Task-shifted Adaptation of the WHO-PEN Intervention to Address Cardio-metabolic Complications in People Living With HIV in Zambia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05005130

Acronym

TASKPEN

Enrollment

1129

Registered

2021-08-13

Start date

2021-09-20

Completion date

2022-12-23

Last updated

2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Non Communicable Diseases

Keywords

HIV, Non Communicable Diseases, WHO-PEN

Brief 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.

Detailed description

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

Interventions

OTHERTASKPEN

TASKPEN is the name of the package of implementation strategies proposed by the investigators that are intended to deliver the WHO PEN intervention in routine HIV clinical practice settings in Zambia. TASKPEN has five components which will be the subject of stakeholder consultation and adaptation in this formative research protocol. The package of integrated HIV/NCD services includes: 1. WHO PEN protocols, algorithm, & training materials adapted for Zambia 2. Access to cardio-metabolic condition screening & laboratory monitoring 3. Non communicable disease-focused electronic medical record module 4. Integrated non-communicable/HIV care (one stop shop for services) 5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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 \<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.

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Percent of Participants With Dual HIV and Blood Pressure Control	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)

Secondary

Measure	Time frame	Description
Number of Trained Healthcare Providers (Intervention Reach)	During 2 weeks prior to initiation of TASKPEN	Number of healthcare providers working at the pilot clinic antiretroviral therapy (ART), differentiated service delivery (DSD), and outpatient departments who were trained in the implementation of the TASKPEN intervention package.
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	Measured by the percent of patient participants with HIV RNA suppression (defined as \<1,000 copies/mL)
Change in Intervention Appropriateness	Baseline to 6 months	The Intervention appropriateness measure (IAM) among healthcare providers. The minimum score is 1 and maximum is 5. Higher scores indicate greater appropriateness.
Number of Clinics That Adopted the Intervention (Intervention Adoption)	6 months	Adoption measured based on Reach Evaluation Adoption Implementation and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR) which are implementation-oriented and empirically supported frameworks for adapting, introducing, and evaluating evidence-based interventions in routine practice settings. The number of facilities initiating TASKPEN intervention integrated care at approximately 6 months after TASKPEN introduction.
Change in Intervention Feasibility	Baseline to 6 months	Measured by the Feasibility of Intervention Measure (FIM) among Healthcare providers. The minimum score is 1 and maximum is 5. Higher scores indicate greater feasibility.
Intervention Cost Per Patient	6 months	Measured by cost per patient and reported in Zambian Kwacha. The analysis focused on the expenditures paid out of pocket for HIV and hypertension care. These data were collected from one site only (Chilenje).
Change in Intervention Acceptability	Baseline to 6 months	Measured by the Acceptability of Intervention measure (AIM) among health care providers. The minimum score is 1 and maximum is 5. Higher scores indicate greater acceptability.

Countries

Zambia

Participant flow

Pre-assignment details

28 Healthcare Providers and 1101 patient participants were enrolled and 11 were excluded from the analysis. This 'mini' stepped wedge pilot had 2 clinic clusters to establish approach feasibility. In a stepped wedge fashion, participants at both clinics were surveyed at baseline and then one site was randomly selected to receive the intervention for 3 months. A midline survey was then conducted and the second site was switched to the intervention before an endline survey 3 months later.

Participants by arm

Arm	Count
Standard of Care Patients During the control period, participants receive the current standard of care (SOC) in Zambia. Under the SOC in Zambian health facilities, the screening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services (i.e., ART and DSD clinics), and typically are only offered for hypertension in the general outpatient medical settings that provide urgent care-like services. Under the SOC, health worker capacity to diagnose and manage cardio-metabolic NCDs, including among non-physicians and community health workers, is severely limited and not protocolized like HIV services.	634
TASKPEN Patients During the intervention period, participants receive TASKPEN intervention services. TASKPEN: The package of integrated HIV/NCD services: 1. WHO PEN protocols, algorithm, & training materials adapted for Zambia 2. Access to cardio-metabolic condition screening & laboratory monitoring 3. Non communicable disease-focused electronic medical record module 4. Integrated non-communicable/HIV care (one stop shop for services) 5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD)	456
Standard of Care Healthcare Providers Healthcare Providers employed at either of the clinics who participated in study surverys.	20
TASKPEN Healthcare Providers Healthcare Providers employed at either of the clinics who participated in study surverys.	8
Total	1,118

