SEARCH SAPPHIRE Phase B

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: HIV

Treatments: Behavioral: Standard of Care; Behavioral: Person-centered care delivery; Behavioral: Community-enhanced reach activities; Other: Data system enhancement to improve reach and person-centered delivery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05768763

U01AI150510 (U.S. NIH Grant/Contract)

SEARCH SAPPHIRE Phase B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80,000 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80,000 participants in 2 patient groups

Precision Community Health

Experimental group

Description:

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

Treatment:

Other: Data system enhancement to improve reach and person-centered delivery

Behavioral: Community-enhanced reach activities

Behavioral: Person-centered care delivery

Control

Active Comparator group

Description:

Standard of Care

Treatment:

Behavioral: Standard of Care