Community-Based Model for Delivery of Antiretroviral Therapy in Cambodia

NCT04766710 | Unknown DMC

• 1 other identifier: 030_PV_KHANA
• Study Type: interventional
• Target: 4,102
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

HIV Infections; AIDS

Keywords

HIV; Community-based services; ART; Operational research; Intervention; Cambodia

Outcome Measures

Primary Outcomes (4)

• Percent of people living with HIV with viral suppression

  Viral load At least 90% of participants in intervention arm will have a viral load \<1000 RNA copies/mL by the endline of the intervention

  24 months after the intervention started

• Percent of people living with HIV who remained in HIV care and treatment

  At least 90% of participants in the intervention will be retained in care and treatment 12 months after the treatment started

  24 months after the intervention started

• Percent of people living with HIV with good adherence to ART

  At least 90% of the participants in the intervention will report good adherence to ART at the endline.

  24 months after the intervention started

• Percent of healthcare providers at ART clinics who reported reduced workload

  Workload at ART clinics will be self-reported by health care workers providing ART services at the clinics. The investigators hypothesize that a significantly higher proportion of health care providers at ART clinics under the CAD intervention arm will agree that their workload has been reduced at endline compared to baseline.

  24 months after the intervention started

Secondary Outcomes (4)

• Cost-effectiveness of community-based ART delivery (CAD) model intervention

  24 months after the intervention started

• Percent of people living with HIV who reported improved quality of life

  24 months after the intervention started

• Percent of people living with HIV who reported improved mental health

  24 months after the intervention started

• Percent of people living with HIV who reported improved social support health

  24 months after the intervention started

Study Arms (2)

Community-based ART delivery (CAD)

EXPERIMENTAL

The CAD model intervention will take place for 24 months. A total of 2000 registered stable people living with HIV will form into the CAD group. The investigators have developed the implementation guide, monitoring tools, quality assurance checklist, and lists of people living with HIV in selected ART clinics for the CAD model intervention. The first step will be to extract the data disaggregated by gender, age, and type of sub-populations, including adolescents, female entertainment workers, men who have sex with men, transgender women, and people who use drugs from the national database using the definitions introduced by the WHO. Once the list is completed with patient ART codes, a consultative meeting combined with the project orientation will be convened. Providers from the selected ART clinics and implementing partners at each site will divide stable people living with HIV into their respective groups based on the ART sites.

Other: Community-based ART delivery (CAD)

ART multi-month dispensing (MMD)

ACTIVE COMPARATOR

A total of 2000 registered stable people living with HIV will form into the control group and received standard services under the MDD model. The control-arm participants will visit the ART clinics and collect their ARVs from the facility-based staff.

Other: ART multi-month dispensing (MMD)

Interventions

Community-based ART delivery (CAD) OTHER

The frontline workers to implement the CAD model intervention will be people living with HIV recruited from the community who will plays roles as CAWs. The CAWs will receive intensive training, coaching, and mentoring from their respective ART clinics and implementing partners' field staff on ARV dispensing, drug storage, patient's vital sign assessment and recording, HIV education and counseling, medication adherence, referral systems, mental health, stigma and discrimination, and sexual and reproductive health of people living with HIV. To closely monitor the work of the CAWs, a respective ART clinic team, consisting of an ART counselor and a physician, will be tasked to conduct regular supervision along with the program team of the implementing partners to the community groups at least once a month in the first six months. After the six months, supervisory visits will be extended to once every two months.

Community-based ART delivery (CAD)

ART multi-month dispensing (MMD) OTHER

The control arm participants will receive routine services under the MMD model based on standard community-based prevention, care, and support practices in Cambodia. The NCHADS has introduced MDD in all ART sites across the country. However, so far, not all ART sites currently operate the MMD. The MMD is designed to help ART service providers implement MMD for eligible patients-that is, patients whose condition is determined to be stable-which will reduce the need for frequent visits and providers' workload. Stable people living with HIV receive care and support from counselors and ARVs at the clinics every four to six months.

