Implementation and Evaluation of a Community-Based Model for Delivery of Antiretroviral Therapy in Cambodia: A Quasi-Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,049
- 试验地点
- 9
- 主要终点
- Percent of people living with HIV who remained in HIV care and treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 15 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Unstable people living with HIV as defined above
- •Mobile populations
研究组 & 干预措施
ART multi-month dispensing (MMD)
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.
干预措施: ART multi-month dispensing (MMD) (Other)
Community-based ART delivery (CAD)
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.
干预措施: Community-based ART delivery (CAD) (Other)
结局指标
主要结局
Percent of people living with HIV who remained in HIV care and treatment
时间窗: 24 months after the intervention started
At least 90% of participants in the intervention will be retained in care and treatment 12 months after the treatment started
Percent of people living with HIV with viral suppression
时间窗: 24 months after the intervention started
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
Percent of people living with HIV with good adherence to ART
时间窗: 24 months after the intervention started
At least 90% of the participants in the intervention will report good adherence to ART at the endline.
Percent of healthcare providers at ART clinics who reported reduced workload
时间窗: 24 months after the intervention started
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.
次要结局
- 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 social support health(24 months after the intervention started)
- Percent of people living with HIV who reported improved mental health(24 months after the intervention started)
- Cost-effectiveness of community-based ART delivery (CAD) model intervention(24 months after the intervention started)
研究者
Siyan Yi
Assistant Professor
National University of Singapore
