Pre-exposure prophylaxis uptake and early continuation among pregnant and post-partum women within maternal and child health clinics in Kenya: results from an implementation programme

Summary

Background

Pregnant women in settings with high HIV prevalence are at increased risk of HIV acquisition and subsequent vertical transmission. We implemented and evaluated a novel programme to provide pre-exposure prophylaxis (PrEP) in maternal and child health clinics in Kenya.

Methods

In collaboration with Kisumu County Department of Health, we integrated PrEP delivery within 16 maternal and child health clinics in Kisumu County (Kenya). Women and girls older than 15 years seeking maternal and child health services who tested HIV negative at that visit or within a month and were willing to receive PrEP counselling were interviewed to assess for HIV behavioural risk factors and offered PrEP. Correlates of PrEP initiation and continuation were assessed using Poisson regression in univariate and multivariate analyses. Potential correlates included in our analyses were age, marital status, marriage type, whether pregnant or post partum, gestational age (if pregnant), and HIV risk factors in the previous 6 months. Reasons for the decision to discontinue after having decided to initiate PrEP were evaluated. Women who initiated PrEP were followed up 1 month, 3 months, and 6 months after initiation.

Findings

Between Nov 20, 2017, and June 13, 2018, 9376 pregnant and post-partum women were assessed for behavioural risk factors and willingness to initiate PrEP. Overall, 2030 (21·7%) initiated PrEP, and 2027 had the status of their partner captured (153 [79·3%] of 193 women with partners living with HIV, 1178 [37·2%] of 3165 women with partners of unknown HIV status, and 696 [11·6%] of 5997 women with HIV-negative partners). Predictors of PrEP initiation in the multivariate analysis were: being younger than 24 years (adjusted prevalence ratio 1·14, 95% CI 1·02–1·28); having a partner living with HIV (6·96, 5·46–8·89) or of unknown HIV status (3·08, 2·50–3·81); gestational age of less than 26 weeks (1·22, 1·02–1·47); having been diagnosed or treated for a sexually transmitted infection (1·57, 1·20–2·06); having been forced to have sex (1·82, 1·38–2·42); having experienced intimate partner violence during the previous 6 months (1·65, 1·10–2·48); having shared needles while engaging in injection drug use (2·43, 1·69–3·50); and recurrent use of post-exposure prophylaxis (1·96, 1·36–2·82). Overall, 786 (38·7%) of 2030 women who initiated PrEP continued use after the first month, with 104 (68·0%) of 153 women who had a partner living with HIV continuing use. Having a partner living with HIV was the only predictor of PrEP continuation at 1 month in the multivariable model (1·98, 1·54–2·55). Frequent reasons for discontinuation were side effects and low HIV risk perception. No incident HIV infection was reported among women on PrEP.

Interpretation

Many women attending maternal and child health clinics had risk factors for HIV and elected to use PrEP, indicating that routinely accessed maternal and child health clinics can be an effective platform for PrEP delivery for young women. As PrEP awareness rises, PrEP provision in routine clinical settings such as maternal and child health facilities might contribute to decreased HIV incidence among young women.

Funding

US Department of State.

Introduction

High HIV incidence has been reported among pregnant and post-partum women in sub-Saharan Africa.1, 2, 3 A meta-analysis of 19 studies among pregnant and post-partum women representing 22 803 person-years estimated a HIV incidence of 3·8 cases per 100 person-years.⁴ This rate is similar to that reported among high-risk groups such as female sex workers and HIV-discordant couples.5, 6 The high HIV incidence estimates during pregnancy and after delivery are particularly concerning because they included all women, even those with HIV-uninfected partners, and because the new infections occurred despite reduced sexual activity in these periods.⁷

Research in context

Evidence before this study

In many regions of sub-Saharan Africa, young women are at high risk for HIV infection. Pregnancy and the post-partum period are associated with increased risk of HIV because of biological or behavioural factors. Many pregnant women do not know their partner's HIV status and are unable to negotiate condom use. Pre-exposure prophylaxis (PrEP) could decrease these women's risk for HIV and prevent onward transmission to their infants. PrEP is safe for use in pregnancy and during the post-partum period. WHO guidelines recommend PrEP for women at risk, including during pregnancy and the post-partum period. We searched PubMed for original research articles published between Sept 30, 2015 (first WHO PrEP guidelines), and Jan 31, 2019, on real-world delivery of PrEP integrated into maternal and child health clinics providing antenatal or postnatal care services. We used the search terms: “antenatal care”, “pre-exposure prophylaxis”, “PrEP”, “HIV prevention”, “maternal child health”, “postnatal care”, and “implementation”. We found no studies of real-world implementations of PrEP within routine antenatal care in sub-Saharan Africa. It was unclear whether women attending antenatal care would recognise their risk for HIV, accept PrEP, or continue PrEP after initiating. We only found one original research article, published by our team, on integration models for PrEP in maternal and child health clinics, but it did not provide real-world programmatic data on PrEP uptake or continuation in maternal and child health settings.

