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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. [ABSTRACT FROM AUTHOR]

In a pre-exposure prophylaxis program for Kenyan women, we detected tenofovir-diphosphate in 61% (125/201) of randomly selected dried blood spots collected at the first follow-up visit. Tenofovir-diphosphate was detected more frequently among women who had partners living with human immunodeficiency virus, who were not pregnant, and who were ≥24 years. [ABSTRACT FROM AUTHOR]

Introduction: The World Health Organization, while recommending pre‐exposure prophylaxis (PrEP) for HIV‐negative pregnant and postpartum women in HIV high‐burden settings, advocates for continued safety evaluation of PrEP in this population. Methods: The PrEP Implementation in Young Women and Adolescents (PrIYA) program delivered PrEP to pregnant and postpartum women integrated within routine maternal and child health clinics (MCH) at 16 sites in Western Kenya. PrEP exposure and perinatal outcome data were collected among women obtaining postnatal services during programme evaluation. PrEP use was self‐reported and confirmed with clinical records. Perinatal outcomes including gestational age at birth, birthweight, congenital malformations and infant growth outcomes were abstracted from clinical records for mother‐infant pairs attending the six week visit. Associations between infant outcomes and maternal prenatal PrEP use were assessed using univariate and multivariate logistic and linear regression. Results: The PrIYA evaluation identified 1530 postpartum mother‐infant pairs with data on prenatal PrEP exposure: 206 with prenatal PrEP use, 1324 without. Median maternal age was 24 years in both groups. PrEP users (any reported PrEP use) were significantly more likely to report HIV risk factors such as: intimate partner violence, sexually transmitted infections and having a partner with positive or unknown HIV status. Most mothers initiated PrEP during the second trimester (n = 116, 57%) and used PrEP for more than one month (n = 110, 58%). The mean birthweight was 3.3 kg and gestational age at birth was 38.5 weeks in both groups. There were no major differences between PrEP exposed and unexposed infants in rates of preterm birth and low birthweight. There were no congenital malformations identified in the PrEP‐exposed group and five reported in the PrEP unexposed group. At six weeks postpartum, infants in both groups had similar growth. No differences in infant outcomes were found by duration PrEP exposure, trimester of PrEP initiation, a subset analysis of women 15 to 24 years old or in multivariate analyses. This analysis demonstrates that monitoring of infant outcomes is feasible within large‐scale programmatic implementation of PrEP among pregnant and postpartum populations. Conclusions: Pregnancy outcomes and early infant growth did not differ by PrEP exposure. [ABSTRACT FROM AUTHOR]

We sought to understand influences on PrEP uptake among Kenyan adolescent girls and young women (AGYW) whose decision on PrEP use was misaligned with their risk for HIV acquisition. In-depth interviews were conducted with 47 Kenyan HIV-negative AGYW aged 15–24 years who were offered PrEP during routine maternal and child health and family planning services. AGYW were sampled from two groups (1) declined PrEP and had ≥1 sexual partner(s) of unknown HIV status and (2) initiated PrEP and reported having one HIV-negative partner. AGYW with HIV-negative partners initiated PrEP due to known or suspected infidelity. AGYW with partners of unknown HIV status recognized PrEP as a helpful HIV prevention tool, yet worried about partner reactions and prioritized avoiding uncomfortable or unsafe situations over PrEP. Among pregnant AGYW, the responsibility of motherhood and providing a future for one's family, through staying healthy and remaining HIV-free, was a strong PrEP use motivator. Among AGYW who desired future motherhood, fears that PrEP could negatively impact fertility or reduce contraceptive effectiveness led to declining PrEP. Peers positively influenced PrEP decision-making, especially personally knowing a PrEP user. Strategies are needed to enhance messaging and delivery approaches that are tailored to AGYW, including peer-led strategies. [ABSTRACT FROM AUTHOR]

Some data gaps will be addressed in an ongoing cluster randomized trial evaluating PrEP delivery approaches in antenatal care (ANC) visits [10] (PrEP Implementation for Mothers in Antenatal Care (PrIMA, NCT03070600)). ANC, antenatal care; PrEP, pre-exposure prophylaxis; PrIMA, PrEP Implementation for Mothers in Antenatal Care. Perinatal outcomes following maternal pre-exposure prophylaxis (PrEP) use during pregnancy: results from a large PrEP implementation program in Kenya. [Extracted from the article]

In sub-Saharan Africa little is known about how often women use pregnancy self-tests or characteristics of these women despite evidence that pregnancy self-testing is associated with early antenatal care (ANC) initiation. Understanding the characteristics of women who use pregnancy self-tests can facilitate more targeted efforts to improve pregnancy testing experiences and entry into the ANC pathway. We conducted a cross-sectional survey among pregnant women enrolling in a pre-exposure prophylaxis (PrEP) implementation study to determine the prevalence and factors associated with pregnancy self-testing among women in western Kenya. Overall, in our study population, 17% of women obtained a pregnancy self-test from a pharmacy. Pregnancy test use was higher among employed women, women with secondary and college-level educated partners, and women who spent 30 minutes or less traveling to the maternal and child health (MCH) clinic. The most reported reasons for non-use of pregnancy self-tests included not thinking it was necessary, lack of knowledge, and money to pay for the test. Future research should focus on understanding the knowledge and attitudes of women toward pregnancy self-testing as well as developing community-based models to improve access to pregnancy testing and ANC. [ABSTRACT FROM AUTHOR]

Background: Discontinuation of daily oral pre-exposure prophylaxis (PrEP) is frequent among adolescent girls and young women (AGYW) in African settings. We explored factors influencing early PrEP discontinuation and persistence among Kenyan AGYW who accepted PrEP within a programmatic setting. Methods: We conducted in-depth interviews with AGYW (aged 15-24 years) who accepted PrEP from 4 maternal child health (MCH) and family planning (FP) clinics. AGYW were identified by nurses at routine clinic visits and purposively sampled based on 4 categories: (1) accepted PrEP pills, but never initiated PrEP use (eg, never swallowed PrEP pills), (2) discontinued PrEP <1 month after initiation, (3) discontinued PrEP within 1-3 months, and (4) persisted with PrEP use >3 months. Informed by the Stages of Change Model, thematic analysis characterized key influences on PrEP discontinuation/persistence. Results: We conducted 93 in-depth interviews with AGYW who accepted pills. Median age was 22 years, 71% were married; 89% were from MCH, and 11% were from FP clinics. Early PrEP use was positively influenced by encouragement from close confidants and effective concealment of PrEP pill-taking when necessary to avoid stigma or negative reactions from partners. Pregnancy helped conceal PrEP use because pill-taking is normalized during pregnancy, but concealment became more difficult postpartum. AGYW found keeping up with daily PrEP pill-taking challenging, and many noted only episodic periods of the HIV risk. Frequently testing HIV-negative reassured AGYW that PrEP was working and motivated persistence. Discussion: As PrEP programs scale-up in MCH/FP, it is increasingly important to enhance protection-effective PrEP use through approaches tailored to AGYW, with special considerations during pregnancy and postpartum. [ABSTRACT FROM AUTHOR]

Adolescent girls and young women (AGYW) are a priority population for HIV prevention in high-burden settings. We evaluated psychosocial characteristics, behavioral risk factors for HIV, and pre-exposure prophylaxis (PrEP) awareness and uptake among AGYW seeking contraceptive services at four public sector family planning (FP) clinics offering integrated PrEP delivery in Kisumu, Kenya. From October 2018 to June 2019, we approached all AGYW (aged 15–24 years) seeking contraception to participate in a survey following receipt of FP services and PrEP screening. Overall, 470 AGYW were screened for PrEP at their FP visit by facility staff and subsequently enrolled in the survey. Median age was 22 years (interquartile range 20–23), 22% of AGYW were in school, and 55% were married. The most frequent forms of contraception were implants and injectables (41% each). Over a third of AGYW (36%) reported low social support, 13% had symptoms of moderate to severe depression, and 3% reported intimate partner violence. Three-quarters (75%) of AGYW reported recent condomless sex and 42% suspected that their primary partner had other sexual partners. Most AGYW (89%) had previously heard of PrEP; 76% had at least one PrEP eligibility criterion as per national guidelines; however, only 4% initiated PrEP at their current FP visit. PrEP initiators more frequently had high HIV risk perception than noninitiators (85% vs. 10%, p < 0.001). Low perceived HIV risk (76%) and pill burden (51%) were common reasons for declining PrEP among AGYW with HIV behavioral risk factors. PrEP counseling should be tailored to AGYW to guide appropriate PrEP decision-making in this important population. [ABSTRACT FROM AUTHOR]

