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Tambua Mapema Plus - to Discover HIV Infection Early and Prevent Onward Transmission

NCT03508908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2887

Last updated 2023-11-13

Study results available
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Summary

This study will assess the impact of an HIV-1 RNA testing intervention targeting adult patients aged 18-39 years who seek urgent care for symptoms at primary care facilities and meet specific risk criteria for acute HIV infection. All newly diagnosed HIV-infected patients in the intervention arm will be linked to care and offered both immediate treatment and assisted partner notification. Partners will also be tested using the HIV testing intervention, and pre-exposure prophylaxis will be offered to uninfected individuals with HIV-infected partners. The cost-effectiveness of this intervention will be evaluated.

Conditions

  • HIV Infections

Interventions

DIAGNOSTIC_TEST

HIV-1 RNA testing

During the intervention period, a blood sample will be obtained and tested for AHI using point-of-care Xpert® HIV Qual assay (Cepheid, Sunnyvale, California, USA). Individuals who test positive will undergo rapid tests to differentiate acute from prevalent HIV infection. Newly diagnosed individuals will be offered immediate ART and assisted partner notification with the HIV-1 RNA testing intervention delivered to partners following the same approach.

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Oxford

    lead OTHER

Principal Investigators

  • SUSAN M GRAHAM, MD MPH PHD · University of Washington

  • EDUARD J SANDERS, MD MPH PHD · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2020-07-31
Completion
2022-07-31

Countries

  • Kenya

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03508908 on ClinicalTrials.gov