Clinical trial NCT05768763: SEARCH SAPPHIRE Phase B
Official title: SEARCH Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa Phase B
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Keywords: PrEP
HIV Treatment
HIV Prevention
Community Health
Youth and Adolescents
Hypertension
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Infectious Diseases Research Collaboration, Uganda
name: Makerere University
name: Kenya Medical Research Institute
name: University of California, Berkeley
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: National Institute of Mental Health (NIMH)
name: National Heart, Lung, and Blood Institute (NHLBI)
name: University College, London
First posted: 2023-03-14
Enrollment: 80000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Age \>= 15 years
2. Living in SEARCH study communities
3. Provided informed consent

Exclusion Criteria:

1. \<15 years of age
2. Living outside SEARCH study communities
3. Unable to provide consent or parental co-consent as per country guidelines

Primary outcomes:
measure: HIV incidence
timeFrame: 24 months
Secondary outcomes:
measure: Population-Level Viremia
timeFrame: 24 months
measure: Prevention Coverage
timeFrame: assessed between 18-24 month follow up
measure: Population Level Viral Suppression among PWH
timeFrame: assessed between 18-24 month follow up
measure: Mortality risk
timeFrame: assessed between 18-24 month follow up
measure: Hypertension Control
timeFrame: assessed between 18-24 month follow up
measure: Severe Hypertension
timeFrame: assessed between 18-24 month follow up
measure: Persons presenting with late HIV disease
timeFrame: assessed between 18-24 month follow up
measure: Late Pediatric HIV Diagnosis
timeFrame: assessed between 18-24 month follow up
measure: Heavy Alcohol Use
timeFrame: assessed between 18-24 month follow up
measure: HPV Immunization Coverage
timeFrame: assessed between 18-24 month follow up
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: SEARCH Office / GPRT
city: Kampala
country: Uganda
facility: Infectious Diseases Research Collaboration
Study officials:
affiliation: University of California, San Francisco
name: Diane Havlir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University; Infectious Diseases Research Collaboration
name: Moses Kamya, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Berkeley
name: Maya Petersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: