Expanding Health Systems Research to Optimize Hypertension Care Cascade in HIV-Infected Individuals in Mozambique

NCT05002322 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-02-27

No results posted yet for this study

Summary

Undiagnosed and untreated hypertension is a main driver of cardiovascular disease, affecting disproportionately low and middle-income countries, where guidelines to screen and manage hypertension are poorly used. More than 13% of Mozambique adults are infected with HIV, and over 900,000 are on anti-retroviral therapy. HIV clinics are the only services within primary care providing continued care, and can be used to standardize and scale the hypertension care cascade. Hypertension affects 40% of Mozambican adults, and thus HIV and HTN often coexist in the same person.

The investigators propose to use low-cost tools that improve service performance, promote routine hypertension diagnosis and management, and ameliorate flow through the hypertension cascade, thus improving patients outcomes. Building on a current project some districts of two provinces of central Mozambique, the investigators will establish scientific evidence on the effectiveness of a tool that uses cycles of evaluation and improvement of health system, to address the hypertension care cascade in HIV-infected people. The investigators will strengthen the framework currently in use (based on nurses) setting a novel modality delivered by district health supervisors, and will expand the geographic study area by adding 6 districts of one additional province in southern Mozambique (Maputo Province), to create a foundation for national scale-up.

The Project planning phase (two years) will develop a multi-sectoral partnership of key stakeholders, establish national technical working groups with the participation of the provinces, and identify key facilitators and barriers that could affect uptake of the results, integration of high blood pressure and HIV services, scale-up to the entire country, and sustainability of the tested framework. Additionally, the investigators will i) conduct a six-months pilot study to assess feasibility and acceptability of the district supervisor-led intervention in one primary care facility; and, ii) redesign tools and standard operating procedures, as necessary. During the implementation phase (last three years) the investigators will deploy the district-based dissemination and implementation randomized trial in 18 health facilities - using an intervention that involves assessment, effectiveness evaluation, promotion of local uptake, implementation and maintenance - and determine the costs of the hypertension care cascade optimization, by estimating the total incremental costs.

Conditions

Interventions

OTHER

Systems Analysis and Improvement Approach

Intensive phase: district MOH supervisors receive a one-week training on SAIA-HTN. The nine-month intervention wave will be mentored by INS study personnel who will accompany and support district MOH supervisors as they implement at the facility level. Over the first week of each iterative cycle, facility teams populate and interpret the HCAT, develop process maps, define one to two micro-interventions and indicators to monitor these modifications. Facility teams receive two mentorship visits by district supervisors and study personnel for the first month, followed by monthly visits throughout intensive implementation. Sustainment phase (depending on implementation wave allocation): district supervisors will independently lead implementation, with financial support for travel to clinics and to hold meetings, but without intensive support from study personnel.

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER
  • Instituto Nacional de Saúde, Mozambique

    collaborator OTHER_GOV
  • Mozambique Institute for Health Education and Research

    collaborator UNKNOWN
  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Eduardo Mondlane University

    lead OTHER

Principal Investigators

  • Ana OH Mocumbi, MD PhD · Eduardo Mondlane University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-14
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Mozambique

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05002322 on ClinicalTrials.gov