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 >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.

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.

BACKGROUND: Nonhygienic 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 substudy 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 February 7, 2021. A total of 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 to 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 to 1.75]), as was the mean relative abundance of L. crispatus (3.95% [95% CI 1.92 to 5.99]). There was no effect of intervention on STIs (relative risk 0.82 [95% CI 0.50 to 1.35]). The primary limitations of this study were insufficient power for subgroup analyses, and generalizability of findings to nonschool 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT03051789.

The long-term impact of HIV/AIDS on socio-economic status: a comparative analysis of households headed by HIV-positive and HIV-negative individuals in Western Kenya.

HIV/AIDS is known to have adverse effects on individual and family socio-economic status due to the loss of productive time and over-expenditure in treatment. However, empirical data on how HIV/AIDS affects households' socio-economic status are insufficient. We linked socio-economic data from a Health and Demographic Surveillance System (HDSS) that implements an HIV/AIDS Longitudinal bio-behavioural survey (LBBS) to understand the long-term impact of HIV/AIDS on households' socio-economic status between 2010 and 2018. We compared changes in socio-economic status between households headed by HIV-negative and -positive individuals. A logistic regression was used to assess factors that influence socio-economic status. The level of education and household size were not significant predictors of households' socio-economic status. Households headed by HIV-positive individuals could maintain their baseline socio-economic status (unadjusted RRR = 1.17, 95% CI: 1.01, 1.36) but improvement chances were reduced despite a non-significant association (unadjusted RRR = 0.98, 95% CI: 0.80, 1.20). While HIV/AIDS is known to disrupt economic growth, in this setting, being a male household head, old and widowed reduces chances of improved socio-economic status. The elderly people, widows and widowers are disadvantaged. Consequently, there is a need for special programmes, which seek to empower the identified vulnerable groups economically. .

Evaluating the impact of DREAMS on HIV incidence among adolescent girls and young women: A population-based cohort study in Kenya and South Africa.

BACKGROUND: Through a multisectoral approach, the DREAMS Partnership aimed to reduce HIV incidence among adolescent girls and young women (AGYW) by 40% over 2 years in high-burden districts across sub-Saharan Africa. DREAMS promotes a combination package of evidence-based interventions to reduce individual, family, partner, and community-based drivers of young women's heightened HIV risk. We evaluated the impact of DREAMS on HIV incidence among AGYW and young men in 2 settings. METHODS AND FINDINGS: We directly estimated HIV incidence rates among open population-based cohorts participating in demographic and HIV serological surveys from 2006 to 2018 annually in uMkhanyakude (KwaZulu-Natal, South Africa) and over 6 rounds from 2010 to 2019 in Gem (Siaya, Kenya). We compared HIV incidence among AGYW aged 15 to 24 years before DREAMS and up to 3 years after DREAMS implementation began in 2016. We investigated the timing of any change in HIV incidence and whether the rate of any change accelerated during DREAMS implementation. Comparable analyses were also conducted for young men (20 to 29/34 years). In uMkhanyakude, between 5,000 and 6,000 AGYW were eligible for the serological survey each year, an average of 85% were contacted, and consent rates varied from 37% to 67%. During 26,395 person-years (py), HIV incidence was lower during DREAMS implementation (2016 to 2018) than in the previous 5-year period among 15- to 19-year-old females (4.5 new infections per 100 py as compared with 2.8; age-adjusted rate ratio (aRR) = 0.62, 95% confidence interval [CI] 0.48 to 0.82), and lower among 20- to 24-year-olds (7.1/100 py as compared with 5.8; aRR = 0.82, 95% CI 0.65 to 1.04). Declines preceded DREAMS introduction, beginning from 2012 to 2013 among the younger and 2014 for the older women, with no evidence of more rapid decline during DREAMS implementation. In Gem, between 8,515 and 11,428 AGYW were eligible each survey round, an average of 34% were contacted and offered an HIV test, and consent rates ranged from 84% to 99%. During 10,382 py, declines in HIV incidence among 15- to 19-year-olds began before DREAMS and did not change after DREAMS introduction. Among 20- to 24-year-olds in Gem, HIV incidence estimates were lower during DREAMS implementation (0.64/100 py) compared with the pre-DREAMS period (0.94/100 py), with no statistical evidence of a decline (aRR = 0.69, 95% CI 0.53 to 2.18). Among young men, declines in HIV incidence were greater than those observed among AGYW and also began prior to DREAMS investments. Study limitations include low study power in Kenya and the introduction of other interventions such as universal treatment for HIV during the study period. CONCLUSIONS: Substantial declines in HIV incidence among AGYW were observed, but most began before DREAMS introduction and did not accelerate in the first 3 years of DREAMS implementation. Like the declines observed among young men, they are likely driven by earlier and ongoing investments in HIV testing and treatment. Longer-term implementation and evaluation are needed to assess the impact of such a complex HIV prevention intervention and to help accelerate reductions in HIV incidence among young women.

