Table 1 HLB-SIMPLe Alliance Countries, Research Projects, and Trial Registrations

NCT05414526

Botswana –

Integrating Hypertension and Cardiovascular Disease Care into Existing HIV Service Package in Botswana (InterCARE)

The InterCARE package includes: a tailored inter-professional training curriculum on management of Cardiovascular Disease (CVD) risk and HIV; adaptation of the existing electronic health records; and adoption of a treatment partner support system.

Cluster randomized trial in 14 clinics. 7 clinics will receive the InterCARE package while the remaining 7 clinics will receive the local standard of care

Primary: RE-AIM assessment of InterCARE package (reach, effectiveness, adoption, implementation fidelity and maintenance).

Secondary: Implementation feasibility, acceptability, CVD risk factor % change.

NCT05002322

Mozambique –

Scaling Out and Scaling Up the Systems Analysis and Improvement Approach to Optimize the Hypertension Diagnosis and Care Cascade for HIV-infected Individuals (SCALE-SAIA HTN)

The SAIA-HTN implementation strategy uses an iterative, five-step process applied at the facility level to give clinic staff and managers a systems view of cascade performance, identify priority areas for improvement, discern modifiable solutions, and test workflow modifications.

Stepped wedge design with random assignment of two districts to each of the three nine-month intervention waves, to reach 6 districts in Maputo Province, Mozambique

Effectiveness outcomes:

Individual clinical (controlled HTN and viral load suppression)

Service-level (HTN screening, diagnosis, treatment and medication adherence).

Other outcomes: RE-AIM assessment of SAIA-HTN strategy (reach, adoption, implementation, maintenance), and cost-effectiveness

NCT05031819

Nigeria –

Managing Hypertension Among People Living with HIV: an Integrated Model (MAP-IT)

A nurse-led task-strengthening program, which includes CVD risk assessment; medication initiation and titration; lifestyle counseling and patient referral to physician care for complex cases of HTN in PLHIV.

A stepped wedge cluster randomized control trial across 30 primary healthcare centers

Primary: Adoption of task-strengthening program.

Secondary: Blood pressure control, rate of adoption and implementation fidelity

NCT05846503

South Africa –

Integrating HIV and Heart Health in South Africa (iHEART-SA)

iHEART-SA intervention comprises: Information management systems;

task shifting; audit and feedback;

healthcare worker education and training; patient education and support

Type 2 hybrid cluster randomized stepped wedge effectiveness-implementation across 9 primary healthcare centers

Primary: Difference in mean systolic BP between intervention and control groups.

Secondary: Implementation fidelity, adoption, maintenance, satisfaction, cost-effectiveness of iHEART-SA intervention.

NCT05609513

Uganda –

Strengthening the Blood Pressure Care and Treatment Cascade for Ugandans Living with HIV – Implementation Strategies to Save Lives (PULESA)

HTN-BASIC package: provision of diagnostic equipment and evidence-based antihypertensive drugs

HTN-PLUS package: hypertension training; differentiated service delivery; remote patient monitoring; Performance Improvement Program, in addition to HTN-BASIC package

Stepped Wedge Cluster Randomized Control Trial. 16 clinics will be randomized to receive the HTN-BASIC package only or the enhanced HTN-PLUS intervention.

Primary: Blood Pressure (BP) control (% with BP < 140/90)

Secondary: Scalability, sustainability, cost-effectiveness of PULESA packages

NCT05005130; NCT05950919

Zambia –

Task-shifted Adaptation of the WHO-PEN Intervention to Address Cardio-metabolic Complications in People Living with HIV in Zambia (TASKPEN)

The TASKPEN package includes; adapted WHO-PEN protocols, algorithm, & training materials; access to cardio-metabolic condition screening & laboratory monitoring; Noncommunicable disease (NCD)-focused electronic medical record module;

Integrated NCD/HIV care (“one stop shop” for services); strengthened NCD medication supply chain, including multi-month dispensing.

Type II Hybrid Effectiveness-implementation Stepped Wedge Trial across 12 sites

Primary: Proportion of participants with both HIV viral suppression and control of hypertension, diabetes and tobacco use.

Secondary: Implementation fidelity, adoption, reach, cost-effectiveness, acceptability of TASKPEN package.