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  • Point-of-care testing for sexually transmitted infections and HIV pre-exposure prophylaxis among pregnant women in South Africa, 2021–2022: randomised controlled trial

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Original research
Point-of-care testing for sexually transmitted infections and HIV pre-exposure prophylaxis among pregnant women in South Africa, 2021–2022: randomised controlled trial
  1. Alex de Voux1,
  2. Dorothy Chiwoniso Nyemba1,2,
  3. Miriam Silliman3,
  4. Nyiko Mashele1,
  5. Rufaro Mvududu1,
  6. Landon Myer1,
  7. Dvora Joseph Davey1,3,4
  1. 1 Division of Epidemiology and Biostatistics, School of Public Health, University of Cape Town Faculty of Health Sciences, Observatory, Western Cape, South Africa
  2. 2 Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, Gauteng, South Africa
  3. 3 Department of Epidemiology, Fielding School of Public Health, University of California Los Angeles, Los Angeles, California, USA
  4. 4 David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA
  1. Correspondence to Dr Alex de Voux, School of Public Health, University of Cape Town Faculty of Health Sciences, Observatory, Western Cape 7795, South Africa; alex.devoux{at}uct.ac.za

Abstract

Objective Pregnant and postpartum women (PPW) in Southern Africa are at increased risk of acquiring HIV and curable sexually transmitted infections (STIs). Oral pre-exposure prophylaxis (PrEP) is safe and effective to use during pregnancy to reduce HIV acquisition and vertical transmission. Point-of-care (POC) STI testing can identify PPW at risk of HIV and facilitate risk-differentiated and person-centred counselling to improve PrEP initiation, persistence and adherence. We evaluated the impact of POC STI testing compared with STI syndromic management on PrEP outcomes among PPW in Cape Town, South Africa.

Methods The STI and PrEP in Pregnancy Study enrolled PPW without HIV and ≤34 weeks pregnant at their regular antenatal care visit with follow-up after 1 month. PPW were randomised to receive POC STI testing or STI syndromic management. PPW randomised to POC STI testing self-collected vaginal swabs for Chlamydia trachomatis, Neisseria gonorhoeae and Trichomonas vaginalis (Cepheid GeneXpert) testing and were offered same-day treatment if diagnosed. We compared PrEP initiation at baseline, PrEP prescription refill at 1 month (persistence) and adherence through tenofovir-diphosphate detection in dried blood spots by randomisation arm. In a secondary analysis, we evaluated the association between an STI diagnosis (positive STI test or reporting STI symptoms) with PrEP outcomes.

Results We enrolled and randomised 268 pregnant women. Twenty-eight per cent of women were diagnosed with ≥1 STI. Overall, 65% of women initiated and 79% persisted on PrEP with no significant differences by randomisation arm. Secondary analysis demonstrated that an STI diagnosis (positive STI test or reporting STI symptoms) was associated with higher PrEP initiation (adjusted relative risk=1.28; 95% CI 1.08 to 1.52), controlling for arm, maternal and gestational age.

Conclusions POC STI testing was not associated with PrEP initiation or persistence relative to syndromic management. However, improving STI diagnosis by supplementing syndromic management with POC STI testing could improve PrEP initiation among PPW.

Trial registration number NCT03902418; Clinical Trials.gov; 1 April 2019.

  • NEISSERIA GONORRHOEAE
  • CHLAMYDIA TRACHOMATIS
  • TRICHOMONAS
  • Pre-Exposure Prophylaxis
  • Point-of-Care Testing

Data availability statement

Data are available upon reasonable request. The datasets used and/or analyses during the current study are available from the corresponding author on reasonable request.

https://doi.org/10.1136/sextrans-2023-055975

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    Data availability statement

    Data are available upon reasonable request. The datasets used and/or analyses during the current study are available from the corresponding author on reasonable request.

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    Footnotes

    • Handling editor Claudia S Estcourt

    • Contributors DJD, NM, RM, DCN and LM conceptualised and designed the study. DJD, NM, RM, DCN and LM implemented the study. AdV cleaned and analysed the data, with support from DJD, DCN, MS and RM. AdV wrote the first draft of the manuscript and DJD, DCN, MS, NM, RM and LM contributed to subsequent drafts of the manuscript. All authors have read and approved the final manuscript. DJD is the guarantor for this article.

    • Funding The current project was funded by the National Institutes of Mental Health (R01MH116771) and the Fogarty International Center (K01TW011187). Study drug (Truvada®) was provided in-kind from Gilead and GeneXpert® STI tests donated by Cepheid Inc. (Sunnyvale, USA).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.