Added value of this study

Ours is the first study of real-world PrEP delivery for at-risk pregnant and post-partum women integrated into maternal and child health clinics in an African region with high HIV prevalence. Our results show that maternal and child health clinics can be an effective platform to reach women who need PrEP, and this integration could contribute to elimination of mother-to-child transmission by preventing both maternal and infant HIV infection. With expanding awareness, PrEP uptake and continuation is likely to increase among pregnant women at risk. Importantly, our data show that it is feasible to integrate PrEP delivery in maternal and child health clinics, making this a one-stop location for maternal and child health services and PrEP, which saves women time, increases accessibility, and supports efforts to eliminate mother-to-child transmission. Maternal and child health clinics have in-built staffing, supply chain, and serial HIV testing, which facilitates integrated PrEP delivery.

Implications of all the available evidence

In this first real-world implementation programme of PrEP within maternal and child health clinics in a setting with high HIV prevalence, we showed that pregnant and post-partum women accept PrEP when offered and that PrEP uptake aligns with behavioural risk factors. PrEP integration into public sector maternal and child health clinics is feasible and can be an important pillar of efforts to eliminate mother-to-child transmission.

A 2018 study modelling the risk of transmission per coital act among women with HIV-infected partners, found increased risk throughout pregnancy and the post-partum period, indicating a potential biological basis for heightened susceptibility.⁸ Increased susceptibility might also be due to male partners' sexual behaviour during this period.⁹ It is estimated that approximately 30% of new infant HIV infections are due to maternal HIV acquisition in pregnancy or the post-partum period.10, 11

The proportion of paediatric HIV infection from acute maternal HIV infection is likely to increase as the proportion of paediatric HIV infection from chronic HIV infection decreases as a result of prevention of mother-to-child HIV transmission programmes that routinely identify and treat women living with HIV. Therefore, primary HIV prevention during pregnancy and the post-partum period is essential to keep HIV-negative women uninfected and to achieve elimination of mother-to-child transmission of HIV.

WHO recommends a comprehensive HIV prevention package for pregnant and breastfeeding women that includes partner HIV testing and treatment, condom use, management of sexually transmitted infections, and offer of pre-exposure prophylaxis (PrEP) to women with substantial HIV risk.¹² PrEP is an effective HIV prevention strategy that allows women to be in charge of their HIV protection, does not require approval or knowledge of male partners, and is safe for infants.5, 13 Kenyan guidelines recommend PrEP for pregnant and breastfeeding women at substantial risk of HIV.¹⁴ Maternal and child health clinics offer a convenient platform for PrEP delivery since most women visit such clinics during pregnancy and after delivery. In a recent qualitative study, women expressed fears of being mistaken as HIV-infected if they were seen collecting drugs from HIV clinics.¹⁵ By contrast, maternal and child health clinics attend to women both living with HIV and not infected and provide medications such as prenatal vitamins; therefore they might offer a less stigmatising way of delivering PrEP.

However, there are unanswered questions regarding PrEP implementation in maternal and child health clinics. It is unknown whether pregnant and breastfeeding women perceive their HIV risk and will accept PrEP. Although there is a reassuring body of evidence showing the safety of PrEP during pregnancy and breastfeeding, women and their providers might remain concerned about effects of the drug on the fetus or baby, which could affect uptake.¹³ It is also unclear which pregnant or breastfeeding women should be offered PrEP and whether gastrointestinal side effects with PrEP initiation could exacerbate pregnancy-related gastrointestinal side effects and discourage adherence. In addition, while extensive data about PrEP implementation in high-income countries and some data about implementation in populations at risk in Africa are available, little is known about PrEP implementation among pregnant and breastfeeding women. To address these questions, we implemented a novel PrEP delivery programme within maternal and child health clinics. The goal of the PrEP Implementation for Young Women and Adolescents (PrIYA) programme was to provide real-world evidence on delivering PrEP to women attending maternal and child health clinics in a region with high HIV prevalence, particularly among adolescent girls and young women.