Study title: 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
Research question: Does an evidence-based package of cardio-metabolic health services for people living with HIV in Zambia – delivered using a multi-faceted implementation strategy – lead to improved HIV/non-communicable disease (NCD) control and quality of life in an implementable and cost-effective way?
Study design: Type 2 hybrid effectiveness-implementation, stepped wedge cluster randomized trial
Setting/location: Lusaka, Zambia (12 public health facilities)
Study participants: HIV-positive patients over 18 years of age who are enrolled in HIV services.
Contact PI: Wilbroad Mutale, University of Zambia and Centre for Infectious Disease Research in Zambia (CIDRZ)
MPIs: Michael Herce, University of North Carolina (USA) and CIDRZ
Co-Investigators: Samuel Bosomprah, CIDRZ; Felix Masiye, University of Zambia; Michael Vinikoor, CIDRZ; Jessie K. Edwards, University of North Carolina; Maurice Musheke, CIDRZ; Oliver Mweemba, University of Zambia; Mmamulatelo Siame, University of Zambia; Chilambwe Mwila, CIDRZ; Christiana Frimpong, CIDRZ; Perfect Shankalala, University of Zambia; Peter Mbewe, CIDRZ; Chomba Mandyata, University of Zambia; Tulani Matenga, University of Zambia
Collaborating institutions: Zambia Ministry of Health, University of Alabama at Birmingham
The primary objectives of the TASKPEN study are to 1) estimate the effectiveness of an intervention package on dual control of HIV and cardio-metabolic NCDs, as well as measures of cardiovascular risk and quality of life; and 2) to evaluate implementation outcomes of the TASKPEN intervention package in Zambia including cost-effectiveness.
TASKPEN is an adapted version of the WHO PEN Package of Essential Non-Communicable Disease Interventions for Primary Healthcare, an innovative set of cost-effective interventions to control NCDs in primary health care settings. The TASKPEN interventions include: 1) integration of services (meaning patients can access HIV care and NCD care at the same place at the same visit); 2) training non-physician healthcare workers to measure, diagnose, and treat hypertension, diabetes, and dyslipidaemia properly; 3) adapting the electronic medical records used at HIV clinics to include data collection fields and clinical decision support prompts about cardio-metabolic NCDs; 4) strengthen laboratory systems to enable screening and diagnostic testing for NCDs at health facilities; and 5) work with the Zambia Ministry of Health to improve tracking and delivery of NCD medications.
The study team will conduct a series of surveys from participating patients every four months to monitor their HIV and NCD control status and wellbeing. To gain more detailed insights into the long-term effects of the TASKPEN package, a representative sample of people living with HIV who also have one or more cardio-metabolic NCDs will be enrolled into a “nested” cohort and followed longitudinally by the study team until the end of the trial.
To assess implementation outcomes, the TASKPEN study will conduct a mix of implementation questionnaires with patients and providers, including non-physician health workers; in-depth interviews with patients; focus group discussions with health workers participating in the delivery of the TASKPEN intervention; and key informant interviews with others involved with implementation. The primary implementation outcome of interest is reach, and the team is also considering secondary implementation outcomes of adoption and implementation according to the RE-AIM framework.
· Meet Our Team ·
Wilbroad Mutale, MBChB, PhD
University of Zambia, Lusaka, Zambia
Michael Emmanuel Herce
University of North Carolina, Chapel Hill, North Carolina, USA