Clinical trial NCT04766710: Community-Based Model for Delivery of Antiretroviral Therapy in Cambodia
Official title: Implementation and Evaluation of a Community-Based Model for Delivery of Antiretroviral Therapy in Cambodia: A Quasi-Experimental Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
AIDS
Keywords: HIV
Community-based services
ART
Operational research
Intervention
Cambodia
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: KHANA Center for Population Health Research
First posted: 2021-02-23
Enrollment: 4102
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: One of the challenges in the Cambodian HIV response is the relatively low rate of retention in care and viral load suppression among people living with HIV on ART. According to a report from the National Center for HIV/AIDS, Dermatology and STD (NCHADS), by the end of September 2017, approximately 98% (n= 58,268) of people living with HIV diagnosed in the whole country were initiated on ART. Of them, 75% were virally suppressed, and 89% were retained on the treatment 12 months after the treatment initiation. Similarly, a recent study conducted by KHANA Center for Population Research in 11 ART clinics across the country found that the rate of viral suppression among adolescents living with HIV aged 15-17 was 76.8%.

To date, ART in Cambodia has been administered only at the government ART clinics. Nationally, there are 66 ART Clinics in 22 of the 25 provinces. Making a trip to an ART clinic on a monthly or bimonthly basis to receive repeated prescriptions poses a heavy burden on the clients in terms of both time and money. Besides, as the Global Fund Funding Request points out (pp.7-8), besides self-stigma, people living with HIV and key populations continue to face stigma and discrimination in their communities, in accessing health and other services, and at the household level. Furthermore, under the current scheme, the necessity for the ART clinics to meet the demand of all of the ART clients, including the stable clients who visit bi-monthly, is a huge burden on the facilities and the service providers. Fewer client visits per given timeframe are expected to help the health workers spend more time per visiting client and improve the service quality.

Community-based service delivery has been an integral part of the response to HIV in other parts of the world. Cambodia's national HIV program acknowledges the major contribution of such an approach, including the proposed CAD model. In 2016, the World Health Organization (WHO) recommended that stable ART clients can safely reduce the frequency of clinic visits, potentially receiving ART in community settings. Researches from other contexts have also suggested that communities can be engaged to provide ART with good outcomes. Most CAD models have been demonstrated to reduce burdens for patients and the health systems, increased retention in care, and lower service provider costs. KHANA and its partners, including NCHADS, believe that an adaptation of an ART delivery model that meaningfully includes community-based services will be essential, particularly as the national program intensifies case-finding and the "Treat All" approach, to meet the national targets.

KHANA has been a leader of the country's community-led HIV response and was one of the key members in developing the "Consolidated Operational Framework on Community Action Approach to Implement B-IACM towards achieving 90-90-90 in Cambodia (Community Action Framework)" of NCHADS. For the past 20 years, KHANA has supported the capacity building of the HIV-affected communities, who now bring invaluable contributions to the design of the HIV response in Cambodia. The Community Action Framework aims to ensure the continued participation of the communities, thus strengthening the health system and empowering the HIV-affected communities. The current Global Fund-supported project applies this framework to detect undiagnosed people living with HIV by promoting HIV testing and counseling in the communities and improve the HIV care cascade. KHANA sees an opportunity to extend this framework's application in the form of CAD with the support of the 5% Initiative.

The Community Action Framework has a section on CAD; however, there is a need to operationalize this model and demonstrating its applicability in the Cambodian context. The proposed project will develop a CAD model considering the evidence and findings of previous studies, the Cambodian local context, and the principles set by the national HIV program. As an operational research project, it will be implemented to reach approximately 2,000 people living with HIV who are categorized as 'stable' (on ART for 12 months or more, clinically stable, undetectable viral load) in nine selected ART clinics, five urban and four rural, in the five provinces. In total, 82 community-based ART groups will be established, with approximately 25 members in each group. The designated CAW will coordinate the groups with technical support from five project assistants, one per province.

