Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80000 participants
INTERVENTIONAL
2023-03-28
2026-03-31
Brief Summary
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Detailed Description
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The Phase B precision community health intervention will consist of a three part intervention: 1) Community-enhanced reach activities 2) Person-centered care delivery; and, 3) Data-enhancement to improve precision of interventions.
The study hypothesis for the Phase B population level study is: A Precision Community Health Model leveraging existing facility-based outreach and community health workers, enabled by dynamic choice prevention/treatment multi-disease approaches and interactive data systems -will reduce HIV infections, deaths and improve health.
Structured stakeholder consultations are formally incorporated in the study design and leverage regular and ongoing collaborations the study team has with the HIV, non-communicable disease and general health leads in Kenya and Uganda Ministries of Health and PEPFAR implementing partners at the national and the regional level.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Precision Community Health
The Phase B precision community health intervention will consist of a three part intervention: 1) Community-enhanced reach activities 2) Person-centered care delivery; and, 3) Data system enhancement to improve reach and person-centered delivery
Community-enhanced reach activities
We will conduct a series of community engagement activities designed to reach persons at risk for HIV, undiagnosed with HIV or diagnosed, or hypertension, and fallen out of care, working closely with community health workers, integrated in the community health system.
Person-centered care delivery
Structured approach to provide patient-centered biomedical options for HIV prevention (dynamic choice prevention). Tailored services for HIV treatment support using structured life stage evaluation and assessment plan (LEAP) for youth, pregnant women, and persons with or at risk of HIV viral non-suppression, that includes counselling for heavy alcohol users. Structured approach to offer telehealth for severe hypertension follow up.
Data system enhancement to improve reach and person-centered delivery
Both community-enhanced reach and person-centered delivery will be strengthened through a customized in-country Ministry of Health-compatible community health worker smartphone app and two-way data system linking community health workers and clinical records.
Control
Standard of Care
Standard of Care
Standard of Care in Uganda and Kenya
Interventions
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Community-enhanced reach activities
We will conduct a series of community engagement activities designed to reach persons at risk for HIV, undiagnosed with HIV or diagnosed, or hypertension, and fallen out of care, working closely with community health workers, integrated in the community health system.
Person-centered care delivery
Structured approach to provide patient-centered biomedical options for HIV prevention (dynamic choice prevention). Tailored services for HIV treatment support using structured life stage evaluation and assessment plan (LEAP) for youth, pregnant women, and persons with or at risk of HIV viral non-suppression, that includes counselling for heavy alcohol users. Structured approach to offer telehealth for severe hypertension follow up.
Data system enhancement to improve reach and person-centered delivery
Both community-enhanced reach and person-centered delivery will be strengthened through a customized in-country Ministry of Health-compatible community health worker smartphone app and two-way data system linking community health workers and clinical records.
Standard of Care
Standard of Care in Uganda and Kenya
Eligibility Criteria
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Inclusion Criteria
2. Living in SEARCH study communities
3. Provided informed consent
Exclusion Criteria
2. Living outside SEARCH study communities
3. Unable to provide consent or parental co-consent as per country guidelines
15 Years
ALL
Yes
Sponsors
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Infectious Diseases Research Collaboration, Uganda
OTHER
Makerere University
OTHER
Kenya Medical Research Institute
OTHER
University of California, Berkeley
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
National Institute of Mental Health (NIMH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University College, London
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Diane Havlir, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Moses Kamya, MBChB, PhD
Role: PRINCIPAL_INVESTIGATOR
Makerere University; Infectious Diseases Research Collaboration
Maya Petersen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Berkeley
Locations
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SEARCH Office / GPRT
Kisumu, , Kenya
Infectious Diseases Research Collaboration
Kampala, , Uganda
Countries
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Central Contacts
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Facility Contacts
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James Ayeiko, MBChB, PhD
Role: primary
Jane Kabami, MPH
Role: primary
Other Identifiers
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SEARCH SAPPHIRE Phase B
Identifier Type: -
Identifier Source: org_study_id
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