Effects of a Package of Evidence-based Interventions and Implementation Strategies Based on WHO PEN for People Living With HIV and Cardio-metabolic Conditions in Lusaka, Zambia (TASKPEN UH3)
HIV, Cardio-metabolic Conditions, Non Communicable Diseases
About this trial
This is an interventional other trial for HIV focused on measuring HIV, cardio-metabolic conditions, TASKPEN, Non Communicable Diseases
Eligibility Criteria
Objective 1: Cross-sectional patient surveys (n=5100): all HIV-infected adults aged 18 years and older who seek HIV services at the study sites. Following the baseline survey, investigators will exclude anyone who previously participated in a study survey. Investigators will also exclude people who present for one time services or who plan to transfer their HIV care to another site. Finally, people unwilling or unable to provide written informed consent will be excluded. For the nested cohort, inclusion (n=320) participants will need to have been enrolled in a study survey and have evidence of one or more of the following cardio-metabolic conditions or risk factors at the time of the survey: Any current tobacco use (any tobacco use within 30 days of the survey, whether daily or non-daily use); Hypertension as defined by WHO PEN/ HEARTS (i.e., systolic blood pressure (SBP) =140 mmHg and/or diastolic blood pressure (DBP) =90 mmHg); Diabetes mellitus as defined by WHO PEN/ HEARTS (i.e., random plasma glucose = 11.1 mmol/L, fasting plasma glucose = 7 mmol/L, and/or hemoglobin A1c = 48 mmol/mol or =6.5%; and/or compatible clinical diagnosis); Prediabetes (defined as having impaired fasting glucose of 6.1 to 6.9 mmol/L and/or haemoglobin A1c 42 to 48 mmol/mol or between 6.0-6.4%); and/or Dyslipidaemia (defined as total cholesterol =5.2 mmol/L or low-density lipoprotein =3.4 mmol/L). Investigators will exclude adults who have no documented evidence of HIV infection, or who do not have a cardio-metabolic NCD or risk factor of interest. Investigators will also exclude people who did not participate in a patient survey, plan to transfer their HIV care to another site, or are unwilling/ unable to provide written informed consent. Objective 2 Participant inclusion criteria In-depth interview (IDI) participants must be HIV-positive adults =18 years of age survey and/or cohort participants and had received HIV and/or NCD services at a TASKPEN study site. Focus group discussion (FGD) participants must be: =18 years of age; a non-physician health care worker (NPHW) or community health worker (CHW)/ lay health provider involved with TASKPEN or integrated HIV/NCD service delivery; and generally familiar with HIV and/or NCD service delivery at their facility. Key informant interview (KII) participants must be: =18 years of age; a facility-level ART, DSD, out-patient department (OPD), or relevant clinic leader/ 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. Implementation questionnaire participants must be: HIV-positive adults =18 years of age who had exposure to the TASKPEN intervention at a study site OR =18 years of age, a facility-level healthcare provider or manager at district, provincial, or national level in Zambia, and familiar with the TASKPEN intervention. Costing study participants must be: HIV-positive adults =18 years of age who had received HIV and/or NCD services at a TASKPEN study site OR =18 years of age and a facility-level healthcare provider or manager at facility, district, provincial, or national level in Zambia, and generally familiar with HIV and/or NCD-related issues. Participant exclusion criteria Investigators will exclude adult IDI participants who have no evidence of having received HIV and/or NCD services at the sites during the study period, adult implementation questionnaire participants who were not exposed/ familiar with the TASKPEN intervention, as well as - people unwilling or unable to provide written informed consent. Investigators will exclude any potential IDI, FGD, or KII study participant if they are unwilling or unable to provide written informed consent.
Sites / Locations
- Bauleni Health CenterRecruiting
- Chawama 1st Level HospitalRecruiting
- Chelstone Urban Health CenterRecruiting
- Chipata 1st Level HospitalRecruiting
- Kabwata Urban Health CenterRecruiting
- Kalingalinga Urban Health CenterRecruiting
- Kamwala Urban Health CenterRecruiting
- Kanyama 1st Level HospitalRecruiting
- Makeni Urban Health CenterRecruiting
- Mtendere Health CenterRecruiting
- Ng'ombe Urban Health CenterRecruiting
- Railway Urban Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
TASKPEN
Standard of Care
The TASKPEN intervention is a package of five evidence-based intervention (EBI) components that enhances WHO's Package of Essential Noncommunicable Disease Intervention for Primary Care (WHO-PEN) and includes a multi-faceted implementation strategy centred on service integration within routine HIV care settings. The EBI components and multi-faceted strategy have been adapted to the Zambian setting during recently completed formative work."
Screening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services. When these services are available, they tend to be siloed and offered only for hypertension in general outpatient medical settings that provide urgent care-like services. Healthcare workers do not have protocolized algorithms for NCD management in HIV service delivery settings. NCD equipment is often unavailable in ART and differentiated service delivery (DSD) clinics; most health facilities do not offer haemoglobin A1c or lipid panel testing; and fragmented NCD supply chain management systems mean that essential medications for the management of hypertension, diabetes, and dyslipidemia are often unavailable