Comparison of practicability and effectiveness between unassisted HIV self-testing and directly assisted HIV self-testing in the Democratic Republic of the Congo: a randomized feasibility trial

Serge Tonen-Wolyec,Laurent Belec,Charles Kayembe Tshilumba,Marie-Pierre Hayette,Salomon Batina-Agasa,Roland Marini Djang’Eing’A

doi:10.1186/s12879-020-05554-x

Abstract

BackgroundHIV self-testing (HIVST) can be performed using directly assisted and unassisted approaches in facilities or communities to reach different populations. The aim of this study was to compare the practicability and effectiveness of the two delivery approaches for HIVST, unassisted HIVST (UH) and directly assisted HIVST (DAH), in the field setting of Kisangani, the Democratic Republic of the Congo (DRC).MethodsA randomized (1:1), non-blinded, non-inferiority trial using a blood-based and facility-based HIVST method was carried out in four facilities in Kisangani, the DRC, targeting populations at high risk for HIV infection. The primary outcome was the difference in the practicability of the HIV self-test between the two arms. Practicability was defined as successfully performing the test and correctly interpreting the result. Requests for assistance, positivity rate, linkage to care, and willingness to buy an HIV self-test kit constituted the secondary outcomes for HIVST effectiveness. The adjusted risk ratios (aRRs) were calculated using Poisson regression.ResultsThe rate of successfully performing the test was same (93.2%) in the UH and DAH arms. The rate of correctly interpreting the results was 86.9% in the UH arm versus 93.2% in the DAH arm, for a difference of − 6.3%. After the follow-up 72 h later, participants in the UH arm had a significantly lower chance of correctly interpreting the test results than those in the DAH arm (aRR: 0.60; P = 0.019). Although the positivity rate was 3.4% among the participants in the DAH arm and 1.7% among those in the UH arm, no significant differences were found between the two arms in the positivity rate, requests for assistance, and linkage to care. Willingness to buy an HIV self-test was higher in the UH arm than in the DAH arm (92.3% versus 74.1%; aRR: 4.20; P < 0.001).ConclusionThe results of this study indicate that UH is as practicable and effective as DAH among individuals at high risk for HIV infection in Kisangani, the DRC. However, additional support tools need to be assessed to improve the interpretation of the self-test results when using the UH approach.Trial registrationPACTR201904546865585. Registered 03 April 2019 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=6032

Highlights

Human immunodeficiency virus (HIV) self-testing (HIVST) can be performed using directly assisted and unassisted approaches in facilities or communities to reach different populations
The results of this study indicate that unassisted HIVST (UH) is as practicable and effective as directly assisted HIV self-testing (HIVST) (DAH) among individuals at high risk for HIV infection in Kisangani, the Democratic Republic of the Congo (DRC)
28 participants were lost to follow-up in the UH arm, and 2 participants withdrew from study in the DAH arm (Fig. 1)

Summary

Introduction

HIV self-testing (HIVST) can be performed using directly assisted and unassisted approaches in facilities or communities to reach different populations. According to the World Health Organization (WHO) [6], directly assisted HIVS T (DAH) is when an individual self-tests for HIV and receives a face-to-face demonstration by a trained provider or peer of how to perform the test and interpret the result. This approach is recommended in cases where people with disabilities and low literacy skills require assistance. Unassisted HIVST (UH) is when an individual self-tests for HIV and performs the self-test guided only by the instructions for use provided by the manufacturer without assistance from a trained provider [6]

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