Leveraging the HIV Platform for Hypertension Control in Uganda
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,600
- 试验地点
- 1
- 主要终点
- Proportion of HIV/HTN patients with HIV/HTN Dual Control: (who are both "HTN controlled" and have undetectable HIV viral load (at 12 months and 24 months).
研究概览
简要总结
The INTEGRATED HIV/HTN is a hybrid type-1 effectiveness/implementation cluster randomised trial evaluating the introduction of a multi-component integrated HIV/HTN care model intervention, randomised to 13 districts in the intervention arm compared to 13 districts in the control. Selected health facilities within the 13 intervention districts will receive the intervention while those in the 13 control districts will continue implementing the standard of care as per the Ministry of Health (MoH) guidelines. All the participating facilities will receive blood pressure (BP) machines, and Non- communicable diseases (NCDs) registers as a standard of care.
详细描述
The investigators propose to evaluate a multi-component integrated HIV/HTN care intervention through a cluster randomised controlled trial. A cluster has been defined at the level of the district which is the randomisation unit. A total of 26 districts will be randomised. Selected health facilities within the 13 intervention districts will receive the multi-component intervention of combined HIV and (hypertension) HTN care which includes; 1) Training and capacity building on the INTEGRATED HIV/HTN model and NCD care; 2) the Integrated HIV/HTN care delivery model by promoting HTN screening and care in HIV clinics; 3) Health management information system (HMIS) enhancements through mentorship and coaching on the use of NCD registers and NCD patient cards and HTN data capture in the EMR system; and 4) Short messaging system (SMS) and/or WhatsApp for data coordination and communication among providers, DHOs and the study team (who acts as mentors). The 13 control districts will continue implementing the current standard of care as per MoH guidelines.
The investigators will test the hypothesis that a multi-component intervention of combined HIV and HTN care, based on the PRECEDE framework, to continuously identify barriers and facilitators leads to better health outcomes including dual control of HIV/HTN among adults in HIV care in the intervention compared to control facilities.
Specific Objectives are as follows;
- To determine the effectiveness of an integrated HIV/HTN care model on HTN and dual HIV/HTN control among adult patients in HIV clinics.
- To assess the barriers and facilitators of the integrated HIV/HTN care model for HIV patients at different levels.
- To determine the cost, cost-effectiveness and incremental gain costs of the integrated HIV/Hypertension care model approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 years and above with HIV for one category
- •Adults 18 years and above with HIV and hypertension for the second category
- •Willing to consent
排除标准
- •Patients who are very sick
- •Patients not willing to continue seeking care from the study health facility
结局指标
主要结局
Proportion of HIV/HTN patients with HIV/HTN Dual Control: (who are both "HTN controlled" and have undetectable HIV viral load (at 12 months and 24 months).
时间窗: 24 months
Proportion of HIV/HTN patients with HIV/HTN Dual Control: (who are both "HTN controlled" and have undetectable HIV viral load (at 12 months and 24 months).
Proportion of HIV patients screened for Hypertension(HTN) at Month 24
时间窗: Month 24
Proportion of HIV patients Screened for HTN at 24 months months of follow up
Proportion of HTN patients diagnosed and started on treatment
时间窗: Month 24
Proportion of HTN patients diagnosed and started on treatment
Proportion of HIV/HTN patients with HTN Control (systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg) at 12 months and 24 months.
时间窗: 24 months
Proportion of HIV infected patients with with documented history of elevated blood pressure or prior HTN diagnosis on medication who are controlled (systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg) at 12 months and 24 months.
次要结局
- Lowered blood pressure(24 months)
- Routine Hypertension care(12 and 24 months)
- Adherence to national guidelines(24 months)
- Cost effectiveness of the integrated HIV/HTN care model(24 months)
- Adoption of the integrated model(12 and 24 months)
- Knowledge of HTN management and HTN complications among health workers(12 and 24 months)
- Patient satisfaction(12 and 24 months)
- Adoption of HMIS tools(24 months)
- Service readiness for delivering hypertension care(24 months)