Integrating Hypertension and Cardiovascular Diseases Care Into Existing HIV Services Package in Botswana (InterCARE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,655
- 试验地点
- 4
- 主要终点
- Implementation
研究概览
简要总结
The InterCARE research project proposes to leverage a successful national ART program to develop an effective package to improve the uptake of established effective hypertension and CVD risk factors management interventions among PLWHIV in Botswana and other low- and middle-income countries.
Being the first project of its kind in Botswana, if successful, the InterCARE package could be readily rolled out to health facilities nationwide to diagnose, treat, track, and support the estimated 25-30% Batswana with hypertension.
详细描述
The InterCARE research project is in 2 phases:
- Phase 1 is a pilot study to refine the 3 interventions mentioned above. This formative phase will take place between September 2021 and November 2022. Clinics staff will receive training on the management of CVD (and hypertension in particular) in-person or online. Attendees feedback will be sought to improve the curriculum prior to being rolled-out in the next phase of this research project.
In parallel, the InterCARE Study Team will work with the 2 clinics Information Technology teams to adapt the existing electronic health records with CVD-specific flags, medication lists and laboratory panels.
Finally, up to 288 participants (PLWHIV) and their treatment partners will be enrolled from those 2 clinics patients lists to pilot the overall InterCARE package.
The results and experiences from the pilot stage will be assessed and collated to make improvements to each of the 3 intervention in the package. This final set of improved interventions will be the basis of the second phase of the InterCARE research project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for participants:
- •Adults aged 20-75 years old
- •Documented HIV-infection on ART
- •Confirmed diagnosis of hypertension or elevated blood pressure >140/90mmHg versus >130/80mmHg if they have underlying Diabetes Mellitus or Chronic Kidney Disease
- •Receiving regular care at the selected clinics
排除标准
- •● Positive for HIV-related dementia
- •Inclusion criteria for participants' treatment partners:
- •Adults aged 18 years of age or older
- •Selected to be a treatment partner by participant.
研究组 & 干预措施
InterCARE package
The type 2 hybrid effectiveness-implementation study will be cluster randomized trial with 1:1 paired randomization (Intervention arm vs Control arm )Using the coin flip randomization method, one clinic will be randomized to the intervention condition, and one to the control condition.
干预措施: InterCARE package (Other)
结局指标
主要结局
Implementation
时间窗: Every 6 months for 2 years
Proportion of clinic encounters in electronic health records where anti-hypertensive medications are prescribed if indicated, as attained from electronic health records
Effectiveness
时间窗: Every 6 months for 2 years
Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication with controlled blood pressure
次要结局
- Fidelity(Every 6 months for 2 years)
- Maintenance(At the end of the trial (24 months))
- Effectiveness(Every 6 months for 2 years)
- Acceptability(At the end of the trial)
- Reach(Every 6 months for 2 years)
- Adoption(Every 6 months for 2 years)
研究者
Mosepele Mosepele
Associate Professor
University of Botswana