Clinical trial NCT04088656: Systems Analysis and Improvement Approach for the Hypertension Care Cascade
Official title: Systems Analysis and Improvement Approach to Optimize the Hypertension Diagnosis and Care Cascade for HIV-infected Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Hypertension
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-09-13
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: As undiagnosed and untreated hypertension is one of the largest drivers of cardiovascular disease in sub-Saharan Africa approaches are needed to optimize the hypertension care cascade. The HIV treatment platform in low and middle income countries provides a robust, scalable foundation to address other chronic care priorities, such as hypertension. This proposal will evaluate an evidence-based intervention designed to improve chronic care services (the Systems Analysis and Improvement Approach (SAIA)) for hypertension detection and management in people living with HIV, and will build evidence on how to achieve rapid, sustainable and scalable improvements in services that can dramatically improve population health in resource-limited countries.


Eligibility criteria: Inclusion Criteria:

* (A1) Frontline Health Workers / Health Facility Managers currently working in outpatient, emergency or related (pharmacy, laboratory) services at one of the study clinics in Manica and Sofala provinces, Mozambique; (A2) District Health Supervisors currently employed in a study district in Manica and Sofala provinces, Mozambique regularly engaged in service provision or management of HIV-infected and/or hypertensive populations; and (A3) Clinical Experts currently working in Mozambique in the clinical delivery of HIV and/or hypertension care and treatment or (B1) People Living with HIV \>14 years old (B2) access HIV care and treatment services via outpatient/emergency services in study clinics. \>14 years is being used as the current Ministry of Health forms only use the age bounds of \<15y, \>14y and there is significant concern by the Mozambican Ministry of Health to minimize additional data collection when not absolutely necessary.

Exclusion Criteria:

* (A1) not currently working as a Frontline Health Worker/Health Facility Manager at a participating study facility or (A2) not currently working as a District Health Supervisor in a participating district or (A3) not currently working in Mozambique in the clinical delivery of HIV and/or hypertension care and treatment or (B1) HIV-negative or of unknown status or (B2) \<15 years old or age not recorded, (B3) or pregnant or postpartum.

Primary outcomes:
measure: Controlled Hypertension
timeFrame: Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.
Secondary outcomes:
measure: Blood Pressure Screening
timeFrame: Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.
measure: Hypertension Diagnosis
timeFrame: Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.
measure: Hypertension Treatment Prescription
timeFrame: Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.
measure: Hypertension Medication Pick up
timeFrame: Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.
Other outcomes:
Locations:
city: Catandica
country: Mozambique
facility: Hospital Distrital de Catandica
state: Manica
city: Chimoio
country: Mozambique
facility: Centro de Saude 1 de Maio
state: Manica
city: Chimoio
country: Mozambique
facility: Centro de Saude 7 de Abril
state: Manica
city: Chimoio
country: Mozambique
facility: Centro de Saude Eduardo Mondlane
state: Manica
city: Chimoio
country: Mozambique
facility: Centro de Saude Nhamaonha
state: Manica
city: Sussundenga
country: Mozambique
facility: Centro de Saude de Sussundenga
state: Manica
city: Vanduzi
country: Mozambique
facility: Centro de Saude Vanduzi
state: Manica
city: Beira
country: Mozambique
facility: Centro de Saude de Macurungo
state: Sofala
city: Beira
country: Mozambique
facility: Centro de Saude de Manga Mascarenhas
state: Sofala
city: Beira
country: Mozambique
facility: Centro de Saude de Manga Nhanconjo
state: Sofala
city: Beira
country: Mozambique
facility: Centro de Saude de Ponte Gea
state: Sofala
city: Buzi
country: Mozambique
facility: Hospital Rural de Buzi
state: Sofala
city: Dondo
country: Mozambique
facility: Centro de Saude de Dondo
state: Sofala
city: Dondo
country: Mozambique
facility: Centro de Saude de Mafambisse
state: Sofala
city: Nhamatanda
country: Mozambique
facility: Hospital Rural de Nhamatanda
state: Sofala
city: Manica
country: Mozambique
facility: Hospital Distrital de Manica
Study officials:
affiliation: University of Washington
name: Sarah O Gimbel-Sherr, RN, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gimbel S, Mocumbi AO, Asbjornsdottir K, Coutinho J, Andela L, Cebola B, Craine H, Crocker J, Hicks L, Holte S, Hossieke R, Itai E, Levin C, Manaca N, Murgorgo F, Nhumba M, Pfeiffer J, Ramiro I, Ronen K, Sotoodehnia N, Uetela O, Wagner A, Weiner BJ, Sherr K. Systems analysis and improvement approach to optimize the hypertension diagnosis and care cascade for PLHIV individuals (SAIA-HTN): a hybrid type III cluster randomized trial. Implement Sci. 2020 Mar 6;15(1):15. doi: 10.1186/s13012-020-0973-4.