Status:
UNKNOWN
Operations Research of the 'Real World' Effectiveness of Multi-Month Dispensing of ART for Stable Patients in CARGs in Zimbabwe
Lead Sponsor:
Kheth'Impilo
Collaborating Sponsors:
Ministry of Health and Child Welfare, Zimbabwe
EQUIP Innovation for Health
Conditions:
HIV/AIDS
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to evaluate the effectiveness of two strategies for multi-month dispensing (MMD) of ART in Community ART Refill Groups (CARGs) on retention, virologic suppression, and cost compared to...
Detailed Description
This study will use a cluster (facility) randomized trial with 3 arms; patients receiving 3 monthly ART supply at facilities-standard of care (3MF) (Control group), patients receiving 3 monthly ART su...
Eligibility Criteria
Inclusion
- At least 18 years of age and willing and able to provide written informed consent for participation in this study
- Willing to be part of a CARG if in a facility that has been randomized to 3MC or 6MC,
- Confirmed HIV-1 infection based on the Zimbabwe National HIV testing algorithm.
- On ART ≥ 6 months
- On first line ART regimen
- No drug toxicity/tolerability issues within the prior 6 months
- No active opportunistic infection suspected (including TB) and not treated for an opportunistic infection in the last 30 days
- Viral load \< 1000 copies/ml done at baseline of the study
- Weight ≥ 35kgs
Exclusion
- Unwilling or unable to provide informed consent
- On alternative first line or second line regimen
- ARV toxicity or tolerability issue within the prior 6 months
- Co-morbidities requiring facility visits more often than 3 months if in the 3MC/3MF ARMS and 6 monthly if in the 6MC ARM
- Viral load \> lower limit of standard assay (\>1000) within the prior 6 months
- Confirmed pregnancy, or less than 18 months postpartum.
- Weight criteria is less than 35kgs
Key Trial Info
Start Date :
July 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
4676 Patients enrolled
Trial Details
Trial ID
NCT03238846
Start Date
July 28 2017
End Date
September 30 2019
Last Update
October 17 2018
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
Seke North Clinic
Chitungwiza, Harare, Zimbabwe
2
Seke South Clinic
Chitungwiza, Harare, Zimbabwe
3
St Mary's Clinic
Chitungwiza, Harare, Zimbabwe
4
Zengeza Clinic
Chitungwiza, Harare, Zimbabwe