NCT04766710

Community-Based Model for Delivery of Antiretroviral Therapy in Cambodia

Status unknown NA Last updated 9 November 2023

What this trial tests

NA trial testing Community-based ART delivery (CAD) in HIV Infections in 4,102 participants. Status unknown.

Timeline

1 April 2021

Primary endpoint
31 March 2023

31 March 2024

Quick facts

Lead sponsor	National University of Singapore
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	4,102
Start date	1 April 2021
Primary completion	31 March 2023
Estimated completion	31 March 2024
Sites	3 locations across Cambodia

Drugs / interventions tested

• Community-based ART delivery (CAD)
• ART multi-month dispensing (MMD)

Conditions studied

• HIV Infections — all drugs for HIV Infections →
• AIDS — all drugs for AIDS →

Sponsor

National University of Singapore

Who can join

15 and older, any sex, with HIV Infections or AIDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The community-based ART delivery (CAD) model will build on the existing framework to engage community action, operationalized in the current Global Fund-supported project. Community Action Workers (CAW), who are assigned to ART centers and conduct outreach work, are well-suited to administer CAD scheme. KHANA and the project partners all have implementation roles in the Global Fund-supported project and established working channels with the CAW.

While the previous experiences suggest the CAD model's effectiveness, implementing it in Cambodia requires adaptation to its specific local context. The proposed project will be implemented as an implementation study in nine ART sites and supported by a concrete evaluation plan. KHANA Center for Population Health Research will lead the research component.

The project has three strategic areas and corresponding deliverables as follows:

A. The development of a locally-fitted model: bringing ART closer to the people living with HIV B. The research: formulation, evaluation, documentation, and dissemination of the evidence, knowledge, and lessons learned C. The scale-up: advocacy for the SOP development to replicate/scale-up the CAD model

The project will benefit a wide range of stakeholders. The approximately 2,000 ART clients enrolled in the nine selected clinics will face less cost, time, and discrimination, which will also benefit their families. The clinics will have a reduced workload on site, and they would be able to improve the quality of care for the visiting clients. The Cambodian health system will obtain a CAD model tailored to the country's local context and develop Standard Operating Procedures for the scheme with readily involved stakeholders. The scale-up of the model will benefit all other ART clinics and clients in the country.

The 36-months project starting from June 1, 2019, will include six months of start-up and baseline assessments, 24-month intervention, and six-month evaluation.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Community-based model for the delivery of antiretroviral therapy in Cambodia: a quasi-experimental study protocol.
   Tuot S, Teo AKJ, Prem K, Chhoun P, et al · · 2021 · cited 7× · PMID 34362310 · DOI 10.1186/s12879-021-06414-y
2. Impact of a community-based antiretroviral therapy delivery model for people living with HIV in Cambodia.
   Tian Z, Chhoun P, Tuot S, Yam LYE, et al · · 2025 · PMID 41290647 · DOI 10.1038/s41467-025-66606-x
3. Cost-effectiveness analysis of a community-based model for delivery of antiretroviral therapy to people with clinically stable HIV in Cambodia.
   Yam LYE, Chhoun P, Tian Z, Nagashima-Hayashi M, et al · · 2025 · PMID 40623943 · DOI 10.1002/jia2.26476
4. Community-based model for the delivery of antiretroviral therapy in Cambodia: a quasi-experimental study protocol
   Tuot S, Teo AKJ, Prem K, Chhoun P, et al · · 2021 · DOI 10.21203/rs.3.rs-497277/v1