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Differentiated Care for Improved Health Systems Efficiency and Health Outcomes in Zambia (CommART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02776254
Recruitment Status : Completed
First Posted : May 18, 2016
Last Update Posted : February 8, 2019
Sponsor:
Collaborators:
Johns Hopkins University
University of Alabama at Birmingham
University of California, San Francisco
American Institutes for Research
University of Zambia
Ministry of Health, Zambia
Johns Hopkins Bloomberg School of Public Health
Information provided by (Responsible Party):
Centre for Infectious Disease Research in Zambia

Brief Summary:
This study seeks to create generalizable knowledge about the implementation process as well as the effectiveness and efficiency of a differentiated care system, by measuring patient health outcomes and implementation outcomes such as acceptability, feasibility, fidelity, and costs

Condition or disease Intervention/treatment Phase
HIV Other: START Other: CAG Other: UAG Other: FAST-TRACK Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Community ART for Retention in Zambia: Evaluating the Feasibility, Effectiveness, and Efficiency of Decentralized and Streamlined Antiretroviral Therapy Care Models
Actual Study Start Date : March 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: START
The START model aims to deliver a higher intensity of treatment services by offering same-day CD4 testing and results, streamlined adherence counseling, and quicker initiation of life-long ART to patients enrolling in HIV care and treatment services.
Other: START
Point of care testing for rapid ART initiation

Experimental: FAST Track
In the FAST-TRACK model a pharmacy technician will dispense drugs) and lay health care workers will provide brief symptom screening to identify patients in need of higher-level care. If there is no need of higher-level care, then the clinic visit is over.
Other: FAST-TRACK
Prescription refill only

Experimental: CAG (intervention)
CAG intervention, consists of facilitated groups of six people based on geographic proximity of home address and patient preference. This group of six people, will meet monthly at a designated place in the community to provide support and receive medications. Each month one of the members will rotate visiting the clinic for their routine medical visit and will pick up medications for the entire CAG and bring them back to the community. This rotation schedule will recur every six months. Lay health care workers will provide brief symptom screening to identify patients in the group that need of higher-level care.
Other: CAG
Community Adherence Group

Active Comparator: CAG (comparison)
Eligible patients at control sites will be approached for willingness to participate in the study. Those who are willing will be enrolled in the study and consent will be obtained to use patient data within SmartCare to evaluate the primary outcome of retention.
Other: CAG
Community Adherence Group

Experimental: UAG (intervention)
Urban sites will be eligible for the UAG model in which patients will be joined into a UAG group consisting of 30 people. Each UAG group will meet every two to three months at a designated site (either at the clinic facility or another site in the community). Patients will receive (a) group adherence counseling led by a lay HCW (b) two to three month supply of ART medications via a pharmacy tech (c) attendance record and symptom assessment. As in the CAG model, patients may be referred up-referred for care based on acute illness or patient preference. Patients will continue to visit the facility for a routine medical visit with a professional HCW every six months.
Other: UAG
Urban Adherence Group

Active Comparator: UAG (comparison)
Eligible patients at control sites will be approached for willingness to participate in the study. Those who are willing will be enrolled in the study and consent will be obtained to use patient data within SmartCare to evaluate the primary outcome of retention.
Other: UAG
Urban Adherence Group




Primary Outcome Measures :
  1. Retention in care (Time to first missed pharmacy pick-up) [ Time Frame: 12 months ]
    Time to first missed pharmacy pick-up (>7 days)


Secondary Outcome Measures :
  1. Feasibility of implementing differentiated care from stakeholder perspectives [ Time Frame: 12 months ]
    stakeholders' perceptions on factors that facilitate or impede delivery of differential models of care through qualitative assessments (i.e. HCW interviews at end of follow-up period).

  2. Feasibility of implementing differentiated care based on ART availability [ Time Frame: 12 months ]
    facility-level assessments (i.e. frequency of pharmacy stock outs) that facilitate or impede delivery of differential models of care

  3. Activity Based Costing (cost per activity based on Time and Motion) [ Time Frame: 12 months ]
    Cost per activity will be estimated using time-in-motion forms among health care workers prior to and during implementation

  4. Cost to patient based on semi-structured interviews [ Time Frame: 12 months ]
    Cost will be estimated through a semi-structured costing questionnaire administered to a subset of intervention participants to assess direct and indirect health costs of the intervention.

