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NCT Number: NCT05768763

SEARCH SAPPHIRE Phase B

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.

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Key information

Conditions

HIV Cardiovascular Diseases Hypertension Vascular Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SEARCH Office / GPRT, Kisumu, Kenya

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community-enhanced reach activities

Behavioral

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.

Person-centered care delivery

Behavioral

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.

Data system enhancement to improve reach and person-centered delivery

Other

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

Behavioral

Standard of Care in Uganda and Kenya

Primary outcomes

  1. HIV incidence

    Time frame: 24 months

    HIV incidence per 100 person-year

Secondary outcomes

  1. Population-Level Viremia

    Time frame: 24 months

    Proportion of adults with plasma RNA levels > 1000 c/mL

  2. Prevention Coverage

    Time frame: assessed between 18-24 month follow up

    Proportion of HIV-negative follow-up months during which PrEP/PEP was used

  3. Population Level Viral Suppression among PWH

    Time frame: assessed between 18-24 month follow up

    Proportion of HIV+ adults with plasma RNA level <400 cps/mL

  4. Mortality risk

    Time frame: assessed between 18-24 month follow up

    Mortality risk of all community members aged ≥ 15 years at baseline

  5. Hypertension Control

    Time frame: assessed between 18-24 month follow up

    HTN control (BP <140/90 mmHG) of community members aged ≥ 40 years with blood pressure >160/100 mmHG

  6. Severe Hypertension

    Time frame: assessed between 18-24 month follow up

    Severe HTN (BP >160/100 mmHG)

  7. Persons presenting with late HIV disease

    Time frame: assessed between 18-24 month follow up

    Proportion of PWH adults with CD4 T-cell count < 200

  8. Late Pediatric HIV Diagnosis

    Time frame: assessed between 18-24 month follow up

    Proportion of children of HIV+/unknown status mothers diagnosed with HIV

  9. Heavy Alcohol Use

    Time frame: assessed between 18-24 month follow up

    AUDIT-C score ≥3 for women, ≥4 for men

  10. HPV Immunization Coverage

    Time frame: assessed between 18-24 month follow up

    Proportion of adolescent girls who have received ≥1 HPV vaccine

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 14, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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