Factors associated with the prevalence of HIV, HSV-2, pregnancy, and reported sexual activity among adolescent girls in rural western Kenya: A cross-sectional analysis of baseline data in a cluster randomized controlled trial.

BACKGROUND: Adolescence is a sensitive time for girls' sexual and reproductive health (SRH), as biological changes occur concurrently with heightening pressures for sexual activity. In western Kenya, adolescent girls are vulnerable to acquiring sexually transmitted infections (STIs), such as HIV and herpes simplex virus type 2 (HSV-2), and to becoming pregnant prior to reaching adulthood. This study examines associations between individual, household, and partner-related risk factors and the prevalence of sex, adolescent pregnancy, HIV, and HSV-2. METHODS AND FINDINGS: We report baseline findings among 4,138 girls attending secondary school who were enrolled between 2017 and 2018 in the Cups or Cash for Girls (CCG) cluster randomized controlled trial in Siaya County, rural western Kenya. Laboratory confirmed biomarkers and survey data were utilized to assess the effects of girls' individual, household, and partner characteristics on the main outcome measures (adolescent reported sex, prior pregnancy, HIV, and HSV-2) through generalized linear model (GLM) analysis. Complete data were available for 3,998 girls (97%) with median age 17.1 years (interquartile range [IQR] 16.3 to 18.0 years); 17.2% were HSV-2 seropositive (n = 686) and 1.7% tested positive for HIV (n = 66). Sexual activity was reported by 27.3% girls (n = 1,090), of whom 12.2% had been pregnant (n = 133). After adjustment, orphanhood (adjusted risk ratio [aRR] 2.81, 95% confidence interval [CI] 1.18 to 6.71, p-value [p] = 0.020), low body mass index (BMI) (aRR 2.07; CI: 1.00 to 4.30, p = 0.051), and age (aRR 1.34, 1.18 to 1.53, p < 0.001) were all associated with HIV infection. Girls reporting light menstrual bleeding (aRR 2.42, 1.22 to 4.79, p = 0.012) for fewer than 3 days (aRR 2.81, 1.16 to 6.82, p = 0.023) were over twice as likely to have HIV. Early menarche (aRR 2.05, 1.33 to 3.17, p = 0.001) was associated with adolescent pregnancy and HSV-2-seropositive girls reported higher rates of pregnancy (aRR 1.62, CI: 1.16 to 2.27, p = 0.005). High BMI was associated with HSV-2 (aRR 1.24, 1.05 to 1.46, p = 0.010) and sexual activity (aRR 1.14, 1.02 to 1.28, p = 0.016). High levels of harassment were detected in the cohort (41.2%); being touched indecently conveyed the strongest association related to reported sexual activity (aRR 2.52, 2.26 to 2.81, p < 0.001). Study limitations include the cross-sectional design of the study, which informs on the SRH burdens found in this population but limits causal interpretation of associations, and the self-reported exposure ascertainment, which may have led to possible underreporting of risk factors, most notably prior sexual activity. CONCLUSIONS: Our findings indicate that adolescent girls attending school in Kenya face frequent harassment for sex and are at high risk of pregnancy and HSV-2, with girls experiencing early menarche particularly vulnerable. Targeted interventions, such as earlier sexual education programs, are warranted to address their vulnerability to SRH harms. TRIAL REGISTRATION: ClinicalTrials.gov NCT03051789.

