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

NCT05002322 | Completed DMC

• 2 other identifiers: SCALESAIA20204UH3HL156390-03
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 6

Brief 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

Hypertension

Keywords

Systems analysis and improvement approach (SAIA),; Hypertension; CFIR; ORIC; Process mapping; Cascade analysis; Continuous quality improvement; Implementation science; Systems engineering; HIV

Outcome Measures

Primary Outcomes (1)

• Controlled hypertension

  The proportion of PLHIV with controlled hypertension a minimum of 75 days after starting treatment, among those who were diagnosed with hypertension, prescribed hypertension treatment, and who picked up their medications

  Per Phase: up 2 months for Baseline Phase, up to 9 months for Intensive Implementation Phase, up to 18 months for Wave 1 or up to 9 months for Wave 2 Sustainment Phase.

Secondary Outcomes (5)

• Blood pressure screening

  Per Phase: up 2 months for Baseline Phase, up to 9 months for Intensive Implementation Phase, up to 18 months for Wave 1 or up to 9 months for Wave 2 Sustainment Phase

• Hypertension diagnosis

  Per Phase: up 2 months for Baseline Phase, up to 9 months for Intensive Implementation Phase, up to 18 months for Wave 1 or up to 9 months for Wave 2 Sustainment Phase

• New hypertension diagnosis

  Per Phase: up 2 months for Baseline Phase, up to 9 months for Intensive Implementation Phase, up to 18 months for Wave 1 or up to 9 months for Wave 2 Sustainment Phase

• Hypertension treatment prescription

  Per Phase: up 2 months for Baseline Phase, up to 9 months for Intensive Implementation Phase, up to 18 months for Wave 1 or up to 9 months for Wave 2 Sustainment Phase

• Hypertension medication pick-up

  Per Phase: up 2 months for Baseline Phase, up to 9 months for Intensive Implementation Phase, up to 18 months for Wave 1 or up to 9 months for Wave 2 Sustainment Phase

Study Arms (2)

intervention health facilities

EXPERIMENTAL

Health facilities implement the optimization of the cascade under research team support and continuous supervision.

Other: Systems Analysis and Improvement Approach

Control

NO INTERVENTION

Health facilities prior to intensive phase receive standard supervision without research team support

Interventions

Systems Analysis and Improvement Approach OTHER

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.

intervention health facilities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care facility with ongoing cohort of ART patients (minimum 800 patients)

You may not qualify if:

• Health facility unaccessible during part of the year

Sponsors & Collaborators

• Mozambique Institute for Health Education and Research: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Instituto Nacional de Saúde, Mozambique: collaborator
• Eduardo Mondlane University: lead
• University of Washington: collaborator

Study Sites (6)

Centro de Saude da Ponta do Ouro

Bela Vista, Maputo Province, Mozambique

Location

Centro de Saude de Matutuine

Bela Vista, Maputo Province, Mozambique

Location

Centro de Saude de Salamanga

Bela Vista, Maputo Province, Mozambique

Location

Centro de Saúde de Magude

Magude, Maputo Province, Mozambique

Location

Centro de Saúde de Motaze

Magude, Maputo Province, Mozambique

Location

Centro de Saúde de Chichuco

Magude, Mozambique

Location

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MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ana OH Mocumbi, MD PhD

  Eduardo Mondlane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: phased-in (stepped wedge) design with random assignment of two districts to each of the three nine-month intervention waves, to reach six districts in Maputo Province by the end of the trial

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: August 12, 2021
• Study Start: February 14, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

MO (6)