HIVNCT05768763
SEARCH SAPPHIRE Phase B
A study testing Community-enhanced reach activities, Person-centered care delivery and Data system enhancement to improve reach and person-centered delivery in people with HIV, run by University of California, San Francisco at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Community-enhanced reach activities, Person-centered care delivery and Data system enhancement to improve reach and person-centered delivery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81,952 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Mar 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age >= 15 years
- Living in SEARCH study communities
- Provided informed consent
Who cannot join
- <15 years of age
- Living outside SEARCH study communities
- Unable to provide consent or parental co-consent as per country guidelines
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: SEARCH Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa 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.
Read the 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.
- Conditions
- HIV
- Being tested
- Community-enhanced reach activities, Person-centered care delivery, Data system enhancement to improve reach and person-centered delivery, Standard of Care
- Keywords
- PrEP, HIV Treatment, HIV Prevention, Community Health, Youth and Adolescents, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-enhanced reach activitiesBehavioural
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 deliveryBehavioural
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 deliveryOther
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 CareBehavioural
Standard of Care in Uganda and Kenya
| Study group | Role | What they receive |
|---|---|---|
| Precision Community Health | Experimental | 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 Receives: Behavioral: Community-enhanced reach activities; Behavioral: Person-centered care delivery; Other: Data system enhancement to improve reach and person-centered delivery |
| Control | Active comparator | Standard of Care Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV incidence
HIV incidence per 100 person-year
Measured: 24 months
Secondary outcomes (10)
Population-Level Viremia
Proportion of adults with plasma RNA levels > 1000 c/mL
Measured: 24 months
Prevention Coverage
Proportion of HIV-negative follow-up months during which PrEP/PEP was used
Measured: assessed between 18-24 month follow up
Population Level Viral Suppression among PWH
Proportion of HIV+ adults with plasma RNA level <400 cps/mL
Measured: assessed between 18-24 month follow up
Mortality risk
Mortality risk of all community members aged ≥ 15 years at baseline
Measured: assessed between 18-24 month follow up
Hypertension Control
HTN control (BP <140/90 mmHG) of community members aged ≥ 40 years with blood pressure >160/100 mmHG
Measured: assessed between 18-24 month follow up
Severe Hypertension
Severe HTN (BP >160/100 mmHG)
Measured: assessed between 18-24 month follow up
Persons presenting with late HIV disease
Proportion of PWH adults with CD4 T-cell count < 200
Measured: assessed between 18-24 month follow up
Late Pediatric HIV Diagnosis
Proportion of children of HIV+/unknown status mothers diagnosed with HIV
Measured: assessed between 18-24 month follow up
Heavy Alcohol Use
AUDIT-C score ≥3 for women, ≥4 for men
Measured: assessed between 18-24 month follow up
HPV Immunization Coverage
Proportion of adolescent girls who have received ≥1 HPV vaccine
Measured: assessed between 18-24 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start28 Mar 2023
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 81,952 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Infectious Diseases Research Collaboration, Uganda, Makerere University, Kenya Medical Research Institute, University of California, Berkeley, National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Mental Health (NIMH), National Heart, Lung, and Blood Institute (NHLBI), University College, London
- Responsible party
- Sponsor
- Investigators
- Diane Havlir, MD, Principal investigator, University of California, San FranciscoMoses Kamya, MBChB, PhD, Principal investigator, Makerere University; Infectious Diseases Research CollaborationMaya Petersen, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768763
- Sponsor's protocol ID
- SEARCH SAPPHIRE Phase B
- Other IDs
- U01AI150510
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEARCH Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa Phase B
- ClinicalTrials.gov ID
- NCT05768763
- Acronym / sponsor ID
- SEARCH SAPPHIRE Phase B
- Conditions
- HIV
- Keywords
- PrEP, HIV Treatment, HIV Prevention, Community Health, Youth and Adolescents, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81,952 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Infectious Diseases Research Collaboration, Uganda, Makerere University, Kenya Medical Research Institute, University of California, Berkeley, National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Mental Health (NIMH), National Heart, Lung, and Blood Institute (NHLBI), University College, London
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Precision Community Health | Experimental | Behavioral: Community-enhanced reach activities, Behavioral: Person-centered care delivery, Other: Data system enhancement to improve reach and person-centered deliveryThe 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 |
| Control | Active comparator | Behavioral: Standard of CareStandard of Care |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 15 years
- Living in SEARCH study communities
- Provided informed consent
Key exclusion criteria (3 listed)
- <15 years of age
- Living outside SEARCH study communities
- Unable to provide consent or parental co-consent as per country guidelines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-enhanced reach activitiesWe 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. | Behavioural | Precision Community Health |
| Person-centered care deliveryStructured 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. | Behavioural | Precision Community Health |
| Data system enhancement to improve reach and person-centered deliveryBoth 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. | Other | Precision Community Health |
| Standard of CareStandard of Care in Uganda and Kenya | Behavioural | Control |
Primary outcome
HIV incidence
Time frame: 24 months
HIV incidence per 100 person-year
10 secondary outcomes
Population-Level Viremia
Time frame: 24 months
Prevention Coverage
Time frame: assessed between 18-24 month follow up
Population Level Viral Suppression among PWH
Time frame: assessed between 18-24 month follow up
Mortality risk
Time frame: assessed between 18-24 month follow up
Hypertension Control
Time frame: assessed between 18-24 month follow up
Severe Hypertension
Time frame: assessed between 18-24 month follow up
Persons presenting with late HIV disease
Time frame: assessed between 18-24 month follow up
Late Pediatric HIV Diagnosis
Time frame: assessed between 18-24 month follow up
Heavy Alcohol Use
Time frame: assessed between 18-24 month follow up
HPV Immunization Coverage
Time frame: assessed between 18-24 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane Havlir, MD principal investigator
University of California, San Francisco
Moses Kamya, MBChB, PhD principal investigator
Makerere University; Infectious Diseases Research Collaboration
Maya Petersen, PhD principal investigator
University of California, Berkeley
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-enhanced reach activities, Person-centered care delivery and Data system enhancement to improve reach and person-centered delivery in people with HIV, run by University of California, San Francisco at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV incidence (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.