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. 2024 Mar;11(3):e167-e175.
doi: 10.1016/S2352-3018(23)00268-0. Epub 2024 Jan 29.

Impact of HIV self-testing for oral pre-exposure prophylaxis scale-up on drug resistance and HIV outcomes in western Kenya: a modelling study

Sarah N Cox  1 , Linxuan Wu  1 , Rachel Wittenauer  2 , Samantha Clark  2 , D Allen Roberts  3 , Ifechukwu Benedict Nwogu  2 , Olga Vitruk  1 , Alexandra P Kuo  4 , Cheryl Johnson  5 , Muhammad S Jamil  5 , Anita Sands  6 , Robin Schaefer  5 , Christine Kisia  7 , Rachel Baggaley  5 , Joanne D Stekler  8 , Adam Akullian  9 , Monisha Sharma  10
Affiliations

Impact of HIV self-testing for oral pre-exposure prophylaxis scale-up on drug resistance and HIV outcomes in western Kenya: a modelling study

Sarah N Cox et al. Lancet HIV. 2024 Mar.

Abstract

Background: Community-based oral pre-exposure prophylaxis (PrEP) provision has the potential to expand PrEP coverage. HIV self-testing can facilitate PrEP community-based delivery but might have lower sensitivity than facility-based HIV testing, potentially leading to inappropriate PrEP use among people with HIV and subsequent development of drug resistance. We aimed to evaluate the impact of HIV self-testing use for PrEP scale-up.

Methods: We parameterised an agent-based network model, EMOD-HIV, to simulate generic tenofovir disoproxil fumarate and emtricitabine PrEP scale-up in western Kenya using four testing scenarios: provider-administered nucleic acid testing, provider-administered rapid diagnostic tests detecting antibodies, blood-based HIV self-testing, or oral fluid HIV self-testing. Scenarios were compared with a no PrEP counterfactual. Individuals aged 18-49 years with one or more heterosexual partners who screened HIV-negative were eligible for PrEP. We assessed the cost and health impact of rapid PrEP scale-up with high coverage over 20 years, and the budget impact over 5 years, using various HIV testing modalities.

Findings: PrEP coverage of 29% was projected to avert approximately 54% of HIV infections and 17% of HIV-related deaths among adults aged 18-49 years over 20 years; health impacts were similar across HIV testing modalities used to deliver PrEP. The percentage of HIV infections with PrEP-associated nucleoside reverse transcriptase inhibitor (NRTI) drug resistance was 0·6% (95% uncertainty intervals 0·4-0·9) in the blood HIV self-testing scenario and 0·8% (0·6-1·0) in the oral HIV self-testing scenario, compared with 0·3% (0·2-0·3) in the antibody rapid diagnostic testing scenario and 0·2% (0·1-0·2) in the nucleic acid testing scenario. Accounting for background NRTI resistance, we found similarly low proportions of drug resistance across scenarios. The budget impact of implementing PrEP using HIV self-testing and provider-administered rapid diagnostic tests were similar, while nucleic acid testing was approximately 50% more costly.

Interpretation: Scaling up PrEP using HIV self-testing has similar health impacts, costs, and low risk of drug resistance as provider-administered rapid diagnostic tests. Policy makers should consider leveraging HIV self-testing to expand PrEP access among those at HIV risk.

Funding: The Bill and Melinda Gates Foundation.

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Conflict of interest statement

Declaration of interests MS reports funding from National Institutes of Health during the conduct of this study. RB reports funds from Unitaid, United States Agency for International Development, and the Bill & Melinda Gates Foundation awarded to WHO. JDS reports receipt of HIV diagnostic device and test kits for conduct of Centers for Disease Control and Prevention-sponsored research from Diagnostics for the Real World. All other authors declare no conflicts of interests. The views expressed in this article do not necessarily represent the views, decisions or policies of the institutions with which they are affiliated.

Figures

Figure 1
Figure 1
HIV test sensitivity by days since HIV acquisition
Figure 2
Figure 2
People with HIV inappropriately initiated on PrEP by scenario Assumes a population of 3·7 million individuals. Error bars refer to the 95% uncertainty intervals across the 100 parameter sets. NRTI=nucleoside reverse transcriptase inhibitor. PrEP=pre-exposure prophylaxis.
Figure 3
Figure 3
Average person-time inappropriately on PrEP with HIV overall (A), acute stage HIV infection (B), chronic stage HIV infection (C), and incident HIV infection (D) Error bars refer to the 95% uncertainty intervals across the 100 parameter sets. PrEP=pre-exposure prophylaxis.
Figure 4
Figure 4
5-year budget impact of PrEP scale-up by HIV testing modality in a population of 3·1 million individuals PrEP=pre-exposure prophylaxis.
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