In the architecture of the current Global Fund-supported project, the Community-Based Prevention, Care and Support (CBPCS) are implemented for people living with HIV in greatest needs and other target populations by civil society organization (CSO) workers at the ART clinics; i.e., Community Action Counsellors (CAC), Facility-Based Workers (FBW) and CAW. They will contribute to the daily facility activities and perform outreach work as needed. CAWs are assigned to 37 ART sites, and their responsibilities will include: a) provision of case management and support for people living with HIV in greatest needs (e.g., people living with HIV who are newly enrolled in ART, pregnant women, children under five years and adolescents) to improve drug adherence, missed appointment issues or treatment failure and b) being in contact with Village Health Support Groups (VHSG) to encourage HIV testing and counseling and trace new cases. The administration of CAD fits well in the function of CAW.

The project is strategized around three key areas as follows:

1. Bringing ART closer to the people living with HIV This innovative CAD model's main concept is that the community-based ART provision brings the treatment to come closer to people living with HIV. It is made possible by CAW who bring pre-packed ARV refill and various support services to the members of Community ART Groups. A technology-based tool using tablets will be introduced to the CAW as educational materials and monitoring tools.

   Accessibility of ARV distribution points is crucial to the success of this scheme. Therefore, the distribution points will be located at the monthly meeting sites of the local self-help groups. Stable ART clients who are members of the scheme will visit the designated ART clinic for consultation and viral load monitoring every six months. The project will also work to reactivate the existing savings initiative within such self-help groups to contribute to such community groups' sustainability.

   Linkages with the designated ART clinics will be strengthened through capacity-building activities, coaching, and mentoring. Training will be provided to the relevant ART clinic staff members on the new CAD model's overall objectives and on the roles they will play in the project implementation.

   Gender, age, and populations are parameters that are expected to determine the effectiveness of the model significantly. The project will have mixed-gender groups and population-specific groups (e.g., male, female, transgender women, men who have sex with men). The project design will also consider the special needs of different population groups such as female entertainment workers (FEWs) and lesbian, gay, bisexual, transgender, and intersex (LGBTI) more broadly.
2. Evaluation, documentation, and dissemination of the project findings and lessons learned

The project will provide an opportunity to generate various program findings, evidence and lessons learned, which will be documented and disseminated through:

* Routine data collection for project monitoring and harmonization with/integration into the B-IACM approach and national ART database system.
* Case study documentation per site and comparative analyses.
* Presentations at national HIV/AIDS Technical Working Group meetings to support knowledge sharing and replication of the model.
* Dissemination of the findings nationally to the Ministry of Health and other national and international stakeholders to inform evidence-based policy dialogues.
* Presentations at national, regional, and international scientific conferences.
* Operational reports and international peer-reviewed publications.

Eligibility criteria: Inclusion criteria:

1. Receiving ART for at least one year.
2. No adverse drug reactions or ARV drug interactions requiring regular monitoring.
3. No suspected or confirmed tuberculosis, no other opportunistic infections, and not on any prophylaxis.
4. Not pregnant/breastfeeding (for women).
5. Having a good understanding of lifelong treatment and adherence to the medication.
6. 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).
7. Aged ≥15 years.
8. On the first-line ARV regimen.

Exclusion criteria

1. Unstable people living with HIV as defined above
2. Mobile populations

Primary outcomes:
measure: Percent of people living with HIV with viral suppression
timeFrame: 24 months after the intervention started
measure: Percent of people living with HIV who remained in HIV care and treatment
timeFrame: 24 months after the intervention started
measure: Percent of people living with HIV with good adherence to ART
timeFrame: 24 months after the intervention started
measure: Percent of healthcare providers at ART clinics who reported reduced workload
timeFrame: 24 months after the intervention started
Secondary outcomes:
measure: Cost-effectiveness of community-based ART delivery (CAD) model intervention
timeFrame: 24 months after the intervention started
measure: Percent of people living with HIV who reported improved quality of life
timeFrame: 24 months after the intervention started
measure: Percent of people living with HIV who reported improved mental health
timeFrame: 24 months after the intervention started
measure: Percent of people living with HIV who reported improved social support health
timeFrame: 24 months after the intervention started
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: KHANA Center for Population Health Research
city: Phnom Penh
country: Cambodia
facility: Cambodia Anti-Tuberculosis Association
city: Phnom Penh
country: Cambodia
facility: National Center for Tuberculosis and Leprosy Control
Study officials:
affiliation: KHANA Center for Population Health Research
name: Sok Chamreun Choub, MA
role: STUDY_CHAIR
affiliation: National Center for HIV, Dermatology and STD
name: Penh Sun Ly, MD
role: STUDY_CHAIR
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