SEARCH SAPPHIRE Phase B

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768763
• Other study ID #: SEARCH SAPPHIRE Phase B
• Secondary ID: U01AI150510
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: June 2026

Study information

• Verified date: June 2023
• Source: University of California, San Francisco
• Contact: Tamara Clark, MHS
• Phone: 628-206-8790
• Email: tamara.clark[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160000
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Community-enhanced reach activities
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.
• Person-centered care delivery
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.

Other:
• Data-enhancement to improve precision of interventions
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.

Behavioral:
• Standard of Care
Standard of Care in Uganda and Kenya

Locations

Country	Name	City	State
Kenya	SEARCH Office / GPRT	Kisumu
Uganda	Infectious Diseases Research Collaboration	Kampala

Sponsors (10)

Lead Sponsor	Collaborator
University of California, San Francisco	Infectious Diseases Research Collaboration, Uganda, Kenya Medical Research Institute, Makerere University, National Heart, Lung, and Blood Institute (NHLBI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), University College, London, University of California, Berkeley

Countries where clinical trial is conducted

Kenya,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of persons with new HIV infections	HIV incidences per 100 person-year	2.5 years