Operations Research of the 'Real World' Effectiveness of Multi-Month Dispensing of ART for Stable Patients in CARGs in Zimbabwe

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.

Conditions

• HIV/AIDS

Interventions

OTHER

Three month dispensing of ART in CARGs

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.

OTHER

Six month dispensing of ART in CARGs

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.

Sponsors & Collaborators

• Ministry of Health and Child Welfare, Zimbabwe

  collaborator OTHER

• EQUIP Innovation for Health

  collaborator UNKNOWN

• Organization for Public Health Interventions and Development (OPHID)

  collaborator UNKNOWN

• Family Health International (FHI 360)

  collaborator UNKNOWN

• Population Services International (PSI)

  collaborator UNKNOWN

• Kheth'Impilo

  lead OTHER

Principal Investigators

• Nicoletta Ngorima-Mabhena, MBChB, MSc Epidemiology · Kheth'Impilo

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-28

Primary Completion

2019-09-30

Completion

2019-09-30

Countries

• Zimbabwe

Study Locations