Status:
COMPLETED
Immediate Fast-Track Versus Standard Care for Persons Living With HIV in Haiti
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Weill Medical College of Cornell University
Conditions:
HIV/AIDS
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
This study is a randomized, open-label pilot study comparing immediate fast-track vs. standard care for patients with WHO Stage 1 or 2 disease at HIV diagnosis. Participants will be enrolled on the da...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT03358927
Start Date
November 27 2018
End Date
April 1 2021
Last Update
April 9 2021
Active Locations (1)
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1
GHESKIO
Port-au-Prince, Haiti