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Randomized Controlled Trial
. 2019 Dec 1;33(15):2337-2350.
doi: 10.1097/QAD.0000000000002359.

Impact of early antiretroviral treatment on sexual behaviour: a randomised comparison

Fiona C Lampe  1 , Alison J Rodger  1 , William Burman  2 , Andrew Grulich  3 , Gerald Friedland  4 , Wafaa El Sadr  5 , James Neaton  6 , Giulio M Corbelli  7 , Sean Emery  3 , Jean Michel Molina  8 , Chloe Orkin  9 , Jose Gatell  10 , Jan Gerstoft  11 , Kiat Ruxrungtham  12 , Monica Barbosa de Souza  13 , Andrew N Phillips  1 ; INSIGHT START Study Group
Affiliations
Randomized Controlled Trial

Impact of early antiretroviral treatment on sexual behaviour: a randomised comparison

Fiona C Lampe et al. AIDS. .

Abstract

Background: Antiretroviral treatment (ART) reduces HIV infectiousness but the effect of early ART on sexual behaviour is unclear.

Methods: We assessed, within the START randomized trial that enrolled HIV-positive adults with CD4 cell count greater than 500 cells/μl, the effect of early (immediate) versus deferred ART on: condomless sex with HIV-serodifferent partners (CLS-D); all condomless sex (CLS); HIV transmission-risk sex (CLS-D-HIV risk, defined as CLS-D and: not on ART or started ART <6 months ago or viral load greater than 200 copies/ml or no viral load in past 6 months), during 2-year follow-up. Month-12 CLS-D (2010-2014) was the primary outcome.

Results: Among 2562 MSM, there was no difference between immediate and deferred arms in CLS-D at month 12 [12.6 versus 13.1%; difference (95% CI): -0.4% (-3.1 to 2.2%), P = 0.75] or month 24, or in CLS. Among 2010 heterosexual men and women, CLS-D at month 12 tended to be higher in the immediate versus deferred arm [10.8 versus 8.3%; difference:2.5% (-0.1 to 5.2%), P = 0.062]; the difference was greater at month 24 [9.3 versus 5.6%; difference: 3.7% (1.0 to 6.4%), P = 0.007], at which time CLS was higher in the immediate arm (20.7 versus 15.7%, P = 0.013). CLS-D-HIV risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2 versus 11%; difference: -10.7% (-12.5 to -8.9%), P < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8 to -5.3%), P < 0.001], because of viral suppression on ART.

Conclusion: A strategy of early ART had no effect on condomless sex with HIV-serodifferent partners among MSM, but resulted in modestly higher prevalence among heterosexuals. However, among MSM and heterosexuals, early ART resulted in a substantial reduction in HIV-transmission-risk sex, to a very low absolute level.

Trial registration: ClinicalTrials.gov NCT00867048.

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Figures

Fig. 1
Fig. 1
Effect of randomised group on CLS-D at month 12, according to baseline factors among MSM and heterosexual men and women.
Fig. 2
Fig. 2
Prevalence of sexual behaviour in the past 3 months by time point and randomized arm among MSM, and heterosexual men and women: (a) CLS-D; (b) CLS; (c) CLS-D-HIV-risk.
See this image and copyright information in PMC

References

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