Differentiated Care for Improved Health Systems Efficiency and Health Outcomes in Zambia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02776254
• Date of registration: 13/03/2016
• Prospective Registration: No
• Primary sponsor: Centre for Infectious Disease Research in Zambia
• Public title: Differentiated Care for Improved Health Systems Efficiency and Health Outcomes in Zambia CommART
• Scientific title: Community ART for Retention in Zambia: Evaluating the Feasibility, Effectiveness, and Efficiency of Decentralized and Streamlined Antiretroviral Therapy Care Models
• Date of first enrolment: March 2016
• Target sample size: 3100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02776254
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Zambia

Contacts

• Name: Izukanji Sikazwe, MBChB
• Affiliation: Centre for Infectious Disease Research in Zambia

• Name: Charles Holmes, MD, MPH
• Affiliation: Centre for Infectious Disease Research in Zambia

Key inclusion & exclusion 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



Age minimum: 15 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Other: CAG

Other: START

Other: UAG

Other: FAST-TRACK

Primary Outcome(s)

Retention in care (Time to first missed pharmacy pick-up) [Time Frame: 12 months]

Secondary Outcome(s)

Proportion of patients with appropriate symptom screening [Time Frame: Every 1-3 months for 12 months]

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

Research Costs (cost of conducting implementation science) [Time Frame: 12 months]

Feasibility of implementing differentiated care based on ART availability [Time Frame: 12 months]

Feasibility of implementing differentiated care from stakeholder perspectives [Time Frame: 12 months]

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

Cost to patient based on semi-structured interviews [Time Frame: 12 months]

Proportion of patients with appropriate laboratory monitoring (CD4 count testing) [Time Frame: every 6 months for a year]

Patient satisfaction using patient exit-survey [Time Frame: 12 months]

Proportion of patients with appropriate laboratory monitoring through viral load testing [Time Frame: 12 months]

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]

Retention rate disaggregated by sex (male and female) [Time Frame: 12 months]

Activity Based Costing (cost per activity based on Time and Motion) [Time Frame: 12 months]

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]

Retention rate disaggregated by age (adult and adolescent) [Time Frame: 12 months]

Secondary ID(s)

ID OPP1105306

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

American Institutes for Research

University of California, San Francisco

University of Alabama at Birmingham

University of Zambia

Johns Hopkins Bloomberg School of Public Health

Johns Hopkins University

Ministry of Health, Zambia