  5. Research Costs (cost of conducting implementation science) [ Time Frame: 12 months ]
    Activity-based cost of researching differentiated care based on budgets and spending reports

  6. Fidelity by monitoring the proportion of eligible patients successfully enrolled and retained in a model. [ Time Frame: 12 months ]
    proportion of eligible patients successfully enrolled and retained in a model

  7. Access to care (time in days from positive symptom screen to appropriate referral) [ Time Frame: 12 months ]
    Time (days) from positive symptom screen to appropriate referral

  8. Efficiency (Difference between cost per additional patient retained and the cost per death averted divided by the difference in their effect) [ Time Frame: 12 months ]
    Difference between Incremental cost per additional patient retained and the cost per death averted divided by the difference in their effect

  9. Proportion of patients with appropriate laboratory monitoring (CD4 count testing) [ Time Frame: every 6 months for a year ]
    As this is an assessment of models of delivering ART in a manner more efficient than presentation to clinician every month, safety is estimated by appropriate referral based on laboratory monitoring by clinical staff (CD4 count every 6 months for a year)

  10. Proportion of patients with appropriate laboratory monitoring through viral load testing [ Time Frame: 12 months ]
    As this is an assessment of models of delivering ART in a manner more efficient than presentation to clinician every month, safety is estimated by appropriate referral based on laboratory monitoring by clinical staff (Viral load every 12 months)

  11. Proportion of patients with appropriate symptom screening [ Time Frame: Every 1-3 months for 12 months ]
    As this is an assessment of models of delivering ART in a manner more efficient than presentation to clinician every month, safety is estimated by appropriate referral based on symptom screening by study staff (every 1-3 months per year)

  12. Retention rate disaggregated by age (adult and adolescent) [ Time Frame: 12 months ]
    Comparison of retention rates between adults and adolescents will be used as a measure of equity

  13. Retention rate disaggregated by sex (male and female) [ Time Frame: 12 months ]
    Comparison of retention rates between men and women will be used as a measure of equity

  14. Proportion of patients virally suppressed at one year among those exposed to the intervention compared to control conditions using mixed effects logistic regression [ Time Frame: 12 months ]
    Viral suppression should be comparable between the intervention and control groups to ascertain whether patient outcomes are better or at least the same as current routine practice

  15. Patient satisfaction using patient exit-survey [ Time Frame: 12 months ]
    Effect of the intervention on patient satisfaction through mixed effects linear regression



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-positive adolescents and adults (> 14 years of age)
  • Last CD4 count (obtained within the last six months) > 200
  • Not acutely ill
  • For CAGs, UAGs, and Fast-Track models: on ART for at least 6 months
  • For the START model: ART naïve and meet the Zambian HIV guidelines for treatment initiation

Exclusion Criteria:

  • For CAGs, UAGs: Inability to participate in the group activities due to cognition deficits or mental illness.
  • Unable to provide consent or unwilling to participate in study
  • Pregnancy

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): NCT02776254


Locations
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Zambia
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia, 10101
Sponsors and Collaborators
Centre for Infectious Disease Research in Zambia
Johns Hopkins University
University of Alabama at Birmingham
University of California, San Francisco
American Institutes for Research
University of Zambia
Ministry of Health, Zambia
Johns Hopkins Bloomberg School of Public Health
Investigators
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Principal Investigator: Charles Holmes, MD, MPH Centre for Infectious Disease Research in Zambia
Principal Investigator: Izukanji Sikazwe, MBChB Centre for Infectious Disease Research in Zambia
Additional Information:
Publications:
Health ZMo. UNAIDS Country Progress Report Zambia. March 31, 2012 2012.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre for Infectious Disease Research in Zambia
ClinicalTrials.gov Identifier: NCT02776254    
Other Study ID Numbers: ID OPP1105306
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre for Infectious Disease Research in Zambia:
anti-retroviral therapy
differentiated care