CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,887 enrolled
Drug / intervention
HIV-1 RNA testingother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03508908
NCT03508908N/ACompleted

Impact of a Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection and Reduce HIV Transmission - Tambua Mapema Plus

University of Oxford·interventional·Posted Apr 26, 2018·Updated Nov 13, 2023

In Brief

A clinical study evaluating HIV-1 RNA testing for HIV Infections. Completed, enrolled 2,887 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesKenya

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 26, 2018
Enrollment StartDec 1, 2017
Primary CompletionJul 31, 2020
Study CompletionJul 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.2 years ago

Interventions

HIV-1 RNA testingother

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.