viral Suppression; cut-off <1000 copies/ml [Time Frame: 48 weeks after enrollment]

Adherence by pharmacy refill records [Time Frame: 48 weeks after enrollment]

State Hope Scale [Time Frame: Day of enrollment, and 24 weeks and 48 weeks after enrollment]

Secondary ID(s)

R34MH114739

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Florida International University

Analysis Group, Inc.

Duke University

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

Weill Medical College of Cornell University