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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80,000
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.
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.
SEARCH Office / GPRT
Kisumu, Kenya
RECRUITINGInfectious Diseases Research Collaboration
Kampala, Uganda
RECRUITINGHIV incidence
HIV incidence per 100 person-year
Time frame: 24 months
Population-Level Viremia
Proportion of adults with plasma RNA levels \> 1000 c/mL
Time frame: 24 months
Prevention Coverage
Proportion of HIV-negative follow-up months during which PrEP/PEP was used
Time frame: assessed between 18-24 month follow up
Population Level Viral Suppression among PWH
Proportion of HIV+ adults with plasma RNA level \<400 cps/mL
Time frame: assessed between 18-24 month follow up
Mortality risk
Mortality risk of all community members aged ≥ 15 years at baseline
Time frame: 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
Time frame: assessed between 18-24 month follow up
Severe Hypertension
Severe HTN (BP \>160/100 mmHG)
Time frame: assessed between 18-24 month follow up
Persons presenting with late HIV disease
Proportion of PWH adults with CD4 T-cell count \< 200
Time frame: assessed between 18-24 month follow up
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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 in Uganda and Kenya
Late Pediatric HIV Diagnosis
Proportion of children of HIV+/unknown status mothers diagnosed with HIV
Time frame: assessed between 18-24 month follow up
Heavy Alcohol Use
AUDIT-C score ≥3 for women, ≥4 for men
Time frame: assessed between 18-24 month follow up
HPV Immunization Coverage
Proportion of adolescent girls who have received ≥1 HPV vaccine
Time frame: assessed between 18-24 month follow up