Pathways to Depression and Poor Quality of Life Among Adolescents in Western Kenya: Role of Anticipated HIV Stigma, HIV Risk Perception, and Sexual Behaviors.

Depression is a major cause of disease burden and is linked to poor quality of life (QOL) among adolescents. We examined the roles of sexual behaviors, HIV risk perception, and anticipated HIV stigma on depressive symptomatology and QOL among 4096 adolescents in a rural region of western Kenya with a high burden of HIV. Participants were aged 15-19 years, had not been tested for HIV in the previous 6 months, and had never been diagnosed with HIV. Anticipated stigma and risk perception were directly associated with depressive symptomatology and QOL. There was evidence of small indirect effects-through stigma-of risk perception on depressive symptomatology and QOL. Gender moderated relationships between sexual behavior and risk perception, depressive symptomatology, and QOL. Results suggest that developing effective gender-based interventions to address stigma, sexual behavior, and risk perception may be important for improving adolescent well-being in high HIV prevalence contexts.

RESUMEN: La depresión es una de las principales causas de carga de morbilidad y se asocia con una pobre calidad de vida (CdV) de los adolescentes. Nosotros estudiamos el papel de los comportamientos sexuales, la percepción de riesgo del VIH, y el estigma anticipado del VIH en relación con la sintomatología depresiva y la CdV de 4 096 adolescentes provenientes de una región rural del oeste de Kenia con alta carga de VIH. Los participantes, adolescentes de entre 15 y 19 años, no se habían hecho la prueba de detección del VIH en los últimos 6 meses y, además, nunca habían sido diagnosticados con VIH. El estigma anticipado y la percepción de riesgo estaban asociados directamente con la sintomatología depresiva y la CdV. Hubo evidencia de pocos efectos indirectos de percepción de riesgo­generados por el estigma­en la sintomatología depresiva y la CdV. El género moderó las relaciones entre el comportamiento sexual y la percepción de riesgo, la sintomatología depresiva y la CdV. Los resultados sugieren que desarrollar intervenciones con enfoque de género para abordar el tema del estigma, los comportamientos sexuales y la percepción de riesgo, puede ser importante para mejorar el bienestar de los adolescentes que viven en un contexto con alta prevalencia de VIH.

Experiences and lessons learned from the real-world implementation of an HIV recent infection testing algorithm in three routine service-delivery settings in Kenya and Zimbabwe.

INTRODUCTION: Testing for recent HIV infection can distinguish recently acquired infection from long-standing infections. Given current interest in the implementation of recent infection testing algorithms (RITA), we report our experiences in implementing a RITA in three pilot studies and highlight important issues to consider when conducting recency testing in routine settings. METHODS: We applied a RITA, incorporating a limited antigen (LAg) avidity assay, in different routine HIV service-delivery settings in 2018: antenatal care clinics in Siaya County, Kenya, HIV testing and counselling facilities in Nairobi, Kenya, and female sex workers clinics in Zimbabwe. Discussions were conducted with study coordinators, laboratory leads, and facility-based stakeholders to evaluate experiences and lessons learned in relation to implementing recency testing. RESULTS: In Siaya County 10/426 (2.3%) of women testing HIV positive were classified as recent, compared to 46/530 (8.7%) of women and men in Nairobi and 33/313 (10.5%) of female sex workers in Zimbabwe. Across the study setting, we observed differences in acceptance, transport and storage of dried blood spot (DBS) or venous blood samples. For example, the acceptance rate when testing venous blood was 11% lower than when using DBS. Integrating our study into existing services ensured a quick start of the study and kept the amount of additional resources required low. From a laboratory perspective, the LAg avidity assay was initially difficult to operationalise, but developing a network of laboratories and experts to work together helped to improve this. A challenge that was not overcome was the returning of RITA test results to clients. This was due to delays in laboratory testing, the need for multiple test results to satisfy the RITA, difficulties in aligning clinic visits, and participants opting not to return for test results. CONCLUSION: We completed three pilot studies using HIV recency testing based on a RITA in Kenya and Zimbabwe. The main lessons we learned were related to sample collection and handling, LAg avidity assay performance, integration into existing services and returning of test results to participants. Our real-world experience could provide helpful guidance to people currently working on the implementation of HIV recency testing in sub-Saharan Africa.

A clinical decision support system is associated with reduced loss to follow-up among patients receiving HIV treatment in Kenya: a cluster randomized trial.

BACKGROUND: Loss to follow-up (LFTU) among HIV patients remains a major obstacle to achieving treatment goals with the risk of failure to achieve viral suppression and thereby increased HIV transmission. Although use of clinical decision support systems (CDSS) has been shown to improve adherence to HIV clinical guidance, to our knowledge, this is among the first studies conducted to show its effect on LTFU in low-resource settings. METHODS: We analyzed data from a cluster randomized controlled trial in adults and children (aged ≥ 18 months) who were receiving antiretroviral therapy at 20 HIV clinics in western Kenya between Sept 1, 2012 and Jan 31, 2014. Participating clinics were randomly assigned, via block randomization. Clinics in the control arm had electronic health records (EHR) only while the intervention arm had an EHR with CDSS. The study objectives were to assess the effects of a CDSS, implemented as alerts on an EHR system, on: (1) the proportion of patients that were LTFU, (2) LTFU patients traced and successfully linked back to treatment, and (3) time from enrollment on the study to documentation of LTFU. RESULTS: Among 5901 eligible patients receiving ART, 40.6% (n = 2396) were LTFU during the study period. CDSS was associated with lower LTFU among the patients (Adjusted Odds Ratio-aOR 0.70 (95% CI 0.65-0.77)). The proportions of patients linked back to treatment were 25.8% (95% CI 21.5-25.0) and 30.6% (95% CI 27.9-33.4)) in EHR only and EHR with CDSS sites respectively. CDSS was marginally associated with reduced time from enrollment on the study to first documentation of LTFU (adjusted Hazard Ratio-aHR 0.85 (95% CI 0.78-0.92)). CONCLUSION: A CDSS can potentially improve quality of care through reduction and early detection of defaulting and LTFU among HIV patients and their re-engagement in care in a resource-limited country. Future research is needed on how CDSS can best be combined with other interventions to reduce LTFU. Trial registration NCT01634802. Registered at www.clinicaltrials.gov on 12-Jul-2012. Registered prospectively.

Is maternal HIV infection a risk factor for delayed or missed infant measles vaccination in western Kenya?

Measles is a highly infectious virus and one of the leading causes of childhood morbidity and mortality in areas with low immunization rates. Despite the introduction of the measles vaccine preventing about 20 million deaths between 2000 and 2016, there still is a low uptake of the vaccine, especially in low-income countries. Maternal HIV positive status is identified as one of the factors inhibiting the uptake of the measles vaccine in some settings. Using data from a Health and Demographic surveillance system (HDSS), and a Longitudinal Bio-behavioural Survey (LBBS), we assessed the effect of a mother's HIV status on a child's overall uptake of measles vaccine and timeliness in western Kenya. The findings did not show association between a mother's HIV status and a child's receipt of measles vaccine (OR = 0.84, 95% CI: 0.65, 1.08). However, higher socio-economic status (SES) was a positive factor for receipt of timely measles vaccine (OR = 1.34, 95% CI: 1.03, 1.75) for middle, (OR = 1.43, 95% CI: 1.10, 1.86) upper middle, and (OR = 1.51, 95% CI: 1.15, 1.98) higher quintiles as compared to the lower. Consequently, it is imperative to incorporate interventions that target low SES children and those that improve economic status.

Consent Challenges and Psychosocial Distress in the Scale-up of Voluntary Medical Male Circumcision Among Adolescents in Western Kenya.

