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 standard of care. This study is a three-arm cluster-randomized controlled trial conducted among 5,760 stable HIV-positive patients) in Zimbabwe to compare outcomes of three antiretroviral therapy (ART) dispensing models. Outcomes of retention in care, virologic suppression, and cost effectiveness will be investigated in 30 purposively selected clusters (facilities) which are randomized into three arms; standard of care (3 months dispensing at facilities), three-month dispensing in CARGs, and six-month dispensing in CARGs. Each study arm will have 10 clusters stratified into 2 urban and 8 rural. Study participants will be followed, and outcomes will be measured at 12 months and 24 months. Qualitative research will be conducted at baseline, 12 months, and 24 months (20 participant Focus Group Discussion (FGDs) and 20 provider Key Informant Interview (KII) at each interval) to understand patient and health provider acceptability of multi-month dispensing of ART within CARGs. Other outcomes of interest include measuring gains of facility decongestion and feasibility of multi-month dispensing of ART within CARGs. Cost analysis will include comparisons of patient level costs, cost per patient outcomes and cost effectiveness across the three study arms.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

4,676

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach

1 country

30 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

First Submitted

Initial submission to the registry

July 27, 2017

Completed

1 day until next milestone

Study Start

First participant enrolled

July 28, 2017

Completed

6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed

Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

2.2 years

First QC Date

July 27, 2017

Last Update Submit

October 16, 2018

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (3)

Retention in care
To determine if stable ART patients receiving 3 monthly dispensing of ART within CARGs have noninferior retention in care than stable ART patients receiving 3 monthly dispensing at health facilities after 12 months.
12 months
Retention in care
To determine if stable ART patients receiving 6 monthly dispensing of ART within CARGs have noninferior retention in care than stable ART patients receiving 3 monthly dispensing at health facilities after 12 months.
12 months
Measure change in retention in care
To determine if stable ART patients within CARGs receiving 6 monthly dispensing of ART have noninferior retention in care than stable ART patients receiving 3 monthly dispensing within CARGs after 12 months
12 and 24 months

Secondary Outcomes (7)

Virologic suppression
12 months
Measure change in virologic suppression
12 and 24 months
Measure cost effectiveness at 2 time points
12 and 24 months
Measure change in patient level benefits of implementing CARGs
12 and 24 months
Measuring change in feasibility of multi-month dispensing of ART within CARGs
12 and 24 months
+2 more secondary outcomes

Study Arms (3)

3MF: 3-month ART dispensing at facilities

NO INTERVENTION

Ten sites at which patients will receive standard of care where ART is dispensed three monthly from the facility based on usual practice at the clinic. The approach will be consistent with applicable country guidelines at the time of study.

3MC: 3-month ART dispensing in CARGs

EXPERIMENTAL

Ten sites at which patients will receive ART dispensed three monthly in CARGs. Providers at facilities will assist in the formation of CARGs and will provide all enrolled patients with a 3 month supply of ART and associated HIV medications. All other aspects of care will be as per standard of care for the enrolling clinic.

Other: Three month dispensing of ART in CARGs

6MC: 6-month ART dispensing in CARGs

EXPERIMENTAL

Ten sites at which patients will receive ART dispensed six monthly in CARGs. Providers at facilities will assist in the formation of CARGs and will provide all enrolled patients with a 6 month supply of ART and associated HIV medications. All other aspects of care will be as per standard of care for the enrolling clinic.

Other: Six month dispensing of ART in CARGs

Interventions

Three month dispensing of ART in CARGsOTHER

Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART in CARGs from their provider for the duration of the study. Each CARG will consist of 6-12 stable patients on ART and will meet in the community and select a group member to collect their ART at the facility every 3 months. Patients can have unscheduled clinic visits when unwell. Viral loads for the group will be collected at 12 and 24 months at the facility.

3MC: 3-month ART dispensing in CARGs

Six month dispensing of ART in CARGsOTHER

Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART in CARGs from their provider for the duration of the study. Each CARG will consist of 6-12 stable patients on ART and will meet in the community and select a group member to collect their ART at the facility every 6 months. Patients can have unscheduled clinic visits when unwell. Viral loads for the group will be collected at 12 and 24 months at the facility.

6MC: 6-month ART dispensing in CARGs

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Kheth'Impilolead
Ministry of Health and Child Welfare, Zimbabwecollaborator
EQUIP Innovation for Healthcollaborator
Organization for Public Health Interventions and Development (OPHID)collaborator
Family Health International (FHI 360)collaborator
Population Services International (PSI)collaborator

Study Sites (30)

Seke North Clinic

Chitungwiza, Harare, Zimbabwe

Location

Seke South Clinic

Chitungwiza, Harare, Zimbabwe

Location

St Mary's Clinic

Chitungwiza, Harare, Zimbabwe

Location

Zengeza Clinic

Chitungwiza, Harare, Zimbabwe

Location

Chimombe Rural Hospital

Gutu, Masvingo Province, Zimbabwe

Location

Chinyika Rural Hospital

Gutu, Masvingo Province, Zimbabwe

Location

Gutu Mission Hospital

Gutu, Masvingo Province, Zimbabwe

Location

Gutu Rural Hospital

Gutu, Masvingo Province, Zimbabwe

Location

Bota Rural Hospital

Zaka, Masvingo Province, Zimbabwe

Location

Bvukururu Clinic

Zaka, Masvingo Province, Zimbabwe

Location

Chiredzana Clinic

Zaka, Masvingo Province, Zimbabwe

Location

Harava Rural Health Centre

Zaka, Masvingo Province, Zimbabwe

Location

Siyawareva Clinic

Zaka, Masvingo Province, Zimbabwe

Location

Beitbridge Hospital

Beitbridge, Matebeleland South, Zimbabwe

Location

Chamnangana

Beitbridge, Matebeleland South, Zimbabwe

Location

Chaswingo

Beitbridge, Matebeleland South, Zimbabwe

Location

Dulibadzimu

Beitbridge, Matebeleland South, Zimbabwe

Location

Makakabule

Beitbridge, Matebeleland South, Zimbabwe

Location

Shabwe

Beitbridge, Matebeleland South, Zimbabwe

Location

Chidembeko Mission Hospital