Baseline characteristics

Characteristic	TASKPEN Patients	Standard of Care Patients	Total	Standard of Care Healthcare Providers	TASKPEN Healthcare Providers
Age, Continuous Participants	45 years	46 years	45 years	—	—
Age, Customized Participant age between 18-29	32 Participants	41 Participants	73 Participants	—	—
Age, Customized Participant age between 30-44	185 Participants	246 Participants	431 Participants	—	—
Age, Customized Participant age between 45-59	187 Participants	284 Participants	471 Participants	—	—
Age, Customized Participant age between 60 and older	52 Participants	63 Participants	115 Participants	—	—
Alcohol Consumption No	270 Participants	346 Participants	616 Participants	—	—
Alcohol Consumption Yes	186 Participants	288 Participants	474 Participants	—	—
Body Mass Index (BMI) Healthy weight	246 Participants	257 Participants	503 Participants	—	—
Body Mass Index (BMI) Missing data	6 Participants	0 Participants	6 Participants	—	—
Body Mass Index (BMI) Obese	56 Participants	146 Participants	202 Participants	—	—
Body Mass Index (BMI) Overweight	107 Participants	178 Participants	285 Participants	—	—
Body Mass Index (BMI) Underweight	41 Participants	53 Participants	94 Participants	—	—
Education None	55 Participants	45 Participants	100 Participants	—	—
Education Primary	238 Participants	276 Participants	514 Participants	—	—
Education Secondary plus	163 Participants	313 Participants	476 Participants	—	—
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	456 Participants	634 Participants	1118 Participants	20 Participants	8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
History of Dyslipidemia Don't know	0 Participants	2 Participants	2 Participants	—	—
History of Dyslipidemia No	454 Participants	631 Participants	1085 Participants	—	—
History of Dyslipidemia Yes	2 Participants	1 Participants	3 Participants	—	—
History of Hypertension No	327 Participants	483 Participants	810 Participants	—	—
History of Hypertension Yes	129 Participants	151 Participants	280 Participants	—	—
History of Type II Diabetes Don't know	1 Participants	8 Participants	9 Participants	—	—
History of Type II Diabetes No	445 Participants	603 Participants	1048 Participants	—	—
History of Type II Diabetes Yes	10 Participants	23 Participants	33 Participants	—	—
Marital Status Married or cohabitating	234 Participants	281 Participants	515 Participants	—	—
Marital Status Never married	25 Participants	63 Participants	88 Participants	—	—
Marital Status Separated or Divorced or Widowed	197 Participants	290 Participants	487 Participants	—	—
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	456 Participants	634 Participants	1118 Participants	20 Participants	8 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Region of Enrollment Zambia	456 Participants	634 Participants	1118 Participants	20 Participants	8 Participants
Sex: Female, Male Participants Female	320 Participants	468 Participants	788 Participants	—	—
Sex: Female, Male Participants Male	136 Participants	166 Participants	302 Participants	—	—
Time on ART 10 Years or more	258 Participants	354 Participants	612 Participants	—	—
Time on ART 5-9 Years	111 Participants	141 Participants	252 Participants	—	—
Time on ART Less Than 5 Years	87 Participants	139 Participants	226 Participants	—	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	4 / 636	1 / 465
other Total, other adverse events	158 / 636	222 / 465
serious Total, serious adverse events	0 / 636	0 / 465

Outcome results

Primary

Change in Percent of Participants With Dual HIV and Blood Pressure Control

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)