- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05768763
SEARCH SAPPHIRE Phase B
SEARCH Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa Phase B
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tamara Clark, MHS
- Phone Number: 628-206-8790
- Email: tamara.clark@ucsf.edu
Study Locations
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-
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Kisumu, Kenya
- Recruiting
- SEARCH Office / GPRT
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Contact:
- James Ayeiko, MBChB, PhD
- Phone Number: +254-720-925262
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Principal Investigator:
- Elizabeth Bukusi, MBChB, PhD
-
-
-
-
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Kampala, Uganda
- Recruiting
- Infectious Diseases Research Collaboration
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Principal Investigator:
- Moses Kamya, MBChB, PhD
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Contact:
- Jane Kabami, MPH
- Phone Number: +256-706-315810
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age >= 15 years
- Living in SEARCH study communities
- Provided informed consent
Exclusion Criteria:
- <15 years of age
- Living outside SEARCH study communities
- Unable to provide consent or parental co-consent as per country guidelines
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Standard of Care
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Standard of Care in Uganda and Kenya
|
Experimental: Precision Community Health
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.
|
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.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of persons with new HIV infections
Time Frame: 2.5 years
|
HIV incidences per 100 person-year
|
2.5 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Moses Kamya, MBChB, PhD, Makerere University; Infectious Diseases Research Collaboration
- Principal Investigator: Diane Havlir, MD, University of California, San Francisco
- Principal Investigator: Maya Petersen, PhD, University of California, Berkeley
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SEARCH SAPPHIRE Phase B
- U01AI150510 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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