Risks of adverse perinatal outcomes in relation to maternal depressive symptoms: A prospective cohort study in Kenya.

BACKGROUND: Evidence gaps remain regarding the influence of prenatal psychosocial factors on adverse pregnancy outcomes. OBJECTIVE: The objective of this study is to evaluate relationships between psychosocial factors and adverse perinatal outcomes among Kenyan women. METHODS: We analysed data from a prospective cohort study enrolling HIV-negative women in pregnancy (NCT03070600) in 20 antenatal clinics in Western Kenya. Study nurses assessed depressive symptoms using the Center for Epidemiologic Studies Depression Scale (CESD-10), social support using the Medical Outcomes Survey scale (MOS-SSS), intimate partner violence (IPV) with the Hurt, Insult, Threaten, Scream scale (HITS), and pregnancy outcomes at 6 weeks postpartum. Cox proportional hazards models were used to evaluate relationships between depressive symptoms (moderate-to-severe [MSD, CESD-10 ≥10] and mild-to-severe [Mild-SD, CESD-10 ≥5]), low social support (MOS-SSS <72), and IPV (HITS ≥10) with adverse perinatal outcomes of pregnancy loss, stillbirth, preterm birth (PTB), small for gestational age, and neonatal mortality. We also estimated the population attributable risk. RESULTS: Among 4153 women, 23.9% (n = 994) had MSD, 54.7% (n = 2273) mild-SD, 37.3% (n = 1550) low social support, and 7.8% (n = 323) experienced IPV. Pregnancy loss was 5-fold higher among women with MSD (adjusted hazard ratio [HR] 5.04, 95% confidence interval [CI] 2.44, 10.42); 37.4% of losses were attributable to MSD. Mild-SD was associated with PTB (HR 1.39, 95% CI 1.03, 1.87). Stillbirth risk more than doubled among women reporting low social support (HR 2.37, 95% CI 1.14, 4.94). CONCLUSIONS: Adverse perinatal outcomes were common and associated with prenatal depressive symptoms and low social support in this large cohort of Kenyan mother-infant pairs.

Key influences on the decision to initiate PrEP among adolescent girls and young women within routine maternal child health and family planning clinics in Western Kenya.

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.

Challenges of Discrepant HIV Tests in Pregnant Women in the PrEP era-to Treat or Not to Treat?

BACKGROUND: During HIV retesting in antenatal and preexposure prophylaxis (PrEP) care, discrepant results occur, but guidelines are lacking. METHODS: In a Kenyan trial implementing antenatal PrEP, if 1 test is reactive, a second is performed; if discrepant, both are repeated; if persistently discrepant, DNA polymerase chain reaction (PCR) is performed. RESULTS: Among 4451 women, 23 265 HIV retesting sessions were performed; 14 (0.06%, 95% confidence interval, 0.03%-0.10%) had discrepant results among 10 individuals; in all 10 initial cases, PCR was negative. CONCLUSIONS: Discrepant rapid tests are an expected, rare, and important challenge for antenatal care HIV retesting, with and without PrEP. CLINICAL TRIALS REGISTRATION: NCT03070600.

Frequency and Predictors of Tenofovir-diphosphate Detection Among Young Kenyan Women in a Real-world Pre-exposure Prophylaxis Implementation Program.

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.

Factors Associated With Poor Linkage to Human Immunodeficiency Virus Care Among Index Clients and Sex Partners Receiving Human Immunodeficiency Virus Assisted Partner Services in Kenya.

INTRODUCTION: Human immunodeficiency virus (HIV) assisted partner services (aPS) has been recommended as a strategy to increase HIV case finding. We evaluated factors associated with poor linkage to HIV care among newly diagnosed HIV-positive individuals (index clients) and their partners after receiving aPS in Kenya. METHODS: In a cluster randomized trial conducted between 2013 and 2015, 9 facilities were randomized to immediate aPS (intervention). Linkage to care-defined as HIV clinic registration, and antiretroviral therapy (ART) initiation were self-reported. Antiretroviral therapy was only offered to those with CD4 less than 500 during this period. We estimated linkage to care and ART initiation separately for index clients and their partners using log-binomial generalized estimating equation models with exchangeable correlation structure and robust standard errors. RESULTS: Overall, 550 index clients and 621 sex partners enrolled, of whom 46% (284 of 621) were HIV-positive. Of the 284, 264 (93%) sex partners returned at 6 weeks: 120 newly diagnosed and 144 whom had known HIV-positive status. Among the 120 newly diagnosed, only 69% (83) linked to care at 6 weeks, whereas among the 18 known HIV-positive sex partners not already in care at baseline, 61% (11) linked. Newly diagnosed HIV-positive sex partners who were younger and single were less likely to link to care (P < 0.05 for all). CONCLUSION: Only two thirds of newly diagnosed, and known HIV-positive sex partners not in care linked to care after receiving aPS. The HIV aPS programs should optimize HIV care for newly diagnosed HIV-positive sex partners, especially those who are younger and single.

Integrating preexposure prophylaxis delivery in routine family planning clinics: A feasibility programmatic evaluation in Kenya.

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.

Surveillance of HIV assisted partner services using routine health information systems in Kenya.

BACKGROUND: The utilization of routine health information systems (HIS) for surveillance of assisted partner services (aPS) for HIV in sub-Saharan is sub-optimal, in part due to poor data quality and limited use of information technology. Consequently, little is known about coverage, scope and quality of HIV aPS. Yet, affordable electronic data tools, software and data transmission infrastructure are now widely accessible in sub-Saharan Africa. METHODS: We designed and implemented a cased-based surveillance system using the HIV testing platform in 18 health facilities in Kenya. The components of this system included an electronic HIV Testing and Counseling (HTC) intake form, data transmission on the Global Systems for Mobile Communication (GSM), and data collection using the Open Data Kit (ODK) platform. We defined rates of new HIV diagnoses, and characterized HIV-infected cases. We also determined the proportion of clients who reported testing for HIV because a) they were notified by a sexual partner b) they were notified by a health provider, or c) they were informed of exposure by another other source. Data collection times were evaluated. RESULTS: Among 4351 clients, HIV prevalence was 14.2 %, ranging from 4.4-25.4 % across facilities. Regardless of other reasons for testing, only 107 (2.5 %) of all participants reported testing after being notified by a health provider or sexual partner. A similar proportion, 1.8 % (79 of 4351), reported partner notification as the only reason for seeking an HIV test. Among 79 clients who reported HIV partner services as the reason for testing, the majority (78.5 %), were notified by their sexual partners. The majority (52.8 %) of HIV-infected patients initiated their HIV testing, and 57.2 % tested in a Voluntary Counseling and Testing (VCT) site co-located in a health facility. Median time for data capture was 4 min (IQR: 3-15), with a longer duration for HIV-infected participants, and there was no reported data loss. CONCLUSION: aPS surveillance using new technologies is feasible, and could be readily expanded into HIV registries in Kenya and other sub-Saharan countries. Partner services are under-utilized in Kenya but further documentation of coverage and implementation gaps for HIV and aPS services is required.

Cofactors of Partner HIV Self-testing and Oral PrEP Acceptance Among Pregnant Women at High Risk of HIV in Kenya.

BACKGROUND: Oral pre-exposure prophylaxis (PrEP) and male partner HIV self-testing (HIVST) is being scaled up within antenatal clinics. Few data are available on how co-distribution influences acceptance of both interventions. METHODS: We used data from the PrEP Implementation of Mothers in Antenatal Care (NCT03070600) trial in Kenya. Women included in this analysis were determined to be at high risk of HIV and offered oral PrEP and partner HIVST. Characteristics were compared between women who chose: (1) PrEP and HIVST, (2) HIVST-alone, (3) PrEP-alone, or (4) declined both (reference), excluding women who had partners known to be living with HIV. RESULTS: Among 911 women, median age was 24 years, 87.3% were married, 43.9% perceived themselves to be at high risk of HIV and 13.0% had history of intimate partner violence (IPV). Overall, 68.9% accepted HIVST and 18.4% accepted PrEP, with 54.7% accepting HIVST-alone, 4.2% PrEP-alone, and 14.3% both HIVST and PrEP. Of women accepting HIVST, partner HIV testing increased from 20% to 82% and awareness of partner HIV status increased from 4.7% to 82.0% between pregnancy and 9 months postpartum (P < 0.001). Compared with women who accepted neither, choosing: (1) HIVST-alone was associated with being married, higher level of education, and residing with partner; (2) PrEP-alone was associated with lower social support, IPV, not residing with partner, longer time living with partner, and suspicion of other partners; and (3) PrEP and HIVST was associated with being married, IPV, and suspicion that partner had other partners. CONCLUSIONS: Understanding factors associated with accepting HIVST and PrEP can inform HIV prevention programs for pregnant women. CLINICAL TRIAL NUMBER: NCT03070600.

Patient actor training improves preexposure prophylaxis delivery for adolescent girls and young women in Kenya: a cluster randomized trial.

OBJECTIVE: To evaluate effectiveness of a standardized patient actor (SP) training intervention to improve quality of preexposure prophylaxis (PrEP) services for adolescent girls and young women (AGYW) in Kenya. DESIGN: Cluster randomized trial and mystery shopper evaluation. METHODS: Twelve of 24 maternal child health and family planning facilities were randomized to SP training. Providers at intervention facilities participated in 2-day training in adolescent health, PrEP guidelines, values clarification, and communication skills, followed by role-playing and de-briefing with trained actors. Control facilities received standard national training. The primary outcome was quality of care, assessed by unannounced SPs (USPs) or "mystery shoppers" blinded to intervention arm. Quality was measured in two domains: guideline adherence and communication skills. Intent to treat analysis compared postintervention quality scores by randomization arm, clustering on facility, and adjusting for baseline scores and USP. RESULTS: Overall, 232 providers consented to USP visits, and 94 providers completed the training. Following training, USPs posed as AGYW seeking PrEP in 142 encounters (5-6 encounters per site). The mean quality score was 73.6% at intervention sites and 58.4% at control sites [adjusted mean difference = 15.3, 95% confidence interval (CI): 9.4-21.1, P  < 0.001]. Mean guideline adherence scores were 57.2% at intervention sites and 36.2% at control sites (adjusted mean difference = 21.0, 95% CI: 12.5-29.4, P  < 0.001). Mean communication scores were 90.0% at intervention sites and 80.5% at control sites (adjusted mean difference = 9.5, 95% CI: 5.5-13.6, P  < 0.001). CONCLUSIONS: SP training significantly improved quality of PrEP care for AGYW in Kenya. Incorporating SP training and unannounced SP evaluation could improve PrEP uptake among AGYW.

Comparing depression screening tools (CESD-10, EPDS, PHQ-9, and PHQ-2) for diagnostic performance and epidemiologic associations among postpartum Kenyan women: Implications for research and practice.

BACKGROUND: Identifying optimal depression screening tools for use in maternal health clinics could improve maternal and infant health. We compared four tools for diagnostic performance and epidemiologic associations. METHODS: This study was nested in a cluster-randomized trial in Kenya. Women in 20 maternal health clinics were evaluated at 6 weeks postpartum with Center for Epidemiologic Studies Depression Scale (CESD-10), Edinburgh Postnatal Depression Scale (EPDS), Patient Health Questionnaire-9 and -2 (PHQ-9, PHQ-2) for moderate-to-severe depressive symptoms (MSD) [CESD-10 ≥ 10, EPDS≥13, PHQ-9 ≥ 10, or PHQ-2 ≥ 3]. We assessed area under the curve (AUC) per scale (CESD-10, EPDS) against probable major depressive disorder (MDD) using the PHQ-9 scoring algorithm. Associations between MSD and intimate partner violence (IPV) were compared between scales. RESULTS: Among 3605 women, median age was 24 and 10 % experienced IPV. Prevalence of MSD symptoms varied by tool: 13 % CESD-10, 9 % EPDS, 5 % PHQ-2, 3 % PHQ-9. Compared to probable MDD, the CESD-10 (AUC:0.82) had higher AUC than the EPDS (AUC:0.75). IPV was associated with MSD using all scales: EPDS (RR:2.5, 95%CI:1.7-3.7), PHQ-2 (RR:2.3, 95%CI:1.6-3.4), CESD-10 (RR:1.9, 95%CI:1.2-2.9), PHQ-9 (RR:1.8, 95%CI:0.8-3.8). LIMITATIONS: Our study did not include clinical diagnosis of MDD by a specialized clinician, instead we used provisional diagnosis of probable MDD classified by the PHQ-9 algorithm as a reference standard in diagnostic performance evaluations. CONCLUSION: Depression screening tools varied in detection of postpartum MSD. The PHQ-2 would prompt fewer referrals and showed strong epidemiologic association with a cofactor.

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

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.

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

Background: Risk of HIV acquisition is high during pregnancy and postpartum, and pre-exposure prophylaxis (PrEP) is recommended for peripartum populations. Integrating PrEP into maternal and child health (MCH) clinics is feasible and acceptable. Understanding clinics' service availability and readiness is essential for effective scale up. Methods: The PrEP in Pregnancy, Accelerating Reach and Efficiency study (PrEPARE; NCT04712994) engaged PrEP-experienced facilities previously linked to a programmatic or research study in Western Kenya to document available services and commodities via a modified service availability and readiness assessment (SARA) survey with 20 PrEP tracer items covering: staffing/guidelines, services/equipment, and medicines/commodities. Facilities' prior study engagement occurred between 2017 and 2019; SARA survey data was collected between April 2020 and June 2021. Descriptive statistics were stratified by prior study engagement. ANOVA tests assessed associations between facility characteristics and gaps. Fisher's tests assessed differences in commodity availability and stockouts. Results: Of the 55 facilities surveyed, 60% had received PrEP training in the last two years, 95% offered PrEP integrated into MCH, and 64% and 78% had both auditory and visual privacy in PrEP and HIV testing service (HTS) delivery spaces, respectively. Supervision frequency was heterogeneous, but 82% had received a supervision visit within 3 months. Availability of commodities was variable and the most commonly unavailable commodities were PrEP in MCH (71% available) and risk assessment screening tool (RAST) and PrEP cards (60% and 75% available, respectively). The number of service and commodity gaps per facility ranged from zero to eight (median: 3; IQR: 2, 5). The most frequent gaps were: PrEP training and risk assessment cards (40% each), lack of privacy in PrEP (36%) and HIV testing services (31%) spaces, PrEP pills in MCH (29%), and PrEP cards (25%). There were no differences in mean number of gaps by county, previous study engagement, or public vs. private status. Level 4 facilities had fewer gaps (mean 2.2) than level 2, 3, and 5 facilities (mean 5.7, 4.5, and 5.3 respectively; p < 0.001). Conclusions: PrEP service availability and readiness was generally high across MCH facilities. However, there is a need for increased frequency of provider training and supportive supervision focused on fidelity. To address key commodity stockouts such as PrEP pills, implementation of electronic logistics management information systems may be needed. Targeting these gaps is essential to effectively scale up integrated PrEP delivery, especially among facilities with limited infrastructure.

HIV pre-exposure prophylaxis initiation, persistence, and adherence during pregnancy through the postpartum period.

OBJECTIVE: We evaluated pre-exposure prophylaxis (PrEP) initiation, persistence, and adherence measured via tenofovir-diphosphate (TFV-DP) concentrations in dried blood spots (DBS) among women offered PrEP during pregnancy. METHODS: We prospectively analyzed data from participants in the PrIMA Study (NCT03070600) who were offered PrEP during the second trimester and followed through 9 months postpartum. At follow-up visits (monthly in pregnancy; 6 weeks, 6 months, 9 months postpartum), self-reported PrEP use was assessed, and DBS were collected for quantifying TFV-DP concentrations. RESULTS: In total, 2949 participants were included in the analysis. At enrollment, median age was 24 years [interquartile range IQR) 21-29], gestational age 24 weeks (IQR 20-28), and 4% had a known partner living with HIV. Overall, 405 (14%) participants initiated PrEP in pregnancy with higher frequency among those with risk factors for HIV acquisition, including >2 lifetime sexual partners, syphilis during pregnancy, forced sex, and intimate partner violence ( P  < 0.05). At 9 months postpartum, 58% of PrEP initiators persisted with PrEP use, of which 54% self-reported not missing any PrEP pills in the last 30 days. Among DBS randomly selected from visits where participants persisted with PrEP ( n  = 427), 50% had quantifiable TFV-DP. Quantifiable TFV-DP was twice as likely in pregnancy than postpartum [adjusted risk ratio (aRR) = 1.90, 95% confidence interval (CI) 1.40-2.57, P  < 0.001]. Having a partner known to be living with HIV was the strongest predictor of PrEP initiation, persistence, and quantifiable TFV-DP ( P  < 0.001). CONCLUSIONS: PrEP persistence and adherence waned postpartum, though over half of PrEP initiators persisted through 9-months postpartum. Interventions should prioritize increasing knowledge of partner HIV status and sustaining adherence in the postpartum period.

COVID-19 vaccine hesitancy among pregnant and postpartum Kenyan women.

OBJECTIVE: The authors evaluated factors contributing to coronavirus disease 2019 (COVID-19) vaccine hesitancy among pregnant and postpartum women to inform vaccine scale-up strategies. METHODS: This observational study utilized data from pregnant and postpartum women attending four public maternal child health (MCH) clinics in Western Kenya. From October 2020 to July 2022, nurses assessed COVID-19 vaccine hesitancy, defined as reporting "unlikely" or "very unlikely" to the question, "If a vaccine for COVID-19 were available today, what is the likelihood that you would get vaccinated?" RESULTS: Among 1023 women (235 pregnant, 788 postpartum), 20% reported worsened MCH care during the pandemic and most (92%) perceived themselves or family members to be at risk for COVID-19, yet 54% of women reported COVID-19 vaccine hesitancy. Vaccine hesitancy was more frequent among women reporting worsened MCH care (P < 0.001) since the pandemic and those who did not trust the government as a source of COVID-19 information (P = 0.016). Over the 2-year period, willingness to receive the vaccine almost doubled (38% to 71%, P < 0.001). CONCLUSIONS: Our findings suggest that sustaining access to quality MCH services may decrease COVID-19 vaccine hesitancy. Willingness to receive the vaccine doubled over the 2-year period in our cohort, suggesting increased trust for use and acceptance in the unique context of the pregnancy/postpartum period.

Comparison of methods to engage diverse stakeholder populations in prioritizing PrEP implementation strategies for testing in resource-limited settings: a cross-sectional study.

BACKGROUND: There is a lack of consensus about how to prioritize potential implementation strategies for HIV pre-exposure prophylaxis (PrEP) delivery. We compared several prioritization methods for their agreement and pragmatism in practice in a resource-limited setting. METHODS: We engaged diverse stakeholders with clinical PrEP delivery and PrEP decision-making experience across 55 facilities in Kenya to prioritize 16 PrEP delivery strategies. We compared four strategy prioritization methods: (1) "past experience surveys" with experienced practitioners reflecting on implementation experience (N = 182); (2 and 3) "pre- and post-small-group ranking" surveys before and after group discussion (N = 44 and 40); (4) "go-zone" quadrant plots of perceived effectiveness vs feasibility. Kendall's correlation analysis was used to compare strategy prioritization using the four methods. Additionally, participants were requested to group strategies into three bundles with up to four strategies/bundle by phone and online survey. RESULTS: The strategy ranking correlation was strongest between the pre- and post-small-group rankings (Tau: 0.648; p < 0.001). There was moderate correlation between go-zone plots and post-small-group rankings (Tau: 0.363; p = 0.079) and between past-experience surveys and post-small-group rankings (Tau: 0.385; p = 0.062). For strategy bundling, participants primarily chose bundles of strategies in the order in which they were listed, reflecting option ordering bias. Neither the phone nor online approach was effective in selecting strategy bundles. Participants agreed that the strategy ranking activities conducted during the workshop were useful in prioritizing a final set of strategies. CONCLUSIONS: Both experienced and inexperienced stakeholder participants' strategy rankings tended to prioritize strategies perceived as feasible. Small group discussions focused on feasibility and effectiveness revealed moderately different priorities than individual rankings. The strategy bundling approach, though less time- and resource-intensive, was not effective. Future research should further compare the relative effectiveness and pragmatism of methodologies to prioritize implementation strategies.

An implementation strategy package (video education, HIV self-testing, and co-location) improves PrEP implementation for pregnant women in antenatal care clinics in western Kenya.

Background: Pre-exposure prophylaxis (PrEP) is recommended by the World Health Organization and the Kenyan Ministry of Health for HIV prevention in pregnancy and postpartum for women at risk for HIV. Integration of PrEP into antenatal care is promising, but delivery gaps exist in the face of healthcare provider shortages in resource-limited settings. Methods: Between May and November 2021, we conducted a difference-in-differences study (3 months pre-intervention data collection and 3 months post-intervention data collection) analyzing four intervention facilities, where the strategies were implemented, and four comparison facilities, where no strategies were implemented. We tested a combination of three implementation strategies-video-based PrEP information in the waiting bay, HIV self-testing, and dispensing of PrEP in the antenatal care rooms-to improve PrEP delivery. We compared absolute changes in the proportion of antenatal attendees screened for PrEP (PrEP penetration), the proportion receiving all PrEP-specific steps in a visit (HIV testing, risk screening, and PrEP counseling) (PrEP fidelity), and client PrEP knowledge, client satisfaction, and waiting time and service time (a priori outcomes); post hoc, we compared the proportion offered PrEP (PrEP offer) and completing HIV testing. We measured provider perceptions of the acceptability and appropriateness of the implementation strategies. Results: We observed significant improvements in PrEP penetration, PrEP offer, satisfaction, and knowledge (p < 0.05) and improvements in fidelity that trended towards significance (p = 0.057). PrEP penetration increased 5 percentage points (p = 0.008), PrEP fidelity increased 8 percentage points (p = 0.057), and PrEP offer increased 4 percentage points (p = 0.003) in intervention vs. comparison facilities. Client PrEP knowledge increased by 1.7 out of 6 total points (p < 0.001) and client satisfaction increased by 0.7 out of 24 total points (p = 0.003) in intervention vs. comparison facilities. We observed no changes in service time (0.09-min decrease; p = 0.435) and a small increase in waiting time (0.33-min increase; p = 0.005). HIV testing among those eligible did not change (1.5 percentage point decrease, p = 0.800). Providers felt the implementation strategies were acceptable and appropriate (median acceptability: 20/20; median appropriateness: 19.5/20). However, absolute levels of each step of the PrEP cascade remained suboptimal. Conclusions: An implementation strategy package with video information, HIV self-testing, and co-location of medication dispensing enhanced PrEP delivery across several implementation outcomes and client satisfaction, while not substantially increasing wait time or decreasing provider-client contact time. Clinical trial registration: ClinicalTrials.gov , identifier, NCT04712994.

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

Background: Delivery of PrEP to adolescent girls and young women (AGYW) and to pregnant women through maternal and child health (MCH) and family planning (FP) clinics is scaling up in Kenya. Evaluation of implementation challenges and strategies is critical to optimize delivery. Methods: We conducted focus group discussions (FGDs) with healthcare workers (HCWs) in MCH and FP clinics offering PrEP in a large implementation project in Kisumu, Kenya. Discussion guides were based on the Consolidated Framework for Implementation Research (CFIR). FGDs were audio recorded and transcribed. Directed content analysis was used to identify implementation challenges and strategies to overcome them. Results: Fifty HCWs from 26 facilities participated in 8 FGDs. HCWs believed PrEP integration was appropriate because it met the needs of AGYW and pregnant women by providing a female-controlled prevention strategy and aligned with policy priorities of elimination of vertical HIV transmission. They were universally accepting of PrEP provision, especially through MCH clinics, noting the relative advantage of this approach because it: (1) enabled high coverage, (2) harmonized PrEP and MCH visits, and (3) minimized stigma compared to PrEP offered through HIV care clinics. However, HCWs noted implementation challenges affecting feasibility and adoption including: (1) increased workload and documentation burden amid workforce shortages, (2) insufficient health care worker knowledge (3) multiple implementing partners with competing priorities (4) drug and documentation form stockouts. HCWs employed various implementation strategies to overcome challenges, including task shifting from nurses to HIV testing providers, patient flow modifications (e.g., fast-tracking PrEP clients to reduce wait times), PrEP demand generation and myth clarification during health talks, provider education, dedicated PrEP delivery rooms, and coordination with adolescent-friendly services. Additional suggested strategies to improve PrEP integration included community education to increase broader PrEP awareness and enable shorter counseling sessions, and task-shifting data entry and client risk assessments. Conclusions: HCWs were enthusiastic about the appropriateness and acceptability of integrating PrEP services into MCH and FP clinics but noted challenges to adoption and feasibility. Strategies to address challenges focused on improving provider time and space constraints, and increasing provider and client knowledge.

Selecting implementation strategies to improve implementation of integrated PrEP for pregnant and postpartum populations in Kenya: a sequential explanatory mixed methods analysis.

BACKGROUND: There is a higher risk for HIV acquisition during pregnancy and postpartum. Pre-exposure prophylaxis (PrEP) is recommended during this period for those at high risk of infection; integrated delivery in maternal and child health (MCH) clinics is feasible and acceptable but requires implementation optimization. METHODS: The PrEP in Pregnancy, Accelerating Reach and Efficiency study (PrEPARE; NCT04712994) engaged stakeholders to prioritize determinants of PrEP delivery (using Likert scores) and prioritize PrEP delivery implementation strategies. Using a sequential explanatory mixed methods design, we conducted quantitative surveys with healthcare workers at 55 facilities in Western Kenya and a stakeholder workshop (including nurses, pharmacists, counselors, and county and national policymakers), yielding visual plots of stakeholders' perceived feasibility and effectiveness of the strategies. A stepwise elimination process was used to identify seven strategies for empirical testing. Facilitator debriefing reports from the workshop were used to qualitatively assess the decision-making process. RESULTS: Among 146 healthcare workers, the strongest reported barriers to PrEP delivery were insufficient providers and inadequate training, insufficient space, and high volume of patients. Sixteen strategies were assessed, 14 of which were included in the final analysis. Among rankings from 182 healthcare workers and 44 PrEP policymakers and implementers, seven strategies were eliminated based on low post-workshop ranking scores (bottom 50th percentile) or being perceived as low feasibility or low effectiveness for at least 50% of the workshop groups. The top seven strategies included delivering PrEP within MCH clinics instead of pharmacies, fast-tracking PrEP clients to reduce waiting time, delivering PrEP-related health talks in waiting bays, task shifting PrEP counseling, task shifting PrEP risk assessments, training different providers to deliver PrEP, and retraining providers on PrEP delivery. All top seven ranked strategies were grouped into bundles for subsequent testing. Facilitator debriefing reports generally aligned with rankings but noted how stakeholders' decision-making changed when considering the impact of strategies on facility staff and non-PrEP clients. CONCLUSIONS: The most impactful barriers to integrated PrEP delivery in MCH clinics were insufficient staffing and space. Implementation strategies prioritized through multiple methods of stakeholder input focused on co-location of services and increasing clinic efficiency. Future testing of these stakeholder-prioritized strategy bundles will be conducted to assess the effectiveness and implementation outcomes.

Understanding factors influencing home pregnancy test use among women in western Kenya: A qualitative analysis.

Background: There are limited data on home pregnancy test use among women in low-and-middle-income countries. A prior survey found that only 20% of women in western Kenya used a home pregnancy test to confirm their pregnancies before going to antenatal care. This qualitative study aims to understand why women do not use home pregnancy tests in early pregnancy. Methods: From April 2021 to July 2021, we interviewed women from four antenatal care clinics in Homa Bay and Siaya counties. We recruited women previously enrolled in the PrEP Implementation for Mothers in Antenatal care (PrIMA) study, a cluster-randomized trial that evaluated the best approaches to implementing PrEP in maternal and child health clinics in Western Kenya (NCT03070600). Interviews were conducted via phone, audio recorded, translated, and transcribed verbatim. We coded and analyzed the transcripts to capture factors influencing women's capability, opportunity, and motivation to use home pregnancy tests. Results: We conducted 48 semistructured interviews with women aged 21-42 years. Twenty-seven women did not use a home pregnancy test in their most recent pregnancy. Seventeen of these women reported not using a home pregnancy test before. Lack of knowledge, mistrust in the accuracy of tests, preferring to rely on signs and symptoms of pregnancy or get a test from the health facility, cost, and accessibility were key barriers to home pregnancy test use. Conclusion: Improving the uptake of home pregnancy testing during early pregnancy will require efforts to enhance community knowledge of test use and associated benefits and reduce cost burdens by making tests more affordable and accessible.

