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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 1, 2017
Last Update Posted : December 5, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

November 27, 2017
December 1, 2017
December 5, 2017
April 1, 2018
July 1, 2020   (Final data collection date for primary outcome measure)
Viral Suppression; cut-off <200 copies/ml [ Time Frame: 48 weeks after enrollment ]
HIV-1 RNA <200 copies/ml
Same as current
Complete list of historical versions of study NCT03358927 on ClinicalTrials.gov Archive Site
  • 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
  • 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 [ Time Frame: Day of enrollment, and 24 weeks and 48 weeks after enrollment ]
    Mean score on the Connectedness to Treatment Setting Scale
  • Hope [ Time Frame: Day of enrollment, and 24 weeks and 48 weeks after enrollment ]
    Mean score on the State Hope Scale
  • Social support [ Time Frame: Day of enrollment, and 24 weeks and 48 weeks after enrollment ]
    Mean score on the new START social provision scale
  • Coping [ Time Frame: Weeks 2, 24, and 48 after enrollment ]
    Mean score on the COPE survery
  • Patient satisfaction [ Time Frame: Weeks 2, 24, and 48 after enrollment ]
    Mean score on the HRSA Patient Satisfaction Survey
Not Provided
Not Provided
 
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
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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients will be randomized in a 1:1 ratio
Masking: None (Open Label)
Primary Purpose: Treatment
HIV/AIDS
  • Behavioral: Immediate Fast-Track Care
    Eligible for fast-track care at enrollment
  • Behavioral: Deferred Fast-Track Care
    Eligible for fast-track care after 6 months on ART
  • Active Comparator: Standard Group
    Deferred fast-track care
    Intervention: Behavioral: Deferred Fast-Track Care
  • Experimental: Immediate Fast-Track Group
    Immediate fast-track care
    Intervention: Behavioral: Immediate Fast-Track Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
254
July 1, 2020
July 1, 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Serena P Koenig, MD 6174134090 skoenig@bwh.harvard.edu
Contact: Patrice Severe, MD 011 509 2940 1430 patsevere@gheskio.org
Haiti
 
 
NCT03358927
R34MH114739( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: We will post an anonymized dataset after the study is complete.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data will be available at the time of publication of the primary study results.
Access Criteria: Information will be posted online.
URL: http://
Serena Patricia Koenig, Brigham and Women's Hospital
Brigham and Women's Hospital
  • Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
  • Weill Medical College of Cornell University
  • Duke University
  • Florida International University
  • Analysis Group, Inc.
Principal Investigator: Serena Koenig, MD Brigham and Women's Hospital/GHESKIO
Study Director: Jean Pape, MD GHESKIO; Weill Medical College of Cornell University
Brigham and Women's Hospital
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP