- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03358927
Immediate Fast-Track Versus Standard Care for Persons Living With HIV in Haiti
Immediate Fast-Track Versus Standard Care for Persons Living With HIV in Haiti: A Randomized Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Port-au-Prince, Haiti
- GHESKIO
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Group
Deferred fast-track care
|
Eligible for fast-track care after 6 months on ART
|
Experimental: Immediate Fast-Track Group
Immediate fast-track care
|
Eligible for fast-track care at enrollment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Viral Suppression; cut-off <200 copies/ml
Time Frame: 48 weeks after enrollment
|
HIV-1 RNA <200 copies/ml
|
48 weeks after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Viral Suppression; cut-off <50 copies/ml
Time Frame: 48 weeks after enrollment
|
HIV-1 RNA <50 copies/ml
|
48 weeks after enrollment
|
Viral Suppression; cut-off <1000 copies/ml
Time Frame: 48 weeks after enrollment
|
HIV-1 RNA <1000 copies/ml
|
48 weeks after enrollment
|
Adherence by pharmacy refill records
Time Frame: 48 weeks after enrollment
|
ART dispensed by the pharmacy for at least 90% of the days in the study period (302 days of ART dispensed during the 336-day study period)
|
48 weeks after enrollment
|
Cost-effectiveness
Time Frame: 48 weeks after enrollment
|
Cost per patients with undetectable viral load
|
48 weeks after enrollment
|
Connectedness to Treatment Setting Scale
Time Frame: Day of enrollment, and 24 weeks and 48 weeks after enrollment
|
Mean score; range 10-60; a higher score indicates greater connection to treatment setting
|
Day of enrollment, and 24 weeks and 48 weeks after enrollment
|
State Hope Scale
Time Frame: Day of enrollment, and 24 weeks and 48 weeks after enrollment
|
Mean score; range 6 to 30; a higher score indicates greater hopefulness
|
Day of enrollment, and 24 weeks and 48 weeks after enrollment
|
Patient Satisfaction Survey
Time Frame: Weeks 2, 24, and 48 after enrollment
|
Mean score; range 5 to 25; a higher score indicates greater satisfaction
|
Weeks 2, 24, and 48 after enrollment
|
Social Provisions Scale
Time Frame: Day of enrollment, and 24 and 48 weeks after enrollment
|
Mean score; range 24 to 96; a higher score indicates greater degree of perceived support
|
Day of enrollment, and 24 and 48 weeks after enrollment
|
Coping Survey
Time Frame: Weeks 2, 24, and 48 after enrollment
|
Mean score; range 38 to 152; a higher score indicates a greater sense of being able to cope with a situation
|
Weeks 2, 24, and 48 after enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Serena Koenig, MD, Brigham and Women's Hospital/GHESKIO
- Study Director: Jean Pape, MD, GHESKIO; Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- R34MH114739 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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