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Understanding the public health implications of self-reported condom use in HIV clinical trials: lessons learned in KwaZulu Natal, South Africa (2002–2016)

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Abstract

Aim

To investigate the associations between self-reported condom use and HIV, sexually transmitted infections (STIs) and pregnancy rates among women who enrolled in HIV biomedical intervention trials in South Africa.

Subjects and Methods

Data from 9948 women were analysed. Cox regression models were used to assess the associations between condom use and primary outcomes.

Results

Overall HIV, STI and pregnancy incidence rates were 7, 15 and 9 per 100 person/year. Women reporting condom use (65%) at last sex were younger, had more schooling, had fewer children and were more likely to be single/non-cohabiting, and hormonal injectables were the most common family planning method among women who reported using a condom at last sex. They were at increased risk of HIV (adjusted hazard ratio (aHR) 1.23, 95% CI 1.07, 1.43), STI (aHR 1.20, 95% CI 1.05, 1.34) and pregnancy (aHR 1.23, 95% CI 1.10, 1.40).

Conclusion

In this population, self-reported condom users were identified as a proxy for a combination of high-risk sexual behaviours. They were associated with increased risks of HIV, STI and pregnancy incidence rates. These counterintuitive findings broadly indicate the women’s correct perception about their risky sexual behaviours which may have led them to use condoms. Our findings can have significant implications in clinical research settings by assisting in recruitment and monitoring strategies.

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Data availability statement

No further data are available without ethical approvals.

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Acknowledgements

The current study used the secondary sub-group data from a study supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) through the Centers for Disease Control and Prevention (CDC) under the terms of 3U2GGH000570 and the South African National AIDS Council (SANAC). All the views in this study are solely the responsibility of the authors and do not necessarily represent the official views of CDC or SANAC. For the Clinic-based data, we used the site-specific secondary (subgroup) data and did not receive any funding. The authors did not receive any funding for the current study. However, we acknowledge that main studies associated with these trials have received funding and support from the various sources including: the UK Department for International Development and the Medical Research Council (MDP Feasibility Study: Grant number G0100137); the Bill & Melinda Gates Foundation (MIRA: Grant number 21,082).

Funding

The authors did not receive any funding for the current study.

Author information

Authors and Affiliations

Authors

Contributions

HW and TR participated in the design of the study and performed the statistical analysis. NM and TR extracted and merged the data. HW drafted the manuscript. HW, TR and NM interpreted the results. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Handan Wand.

Ethics declarations

The authors have no disclosures to report.

Conflict of interest

The author(s) declare that they have no competing interests.

Ethical considerations

Ethical approvals were received from the Research Ethics Committee of the Human Sciences Research Council, South Africa (REC: 5/17/11/10); the Associate Director of Science of the National Centre for HIV and AIDS, Viral Hepatitis, STD and TB Prevention at the USA’s CDC in Atlanta, Georgia, USA. The study protocol has received by the Human Sciences Research Council (HSRC) Research Ethics Committee (REC: 5/17/11/10) and by the Centers for Disease Control and Prevention. In addition, the principle investigators of the study have received additional approval from the SABSSM data curation team on June 5, 2018. For the clinic-based data: Ethical approval for the trials, including all study protocols and informed consent forms, were received from the University of KwaZulu-Natal Biomedical Research Ethics Committee and the South African Medical Research Council Ethics Committee; the University of Cape Town Research Ethics Committee; and the South African Medicines Control Council as well as the various study-specific Institutional Review Boards.

Informed consent

Study participants who enrolled in these studies provided either written or verbal consent. Participants confirmed their consent by signature or witnessed thumbprint.

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Appendix

Appendix

Table 4 Summary of the 6-biomedical intervention trials included in our study (2002–2016)

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Wand, H., Morris, N. & Reddy, T. Understanding the public health implications of self-reported condom use in HIV clinical trials: lessons learned in KwaZulu Natal, South Africa (2002–2016). J Public Health (Berl.) 31, 1113–1120 (2023). https://doi.org/10.1007/s10389-021-01639-2

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