Immediate Fast-Track Versus Standard Care for Persons Living With HIV in Haiti
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|ClinicalTrials.gov Identifier: NCT03358927|
Recruitment Status : Not yet recruiting
First Posted : December 2, 2017
Last Update Posted : December 5, 2017
|Condition or disease||Intervention/treatment|
|HIV/AIDS||Behavioral: Immediate Fast-Track Care Behavioral: Deferred Fast-Track Care|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||254 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized in a 1:1 ratio|
|Masking:||None (Open Label)|
|Official Title:||Immediate Fast-Track Versus Standard Care for Persons Living With HIV in Haiti: A Randomized Pilot Study|
|Anticipated Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||July 1, 2020|
Active Comparator: Standard Group
Deferred fast-track care
Behavioral: Deferred Fast-Track Care
Eligible for fast-track care after 6 months on ART
Experimental: Immediate Fast-Track Group
Immediate fast-track care
Behavioral: Immediate Fast-Track Care
Eligible for fast-track care at enrollment
- Viral Suppression; cut-off <200 copies/ml [ Time Frame: 48 weeks after enrollment ]HIV-1 RNA <200 copies/ml
- Viral Suppression; cut-off <50 copies/ml [ Time Frame: 48 weeks after enrollment ]HIV-1 RNA <50 copies/ml
- Viral Suppression; cut-off <1000 copies/ml [ Time Frame: 48 weeks after enrollment ]HIV-1 RNA <1000 copies/ml
- 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)
- Cost-effectiveness [ Time Frame: 48 weeks after enrollment ]Cost per patients with undetectable viral load
- 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
- 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
- Patient Satisfaction Survey [ Time Frame: Weeks 2, 24, and 48 after enrollment ]Mean score; range 5 to 25; a higher score indicates greater satisfaction
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358927
|Contact: Serena P Koenig, MDemail@example.com|
|Contact: Patrice Severe, MD||011 509 2940 firstname.lastname@example.org|
|GHESKIO||Not yet recruiting|
|Contact: Patrice Severe, MD 011 509 2940 1430 email@example.com|
|Contact: Serena Koenig, MD 6174134090 firstname.lastname@example.org|
|Principal Investigator: Jean Pape, MD|
|Principal Investigator: Jessy Devieux, PhD|
|Principal Investigator: Pierre Cremieux, PhD|
|Principal Investigator: Patrice Severe, MD|
|Sub-Investigator: Samuel Pierre, MD|
|Sub-Investigator: Jacky Petion, MD|
|Principal Investigator: Julie O'Brien, PhD|
|Principal Investigator:||Serena Koenig, MD||Brigham and Women's Hospital/GHESKIO|
|Study Director:||Jean Pape, MD||GHESKIO; Weill Medical College of Cornell University|