SEARCH SAPPHIRE Phase B

Study Overview
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Brief Summary
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This study will evaluate the effects of optimized dynamic prevention and treatment packages delivered in a precision community health model on HIV incidence, as well as other health outcomes, in a community randomized trial design.

Detailed Description
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In the evaluation Phase B, the SEARCH SAPPHIRE study will evaluate the effects of Dynamic Prevention and Dynamic Treatment intervention packages based on data from Phase A (NCT04810650) and new advances from outside the study delivered in a precision community health model, on HIV incidence and other health outcomes, in a pair-matched community randomized design. 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.

Official Title
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SEARCH Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa Phase B

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Community-enhanced reach activities
* Behavioral: Person-centered care delivery
* Other: Data-enhancement to improve precision of interventions
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 15 years Living in SEARCH study communities Provided informed consent Exclusion Criteria: <15 years of age Living outside SEARCH study communities Unable to provide consent or parental co-consent as per country guidelines

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In the evaluation Phase B, the SEARCH SAPPHIRE study will evaluate the effects of Dynamic Prevention and Dynamic Treatment intervention packages based on data from Phase A (NCT04810650) and new advances from outside the study delivered in a precision community health model, on HIV incidence and other health outcomes, in a pair-matched community randomized design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Precision Community Health<br>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. | Behavioral: Community-enhanced reach activities<br>* 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 system, leveraging existing mobile outreaches in the community.<br>Behavioral: Person-centered care delivery<br>* Structured approach to provide patient-centered biomedical options for prevention. Tailored services for youth, pregnant women, and persons without viral suppression, mobile populations, with heavy alcohol use, or severe hypertension.<br>Other: Data-enhancement to improve precision of interventions<br>* Both community-enhanced reach and person-centered delivery will be strengthened through the strategic collection and use of data. Analysis will be conducted to enhance the effectiveness of ongoing outreach activities by identifying high yield venues and locations and local regions and persons who would benefit form more frequent or intensive outreach or services due to, eg, elevated risk of HIV infection, unsuppressed viral load, and uncontrolled HTN.<br>|
| Active Comparator: Control<br>Standard of Care | Behavioral: Standard of Care<br>* Standard of Care in Uganda and Kenya<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of persons with new HIV infections | HIV incidences per 100 person-year | 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP, HIV Treatment, HIV Prevention, Community Health, Youth and Adolescents, Hypertension