跳至主要内容
临床试验/NCT05783375
NCT05783375招募中不适用

Accelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 221 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
221
试验地点
1
主要终点
Proportion of persons with RHD reached by the ADUNU program

研究概览

简要总结

The goal of this prospective study is to evaluate the feasibility, sustainability, and public health impact of a district-based program for secondary prevention of Rheumatic Heart Disease (RHD) in Uganda.

详细描述

ADUNU is a non-randomized experiment, testing a strategy for implementing an evidence-based practice, decentralized RHD preventive services.

The objectives of the study are to:

Objective 1: Demonstrate the impact of ADUNU, using the RE-AIM framework to assess program Reach, Effectiveness, Adoption, Implementation and Maintenance.

Objective 2: Estimate the cost-effectiveness and budget impact of ADUNU.

ADUNU is a public health initiative that will be deployed the Uganda ministry of health in partnership with the District Health Offices (DHO) in two districts. The program will be overseen by the Technical and Quality Assurance (TAQA). ADUNU's main components will include a RHD testing program which consists of community and facility based echocardiographic screening of children and young adults and a registry based secondary prophylaxis injections of Benzathine penicillin G (BPG) at local health centers III and IVs in both districts.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • residing in one of two involved districts in Uganda
  • providers at HCIIIs and HCIVs located in one of two involved Ugandan districts

排除标准

  • 未提供

研究组 & 干预措施

ADUNU Participants

Other

Individuals and healthcare providers residing and working in the involved Ugandan Districts.

干预措施: ADUNU program for delivery of RHD care services (Other)

结局指标

主要结局

Proportion of persons with RHD reached by the ADUNU program

时间窗: 5 year endpoint

This objective will involve only secondary analysis of de-identified data collected by districts using routine MOH data collection procedures supplemented by some routine program data during the Ministry's rollout of the ADUNU Programme Package. The number of individuals screened and screening positivity rates will be extracted from screening logs implemented and maintained by DHOs and assessed by modality (school fairs, health days, passive health center screening, and active outreach to family members of RHD diagnosed).

Adoption and implementation of the ADUNU program at the organization level surveys

时间窗: 24 months

Brief surveys will be filled out by providers who are acting as administrators of their health centre and will include questions on a range of logistic (e.g., availability of commodities and stockouts, basic infrastructure reliability) and organizational readiness topics (e.g., staffing levels and turnover, organization of patient scheduling, district support visits)

Adoption and implementation of the ADUNU program at the patient level interview

时间窗: 24 months

We will conduct a limited number of interviews of registry patients in each district stratified by adherence outcomes as well as age group (adult vs children).

Proportion of persons with RHD enrolled in care, retained and adherent to treatment

时间窗: 24 months

Secondary analysis of data from the districts RHD registry will be used to assess the proportion of registrants enrolled, retained and adherent to secondary prophylaxis.

Adoption and implementation of the ADUNU program at the provider level

时间窗: 6 months

Two types of data collection activities from frontline providers will be used to understand individual provider-level adoption and maintenance over time: provider surveys and in-depth interviews of providers. A standardized survey instrument on Adoption and a standardized checklist on implementation fidelity that will be completed by the research staff via direct observation. Research staff will use a standardized checklist that will be developed from the core elements of RHD testing (e.g., ultrasound technique, saving of images) and secondary prevention (e.g., injection technique, adequate post-injection monitoring for anaphylaxis)

Cost-analysis of the ADUNU program

时间窗: 3 year endpoint

To estimate program costs, we will use the standardized data collection instruments. Our instruments will measure fixed and capital costs, as well as variable or recurrent costs. Ingredients-based costing will be used for drugs and consumables, personnel costs, and equipment costs, whereas gross costing will be used for "indirect" costs such as facility rents and utilities and maintenance. Relevant data for ingredients-based costing include study data on participant healthcare utilization and price lists of drugs, consumables, and equipment. DHO budget sheets for health facilities and overall health service utilization will be used for gross costing. Both financial costs and economic costs will be measured. We will also estimate of out-of-pocket costs borne by registrants, which will allow us to estimate costs from the patient/household perspective.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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