HIV Incidence Among Pregnant and Nonpregnant Women in the FACTS-001 Trial: Implications for HIV Prevention, Especially PrEP Use

Helen Rees*, Matthew Francis Chersich, Richard J. Munthali, William Brumskine, Thesla Palanee-Phillips, Busi Nkala, Khatija Ahmed, Modulakgotla Sebe, Zonke Mabude, Maphoshane Nchabeleng, Linda Gail Bekker, Philip Kotze, Thembisile Mogodiri, Ishana Naidoo, Ravindre Panchia, Landon Myer, Carl Lombard, Gustavo F. Doncel, Glenda Gray, Sinead Delany-Moretlwe

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)


Background:During pregnancy and postpartum period, the sexual behaviors of women and their partners change in ways that may either increase or reduce HIV risks. Pregnant women are a priority population for reducing both horizontal and vertical HIV transmission.Setting:Nine sites in 4 South African provinces.Methods:Women aged 18-30 years were randomized to receive pericoital tenofovir 1% gel or placebo gel and required to use reliable modern contraception. We compared HIV incidence in women before, during, and after pregnancy and used multivariate Cox Proportional hazards models to compare HIV incidence by pregnancy status.Results:Rates of pregnancy were 7.1 per 100 woman-years (95% confidence interval [CI]: 6.3 to 8.1) and highest in those who reported oral contraceptive use (25.1 per 100 woman-years; adjusted hazard ratio 22.97 higher than other women; 95% CI: 5.0 to 105.4) or had 2 children. Birth outcomes were similar between trial arms, with 59.8% having full-term live births. No difference was detected in incident HIV during pregnancy compared with nonpregnant women (2.1 versus 4.3%; hazard ratio = 0.56, 95% CI: 0.14 to 2.26). Sexual activity was low in pregnancy and the early postpartum period, as was consistent condom use.Conclusions:Pregnancy incidence was high despite trial participation being contingent on contraceptive use. We found no evidence that rates of HIV acquisition were elevated in pregnancy when compared with those in nonpregnant women. Risks from reductions in condom use may be offset by reduced sexual activity. Nevertheless, high HIV incidence in both pregnant and nonpregnant women supports consideration of introducing antiretroviral-containing pre-exposure prophylaxis for pregnant and nonpregnant women in high HIV prevalence settings.

Original languageEnglish
Pages (from-to)376-383
Number of pages8
JournalJournal of Acquired Immune Deficiency Syndromes
Issue number4
Publication statusPublished - 1 Dec 2021


  • HIV prevention
  • South Africa
  • cohort
  • drug safety in pregnancy
  • pregnancy
  • risk factors
  • sexual behavior


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