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Clinical Trial
. 2022 Feb;98(1):32-37.
doi: 10.1136/sextrans-2020-054718. Epub 2021 Feb 4.

Assessment of risk compensation following use of the dapivirine vaginal ring in southwestern Uganda

Sylvia Kusemererwa  1 , Andrew Abaasa  2   3 , Anita Kabarambi  4 , Martin Onyango  4 , Joseph Okello Mugisha  4
Affiliations
Clinical Trial

Assessment of risk compensation following use of the dapivirine vaginal ring in southwestern Uganda

Sylvia Kusemererwa et al. Sex Transm Infect. 2022 Feb.

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.

Keywords: HIV; sexual behaviour; vaginal microbicides; women.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Study profile of women screened and enrolled into a phase III microbicide trial in southwestern Uganda (September 2013–December 2014).
See this image and copyright information in PMC

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