Background: Young women account for a disproportionate fraction of new HIV infections in Africa and are a priority population for HIV prevention, including implementation of preexposure prophylaxis (PrEP). The overarching goal of this project was to demonstrate the feasibility of integrating PrEP delivery within routine family planning (FP) clinics to serve as a platform to efficiently reach at-risk adolescent girls and young women (AGYW) for PrEP in HIV high-burden settings.Methods and Findings: The PrEP Implementation in Young Women and Adolescents (PrIYA) program is a real-world implementation program to demonstrate integration of PrEP delivery for at-risk AGYW in FP clinics in Kisumu, Kenya. Between November 2017 and June 2018, women aged 15 to 45 from the general population seeking FP services at 8 public health clinics were universally screened for HIV behavioral risk factors and offered PrEP following national PrEP guidelines. We evaluated PrEP uptake and continuation, and robust Poisson regression methods were used to identify correlates of uptake and early continuation of PrEP, with age included as a one-knot linear spline. Overall, 1,271 HIV-uninfected women accessing routine FP clinics were screened for PrEP; the median age was 25 years (interquartile range [IQR]: 22-29), 627 (49%) were <24 years old, 1,026 (82%) were married, more than one-third (34%) had partners of unknown HIV status, and the vast majority (n = 1,200 [94%]) reported recent condom-less sex. Of 1,271 women screened, 278 (22%) initiated PrEP, and 114 (41%) returned for at least one refill visit after initiation. PrEP uptake was independently associated with reported male-partner HIV status (HIV-positive 94%, unknown 35%, HIV-negative 8%; p < 0.001) and marital status (28% unmarried versus married 21%; p = 0.04), and a higher proportion of women ≥24 years (26%; 191/740) initiated PrEP compared to 16% (87/531) of young women <24 years (p < 0.001). There was a moderate and statistically non-significant unadjusted increase in PrEP uptake among women using oral contraception pills (OCPs) compared to women using injectable or long-acting reversible contraception methods (OCP 28% versus injectable/implants/intrauterine devices [IUDs] 18%; p = 0.06). Among women with at least one post-PrEP initiation follow-up visit (n = 278), no HIV infection was documented during the project period. Overall, continuation of PrEP use at 1, 3, and 6 months post initiation was 41%, 24%, and 15%, respectively. The likelihood for early continuation of PrEP use (i.e., return for at least one PrEP refill within 45 days post initiation) was strongly associated with reported male-partner HIV status (HIV-positive 67%, -negative 39%, unknown 31%; overall effect p = 0.001), and a higher proportion of women ≥24 years old continued PrEP at 1 month compared with young women <24 years old (47% versus 29%; p = 0.002). For women ≥24 years old, the likelihood to continue PrEP use at 1 month post initiation increased by 3% for each additional year of a woman's age (adjusted prevalence ratio [PR]: 1.03; 95% confidence interval [CI]: 1.01-1.05; p = 0.01). In contrast, for women <24 years old, the likelihood of continuing PrEP for each additional year of a woman's age was high in magnitude (approximately 6%) but statistically non-significant (adjusted PR: 1.06; 95% CI: 0.97-1.16; p = 0.18). Frequently reported reasons for discontinuing PrEP were low perceived risk of HIV (25%), knowledge that partner was HIV negative (24%), experiencing side effects (20%), and pill burden (17%). Study limitations include lack of qualitative work to provide insights into women's decision-making on PrEP uptake and continuation, the small number of measured covariates imposed by the program data, and a nonrandomized design limiting definitive ascertainment of the robustness of a PrEP-dedicated nurse-led implementation strategy.Conclusions: In this real-world PrEP implementation program in Kenya, integration of universal screening and counseling for PrEP in FP clinics was feasible, making this platform a potential "one-stop" location for FP and PrEP. There was a high drop-off in PrEP continuation, but a subset of women continued PrEP use at least through 1 month, possibly indicating further reflection or decision-making on PrEP use. Greater efforts to support PrEP normalization and persistence for African women are needed to help women navigate their decisions about HIV prevention preferences as their reproductive goals and HIV vulnerability evolve. [ABSTRACT FROM AUTHOR]

Background: Young women account for a disproportionate fraction of new HIV infections in Africa and are a priority population for HIV prevention, including implementation of preexposure prophylaxis (PrEP). The overarching goal of this project was to demonstrate the feasibility of integrating PrEP delivery within routine family planning (FP) clinics to serve as a platform to efficiently reach at-risk adolescent girls and young women (AGYW) for PrEP in HIV high-burden settings. Methods and findings: The PrEP Implementation in Young Women and Adolescents (PrIYA) program is a real-world implementation program to demonstrate integration of PrEP delivery for at-risk AGYW in FP clinics in Kisumu, Kenya. Between November 2017 and June 2018, women aged 15 to 45 from the general population seeking FP services at 8 public health clinics were universally screened for HIV behavioral risk factors and offered PrEP following national PrEP guidelines. We evaluated PrEP uptake and continuation, and robust Poisson regression methods were used to identify correlates of uptake and early continuation of PrEP, with age included as a one-knot linear spline. Overall, 1,271 HIV-uninfected women accessing routine FP clinics were screened for PrEP; the median age was 25 years (interquartile range [IQR]: 22–29), 627 (49%) were <24 years old, 1,026 (82%) were married, more than one-third (34%) had partners of unknown HIV status, and the vast majority (n = 1,200 [94%]) reported recent condom-less sex. Of 1,271 women screened, 278 (22%) initiated PrEP, and 114 (41%) returned for at least one refill visit after initiation. PrEP uptake was independently associated with reported male-partner HIV status (HIV-positive 94%, unknown 35%, HIV-negative 8%; p < 0.001) and marital status (28% unmarried versus married 21%; p = 0.04), and a higher proportion of women ≥24 years (26%; 191/740) initiated PrEP compared to 16% (87/531) of young women <24 years (p < 0.001). There was a moderate and statistically non-significant unadjusted increase in PrEP uptake among women using oral contraception pills (OCPs) compared to women using injectable or long-acting reversible contraception methods (OCP 28% versus injectable/implants/intrauterine devices [IUDs] 18%; p = 0.06). Among women with at least one post-PrEP initiation follow-up visit (n = 278), no HIV infection was documented during the project period. Overall, continuation of PrEP use at 1, 3, and 6 months post initiation was 41%, 24%, and 15%, respectively. The likelihood for early continuation of PrEP use (i.e., return for at least one PrEP refill within 45 days post initiation) was strongly associated with reported male-partner HIV status (HIV-positive 67%, -negative 39%, unknown 31%; overall effect p = 0.001), and a higher proportion of women ≥24 years old continued PrEP at 1 month compared with young women <24 years old (47% versus 29%; p = 0.002). For women ≥24 years old, the likelihood to continue PrEP use at 1 month post initiation increased by 3% for each additional year of a woman's age (adjusted prevalence ratio [PR]: 1.03; 95% confidence interval [CI]: 1.01–1.05; p = 0.01). In contrast, for women <24 years old, the likelihood of continuing PrEP for each additional year of a woman's age was high in magnitude (approximately 6%) but statistically non-significant (adjusted PR: 1.06; 95% CI: 0.97–1.16; p = 0.18). Frequently reported reasons for discontinuing PrEP were low perceived risk of HIV (25%), knowledge that partner was HIV negative (24%), experiencing side effects (20%), and pill burden (17%). Study limitations include lack of qualitative work to provide insights into women's decision-making on PrEP uptake and continuation, the small number of measured covariates imposed by the program data, and a nonrandomized design limiting definitive ascertainment of the robustness of a PrEP-dedicated nurse-led implementation strategy. Conclusions: In this real-world PrEP implementation program in Kenya, integration of universal screening and counseling for PrEP in FP clinics was feasible, making this platform a potential "one-stop" location for FP and PrEP. There was a high drop-off in PrEP continuation, but a subset of women continued PrEP use at least through 1 month, possibly indicating further reflection or decision-making on PrEP use. Greater efforts to support PrEP normalization and persistence for African women are needed to help women navigate their decisions about HIV prevention preferences as their reproductive goals and HIV vulnerability evolve. Kenneth Mugwanya and colleagues report on implementation of a pre-exposure prophylaxis programme for young women and adolescent girls at risk of HIV infection, in Kenya. Author summary: Why was this study done?: Adolescent girls and young women (AGYW) in Africa are disproportionately affected by HIV infections because of cultural, structural, biological, and behavior factors. Preexposure prophylaxis (PrEP), as a highly potent and recommended discreet user-controlled HIV prevention strategy, has the potential to substantially reduce new HIV infections in African women if delivered with high coverage and if used with sufficient adherence. However, data are limited on "real-world" implementation approaches to efficiently reach at-risk women who may benefit from PrEP. Family planning (FP) clinics provide care to young women at risk for acquiring HIV and have in-built staffing, supply chain, and HIV testing access, which could contribute to more efficient PrEP implementation with less cost, but no study has evaluated this model in "real-world" settings. What did the researchers do and find?: We conducted a pilot open-label, "real-world" implementation program to evaluate the feasibility of integrating PrEP delivery into routine FP clinics to reach HIV at-risk young women. General-population women accessing FP services were universally screened for HIV behavior risk factors and were counseled for PrEP by program-dedicated nurses embedded in 8 public health FP clinics in a high–HIV-prevalence region in Kenya. We found that FP clinics can be an effective platform to efficiently reach HIV at-risk women who may benefit from PrEP. PrEP screening was feasible, and 22% of the general population of women took PrEP home. There was a high drop-off in early PrEP continuation (41% PrEP continuation at 1 month) particularly among AGYW <24 years old, but a subset of women persisted on PrEP (25% at month 3 and 15% at month 6), with higher continuation among women with HIV-positive partners, possibly indicating further reflection or decision-making on PrEP use. Women's perceived risk for HIV, including having an HIV-positive partner, was an important driver of initiation and continuation on PrEP. What do these findings mean?: To our knowledge, this project provides the first demonstration of "real-world" delivery of PrEP for at-risk AGYW integrated into FP clinics in Africa, a priority population for HIV prevention. These findings demonstrate that it may be feasible to integrate PrEP delivery in public health FP clinics, making this a platform potential "one-stop" location for FP and PrEP. With expanding PrEP awareness, uptake and continuation are likely to increase among women at risk. Evidence from this work will inform next steps for wider delivery of PrEP and next-generation PrEP formulations (e.g., multipurpose HIV prevention and contraception technologies) in FP clinics, not only in Kenya but in other resource-limited settings globally. [ABSTRACT FROM AUTHOR]

Introduction: Long‐acting pre‐exposure prophylaxis (PrEP) options could overcome barriers to oral PrEP persistence during pregnancy and postpartum. We evaluated long‐acting PrEP preferences among oral PrEP‐experienced pregnant and postpartum women in South Africa and Kenya, countries with high PrEP coverage with pending regulatory approvals for long‐acting injectable cabotegravir and the dapivirine vaginal ring (approved in South Africa, under review in Kenya). Methods: From September 2021 to February 2022, we surveyed pregnant and postpartum women enrolled in oral PrEP studies in South Africa and Kenya. We evaluated oral PrEP attitudes and preferences for long‐acting PrEP methods in multivariable logistic regression models adjusting for maternal age and country. Results: We surveyed 190 women in South Africa (67% postpartum; median age 27 years [IQR = 22–32]) and 204 women in Kenya (79% postpartum; median age 29 years [IQR = 25–33]). Seventy‐five percent of participants reported oral PrEP use within the last 30 days. Overall, forty‐nine percent of participants reported negative oral PrEP attributes, including side effects (21% South Africa, 30% Kenya) and pill burden (20% South Africa, 25% Kenya). Preferred PrEP attributes included long‐acting method, effectiveness, safety while pregnant and breastfeeding, and free medication. Most participants (75%, South Africa and Kenya) preferred a potential long‐acting injectable over oral PrEP, most frequently for a longer duration of effectiveness in South Africa (87% South Africa, 42% Kenya) versus discretion in Kenya (5% South Africa, 49% Kenya). Eighty‐seven percent of participants preferred oral PrEP over a potential long‐acting vaginal ring, mostly due to concern about possible discomfort with vaginal insertion (82% South Africa, 48% Kenya). Significant predictors of long‐acting PrEP preference included past use of injectable contraceptive (aOR = 2.48, 95% CI: 1.34, 4.57), disliking at least one oral PrEP attribute (aOR = 1.72, 95% CI: 1.05, 2.80) and preferring infrequent PrEP use (aOR = 1.58, 95% CI: 0.94, 2.65). Conclusions: Oral PrEP‐experienced pregnant and postpartum women expressed a theoretical preference for long‐acting injectable PrEP over other modalities, demonstrating potential acceptability among a key population who must be at the forefront of injectable PrEP rollout. Reasons for PrEP preferences differed by country, emphasizing the importance of increasing context‐specific options and choice of PrEP modalities for pregnant and postpartum women. [ABSTRACT FROM AUTHOR]

