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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
1,129
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)
Chawama 1st Level hospital
Lusaka, Zambia
Chilenje 1st level hospital
Lusaka, Zambia
George urban health center
Lusaka, Zambia
Mtendere health center
Lusaka, Zambia
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)
Time frame: Baseline to 6 months
Number of Clinics That Adopted the Intervention (Intervention Adoption)
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.
Time frame: 6 months
Number of Trained Healthcare Providers (Intervention Reach)
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.
Time frame: During 2 weeks prior to initiation of TASKPEN
Changes in HIV Disease Control, as Measured by the Percent of Patient Participants With HIV RNA Suppression (Defined as <1,000 Copies/mL)
Measured by the percent of patient participants with HIV RNA suppression (defined as \<1,000 copies/mL)
Time frame: Baseline to 6 months
Change in Intervention Appropriateness
The "Intervention appropriateness measure (IAM)" among healthcare providers. The minimum score is 1 and maximum is 5. Higher scores indicate greater appropriateness.
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Time frame: Baseline to 6 months
Change in Intervention Acceptability
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.
Time frame: Baseline to 6 months
Change in Intervention Feasibility
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.
Time frame: Baseline to 6 months
Intervention Cost Per Patient
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).
Time frame: 6 months