Developing a National-Level Concept Dictionary for EHR Implementations in Kenya

The increasing adoption of Electronic Health Records (EHR) by developing countries comes with the need to develop common terminology standards to assure semantic interoperability. In Kenya, where the Ministry of Health has rolled out an EHR at 646 sites, several challenges have emerged including variable dictionaries across implementations, inability to easily share data across systems, lack of expertise in dictionary management, lack of central coordination and custody of a terminology service, inadequately defined policies and processes, insufficient infrastructure, among others. A Concept Working Group was constituted to address these challenges. The country settled on a common Kenya data dictionary, initially derived as a subset of the Columbia International eHealth Laboratory (CIEL) / Millennium Villages Project (MVP) dictionary. The initial dictionary scope largely focuses on clinical needs. Processes and policies around dictionary management are being guided by the framework developed by Bakhshi-Raiez et al. Technical and infrastructure-based approaches are also underway to streamline workflow for dictionary management and distribution across implementations. Kenya's approach on comprehensive common dictionary can serve as a model for other countries in similar settings

Pregnancy-related mortality up to 1 year postpartum in sub-Saharan Africa: an analysis of verbal autopsy data from six countries

Objective: To compare the causes of death for women who died during pregnancy and within the first 42 days postpartum with those of women who died between \u3e42 days and within 1 year postpartum. Design: Open population cohort (Health and Demographic Surveillance Systems). Setting: Ten Health and Demographic Surveillance Systems (HDSS) in The Gambia, Kenya, Malawi, Tanzania, Ethiopia and South Africa. Population: 2114 deaths which occurred within 1 year of the end of pregnancy where a verbal autopsy interview was conducted from 2000 to 2019. Methods: InterVA5 and InSilicoVA verbal autopsy algorithms were used to at-tribute the most likely underlying cause of death, which were grouped according to adapted International Classification of Diseases-Maternal Mortality categories. Multinomial regression was used to compare differences in causes of deaths within42 days versus 43–365 days postpartum adjusting for HDSS and time period (2000– 2009 and 2010–2019). Main outcome measures: Cause of death and the verbal autopsy Circumstances of Mortality Categories (COMCATs). Results: Of 2114 deaths, 1212 deaths occurred within 42 days postpartum and 902 be-tween 43 and 365 days postpartum. Compared with deaths within 42 days, deaths from HIV and TB, other infectious diseases, and non-communicable diseases constituted a significantly larger proportion of late pregnancy-related deaths beyond 42 days postpar-tum, and health system failures were important in the circumstances of those deaths. The contribution of HIV and TB to deaths beyond 42 days postpartum was greatest in Southern Africa. The causes of pregnancy-related mortality within and beyond 42 days postpartum did not change significantly between 2000–2009 and 2010–2019. Conclusions: Cause of death data from the extended postpartum period are critical to in-form prevention. The dominance of HIV and TB, other infectious and non-communicable diseases to (late) pregnancy-related mortality highlights the need for better integration of non-obstetric care with ante-, intra- and postpartum care in high-burden setting

Comparison of programmatic data from antenatal clinics with population-based HIV prevalence estimates in the era of universal test and treat in western Kenya.

OBJECTIVE: To compare HIV prevalence estimates from routine programme data in antenatal care (ANC) clinics in western Kenya with HIV prevalence estimates in a general population sample in the era of universal test and treat (UTT). METHODS: The study was conducted in the area covered by the Siaya Health Demographic Surveillance System (Siaya HDSS) in western Kenya and used data from ANC clinics and the general population. ANC data (n = 1,724) were collected in 2018 from 13 clinics located within the HDSS. The general population was a random sample of women of reproductive age (15-49) who reside in the Siaya HDSS and participated in an HIV sero-prevalence survey in 2018 (n = 2,019). Total and age-specific HIV prevalence estimates were produced from both datasets and demographic decomposition methods were used to quantify the contribution of the differences in age distributions and age-specific HIV prevalence to the total HIV prevalence estimates. RESULTS: Total HIV prevalence was 18.0% (95% CI 16.3-19.9%) in the ANC population compared with 18.4% (95% CI 16.8-20.2%) in the general population sample. At most ages, HIV prevalence was higher in the ANC population than in the general population. The age distribution of the ANC population was younger than that of the general population, and because HIV prevalence increases with age, this reduced the total HIV prevalence among ANC attendees relative to prevalence standardised to the general population age distribution. CONCLUSION: In the era of UTT, total HIV prevalence among ANC attendees and the general population were comparable, but age-specific HIV prevalence was higher in the ANC population in most age groups. The expansion of treatment may have led to changes in both the fertility of women living with HIV and their use of ANC services, and our results lend support to the assertion that the relationship between ANC and general population HIV prevalence estimates are highly dynamic

Impact of DREAMS interventions on experiences of violence among adolescent girls and young women: Findings from population-based cohort studies in Kenya and South Africa

DREAMS aims to reduce HIV incidence among adolescent girls and young women (AGYW) by tackling drivers of HIV risk including gender-based violence. We evaluate the impact of DREAMS on recent experiences of violence perpetuated by men against AGYW. AGYW cohorts were randomly selected from demographic platforms in South Africa (rural KwaZulu-Natal) and Kenya (Nairobi informal settlements and rural Gem sub-county). AGYW aged 13-22 years were enrolled in 2017 (Nairobi, KwaZulu-Natal) or 2018 (Gem), with annual follow-up to 2019. We described proportions of AGYW who self-reported experiences of violence perpetrated by males in the 12 months preceding the interview, overall and by form (physical, sexual, emotional). We investigated associations with DREAMS (invitation to participate during 2017-2018) through multivariable propensity score-adjusted logistic regression and estimated the causal effect of DREAMS on experiences of violence, under counter-factual scenarios in which all versus no AGYW were DREAMS beneficiaries. Among 852, 1018 and 1712 AGYW followed-up in 2019 in Nairobi, Gem and KZN, respectively, proportions reporting any violence in 2019 were higher in Nairobi (29%) than Gem (18%) and KwaZulu-Natal (19%). By sub-type, emotional and physical violence were more frequently reported than sexual violence. We found no evidence of an impact attributable to DREAMS on overall levels of violence, in any setting. Nor was there evidence of impact on sub-types of violence, with one exception: an increase in physical violence in Nairobi if all, versus no, AGYW were DREAMS beneficiaries (16% vs 11%; +5% difference [95% CI: +0.2%, +10.0%]). Experiences of gender-based violence were common among AGYW, especially in urban settings, and DREAMS had no measurable impact on reducing violence within three years of implementation. Violence prevention programming that reaches more men and the broader community, sustained for longer periods, may yield greater gains in violence reduction than AGYW-focused programming. Additionally, more investment in implementation research is needed to bridge trial-based study findings from efficacy to population-level effectiveness

Does Venue of HIV Testing and Results Disclosure in the Context of a Research Study Affect Adolescent Health and Behavior? Results from a Study in Western Kenya

Ethical concerns about risks to minor adolescents participating in HIV prevention research is a barrier to their inclusion. One concern is whether HIV testing and results disclosure venue affects the health and behavior of adolescent participants. We assessed for differential effects on quality of life (QOL), depressive symptoms, and sexual behavior due to (1) testing venue (home or health facility) and (2) test result (HIV-positive, HIV-negative, indeterminate). We collected data at three timepoints (baseline, 2-month follow-up, 12-month follow-up) from 113 Kenyan adolescents aged 15–19 (51% female). We analyzed the data using linear mixed effects models for the QOL and depressive symptoms outcomes and a logistic model for the sexual behavior outcome. Results showed a small mental health benefit for adolescents tested for HIV at a health facility compared with home. There was little evidence that testing venue influenced sexual behavior or that test results moderated the effects of HIV testing across all outcomes. The decision to conduct HIV testing at home or a health facility may not be very consequential for adolescents’ health and behavior. Findings underscore the need to critically examine assumptions about adolescent vulnerability to better promote responsible conduct of HIV prevention research with youth in sub-Saharan Africa

Analysis of Bacterial vaginosis, the vaginal microbiome, and sexually transmitted infections following the provision of menstrual cups in Kenyan schools: results of a nested study within a cluster randomized controlled trial

