DISCUSSION
HIV infections, two‐thirds
HIV INFECTIONS
In this cRCT, we found that a risk‐guided PrEP offer (Targeted) was not superior to a Universal PrEP offer, based on appropriate PrEP decision and HIV incidence, among women attending MCH in high HIV prevalence regions of Kenya. The frequency of appropriate PrEP decisions did not differ significantly between the study arms, HIV incidence was low in both arms and PrEP continuation was high. These results demonstrate that PrEP decision‐making was not improved by risk‐guided counselling. Universal PrEP offer following simple standard counselling resulted in a comparable proportion of women making appropriate PrEP decisions as the risk‐guided approach.Maternal HIV incidence in this cohort was approximately seven‐fold lower than in a prior study, of pregnant and postpartum women in western Kenya conducted between 2011 and 2013 (maternal HIV incidence of 2.31/100 py) [We found that almost two‐thirds of women made appropriate decisions regarding PrEP use in either study arm. In a qualitative study of HCW perspectives on delivering PrEP to pregnant and postpartum women, it was noted that risk‐guided counselling took time and uncovered issues that were sometimes challenging or uncomfortable to discuss [Our results suggest a Universal approach may be the simplest and most effective option for PrEP counselling in MCH as no screening is required to reach similar levels of appropriate PrEP use and HIV incidence as a risk‐guided strategy. A Universal PrEP offer approach lends itself to group counselling strategies and may allow for task shifting to reduce the burden on nurses. Universal PrEP offer allows women to control all aspects of the PrEP cascade, including assessing their own risk and deciding whether PrEP is the right option. Universal PrEP offer may reduce stigma as it is being generally discussed and not targeted to certain women. Universal PrEP counselling also increases community awareness of PrEP, which can influence PrEP decision‐making and reduce stigma [Our Targeted arm strategy included the provision of HIVST for partner testing. We found high uptake (>60%) of HIVST with very high levels of partner use (>80%). The greatest drop off in HIVST use was at the point of HIVST acceptance by participants, when participants were advised not to accept or offer HIVST to their partners if there were concerns about IPV or negative repercussions. Based on this, additional research is needed to identify strategies to support participants at risk of IPV in partner HIV testing. Almost 100% of women whose partner tested reported seeing the results with their partner. In the Targeted arm, the proportion of women who did not know their partner's status declined from >40% to 18.8% by the end of the study, the majority of cases identified an HIV‐negative partner and decreased the likelihood of being classified “high risk.” At enrolment, some women in the Targeted arm classified as high risk due to unknown partner status correctly speculated that their partner was HIV negative and declined PrEP. HIVST helped women who initiated PrEP discontinue PrEP if they found their partner was negative. Others with a newly identified HIV‐negative partner may have continued PrEP due to having other partners or suspicions of infidelity. The HIVST uptake and impact in the Targeted arm suggests that offering HIVST in MCH clinics for partner testing along with a Universal PrEP offer could be an important strategy.Future implementation science research will be useful to refine strategies for Universal PrEP counselling in MCH including determining whether task shifting of components of the PrEP delivery cascade is appropriate [This study has strengths and limitations. This was a large multisite cRCT with high retention (94%). We included HIV PCR confirmatory testing for all potential new maternal HIV infections [