In priority sub-Saharan African countries, on the ground observations suggest that the success of voluntary medical male circumcision (VMMC) programs should not be based solely on numbers of males circumcised. We identify gaps in the consent process and poor psychosocial outcomes among a key target group: male adolescents. We assessed compliance with consent and assent requirements for VMMC in western Kenya among males aged 15-19 (N = 1939). We also examined differences in quality of life, depression, and anticipated HIV stigma between uncircumcised and circumcised adolescents. A substantial proportion reported receiving VMMC services as minors without parent/guardian consent. In addition, uncircumcised males were significantly more likely than their circumcised peers to have poor quality of life and symptoms of depression. Careful monitoring of male adolescents' well-being is needed in large-scale VMMC programs. There is also urgent need for research to identify effective strategies to address gaps in the delivery of VMMC services.

Awareness and uptake of layered HIV prevention programming for young women: analysis of population-based surveys in three DREAMS settings in Kenya and South Africa.

BACKGROUND: The DREAMS Partnership is an ambitious effort to deliver combinations of biomedical, behavioural and structural interventions to reduce HIV incidence among adolescent girls and young women (AGYW). To inform multi-sectoral programming at scale, across diverse settings in Kenya and South Africa, we identified who the programme is reaching, with which interventions and in what combinations. METHODS: Randomly-selected cohorts of 606 AGYW aged 10-14 years and 1081 aged 15-22 years in Nairobi and 2184 AGYW aged 13-22 years in uMkhanyakude, KwaZulu-Natal, were enrolled in 2017, after ~ 1 year of DREAMS implementation. In Gem, western Kenya, population-wide cross-sectional survey data were collected during roll-out in 2016 (n = 1365 AGYW 15-22 years). We summarised awareness and invitation to participate in DREAMS, uptake of interventions categorised by the DREAMS core package, and uptake of a subset of 'primary' interventions. We stratified by age-group and setting, and compared across AGYW characteristics. RESULTS: Awareness of DREAMS was higher among younger women (Nairobi: 89%v78%, aged 15-17v18-22 years; uMkhanyakude: 56%v31%, aged 13-17v18-22; and Gem: 28%v25%, aged 15-17v18-22, respectively). HIV testing was the most accessed intervention in Nairobi and Gem (77% and 85%, respectively), and school-based HIV prevention in uMkhanyakude (60%). Among those invited, participation in social asset building was > 50%; > 60% accessed ≥2 core package categories, but few accessed all primary interventions intended for their age-group. Parenting programmes and community mobilisation, including those intended for male partners, were accessed infrequently. In Nairobi and uMkhanyakude, AGYW were more likely to be invited to participate and accessed more categories if they were: aged < 18 years, in school and experienced socio-economic vulnerabilities. Those who had had sex, or a pregnancy, were less likely to be invited to participate but accessed more categories. CONCLUSIONS: In representative population-based samples, awareness and uptake of DREAMS were high after 1 year of implementation. Evidence of 'layering' (receiving multiple interventions from the DREAMS core package), particularly among more socio-economically vulnerable AGYW, indicate that intervention packages can be implemented at scale, for intended recipients, in real-world contexts. Challenges remain for higher coverage and greater 'layering', including among older, out-of-school AGYW, and community-based programmes for families and men.

Menstrual cups and cash transfer to reduce sexual and reproductive harm and school dropout in adolescent schoolgirls: study protocol of a cluster-randomised controlled trial in western Kenya.

BACKGROUND: Adolescent girls in sub-Saharan Africa are disproportionally vulnerable to sexual and reproductive health (SRH) harms. In western Kenya, where unprotected transactional sex is common, young females face higher rates of school dropout, often due to pregnancy, and sexually transmitted infections (STIs), including HIV. Staying in school has shown to protect girls against early marriage, teen pregnancy, and HIV infection. This study evaluates the impact of menstrual cups and cash transfer interventions on a composite of deleterious outcomes (HIV, HSV-2, and school dropout) when given to secondary schoolgirls in western Kenya, with the aim to inform evidence-based policy to improve girls' health, school equity, and life-chances. METHODS: Single site, 4-arm, cluster randomised controlled superiority trial. Secondary schools are the unit of randomisation, with schoolgirls as the unit of measurement. Schools will be randomised into one of four intervention arms using a 1:1:1:1 ratio and block randomisation: (1) menstrual cup arm; (2) cash transfer arm, (3) cups and cash combined intervention arm, or (4) control arm. National and county agreement, and school level consent will be obtained prior to recruitment of schools, with parent consent and girls' assent obtained for participant enrolment. Participants will be trained on safe use of interventions, with all arms receiving puberty and hygiene education. Annually, the state of latrines, water availability, water treatment, handwashing units and soap in schools will be measured. The primary endpoint is a composite of incident HIV, HSV-2, and all-cause school dropout, after 3 years follow-up. School dropout will be monitored each term via school registers and confirmed through home visits. HIV and HSV-2 incident infections and risk factors will be measured at baseline, mid-line and end-line. Intention to treat analysis will be conducted among all enrolled participants. Focus group discussions will provide contextual information on uptake of interventions. Monitoring for safety will occur throughout. DISCUSSION: If proved safe and effective, the interventions offer a potential contribution toward girls' schooling, health, and equity in low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT03051789 , 15th February 2017.