Background: Pre-exposure prophylaxis (PrEP) delivery to adolescent girls and young women (AGYW) is scaling up in sub-Saharan African countries. Understanding how AGYW learn about PrEP is needed to inform programs seeking to reach AGYW with HIV prevention tools. Methods: AGYW (ages 15–24), attending routine family planning and maternal child health clinics in Kisumu, Kenya, participated in in-depth interviews. AGYW were recruited if they either declined or accepted PrEP when offered that day in clinic or were currently or previously on PrEP. Thematic analysis was used to identify key themes related to the type and quality of knowledge sources from which AGYW first became aware of PrEP. Results: Overall, 140 in-depth interviews were conducted with AGYW. The median age was 21.5 years (interquartile range: 20.0–23.0), 65% of participants were married, and almost half (45.7%) were currently taking PrEP. Participants reported learning about PrEP from 3 primary sources: (1) clinic-based education; (2) friends, family, or other PrEP users; and (3) media and community outreach. Participants who reported learning about PrEP from friends or family were highly enthusiastic about PrEP. The accuracy and completeness of knowledge varied with most inaccuracies around the cost, dosing, and who benefits from PrEP. Community outreach campaigns provided fewer details, resulting in more inaccurate information and distrust of information received. Conclusion: PrEP information reaches AGYW through many sources with variable accuracy and completeness. Training providers and peer leaders to disseminate thorough and accurate PrEP information when counseling AGYW could positively impact acceptance and proper use. [ABSTRACT FROM AUTHOR]

Introduction: HIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre‐exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout. Methods: We used a standard Preferred Reporting Items for Systematic Reviews and Meta‐Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)‐based oral PrEP safety in pregnant and breastfeeding HIV‐uninfected women. Results and discussion: We identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP‐exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV‐uninfected women who use PrEP during pregnancy and/or lactation. Conclusions: Expanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy. [ABSTRACT FROM AUTHOR]

Introduction: Understanding the cost of strategies to reach and deliver pre‐exposure prophylaxis (PrEP) to priority populations is essential to assess the cost‐effectiveness and budget impact of HIV prevention programmes. Providing PrEP through maternal and child health and family planning clinics offers a promising strategy to reach women in high HIV burden settings. We estimated incremental costs and explored the cost drivers of integrating PrEP delivery into routine maternal and child health and family planning services in Kenya. Methods: We conducted a costing study from the provider perspective within the PrEP Implementation for Young Women and Adolescents programme in western Kenya. We identified all within‐ and above‐facility activities supporting PrEP delivery and measured clinical service time using time‐and‐motion studies. We obtained input costs from programme budgets, expenditure records and staff interviews. We estimated changes in costs if creatinine testing were postponed from initiation to first follow‐up visit and if PrEP were prioritized to clients at high HIV risk using a behavioural risk assessment tool. We also projected costs under Ministry of Health (MOH) implementation assuming MOH salaries and programme supervision. We estimated annual numbers of PrEP visits from programme data abstracted from 16 facilities between November 2017 and June 2018. We report the cost per client‐month of PrEP dispensed in 2017 USD. Results: For an annual programme output of 24,005 screenings, 4198 PrEP initiations and 4427 follow‐up visits, the average cost per client‐month of PrEP dispensed in the study was $26.52. Personnel, drugs and laboratory tests comprised 43%, 25% and 14% of programme costs respectively. Postponing creatinine testing and prioritizing PrEP delivery to clients at high HIV risk reduced total programme costs by 8% and 14% respectively. In the MOH scenario assuming no changes in outputs, the projected cost per client‐month of PrEP dispensed decreased to $16.54 and total programme costs decreased by 38%. Conclusions: Incremental PrEP costs are sensitive to the service delivery strategy used to engage priority populations. Postponing creatinine testing and prioritizing PrEP delivery to clients at high HIV risk may reduce costs. Context‐specific cost data are crucial to assess the cost‐effectiveness and affordability of PrEP delivery models. [ABSTRACT FROM AUTHOR]