Abstract Background: Non-hygienic products for managing menstruation are reported to cause reproductive tract infections. Menstrual cups are a potential solution. We assessed whether menstrual cups would reduce Bacterial vaginosis (BV), vaginal microbiome (VMB), and sexually transmitted infections (STIs) as studies have not evaluated this. Methods and Findings: A cluster-randomized controlled trial was performed in 96 Kenyan secondary schools, randomized (1:1:1:1) to control, menstrual cup, cash transfer, or menstrual cup plus cash transfer. This sub-study assessing the impact of menstrual cups on BV, VMB, and STIs, included 6 schools from the control (3) and menstrual cup only (3) groups, both receiving BV and STI testing and treatment at each visit. Self-collected vaginal swabs were used to measure VMB (16S rRNA gene amplicon sequencing), BV (Nugent score), and STIs. STIs were a composite of Chlamydia trachomatis and Neisseria gonorrhoeae (nucleic acid amplification test)¸ and Trichomonas vaginalis (rapid immunochromatographic assay). Participants were not masked and were followed for 30 months. The primary outcome was diagnosis of BV; secondary outcomes were VMB and STIs. Intention to treat blinded analyses used mixed effects generalized linear regressions, with random effects term for school. The study was conducted between May 2, 2018, and Feb 7, 2021. 436 participants were included: 213 cup, 223 control. There were 289 BV diagnoses: 162 among control participants and 127 among intervention participants (odds ratio 0.76 [95% CI 0.59–0.98]; p=0.038). The occurrence of Lactobacillus crispatus dominated VMB was higher among cup group participants (odds ratio 1.37 [95% CI 1.06–1.75]), as was the mean relative abundance of Lactobacillus crispatus (3.95% [95% CI 1.92–5.99]). There was no effect of intervention on STIs (relative risk 0.82 [95% CI 0.50–1.35]). The primary limitations of this study were insufficient power for sub-group analyses, and generalizability of findings to non-school and other global settings. Conclusions: Menstrual cups with BV and STI testing and treatment benefitted adolescent schoolgirls through lower occurrence of BV and higher L. crispatus compared with only BV and STI testing and treatment during the 30 months of a cluster-randomized menstrual cup intervention. ClinicalTrials.gov, NCT03051789

Quality of life and well-being problems in secondary schoolgirls in Kenya: Prevalence, associated characteristics, and course predictors

Background: Adolescents in sub-Saharan Africa often report low levels of quality of life (QoL) and well-being, but reliable data are limited. This study examines which sociodemographic, health, and behavioral risk factors and adverse adolescent experiences are associated with, and predictive of, QoL in Kenyan secondary schoolgirls. Methods and findings: 3,998 girls at baseline in a randomised controlled trial in Siaya County, western Kenya were median age 17.1 years. Subjectively perceived physical, emotional, social and school functioning was assessed using the Pediatric Quality of Life (QoL) Inventory-23. Laboratory-confirmed and survey data were utilized to assess sociodemographic, health and behavioral characteristics, and adverse adolescent experiences. We identified a group of girls with Low QoL (n=1126; 28.2%), Average QoL (n=1445; 36.1%); and High QoL (n=1427; 35.7%). Significantly higher scores on all well-being indicators in the LQoL compared with HQoL group indicated good construct validity (Odds Ratio's (ORs) varying from 3.31 (95% CI:2.41-4.54, p<.001) for feeling unhappy at home to 11.88 (95%CI:7.96-17.74, p< .001) for PHQ9 defined possible caseness (probable diagnosis) of depression. Adverse adolescent experiences were independently statistically significant in the LQoL compared to the HQoL group for threats of family being hurt (aOR=1.35,1.08-1.68, p=.008), sexual harassment out of school (aOR=2.17,1.79-2.64, p<.001), and for menstrual problems like unavailability of sanitary pads (aOR=1.23,1.05-1.44, p=.008) and stopping activities due to menstruation (aOR=1.77,1.41-2.24, p<.001). After 2-years follow-up of 906 girls in the LQoL group, 22.7% persisted with LQoL. Forced sex (aOR=1.56,1.05-2.32, p=.028) and threats of family being hurt (aOR=1.98,1.38-2.82, p<.001) were independent predictors of persistent LQoL problems. Conclusions: Persistent QoL problems in Kenyan adolescent girls are associated with adverse physical, sexual and emotional experiences and problems with coping with their monthly menstruation. A multi-factorial integral approach to reduce the rate of adverse adolescent experiences is needed, including provision of menstrual hygiene products

Evaluating the impact of the DREAMS partnership to reduce HIV incidence among adolescent girls and young women in four settings: a study protocol.