Ethically providing Routine HIV testing services to bereaved populations.

BACKGROUND:: The delivery of public health policies may be in conflict with individualism. OBJECTIVES:: To propose measures to ethically provide routine HIV testing services to persons visiting a funeral home. RESEARCH DESIGN:: A document analysis of study documents and presentations made to an institutional review board. PARTICIPANTS AND RESEARCH CONTEXT:: Institutional review board members (both lay and professionals) and Study investigators attending an `open session' where study investigators were invited to elaborate on some study procedures. ETHICAL CONSIDERATIONS:: Identities of all parties were anonymized. FINDINGS:: Opt-out approaches to HIV testing, grief counseling, relational ethics, and a modular consenting process were proposed to safeguard clients' autonomy. The golden-rule approach and protective empowering were suggested to protect clientele beneficence. DISCUSSION AND CONCLUSION:: It is possible to ethically provide universal HIV testing and counseling services among grieving populations in this setting; elsewhere, this should be contextualized.

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.

"I think the parent should be there because no one was born alone": Kenyan adolescents' perspectives on parental involvement in HIV research.

Despite a pressing need for adolescent HIV research in sub-Saharan Africa, ethical guidance for conducting research among minor adolescents is lacking. One ethical issue is the degree to which parents should be involved in the research process. The existing discourse is predominantly speculative and focuses on negative consequences of parental involvement. We use empirical data to describe the perspectives of Kenyan adolescents on parental involvement in consent and disclosure of HIV test results within a research study context. We conducted two rounds of focus group discussions with 40 adolescents in western Kenya to ask about minor adolescent participation in HIV research. We analysed data using codes and matrices. Kenyan adolescents were largely in favour of parental involvement during the research process. Half felt adolescent minors should solicit parental consent to participate, and nearly all said parents should learn the HIV test results of adolescent minors in order to provide necessary support. From their perspective, involvement of parents in research extends beyond obtaining their consent to providing essential support for youth, regardless of HIV status, both during and beyond the research study. Ethical guidelines that prioritise adolescent autonomy in research must consider reasons to involve parents considered important by adolescents themselves, particularly in low-resource settings.

From policy to practice: exploring the implementation of antiretroviral therapy access and retention policies between 2013 and 2016 in six sub-Saharan African countries.

BACKGROUND: Understanding the implementation of 2013 World Health Organization (WHO) consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection at the facility level provides important lessons for the roll-out of future HIV policies. METHODS: A national policy review was conducted in six sub-Saharan African countries to map the inclusion of the 2013 WHO HIV treatment recommendations. Twenty indicators of policy adoption were selected to measure ART access (n = 12) and retention (n = 8). Two sequential cross-sectional surveys were conducted in facilities between 2013/2015 (round 1) and 2015/2016 (round 2) from ten health and demographic surveillance sites in Kenya, Malawi, South Africa, Tanzania, Uganda and Zimbabwe. Using standardised questionnaires, facility managers were interviewed. Descriptive analyses were used to assess the change in the proportion of facilities that implemented these policy indicators between rounds. RESULTS: Although, expansion of ART access was explicitly stated in all countries' policies, most lacked policies that enhanced retention. Overall, 145 facilities were included in both rounds. The proportion of facilities that initiated ART at CD4 counts of 500 or less cells/µL increased between round 1 and 2 from 12 to 68%, and facilities initiating patients on 2013 WHO recommended ART regimen increased from 42 to 87%. There were no changes in the proportion of facilities reporting stock-outs of first-line ART in the past year (18 to 11%) nor in the provision of three-month supply of ART (43 to 38%). None of the facilities provided community-based ART delivery. CONCLUSION: The increase in ART initiation CD4 threshold in most countries, and substantial improvements made in the provision of WHO recommended first-line ART regimens demonstrates that rapid adoption of WHO recommendations is possible. However, improved logistics and resources and/or changes in policy are required to further minimise ART stock-outs and allow lay cadres to dispense ART in the community. Increased efforts are needed to offer longer durations between clinic visits, a strategy purported to improve retention. These changes will be important as countries move to implement the revised 2015 WHO guidelines to initiate all HIV positive people onto ART regardless of their immune status.

