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SAPPHIRE STUDY

A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa (SAPPHIRE)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202206832649368
Enrollment
160000
Registered
2022-06-15
Start date
2021-05-19
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Interventions

Standard of care
Dynamic choice prevention

Sponsors

University of Carlifonia San Francisco
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Phase B Community Level Inclusion Criteria 1. Non-adjacent geopolitical units in western Uganda and western Kenya. 2. Most recent census population between 9,000 and 11,000 individuals. 3. Served by an ART/PrEP/PEP providing health center with antenatal and family planning services. 4. Community leader commitment for study participation and implementation. Phase B Individual Level Inclusion Criteria 1. Age =15 years 2. HIV-negative 3. Current or anticipated sexual activity with partner(s) with known HIV-infection or unknown HIV status

Exclusion criteria

Exclusion criteria: Phase B Community Level Exclusion Criteria 1. Presence of ongoing community-based interventions that provide HIV prevention or treatment outside of the current in-country treatment guidelines. 2. An urban setting defined as a city with a population of 100,000 or more inhabitants. 3. Absence of a health center able to provide ART, PrEP and PEP. 4. Community that took part in Phase A. 5. Community that took part in the SEARCH study. Phase B Individual Level Exclusion Criteria 1. <15 years of age 2. Unable to provide consent or parental co-consent as per country guidelines

Design outcomes

Primary

MeasureTime frame
To reduce HIV incidence using innovative strategies for HIV prevention and treatment to simultaneously reach “persistent driver” populations.

Secondary

MeasureTime frame
1. Evaluate and optimize individual intervention component effects, alone (Phase A) and in combination (Phase B), versus control conditions on prevention coverage and HIV viral suppression. 2. Assess the effect of the intervention package on other health outcomes (all-cause mortality, tuberculosis, hypertension control, heavy alcohol use and mother-to-child HIV transmission) in Phase B. 3. Evaluate behavioral and other mechanistic pathways for intervention effects on proximal mediators of HIV incidence in Phase B. 4. Assess the reach, effectiveness, patient and provider adoption, and fidelity and the maintenance of intervention components in Phase B. 5. Use final study data to inform a strategic and sustainable investment model that maximally reduces HIV incidence and improves community health for the combination interventions tested in Phase B.

Countries

Kenya

Contacts

Public ContactJames Ayieko

Investigator

jimayieko@gmail.com+254720925262

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026