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| ID | Type | Description | Link |
|---|---|---|---|
| U01AI150510 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Infectious Diseases Research Collaboration, Uganda | OTHER |
| Makerere University | OTHER |
| Kenya Medical Research Institute | OTHER |
| University of California, Berkeley |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precision Community Health | Experimental | 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 |
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| Control | Active Comparator | Standard of Care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community-enhanced reach activities | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HIV incidence | HIV incidence per 100 person-year | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Population-Level Viremia | Proportion of adults with plasma RNA levels > 1000 c/mL | 24 months |
| Prevention Coverage | Proportion of HIV-negative follow-up months during which PrEP/PEP was used |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane Havlir, MD | University of California, San Francisco | Principal Investigator |
| Moses Kamya, MBChB, PhD | Makerere University; Infectious Diseases Research Collaboration | Principal Investigator |
| Maya Petersen, PhD | University of California, Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SEARCH Office / GPRT | Kisumu | Kenya | ||||
| Infectious Diseases Research Collaboration |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| 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 |
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.
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| Person-centered care delivery | Behavioral | 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. |
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| Data system enhancement to improve reach and person-centered delivery | Other | 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. |
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| Standard of Care | Behavioral | Standard of Care in Uganda and Kenya |
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| assessed between 18-24 month follow up |
| Population Level Viral Suppression among PWH | Proportion of HIV+ adults with plasma RNA level <400 cps/mL | assessed between 18-24 month follow up |
| Mortality risk | Mortality risk of all community members aged ≥ 15 years at baseline | assessed between 18-24 month follow up |
| Hypertension Control | HTN control (BP <140/90 mmHG) of community members aged ≥ 40 years with blood pressure >160/100 mmHG | assessed between 18-24 month follow up |
| Severe Hypertension | Severe HTN (BP >160/100 mmHG) | assessed between 18-24 month follow up |
| Persons presenting with late HIV disease | Proportion of PWH adults with CD4 T-cell count < 200 | assessed between 18-24 month follow up |
| Late Pediatric HIV Diagnosis | Proportion of children of HIV+/unknown status mothers diagnosed with HIV | assessed between 18-24 month follow up |
| Heavy Alcohol Use | AUDIT-C score ≥3 for women, ≥4 for men | assessed between 18-24 month follow up |
| HPV Immunization Coverage | Proportion of adolescent girls who have received ≥1 HPV vaccine | assessed between 18-24 month follow up |
| Kampala |
| Uganda |