Mixed Methods Formative Research and Pilot Testing of a Task-shifted Adaptation of the WHO-PEN Intervention to Address Cardio-metabolic Complications in People Living With HIV in Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,129
- 试验地点
- 4
- 主要终点
- Change in Percent of Participants With Dual HIV and Blood Pressure Control
研究概览
简要总结
This mixed-methods formative research study aims to adapt the WHO Package of Essential Noncommunicable Disease Interventions (WHO-PEN) approach for the Zambian public health system, and pilot test an adapted, streamlined, and task-shifted package of integrated HIV Noncommunicable Disease (NCD) services, collectively called "TASKPEN".
详细描述
Using local data and implementation science theories WHO-PEN will be adapted for Zambia, and TASKPEN developed to focus on addressing challenges faced by persons living with HIV (PLHIV) who have cardio-metabolic complications related to HIV or its treatment (e.g. hypertension, diabetes, dyslipidaemia). TASKPEN aims to improve detection and management of these complications.
Formative research activities for objective 1 include focus group discussions (FGDs), surveys and interviews with key stakeholders, which will include in-depth interviews (IDIs) with patients.
Objective 2 launches the TASKPEN pilot and fully task-shifts the TASKPEN package to non-physician healthcare workers (NPHWs) and integrates it within the President's Emergency Plan for AIDS Relief (PEPFAR) -supported HIV service delivery platform. A mix of IDIs, FGDs, key informant interviews, and patient and implementation surveys with implementation actors to evaluate feasibility, acceptability, and other implementation outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- 否
入选标准
- •Objective 1
- •Focus group discussion participants/implementation survey participants:
- •18 years of age or older
- •non-physician professional or lay/peer health care worker (HCW) involved with HIV and/or NCD service delivery.
- •Key Informant Interview (KII) participants:
- •18 years of age or older
- •a senior Ministry of Health (MOH) policy maker or health official working at national level in Zambia involved in managing, coordinating, and/or overseeing health services for non-communicable diseases in Zambia.
- •In-depth interview participants:
- •emancipated HIV-infected adults 18 years of age or older have a documented cardio-metabolic condition
- •any potential IDI, FGD, or KII participant if they are unwilling or unable to provide informed consent.
- •Objective 2:
- •Cross-sectional assessments:
- •HIV-infected
- •aged 18 years and older
- •seeking care at either of the two ACHIEVE-supported pilot sites who are screened for and/or found to have evidence of one or more of the cardio-metabolic conditions or risk factors.
- •Nested cohort participants:
- •documented HIV infection
- •aged 18 years or older
- •have one or more cardio-metabolic conditions or risk factors:
- •obesity (defined as BMI > 30 kg/m^2);
- •any current tobacco smoking;
- •hypertension as defined by WHO PEN (i.e., systolic blood pressure (SBP) = 140 mmHg and/or diastolic blood pressure (DBP) = 90 mmHg);
- •diabetes mellitus as defined by WHO PEN (i.e. random plasma glucose = 11.1 mmol/L, fasting plasma glucose = 7 mmol/L, and/or haemoglobin A1c = 48 mmol/mol);
- •prediabetes (defined as having impaired fasting glucose of 6.1 to 6.9 mmol/L, impaired glucose tolerance with a two-hour, post-oral glucose tolerance test glucose =7.8 mmol/L but <11.1 mmol/L and a fasting plasma glucose <7.0 mmol/L, and/or haemoglobin A1c 42 to 48 mmol/mol); 6) dyslipidaemia (defined as total cholesterol >4 mmol/L or low density lipoprotein =6 mmol/L); and/or 7) personal history or medication use for heart disease, heart failure, stroke, or other cardio-metabolic complication (including but not limited to coronary artery disease, cerebrovascular disease, myocardial infarction, stroke, or peripheral vascular disease).
- •IDI participants:
- •HIV-infected
- •18 years of age who were enrolled in the nested cohort and had documented exposure to the TASKPEN intervention at a pilot site.
- •FGD participants:
- •18 years of age or older
- •a non physician health care worker (NPHW) or community health worker (CHW)/ lay health provider involved with TASKPEN or integrated HIV/NCD service delivery generally familiar with HIV and/or NCD service delivery at their facility.
- •KII participants:
- •18 years of age or older
- •a facility-level antiretroviral therapy (ART) or out-patient department (OPD) clinic manager/ in-charge or policy maker at district, provincial, or national level in Zambia; and generally familiar with HIV and/or NCD-related issues in their community.
排除标准
- •For the nested cohort component, investigators will exclude:
- •adults who have no documented evidence of having established HIV care at the sites.
- •people unlikely to remain at the site to the completion of the study follow-up.
- •any potential IDI, FGD, or KII participant if they are unwilling or unable to provide written informed consent.
研究组 & 干预措施
Cluster 1 (George)
3 months without TASKPEN (Standard of Care) and 6 months with TASKPEN.
干预措施: TASKPEN (Other)
Cluster 2 (Chilengi)
6 months without TASKPEN (Standard of Care) and 3 months with TASKPEN
干预措施: TASKPEN (Other)
结局指标
主要结局
Change in Percent of Participants With Dual HIV and Blood Pressure Control
时间窗: Baseline to 6 months
Measured by an HIV RNA level of \<1000 copies per mL on the most recent measure and systolic blood pressure \<140 mmHg and/or diasystolic blood pressure \<90 mmHg. Dual control defined as HIV control (i.e., viral load \<1,000 c/mL for those with a documented viral load + evidence of 6MMD for those with missing viral load) + Hypertension control (SBP\<140 mmHg AND DBP\<90 mmHg)
次要结局
- Number of Clinics That Adopted the Intervention (Intervention Adoption)(6 months)
- Changes in HIV Disease Control, as Measured by the Percent of Patient Participants With HIV RNA Suppression (Defined as <1,000 Copies/mL)(Baseline to 6 months)
- Number of Trained Healthcare Providers (Intervention Reach)(During 2 weeks prior to initiation of TASKPEN)
- Change in Intervention Appropriateness(Baseline to 6 months)
- Change in Intervention Acceptability(Baseline to 6 months)
- Change in Intervention Feasibility(Baseline to 6 months)
- Intervention Cost Per Patient(6 months)