task-shifted adaptation of the who-pen intervention to address cardio-metabolic complications in people living with hiv in zambia

Conditions: Non Communicable Diseases; HIV

Summary: 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".

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

Eligibility criteria:
objective 1 focus group discussion participants/implementation survey participants: inclusion: * 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 exclusion: * any potential idi, fgd, or kii participant if they are unwilling or unable to provide informed consent. objective 2: cross-sectional assessments: inclusion: * 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: inclusion: * 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 \ 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. exclusion criteria: 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.

Keywords: hiv non communicable diseases who-pen