HIV
Conditions
Keywords
PrEP, HIV Treatment, HIV Prevention, Community Health, Youth and Adolescents, Hypertension
Brief 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.
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.
Interventions
BEHAVIORALCommunity-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 workers, integrated in the community health system.
BEHAVIORALPerson-centered care delivery
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.
OTHERData system enhancement to improve reach and person-centered delivery
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.
BEHAVIORALStandard of Care
Standard of Care in Uganda and Kenya
Sponsors
University of California, San Francisco
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV incidence | 24 months | HIV incidence per 100 person-year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Population-Level Viremia | 24 months | Proportion of adults with plasma RNA levels \> 1000 c/mL |
| Prevention Coverage | assessed between 18-24 month follow up | Proportion of HIV-negative follow-up months during which PrEP/PEP was used |
| Population Level Viral Suppression among PWH | assessed between 18-24 month follow up | Proportion of HIV+ adults with plasma RNA level \<400 cps/mL |
| Mortality risk | assessed between 18-24 month follow up | Mortality risk of all community members aged ≥ 15 years at baseline |
| Hypertension Control | 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 |
| Severe Hypertension | assessed between 18-24 month follow up | Severe HTN (BP \>160/100 mmHG) |
| Persons presenting with late HIV disease | assessed between 18-24 month follow up | Proportion of PWH adults with CD4 T-cell count \< 200 |
| Late Pediatric HIV Diagnosis | assessed between 18-24 month follow up | Proportion of children of HIV+/unknown status mothers diagnosed with HIV |
| Heavy Alcohol Use | assessed between 18-24 month follow up | AUDIT-C score ≥3 for women, ≥4 for men |
| HPV Immunization Coverage | assessed between 18-24 month follow up | Proportion of adolescent girls who have received ≥1 HPV vaccine |
Countries
Kenya, Uganda
Contacts
PRINCIPAL_INVESTIGATORDiane Havlir, MD
University of California, San Francisco
PRINCIPAL_INVESTIGATORMoses Kamya, MBChB, PhD
Makerere University; Infectious Diseases Research Collaboration
PRINCIPAL_INVESTIGATORMaya Petersen, PhD
University of California, Berkeley
Outcome results
None listed