Risk‐based versus universal PrEP delivery during pregnancy: a cluster randomized trial in Western Kenya from 2018 to 2019

Abstract

Introduction Integrating pre‐exposure prophylaxis (PrEP) delivery for pregnant and postpartum women within maternal and child health (MCH) clinics is feasible and acceptable. It is unknown whether a risk‐guided model would facilitate appropriate PrEP use among MCH attendees better than universally offering PrEP. Methods The PrEP Implementation for Mothers in Antenatal Care (PrIMA) study was a cluster randomized trial to assess two models for PrEP delivery among pregnant women seeking routine MCH care at 20 public clinics in Kenya between January 2018 and July 2019 (NCT03070600). In the Universal arm, all participants received PrEP counselling and self‐selected whether to initiate PrEP. In the Targeted arm, participants underwent an HIV risk assessment, including an objective risk‐scoring tool and an offer of HIV self‐tests for at‐home partner testing; those determined to be at high risk received a PrEP offer. Participants were followed through 9 months postpartum. Primary outcomes included incident HIV and appropriate PrEP use (defined as PrEP uptake among those at high risk and no PrEP uptake for those not at risk). Outcomes were compared using intention‐to‐treat analyses, adjusting for baseline HIV risk and marital status. Results Among 4447 women enrolled, the median age was 24.0 years (interquartile range [IQR]: 20.9, 28.3), and most were married (84.8%). The median gestational age at enrolment was 24 weeks (IQR: 20, 30). Women in the Targeted arm were more likely to be at high risk for HIV acquisition at baseline (51.6% vs. 33.3%). During 4638 person‐years (p‐yr) of follow‐up, there were 16 maternal HIV infections with no difference in maternal HIV incidence between arms: 0.31/100 p‐yr (95% CI: 0.15, 0.65) Targeted and 0.38/100p‐yr (95% CI: 0.20, 0.73) Universal (adjusted relative risk [aRR]: 0.85 [CI: 0.28, 2.55]). There was no significant difference in the frequency of appropriate PrEP use between the arms (68.2% vs. 59.1% in Targeted vs. Universal, respectively) (aRR: 1.03 [CI: 0.96, 1.10]). Conclusions Given comparable maternal HIV incidence and PrEP uptake in Universal and Targeted approaches, and the simplicity that universal PrEP offers, our findings suggest that universal PrEP counselling is optimal for integrating PrEP in MCH systems.

Awareness of and willingness to use oral pre-exposure prophylaxis (PrEP) for HIV prevention among sexually active adults in Malawi: results from the 2020 Malawi population-based HIV impact assessment

“…This specific willingness to take PrEP by those with a perceived high risk may support the need to improve access to PrEP to all persons. A cluster randomized trial in Kenya reported no difference in PrEP uptake and HIV incidence between risk-based and universal PrEP delivery strategies in pregnant women [ 21 ]. The universal approach was reported to be less time-consuming and did not expose clients to uncomfortable discussions, hence being simpler [ 22 ].…”

Implementation determinants and strategies in integration of PrEP into maternal and child health and family planning services: experiences of frontline healthcare workers in Kenya

“…For example, in PrIYA uptake was 22% among pregnant and postpartum women and other AGYW ( 15 , 16 ). In the PrIMA trial, which also involved additional staff support, PrEP acceptance was 18.6% among pregnant and postpartum women ( 29 ). In contrast, PrEP uptake was substantially lower in the PrEPARE implementation science study focused on MCH, which did not provide additional staff, at 3.9% among those offered PrEP ( 30 ) ( Sila & Wagner, under revision ).…”

“…One study utilized standardized patient actors to address lack of effective provider training and found that the training was associated with significantly improved counseling quality ( 34 ). The PrIMA study tested risk-guided versus universal offer of PrEP to assess whether a simplified PrEP offer was sufficient within routine practice to alleviate the time burden of PrEP-specific risk screening; this trial concluded that universal offer is superior to risk-guided offer due to its simplicity and comparable performance ( 29 ). Point-of-care sexually transmitted infection testing was assessed to address the barrier of low risk perception; this pilot found that PrEP uptake was significantly higher among women who accepted point-of-care sexually transmitted infection testing ( 35 ) and point-of-care testing was highly acceptable ( 36 ).…”

Integrating PrEP in maternal and child health clinics in Kenya: analysis of a service availability and readiness assessment (SARA) survey

“…PrIMA description : Finally, PrIMA was a research study that provided additional staff to assist in study activities. The 20 public clinic sites involved in PrIMA were assigned to one of two arms in a cluster randomized trial; pregnant women seeking routine MCH care at these clinics either (a) self-selected into PrEP after receipt of PrEP counseling (Universal arm), or (b) were evaluated for HIV risk via an objective risk-scoring tool and offered HIV self-tests for at-home partner testing (Targeted arm) ( 32 , 33 ). In the Targeted arm, only individuals determined to be high risk for HIV acquisition were offered PrEP.…”