Clinical trial NCT03358927: Immediate Fast-Track Versus Standard Care for Persons Living With HIV in Haiti
Official title: Immediate Fast-Track Versus Standard Care for Persons Living With HIV in Haiti: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV/AIDS
Fast-track care
Behavioral economics
Differentiated care
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
name: Weill Medical College of Cornell University
name: Duke University
name: Florida International University
name: Analysis Group, Inc.
First posted: 2017-12-02
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in a 1:1 ratio
Primary purpose: TREATMENT

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.

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 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.

Eligibility 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

Primary outcomes:
measure: Viral Suppression; cut-off <200 copies/ml
timeFrame: 48 weeks after enrollment
Secondary outcomes:
measure: Viral Suppression; cut-off <50 copies/ml
timeFrame: 48 weeks after enrollment
measure: Viral Suppression; cut-off <1000 copies/ml
timeFrame: 48 weeks after enrollment
measure: Adherence by pharmacy refill records
timeFrame: 48 weeks after enrollment
measure: Cost-effectiveness
timeFrame: 48 weeks after enrollment
measure: Connectedness to Treatment Setting Scale
timeFrame: Day of enrollment, and 24 weeks and 48 weeks after enrollment
measure: State Hope Scale
timeFrame: Day of enrollment, and 24 weeks and 48 weeks after enrollment
measure: Patient Satisfaction Survey
timeFrame: Weeks 2, 24, and 48 after enrollment
measure: Social Provisions Scale
timeFrame: Day of enrollment, and 24 and 48 weeks after enrollment
measure: Coping Survey
timeFrame: Weeks 2, 24, and 48 after enrollment
Other outcomes:
Locations:
city: Port-au-Prince
country: Haiti
facility: GHESKIO
Study officials:
affiliation: Brigham and Women's Hospital/GHESKIO
name: Serena Koenig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GHESKIO; Weill Medical College of Cornell University
name: Jean Pape, MD
role: STUDY_DIRECTOR
References: