Drug Concentrations in Hair and Dried Blood Spots as Preexposure Prophylaxis Adherence Metrics During Pregnancy and Postpartum.

We evaluated hair tenofovir (TFV) concentrations as an adherence metric for HIV preexposure prophylaxis during pregnancy and postpartum and compared hair levels with TFV-diphosphate levels in dried blood spots (DBSs). Overall 152 hair samples from 102 women and 36 hair-DBS paired samples from 29 women were collected from a subset of women in a cluster-randomized trial. Having a partner with HIV was associated with higher hair TFV levels (P < .001). Hair TFV concentrations were strongly correlated with DBS TFV-diphosphate levels (r = 0.76, P < .001), indicating hair as a promising cumulative adherence metric for perinatal preexposure prophylaxis assessment.

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.

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.

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.

Measuring movement towards improved emergency obstetric care in rural Kenya with implementation of the PRONTO simulation and team training program.

As the proportion of facility-based births increases, so does the need to ensure that mothers and their newborns receive quality care. Developing facility-oriented obstetric and neonatal training programs grounded in principles of teamwork utilizing simulation-based training for emergency response is an important strategy for improving the quality care. This study uses 3 dimensions of the Kirkpatrick Model to measure the impact of PRONTO International (PRONTO) simulation-based training as part of the Linda Afya ya Mama na Mtoto (LAMMP, Protect the Health of mother and child) in Kenya. Changes in knowledge of obstetric and neonatal emergency response, self-efficacy, and teamwork were analyzed using longitudinal, fixed-effects, linear regression models. Participants from 26 facilities participated in the training between 2013 and 2014. The results demonstrate improvements in knowledge, self-efficacy, and teamwork self-assessment. When comparing pre-Module I scores with post-training scores, improvements range from 9 to 24 percentage points (p values < .0001 to .026). Compared to baseline, post-Module I and post-Module II (3 months later) scores in these domains were similar. The intervention not only improved participant teamwork skills, obstetric and neonatal knowledge, and self-efficacy but also fostered sustained changes at 3 months. The proportion of facilities achieving self-defined strategic goals was high: 95.8% of the 192 strategic goals. Participants rated the PRONTO intervention as extremely useful, with an overall score of 1.4 out of 5 (1, extremely useful; 5, not at all useful). Evaluation of how these improvements affect maternal and perinatal clinical outcomes is forthcoming.

Team training in obstetric and neonatal emergencies using highly realistic simulation in Mexico: impact on process indicators.

BACKGROUND: Ineffective management of obstetric emergencies contributes significantly to maternal and neonatal morbidity and mortality in Mexico. PRONTO (Programa de Rescate Obstétrico y Neonatal: Tratamiento Óptimo y Oportuno) is a highly-realistic, low-tech simulation-based obstetric and neonatal emergency training program. A pair-matched hospital-based controlled implementation trial was undertaken in three states in Mexico, with pre/post measurement of process indicators at intervention hospitals. This report assesses the impact of PRONTO simulation training on process indicators from the pre/post study design for process indicators. METHODS: Data was collected in twelve intervention facilities on process indicators, including pre/post changes in knowledge and self-efficacy of obstetric emergencies and neonatal resuscitation, achievement of strategic planning goals established during training and changes in teamwork scores. Authors performed a longitudinal fixed-effects linear regression model to estimate changes in knowledge and self-efficacy and logistic regression to assess goal achievement. RESULTS: A total of 450 professionals in interprofessional teams were trained. Significant increases in knowledge and self-efficacy were noted for both physicians and nurses (p <0.001- 0.009) in all domains. Teamwork scores improved and were maintained over a three month period. A mean of 58.8% strategic planning goals per team in each hospital were achieved. There was no association between high goal achievement and knowledge, self-efficacy, proportion of doctors or nurses in training, state, or teamwork score. CONCLUSIONS: These results suggest that PRONTO's highly realistic, locally appropriate simulation and team training in maternal and neonatal emergency care may be a promising avenue for optimizing emergency response and improving quality of facility-based obstetric and neonatal care in resource-limited settings. TRIAL REGISTRATION: NCT01477554.

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.

Digital communication between mothers and community health workers to support neonatal health (CHV-NEO): study protocol for a randomized controlled trial.

BACKGROUND: Provision of essential newborn care at home, rapid identification of illness, and care-seeking by caregivers can prevent neonatal mortality. Mobile technology can connect caregivers with information and healthcare worker advice more rapidly and frequently than healthcare visits. Community health workers (CHWs) are well-suited to deliver such interventions. We developed an interactive short message service (SMS) intervention for neonatal health in Kenya, named CHV-NEO. CHV-NEO sends automated, theory-based, actionable, messages throughout the peripartum period that guide mothers to evaluate maternal and neonatal danger signs and facilitate real-time dialogue with a CHW via SMS. We integrated this intervention into Kenya's national electronic community health information system (eCHIS), which is currently used at scale to support CHW workflow. METHODS: The effect of CHV-NEO on clinical and implementation outcomes will be evaluated through a non-blinded cluster randomized controlled trial. Twenty sites across Kisumu County in Western Kenya were randomized 1:1 to provide either the national eCHIS with integrated CHV-NEO messaging (intervention) or standard of care using eCHIS without CHV-NEO (control). We will compare neonatal mortality between arms based on abstracted eCHIS data from 7200 pregnant women. Secondary outcomes include self-reported provision of essential newborn care (appropriate cord care, thermal care, and timely initiation of breastfeeding), knowledge of neonatal danger signs, and care-seeking for neonatal illness, compared between arms based on questionnaires with a subgroup of 2000 women attending study visits at enrollment in pregnancy and 6 weeks postpartum. We will also determine CHV-NEO's effect on CHW workflows and evaluate determinants of intervention acceptability, adoption, and fidelity of use through questionnaires, individual interviews, and messaging data. DISCUSSION: We hypothesize that the CHV-NEO direct-to-client communication strategy can be successfully integrated within existing CHW workflows and infrastructure, improve the provision of at-home essential newborn care, increase timely referral of neonatal illness to facilities, and reduce neonatal mortality. The intervention's integration into the national eCHIS tool will facilitate rapid scale-up if it is clinically effective and successfully implemented. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05187897 . The CHV-NEO study was registered on January 12, 2022.

Promoting cultural humility during labor and birth: putting theory into action during PRONTO obstetric and neonatal emergency training.

Maternal and neonatal mortality in Northern Guatemala, a region with a high percentage of indigenous people, is disproportionately high. Initiatives to improve quality of care at local health facilities equipped for births, and increasing the number of births attended at these facilities will help address this problem. PRONTO (Programa de Rescate Obstétrico y Neonatal: Tratamiento Óptimo y Oportuno) is a low-tech, high-fidelity, simulation-based, provider-to-provider training in the management of obstetric and neonatal emergencies. This program has been successfully tested and implemented in Mexico. PRONTO will now be implemented in Guatemala as part of an initiative to decrease maternal and perinatal mortality. Guatemalan health authorities have requested that the training include training on cultural humility and humanized birth. This article describes the process of curricular adaptation to satisfy this request. The PRONTO team adapted the existing program through 4 steps: (a) analysis of the problem and context through a review of qualitative data and stakeholder interviews, (b) literature review and adoption of a theoretical framework regarding cultural humility and adult learning, (c) adaptation of the curriculum and design of new activities and simulations, and (d) implementation of adapted and expanded curriculum and further refinement in response to participant response.

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.

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.

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.

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.

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.

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.

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.

Online HIV prophylaxis delivery: Protocol for the ePrEP Kenya pilot study.

Background: Online pharmacies in Kenya provide sexual and reproductive health products (e.g., HIV self-testing, contraception) and could be leveraged to increase the reach of HIV pre-exposure and post-exposure prophylaxis (PrEP/PEP) to populations who do not frequently attend health facilities. To date, evidence is limited for operationalizing online PrEP/PEP delivery and the type of populations reached with this differential service delivery model. Methods: The ePrEP Kenya Pilot will deliver daily oral PrEP and PEP via MYDAWA, a private online pharmacy retailer, to clients in Nairobi for 18 months. Potential clients will obtain information about PrEP/PEP on MYDAWA's sexual wellness page and self-screen for HIV risk. Individuals ≥18 years, identified as at HIV risk, and willing to pay for a blood-based HIV self-test and PrEP/PEP delivery will be eligible for enrollment. To continue with online PrEP/PEP initiation, eligible clients will purchase a blood-based HIV self-test for 250 KES (~USD 2) [delivered to their setting of choice for 99 KES (~USD 1)], upload an image of their self-test result, and attend a telemedicine visit with a MYDAWA provider. During the telemedicine visit, providers will screen clients for PrEP/PEP eligibility, including clinical concerns (e.g., kidney disease), discuss self-test results, and complete counseling on PrEP/PEP use and safety. Providers will refer clients who self-test HIV positive or report any existing medical conditions to the appropriate services at healthcare facilities that meet their preferences. Eligible clients will be prescribed PrEP (30-day PrEP supply at initiation; 90-day PrEP supply at follow-up visits) or PEP (28-day supply) for free and have it delivered for 99 KES (~USD 1). We will measure PrEP and PEP initiation among eligible clients, PEP-to-PrEP transition, PrEP continuation, and implementation outcomes (e.g., feasibility, acceptability, and costs). Discussion: Establishing pathways to increase PrEP and PEP access is crucial to help curb new HIV infections in settings with high HIV prevalence. The findings from this study will provide evidence on the implementation of online pharmacy PrEP and PEP service delivery that can help inform guidelines in Kenya and similar settings.

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.