Trajectories and predictors of perinatal depressive symptoms among Kenyan women: a prospective cohort study.

BACKGROUND: There are gaps in understanding longitudinal patterns and predictors of perinatal depressive symptoms in sub-Saharan Africa. This study aimed to explore trajectories of depressive symptoms and associated factors from pregnancy to 9 months post partum among Kenyan women. METHODS: In this prospective cohort study, we analysed data from the PrEP Implementation for Mothers in Antenatal Care (PrIMA) study in which HIV-negative women were enrolled in pregnancy and followed up to 9 months post partum in 20 public sector maternal-child health clinics in western Kenya. Pregnant women were eligible for enrolment if they were not infected with HIV, aged 15 years or older, and were able to provide consent. Eligible participants were screened and enrolled between Jan 15, 2018, and July 31, 2019, and followed up to 9 months post partum, with the last participant study visit conducted on Jan 15, 2021. Study nurses serially assessed depressive symptoms using the Center for Epidemiologic Studies Depression Scale (CESD-10), intimate partner violence with the Hurt, Insult, Threaten, Scream scale, and social support with the Medical Outcomes Study scale. Generalised estimating equations were used to identify correlates of moderate-to-severe depressive symptoms (CESD-10 score ≥10) and group-based trajectory modelling identified discrete trajectories of perinatal depressive symptoms. FINDINGS: Among 4447 participants in the main PrIMA study, 3555 had complete depressive symptom data in pregnancy and depressive symptom data post partum and were included in the primary analysis. Median age was 24·0 years (IQR 21·0-28·7), 1330 (38%) participants had low social support, and 278 (8%) reported intimate partner violence in pregnancy. All participants (100%) were female and all (100%) were of African Kenyan ethnicity. Prevalence of moderate-to-severe depressive symptoms was higher in pregnancy than post partum (870 [24·5%; 95% CI 23·1-25·9] vs 597 [6·8%; 15·6-18·1]; p<0·0001). Five patterns of depressive symptoms were identified; persistent moderate-to-severe depressive symptoms in pregnancy and post partum (295 [8·3%]), moderate-to-severe depressive symptoms in pregnancy that resolved post partum (139 [3·9%]), moderate-to-severe depressive symptoms that emerged post partum (40 [1·1%]), chronically mild symptoms (2709 [76·2%]), and no depressive symptoms (372 [10·5%]). Emergent moderate-to-severe depressive symptoms were associated with older age. Emergent, persistent, and resolving moderate-to-severe depressive symptoms were associated with intimate partner violence during pregnancy; and persistent and resolving moderate-to-severe depressive symptoms were associated with low social support and high HIV risk (all p<0·05). Moderate-to-severe depressive symptom risk was significantly increased with intimate partner violence (adjusted odds ratio 2·07 [95% CI 1·81-2·31]; p<0·0001), low social support (1·74 [1·56-1·95]; p<0·0001), and partner HIV-positive status (1·48 [1·22-1·78]; p<0·0001). 23·34% (95% CI 18·77-27·65) of cases of perinatal moderate-to-severe depressive symptoms were attributable to low social support. INTERPRETATION: One third of women had perinatal moderate-to-severe depressive symptoms; nearly half of these had higher severity phenotypes of resolving, persistent, and emerging moderate-to-severe depressive symptoms that might require tailored interventions. Perinatal women with comorbid psychosocial stressors such as intimate partner violence and previous pregnancy loss should be prioritised for mental health services that augment social support within routine maternal-child health care. FUNDING: National Institutes of Health. TRANSLATION: For the Kiswahili translation of the abstract see Supplementary Materials section.