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Rapid HIV Viral Load Monitoring in High Risk Patients In Uganda (RAPID-VL)

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ClinicalTrials.gov Identifier: NCT03553693
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Infectious Diseases Research Collaboration, Uganda
Makerere University
Information provided by (Responsible Party):
Vivek Jain, MD, University of California, San Francisco

Brief Summary:
The RAPID-VL study will take place in 20 HIV care health facilities in Southwestern Uganda. The study will test the hypothesis that a multi-component intervention package that targets barriers to efficient and timely HIV viral load (VL) testing will improve test ordering, speed up result turnaround times, and improve the quality of VL results counseling to patients. Phase 1 of the study will consist of a 1-year retrospective medical record review in all participating health facilities. In Phase 2 the intervention will be introduced in 10 randomly chosen health facilities, while the remaining 10 sites will continue with standard VL testing and counseling operations. The study will measure the speed and efficiency of VL testing, experiences of patients and clinicians with the intervention, and the cost of the intervention.

Condition or disease Intervention/treatment Phase
HIV Other: RAPID-VL study intervention Not Applicable

Detailed Description:
We will test the hypothesis that a multi-component intervention grounded in implementation science principles and that targets key barriers to optimal HIV viral load (VL) processing will improve viral load ordering, speed up viral load turnaround, and improve the quality of viral load counseling of results to patients within a Ugandan network of HIV care clinics. Specific objectives are as follows: Objective 1: Determine the comparative effectiveness of the RAPID-VL intervention on VL ordering and VL turnaround time: We will randomize 20 HIV clinics to the RAPID-VL multi-component intervention vs. standard of care VL procedures (n=10 clinics each, 60 patients/health facility). Objective 2: Identify facilitators and barriers to implementation, and perceived utility of the RAPID-VL intervention from both the patient and clinician perspectives. Objective 3: Determine the costs, cost-effectiveness, and incremental change costs of the RAPID-VL intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparative effectiveness cluster-randomized trial
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Optimizing HIV Viral Load Monitoring and Outcomes for High Risk Populations
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention Clinics
RAPID-VL study intervention testing and counseling package, which includes near point-of-care viral load (VL) testing at local testing hubs, structured VL counseling, forms to track VL ordering and testing, with feedback and performance evaluations at regular intervals.
Other: RAPID-VL study intervention
  • Viral load (VL) ordering flowsheet with periodic health facility performance feedback
  • Rapid near-point-of-care VL testing and telephone delivery of results
  • Structured VL counseling package

No Intervention: Control Clinics
Standard of care VL testing and counseling procedures consistent with country guidelines.



Primary Outcome Measures :
  1. Successful VL ordering [ Time Frame: 1 year ]
    Proportion of patients who had a VL ordered when indicated by country guidelines

  2. VL turnaround time [ Time Frame: 1 year ]
    Mean turnaround time in days from VL ordering to delivery of results to patient


Secondary Outcome Measures :
  1. VL suppression 12 months after the start of Phase 2 of trial [ Time Frame: 12 months after the start of Phase 2 of trial ]
    Proportion of subjects suppressed 12 months after start of RAPID-VL participation

  2. Viral re-suppression after positive VL [ Time Frame: 1 year ]
    Proportion of patients with a positive (unsuppressed) VL whose next subsequent VL was suppressed

  3. Number of patients changed from 1st line to 2nd line ART [ Time Frame: 1 year ]
    Number of patients who switched to a 2nd line ART regimen for any reason

  4. CPHL integration process [ Time Frame: 12 months after the start of Phase 2 of trial ]
    Establishment of a process for data transfer to Uganda's Central Public Health Laboratory (CPHL) (yes/no)

  5. VL results in CPHL database [ Time Frame: 12 months after the start of Phase 2 of trial ]
    Proportion of VL results generated in study that are present in CPHL database at study end



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Phase 1, Intervention and Control Clinics:

"High risk" subgroups of patients (n=10 each per clinic, total of 40 per clinic): registered for care, with a clinic visit within a year of the Phase 1 start date, plus the following:

  1. Pregnant or breastfeeding women: Inclusion criteria: (1) pregnant or breastfeeding at any time during Phase 1, confirmed by clinic documentation
  2. Children/adolescents: Inclusion criteria: (1) age 2-17 years, (2) no documentation of pregnancy in clinical record
  3. Persons with most recent VL unsuppressed (i.e. detectable): Inclusion criteria: (1) any age, (2) most recent VL documented in the medical record within the last 1 year, with a value of >1000 copies/mL on any assay, (3) no documentation of pregnancy in clinical record
  4. Persons with no VL in last one year: Inclusion criteria: (1) any age, (2) last VL is dated >1 year ago (if ever started on ART) or no VL on file (if never started ART) (3) no documentation of pregnancy in clinical record

"Non-high-risk" patients (n=20 per clinic): Inclusion criteria (1) adult (age ≥18 years), (2) registered for care, with clinic visit within a year of the Phase 1 start date, (3) already on ART or starting ART at time of study enrollment, (4) do not meet any of the inclusion criteria of a "high risk" subgroup

Phase 2, Intervention Clinics:

We will select 60 patients in each of the 10 intervention clinics (600 patients total; different than the 60 patients in each clinic studied in Phase 1), with inclusion criteria as follows:

"High risk" subgroups of patients (n=10 each per clinic, total of 40 per clinic): registered for care, with a clinic visit within a year of the Phase 2 start date; able to consent for study participation; plus the following:

  1. Pregnant or breastfeeding women: Inclusion criteria: (1) currently pregnant or breastfeeding, confirmed by clinic standard documentation
  2. Children/adolescents: Inclusion criteria: (1) age 2-17 years, (2) parent/guardian able and willing to provide affirmative consent for study participation, except in the case of mature or emancipated minors, (3) no documentation of pregnancy in the clinic record
  3. Persons with most recent VL unsuppressed: Inclusion criteria: (1) any age, (2) most recent VL documented in the medical record within the last 1 year, with a value of >1000 copies/mL on any assay, (3) no documentation of pregnancy in the clinical record
  4. Persons with no VL in last 1 year: Inclusion criteria: (1) any age, (2) last VL is dated >1 year ago (if ever started ART) or no VL on file (if never started ART , (3) no documentation of pregnancy in the clinical record

"Non-high-risk" patients (n=20 per clinic): Inclusion criteria: (1) adult (age ≥18 years), (2) registered in the general HIV clinic, (3) already on ART or starting ART at time of study enrollment, (4) do not meet any of the inclusion criteria of a "high risk" subgroup

Phase 2, Control Clinics:

We will select 60 patients in each of the 10 control clinics (600 patients total; different than the 60 patients in each clinic studied in Phase 1), with inclusion criteria as follows

"High risk" subgroups of patients (n=10 each per clinic, total of 40 per clinic): registered for care, with a clinic visit within a year of the Phase 1 start date; able to provide consent; plus the following:

  1. Pregnant or breastfeeding women: Inclusion criteria: (1) pregnant or breastfeeding at any time during Phase 2, confirmed by clinic documentation
  2. Children/adolescents: Inclusion criteria: (1) age 2-17 years, (2) parent/guardian able and willing to provide affirmative consent for study participation, except in the case of mature or emancipated minors, (3) no documentation of pregnancy in clinical record
  3. Persons with most recent VL suppressed: Inclusion criteria: (1) any age, (2) most recent VL documented in the medical record within the last 1 year, with a value of >1000 copies/mL on any assay, (3) no documentation of pregnancy in clinical record
  4. Persons with no VL in last 1 year: Inclusion criteria: (1) any age, (2) last VL is dated >1 year ago (if ever started ART) or no VL on file (if never started ART), (3) no documentation of pregnancy in clinical record

"Non-high-risk" patients (n=20 per clinic): Inclusion criteria: (1) adult (age ≥18 years), (2) registered for care, with clinic visit within a year of the Phase 2 start date, (3) already on ART or starting ART at time of study enrollment, (4) do not meet any of the inclusion criteria of a "high risk" subgroup

Exclusion criteria: None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553693


Contacts
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Contact: Vivek Jain, MD, MAS 415-476-4082 ext 355 vivek.jain@ucsf.edu
Contact: Moses R Kamya, MBChB, MMed, PhD +256-312-281479 mkamya@infocom.co.ug

Locations
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Uganda
Southwestern Uganda Recruiting
Mbarara, Uganda
Contact: Bonnie Wandera, MBChB, MS    +256-782-290878    bonniewandera@gmail.com   
Principal Investigator: Moses R Kamya, MBChB, MMed, PhD         
Sponsors and Collaborators
University of California, San Francisco
Centers for Disease Control and Prevention
Infectious Diseases Research Collaboration, Uganda
Makerere University
Investigators
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Principal Investigator: Vivek Jain, MD, MAS University of California, San Francisco
Principal Investigator: Moses R Kamya, MBChB, MMed, PhD Makerere University

Publications:
Working Group on Modelling of Antiretroviral Therapy Monitoring Strategies in Sub-Saharan Africa, Phillips A, Shroufi A, Vojnov L, Cohn J, Roberts T, Ellman T, Bonner K, Rousseau C, Garnett G, Cambiano V, Nakagawa F, Ford D, Bansi-Matharu L, Miners A, Lundgren JD, Eaton JW, Parkes-Ratanshi R, Katz Z, Maman D, Ford N, Vitoria M, Doherty M, Dowdy D, Nichols B, Murtagh M, Wareham M, Palamountain KM, Chakanyuka Musanhu C, Stevens W, Katzenstein D, Ciaranello A, Barnabas R, Braithwaite RS, Bendavid E, Nathoo KJ, van de Vijver D, Wilson DP, Holmes C, Bershteyn A, Walker S, Raizes E, Jani I, Nelson LJ, Peeling R, Terris-Prestholt F, Murungu J, Mutasa-Apollo T, Hallett TB, Revill P. Sustainable HIV treatment in Africa through viral-load-informed differentiated care. Nature. 2015 Dec 3;528(7580):S68-76. doi: 10.1038/nature16046.

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Responsible Party: Vivek Jain, MD, Associate Professor of Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03553693     History of Changes
Other Study ID Numbers: RAPID-VL
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vivek Jain, MD, University of California, San Francisco:
HIV
Viral Load
Counseling
Costs and Costs Analysis
Point-Of-Care Systems