BACKGROUND: HIV risk remains unacceptably high among adolescent girls and young women (AGYW) in southern and eastern Africa, reflecting structural and social inequities that drive new infections. In 2015, PEPFAR (the United States President's Emergency Plan for AIDS Relief) with private-sector partners launched the DREAMS Partnership, an ambitious package of interventions in 10 sub-Saharan African countries. DREAMS aims to reduce HIV incidence by 40% among AGYW over two years by addressing multiple causes of AGYW vulnerability. This protocol outlines an impact evaluation of DREAMS in four settings. METHODS: To achieve an impact evaluation that is credible and timely, we describe a mix of methods that build on longitudinal data available in existing surveillance sites prior to DREAMS roll-out. In three long-running surveillance sites (in rural and urban Kenya and rural South Africa), the evaluation will measure: (1) population-level changes over time in HIV incidence and socio-economic, behavioural and health outcomes among AGYW and young men (before, during, after DREAMS); and (2) causal pathways linking uptake of DREAMS interventions to 'mediators' of change such as empowerment, through to behavioural and health outcomes, using nested cohort studies with samples of ~ 1000-1500 AGYW selected randomly from the general population and followed for two years. In Zimbabwe, where DREAMS includes an offer of pre-exposure HIV prophylaxis (PrEP), cohorts of young women who sell sex will be followed for two years to measure the impact of 'DREAMS+PrEP' on HIV incidence among young women at highest risk of HIV. In all four settings, process evaluation and qualitative studies will monitor the delivery and context of DREAMS implementation. The primary evaluation outcome is HIV incidence, and secondary outcomes include indicators of sexual behavior change, and social and biological protection. DISCUSSION: DREAMS is, to date, the most ambitious effort to scale-up combinations or 'packages' of multi-sectoral interventions for HIV prevention. Evidence of its effectiveness in reducing HIV incidence among AGYW, and demonstrating which aspects of the lives of AGYW were changed, will offer valuable lessons for replication

Pregnancy-related mortality up to 1 year postpartum in sub-Saharan Africa:an analysis of verbal autopsy data from six countries

Objective: To compare the causes of death for women who died during pregnancy and within the first 42 days postpartum with those of women who died between &gt;42 days and within 1 year postpartum. Design: Open population cohort (Health and Demographic Surveillance Systems). Setting: Ten Health and Demographic Surveillance Systems (HDSS) in The Gambia, Kenya, Malawi, Tanzania, Ethiopia and South Africa. Population: 2114 deaths which occurred within 1 year of the end of pregnancy where a verbal autopsy interview was conducted from 2000 to 2019. Methods: InterVA5 and InSilicoVA verbal autopsy algorithms were used to attribute the most likely underlying cause of death, which were grouped according to adapted International Classification of Diseases-Maternal Mortality categories. Multinomial regression was used to compare differences in causes of deaths within 42 days versus 43–365 days postpartum adjusting for HDSS and time period (2000–2009 and 2010–2019). Main outcome measures: Cause of death and the verbal autopsy Circumstances of Mortality Categories (COMCATs). Results: Of 2114 deaths, 1212 deaths occurred within 42 days postpartum and 902 between 43 and 365 days postpartum. Compared with deaths within 42 days, deaths from HIV and TB, other infectious diseases, and non-communicable diseases constituted a significantly larger proportion of late pregnancy-related deaths beyond 42 days postpartum, and health system failures were important in the circumstances of those deaths. The contribution of HIV and TB to deaths beyond 42 days postpartum was greatest in Southern Africa. The causes of pregnancy-related mortality within and beyond 42 days postpartum did not change significantly between 2000–2009 and 2010–2019. Conclusions: Cause of death data from the extended postpartum period are critical to inform prevention. The dominance of HIV and TB, other infectious and non-communicable diseases to (late) pregnancy-related mortality highlights the need for better integration of non-obstetric care with ante-, intra- and postpartum care in high-burden settings

High Prevalence of Lactobacillus crispatus Dominated Vaginal Microbiome Among Kenyan Secondary School Girls: Negative Effects of Poor Quality Menstrual Hygiene Management and Sexual Activity

The vaginal microbiome (VMB) impacts numerous health outcomes, but evaluation among adolescents is limited. We characterized the VMB via 16S rRNA gene amplicon sequencing, and its association with Bacterial vaginosis (BV) and sexually transmitted infections (STIs; chlamydia, gonorrhea, trichomoniasis) among 436 schoolgirls in Kenya, median age 16.9 years. BV and STI prevalence was 11.2% and 9.9%, respectively, with 17.6% of girls having any reproductive tract infection. Three community state types (CST) accounted for 95% of observations: CST-I L.crispatus-dominant (N=178, BV 0%, STI 2.8%, sexually active 21%); CST-III L.iners-dominant (N=152, BV 3.3%, STI 9.7%, sexually active 35%); CST-IV G.vaginalis-dominant (N=83, BV 51.8%, STI 25.3%, sexually active 43%). In multivariable adjusted analyses, sexually active girls had increased odds of CST-III and CST-IV, and use of cloth to manage menses had 1.72-fold increased odds of CST-IV vs. CST-I. The predominance of L.crispatus-dominated VMB, substantially higher than observed in prior studies of young adult and adult women in sub-Saharan Africa, indicates that non-optimal VMB can be an acquired state. Interventions to maintain or re-constitute L.crispatus dominance should be considered even in adolescents