ART multi-month dispensing (MMD)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving ART for at least one year.
• No adverse drug reactions or ARV drug interactions requiring regular monitoring.
• No suspected or confirmed tuberculosis, no other opportunistic infections, and not on any prophylaxis.
• Not pregnant/breastfeeding (for women).
• Having a good understanding of lifelong treatment and adherence to the medication.
• Presenting with evidence of treatment success: two consecutive undetectable viral load measures (or, in the absence of viral load monitoring, CD4 counts above 200 cells/mm3 and objective adherence measure).
• Aged ≥15 years.
• On the first-line ARV regimen.

You may not qualify if:

• Unstable people living with HIV as defined above
• Mobile populations

Sponsors & Collaborators

• National University of Singapore: lead
• KHANA Center for Population Health Research: collaborator

Study Sites (3)

KHANA Center for Population Health Research

Phnom Penh, 2361, Cambodia

RECRUITING

Cambodia Anti-Tuberculosis Association

Phnom Penh, 2589-384, Cambodia

RECRUITING

National Center for Tuberculosis and Leprosy Control

Phnom Penh, 2589, Cambodia

RECRUITING

Related Publications (20)

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  PMID: 31265458 BACKGROUND

• Chhim K, Mburu G, Tuot S, Sopha R, Khol V, Chhoun P, Yi S. Factors associated with viral non-suppression among adolescents living with HIV in Cambodia: a cross-sectional study. AIDS Res Ther. 2018 Nov 17;15(1):20. doi: 10.1186/s12981-018-0205-z.

  PMID: 30445984 RESULT

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  PMID: 28801427 RESULT

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• Rasschaert F, Decroo T, Remartinez D, Telfer B, Lessitala F, Biot M, Candrinho B, Van Damme W. Adapting a community-based ART delivery model to the patients' needs: a mixed methods research in Tete, Mozambique. BMC Public Health. 2014 Apr 15;14:364. doi: 10.1186/1471-2458-14-364.

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• Yam LYE, Chhoun P, Tian Z, Nagashima-Hayashi M, Zahari M, Tuot S, Samreth S, Ngauv B, Ouk V, Prem K, Yi S. Cost-effectiveness analysis of a community-based model for delivery of antiretroviral therapy to people with clinically stable HIV in Cambodia. J Int AIDS Soc. 2025 Jul;28 Suppl 3(Suppl 3):e26476. doi: 10.1002/jia2.26476.

  PMID: 40623943 DERIVED

• Tuot S, Teo AKJ, Prem K, Chhoun P, Pall C, Ung M, Ly PS, Jimba M, Yi S. Community-based model for the delivery of antiretroviral therapy in Cambodia: a quasi-experimental study protocol. BMC Infect Dis. 2021 Aug 6;21(1):763. doi: 10.1186/s12879-021-06414-y.

  PMID: 34362310 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Sok Chamreun Choub, MA

  KHANA Center for Population Health Research

  STUDY CHAIR

• Penh Sun Ly, MD

  National Center for HIV, Dermatology and STD

  STUDY CHAIR

Central Study Contacts

Siyan Yi, PhD

CONTACT

6587533823; siyan@doctor.com

Sovannary Tuot, MA

CONTACT

85523211505; tsovannary@khana.or.kh

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Project coordinators and people living with HIV in the selected operational districts will not be masked to the intervention. However, all activities will be done without reference to the intervention group. The data analysts will be masked to intervention allocation and will only analyze de-identified data.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This quasi-experimental study will consist of two arms. People living with HIV in the intervention arm will receive services from the CAD model, and those in the control arm will receive the standard prevention, care, and support services. The investigators will compare the outcome between these two arms.

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 23, 2021
• Study Start: April 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will permanently available after the main report of the project has been published.

Locations

CA (3)