Community-based model for the delivery of antiretroviral therapy in Cambodia: a quasi-experimental study protocol

Abstract

Background: Multi-month dispensing (MMD) is the mainstay mechanism for clinically stable people living with HIV in Cambodia to refill antiretroviral therapy (ART) every 3-6 months. However, less frequent ART dispensing through the community-based ART delivery (CAD) model could further reduce the clients' and health facilities' burden. While community-based services have been recognized as an integral component of HIV response in Cambodia, their role and effectiveness in ART delivery have yet to be systematically assessed. This study aims to evaluate the CAD model's effectiveness on the continuum of care and treatment outcomes for stable people living with HIV in Cambodia.

Methods: We will conduct this quasi-experimental study in 20 ART clinics across the capital city and nine provinces between May 2021 and April 2023. Study sites were purposively selected based on the availability of implementing partners, the number of people living with HIV each clinic serves, and the accessibility of the clinics. In the intervention arm, approximately 2000 stable people living with HIV will receive ART and services from the CAD model. Another 2000 stable people living with HIV in the control arm will receive MMD-a standard care model for stable people living with HIV. The primary outcomes will be retention in care, viral load suppression, and adherence to ART. The secondary endpoints will include health providers' work burden, the model's cost-effectiveness, quality of life, mental health, social support, stigma, and discrimination. We will compare the outcome indicators within each arm at baseline, midline, and endline using descriptive and inferential statistics. We will evaluate the differences between the intervention and control arms using the difference-in-differences method. We will perform economic evaluations to determine if the intervention is cost-effective.

Discussion: This study will build the evidence base for future implementation and scale-up of CAD model in Cambodia and other similar settings. Furthermore, it will strengthen engagements with community stakeholders and further improve community mobilization, a vital pillar of the Cambodian HIV response.

Trial registration: ClinicalTrials.gov, NCT04766710 . Registered 23 February 2021, Version 1.

Keywords: Antiretroviral therapy; Cambodia; Community; HIV; Implementation science; Service delivery.

Fig. 1

Study flowchart in the intervention (community ART delivery) and control arms (multi-month dispensing model). Notes: The department/profiles in red represent the workforce required at the ART clinics to facilitate and implement MMD and CAD. Boxes in green represent activities that will occur in the ART clinics. Boxes in yellow represent activities that will occur in the community

Fig. 2

Conceptual framework reflecting the outcome measures and their effects on the continuum of care. Note: The framework outlines the relationship between the outcome measures (boxed in dotted line) and the HIV continuum of care (blue). The right-most panel (orange) represents the outcome measures in the context of the socioecological levels of influence

Fig. 3

Timelines and data collection activities for the quasi-experimental study to evaluate the community ART model