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

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 day of HIV diagnosis, and will be followed for 48 weeks. The total sample size will be 254 participants; of these, 56 will be patients or providers enrolled in one-time focus groups, 20 will be enrolled for testing the manuals and study procedures, and 178 will be enrolled in the pilot RCT.

The study site is GHESKIO (Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections) in Port-au-Prince, Haiti. The study population includes men and women who are at least 18 years of age who are ART-naïve, and who present with WHO Stage 1 or 2 diseases at HIV diagnosis.

Participants in both groups will initiate ART on the day of HIV testing, prior to enrollment and randomization. They will then be randomized to immediate versus standard (deferred fast-track) care. Those in the immediate group will start fast-track care on the day of HIV testing. Those in the standard group will start fast-track care if they are on time for their 24-week visit, with HIV-1 RNA <200 copies/ml. Participants in both groups will receive identical care from weeks 24 to 48.

Once a patient qualifies for fast-track care, it is provided in the same manner for both groups.

• Reminder phone call and point-of-service dispensing of ART: The CHW calls patient one day in advance, to ensure they can attend visit. If patient responds in the affirmative, then their ART and prophylactic medications are packaged in advance.
• Minimal waiting time to see clinician, with short, focused visits: Total visit time is about 30 minutes.
• Less frequent clinic visits: Other than the first 3 months for the immediate group, fast-track care includes quarterly nurse visits, with CHW phone calls during months when no clinic visit is scheduled;
• Nurse-led care: Fast-track visits are all staffed by nurses, except in the case that a patient has a new symptom; in that case, the patient receives a fast-track physician evaluation, with appropriate fast-track follow-up care. For example, in the rare case that a patient develops active TB, they will receive fast-track care with physician and nurse visits as appropriate.

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