A structured approach to recording AIDS-defining illnesses in Kenya: A SNOMED CT based solution.

INTRODUCTION: Several studies conducted in sub-Saharan Africa (SSA) have shown that routine clinical data in HIV clinics often have errors. Lack of structured and coded documentation of diagnosis of AIDS defining illnesses (ADIs) can compromise data quality and decisions made on clinical care. METHODS: We used a structured framework to derive a reference set of concepts and terms used to describe ADIs. The four sources used were: (i) CDC/Accenture list of opportunistic infections, (ii) SNOMED Clinical Terms (SNOMED CT), (iii) Focus Group Discussion (FGD) among clinicians and nurses attending to patients at a referral provincial hospital in western Kenya, and (iv) chart abstraction from the Maternal Child Health (MCH) and HIV clinics at the same hospital. Using the January 2014 release of SNOMED CT, concepts were retrieved that matched terms abstracted from approach iii & iv, and the content coverage assessed. Post-coordination matching was applied when needed. RESULTS: The final reference set had 1054 unique ADI concepts which were described by 1860 unique terms. Content coverage of SNOMED CT was high (99.9% with pre-coordinated concepts; 100% with post-coordination). The resulting reference set for ADIs was implemented as the interface terminology on OpenMRS data entry forms. CONCLUSION: Different sources demonstrate complementarity in the collection of concepts and terms for an interface terminology. SNOMED CT provides a high coverage in the domain of ADIs. Further work is needed to evaluate the effect of the interface terminology on data quality and quality of care.

Prevalence and risk factors of sexually transmitted infections in the setting of a generalized HIV epidemic-a population-based study, western Kenya.

BACKGROUND: Sexually transmitted infections (STIs) cause adverse health outcomes, including increasing HIV acquisition/transmission risk. We analyzed data from an HIV biomarker and behavioral survey to estimate STI prevalence, and explore associated factors in the setting of a generalized HIV epidemic in Siaya County, western Kenya. METHODS: Data were collected in March-September 2022 through face-to-face interviews using structured questionnaires; records from 9643 sexually active participants aged 13+ years were included in the analysis. We calculated weighted self-reported STI prevalence, by sex, age, and HIV status and explored associated factors using multivariable logistic regression. RESULTS: Median age was 37 years and 59.9% were female; HIV prevalence was 18.0%. Overall STI prevalence was 1.8%; 1.5-fold higher among males vs. females, and 2.6-fold higher among participants living with HIV vs. those without. HIV status and multiple sexual partners were independently associated with STI in both sexes. Mind-altering substance use and being circumcised were associated with STI among males. CONCLUSIONS: This study estimates STI prevalence in the setting of high HIV prevalence. Findings underscore the importance of: effective STI screening in HIV clinics and HIV testing and counseling in STI clinics; screening and counseling on substance use, and HIV pre-exposure prophylaxis; and intensive sexual health counseling in male circumcision programmes.

Assessment of Heat Exposure and Health Outcomes in Rural Populations of Western Kenya by Using Wearable Devices: Observational Case Study.

BACKGROUND: Climate change increasingly impacts health, particularly of rural populations in sub-Saharan Africa due to their limited resources for adaptation. Understanding these impacts remains a challenge, as continuous monitoring of vital signs in such populations is limited. Wearable devices (wearables) present a viable approach to studying these impacts on human health in real time. OBJECTIVE: The aim of this study was to assess the feasibility and effectiveness of consumer-grade wearables in measuring the health impacts of weather exposure on physiological responses (including activity, heart rate, body shell temperature, and sleep) of rural populations in western Kenya and to identify the health impacts associated with the weather exposures. METHODS: We conducted an observational case study in western Kenya by utilizing wearables over a 3-week period to continuously monitor various health metrics such as step count, sleep patterns, heart rate, and body shell temperature. Additionally, a local weather station provided detailed data on environmental conditions such as rainfall and heat, with measurements taken every 15 minutes. RESULTS: Our cohort comprised 83 participants (42 women and 41 men), with an average age of 33 years. We observed a positive correlation between step count and maximum wet bulb globe temperature (estimate 0.06, SE 0.02; P=.008). Although there was a negative correlation between minimum nighttime temperatures and heat index with sleep duration, these were not statistically significant. No significant correlations were found in other applied models. A cautionary heat index level was recorded on 194 (95.1%) of 204 days. Heavy rainfall (>20 mm/day) occurred on 16 (7.8%) out of 204 days. Despite 10 (21%) out of 47 devices failing, data completeness was high for sleep and step count (mean 82.6%, SD 21.3% and mean 86.1%, SD 18.9%, respectively), but low for heart rate (mean 7%, SD 14%), with adult women showing significantly higher data completeness for heart rate than men (2-sided t test: P=.003; Mann-Whitney U test: P=.001). Body shell temperature data achieved 36.2% (SD 24.5%) completeness. CONCLUSIONS: Our study provides a nuanced understanding of the health impacts of weather exposures in rural Kenya. Our study's application of wearables reveals a significant correlation between physical activity levels and high temperature stress, contrasting with other studies suggesting decreased activity in hotter conditions. This discrepancy invites further investigation into the unique socioenvironmental dynamics at play, particularly in sub-Saharan African contexts. Moreover, the nonsignificant trends observed in sleep disruption due to heat expose the need for localized climate change mitigation strategies, considering the vital role of sleep in health. These findings emphasize the need for context-specific research to inform policy and practice in regions susceptible to the adverse health effects of climate change.

Impact of DREAMS interventions on attitudes towards gender norms among adolescent girls and young women: Findings from a prospective cohort in Kenya.

The DREAMS partnership aims to deliver a comprehensive package to reduce HIV incidence among adolescent girls and young women (AGYW), including through shifting gender norms. We evaluate DREAMS' effect on attitudes towards gender norms in two Kenyan settings. AGYW aged 15-22 in Nairobi (n = 852) and Gem (n = 761) were randomly selected for cohort enrolment in 2017-18 and followed-up to 2019. We described the proportion of AGYW and their male peers with equitable attitudes towards gender norms, using an adapted version of the GEM scale. We estimated the association between self-reported invitation to DREAMS (in 2017-18) and AGYW's attitudes towards two dimensions of gender norms, and then applied a causal inference framework to estimate the difference in the proportion of AGYW with equitable attitudes under the counterfactual scenarios that all versus none were DREAMS beneficiaries. We estimated that overall, 90.2% versus 87.1% of AGYW would have equitable norms around sexual and reproductive health decision-making in Nairobi if all versus none were DREAMS beneficiaries (+3.1; 95%CI:-2.5, +9.0). In Gem, we estimated a risk difference of +1.0 (89.6% vs 88.6%, 95%CI: -3.6,+5.6). There was no evidence for an effect of DREAMS on attitudes towards violence-related norms (Nairobi: 82.7% vs 82.2%, +0.5; 95%CI: -5.3,+6.5; Gem: 44.3% vs 48.2%, -3.9; 95%CI: -11.7,+3.0). We found no evidence of an impact of DREAMS invitation on individual attitudes towards gender norms. In some cases, equitable attitudes at enrolment left limited scope for improvement, and additional effort may be required to shift inequitable violence attitudes among both AGYW and their male peers.