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Epidemiology
Original research
Assessment of risk compensation following use of the dapivirine vaginal ring in southwestern Uganda
  1. Sylvia Kusemererwa1,
  2. Andrew Abaasa2,3,
  3. Anita Kabarambi1,
  4. Martin Onyango1,
  5. Joseph Okello Mugisha1
  1. 1 Department of HIV Interventions, MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda
  2. 2 Department of Statistics, MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda
  3. 3 Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK
  1. Correspondence to Dr Sylvia Kusemererwa, MRC/UVRI Uganda Research Unit On AIDS, Entebbe +256, Uganda; sylvia.kusemererwa{at}mrcuganda.org

Abstract

Objectives Participation in HIV prevention trials could trigger risk compensation among participants. We evaluated potential risk compensation following use of a vaginal ring microbicide by women in a phase III trial in southwestern Uganda.

Methods We used markers of sexual risk behaviour documented on standardised questionnaires, tested for STIs at baseline and quarterly for 2 years. Risk compensation was defined as a significant increase (trend p<0.05) in the proportion of women reporting risky sexual behaviour or a diagnosed STI between baseline and end of follow-up.

Results Between September 2013 and December 2016, 197 women (active arm: n=132 and placebo: n=65) were enrolled at the Masaka site. There were decreases in all markers of sexual risk behaviour with statistically significant decreases in only the proportion of women reporting ≥2 sexual partners, p=0.026 and those diagnosed with Trichomonas vaginalis p<0.001 and or Neisseria gonorrhoeae p<0.001

Conclusions No evidence of risk compensation was observed in this trial.

Trial registration number NCT01539226.

  • HIV
  • sexual behaviour
  • vaginal microbicides
  • women

Data availability statement

Data are available on reasonable request.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/sextrans-2020-054718

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    Data availability statement

    Data are available on reasonable request.

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    Footnotes

    • Handling editor Adam Huw Bourne

    • Twitter @Kushylvia

    • Contributors SK, AA, AK and MO designed the study, and AA did the analysis. AK and MO conducted the study, while SK directed the work. JOM contributed to the writing and editing of the manuscript. All authors contributed to the interpretation of the results and critically commented and provided revisions to the manuscript. All authors approved the final version of the manuscript.

    • Funding The study was funded and sponsored by the International Partnership for Microbicides (www.ipmglobal.org) (IND # 110,659). For this manuscript, the funder participated in study design and manuscript review but had no role in data analysis.

    • Competing interests None declared.

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