ODYSSEY clinical trial design: a randomised global study to evaluate the efficacy and safety of dolutegravir-based antiretroviral therapy in HIV-positive children, with nested pharmacokinetic sub-studies to evaluate pragmatic WHO-weight-band based dolutegravir dosing.

Background: Dolutegravir (DTG)-based antiretroviral therapy (ART) is highly effective and well-tolerated in adults and is rapidly being adopted globally. We describe the design of the ODYSSEY trial which evaluates the efficacy and safety of DTG-based ART compared with standard-of-care in children and adolescents. The ODYSSEY trial includes nested pharmacokinetic (PK) sub-studies which evaluated pragmatic World Health Organization (WHO) weight-band-based DTG dosing and opened recruitment to children < 14 kg while dosing was in development.

Tenofovir Diphosphate Concentrations in Dried Blood Spots From Pregnant and Postpartum Adolescent and Young Women Receiving Daily Observed Pre-exposure Prophylaxis in Sub-Saharan Africa.

Background: Intracellular tenofovir diphosphate (TFV-DP) concentration in dried blood spots (DBSs) is used to monitor cumulative pre-exposure prophylaxis (PrEP) adherence. We evaluated TFV-DP in DBSs following daily oral PrEP (emtricitabine 200 mg/tenofovir diphosphate 300 mg) among pregnant and postpartum adolescent girls and young women (AGYW).

Methods: Directly observed PrEP was administered for 12 weeks in a pregnancy (14-24 weeks' gestation, n = 20) and postpartum (6-12 weeks postpartum, n = 20) group of AGYW aged 16-24 years in sub-Saharan Africa.

Predictors of suboptimal adherence to isoniazid preventive therapy among adolescents and children living with HIV.

This study identified factors associated with adherence to a 6-month isoniazid preventive therapy (IPT) course among adolescents and children living with HIV. Forty adolescents living with HIV and 48 primary caregivers of children living with HIV completed a Likert-based survey to measure respondent opinions regarding access to care, quality of care, preferred regimens, perceived stigma, and confidence in self-efficacy. Sociodemographic data were collected and adherence measured as the average of pill counts obtained while on IPT.

Improving Peripheral Intravenous Catheter Care for Children with Cancer Receiving Chemotherapy in Malawi.

Purpose: To change pediatric oncology nursing management of peripheral intravenous catheter (PIVC) insertion and care based on current best evidence.

Design And Methods: Practice change strategies were developed, and nurses completed education on proper PIVC insertion, dressing placement, and ongoing PIVC assessment with emphasis on preventing chemotherapy extravasation. Nurses also completed a chemotherapy course as part of their orientation program.

Tuberculosis prevention in children: a prospective community-based study in South Africa.

Tuberculosis (TB) preventive therapy reduces TB risk in children. However, the effectiveness of TB preventive therapy in children living in high TB burden settings is unclear.In a prospective observational community-based cohort study in Cape Town, South Africa, we assessed the effectiveness of routine TB preventive therapy in children ≤15 years of age in a high TB and HIV prevalence setting.

Genotype-Informed Versus Empiric Management Of VirEmia (GIVE MOVE): study protocol of an open-label randomised clinical trial in children and adolescents living with HIV in Lesotho and Tanzania.

Background: Globally, the majority of people living with HIV have no or only limited access to HIV drug resistance testing to guide the selection of antiretroviral drugs. This is of particular concern for children and adolescents, who experience high rates of treatment failure. The GIVE MOVE trial assesses the clinical impact and cost-effectiveness of routinely providing genotypic resistance testing (GRT) to children and adolescents living with HIV who have an unsuppressed viral load (VL) while taking antiretroviral therapy (ART).

Tuberculosis symptom screening for children and adolescents living with HIV in six high HIV/TB burden countries in Africa.

Objectives: The WHO recommends that children and adolescents living with HIV (CALHIV) complete TB symptom screening at every clinical encounter but evidence supporting this recommendation is limited. We evaluated the performance of the recommended TB symptom screening in six high-burden TB/HIV countries.

Design: Retrospective longitudinal cohort.

Non-uptake of viral load testing among people receiving HIV treatment in Gomba district, rural Uganda.

Background: Viral load (VL) testing is the gold-standard approach for monitoring human immunodeficiency virus (HIV) treatment success and virologic failure, but uptake is suboptimal in resource-limited and rural settings. We conducted a cross-sectional study of risk factors for non-uptake of VL testing in rural Uganda.

Methods: We conducted a cross-sectional analysis of uptake of VL testing among randomly selected people with HIV (PWH) receiving anti-retroviral treatment (ART) for at least 6 months at all eight primary health centers in Gomba district, rural Uganda.

The effect of antiretroviral therapy guideline change on health outcomes among youth living with HIV in Uganda.

Opportunistic infections (OIs) are the primary cause of HIV-related morbidity and mortality. To reduce the risk, the ART eligibility criteria were revised to start treatment before advanced disease onset. We evaluated the effect of 2014 HIV clinical guideline changes in Uganda on opportunistic infections and survival among Youth Living with HIV (YLWH).

Predicting Sexually Transmitted Infections Among HIV+ Adolescents and Young Adults: A Novel Risk Score to Augment Syndromic Management in Eswatini.

Background: Despite poor predictive power, syndromic screening is standard of care for diagnosing sexually transmitted infections (STIs) in low-resource, high HIV-burden settings. Predictive models may augment syndromic screening when diagnostic testing is not universally available for screening high-risk patient populations such as adolescents and young adults living with HIV.

Setting: Four hundred fifteen adolescents and young adults living with HIV, age 15-24 years, participated from 3 clinical sites in Eswatini, provided urine, sexual and medical history, and completed physical examination.

Beyond the facility: An evaluation of seven community-based pediatric HIV testing strategies and linkage to care outcomes in a high prevalence, resource-limited setting.

Diverse challenges in expanding pediatric HIV testing and treatment coverage persist, making the investigation and adoption of innovative strategies urgent. Evidence is mounting for the effectiveness of community-based testing in bringing such lifesaving services to those in need, particularly in resource-limited settings. The Mobilizing HIV Identification and Treatment project piloted seven community-based testing strategies to assess their effectiveness in reaching HIV-positive children and linking them to care in two districts of Lesotho from October 2015 to March 2018.

Neonatal mortality rates and association with antenatal corticosteroids at Kamuzu Central Hospital.

Objective: Malawi has one of the highest child mortality rates in the world, and neonates account for nearly half of all under-five mortality. No previous study has reported neonatal outcomes in Malawi over 12 months. We aimed to evaluate outcomes in the neonatal intensive care unit (NICU) at Kamuzu Central Hospital (KCH) and to determine if there was an association between increased survival and antenatal corticosteroid (ACS) exposure.

Simplified dolutegravir dosing for children with HIV weighing 20 kg or more: pharmacokinetic and safety substudies of the multicentre, randomised ODYSSEY trial.

Background: Paediatric dolutegravir doses approved by stringent regulatory authorities (SRAs) for children weighing 20 kg to less than 40 kg until recently required 25 mg and 10 mg film-coated tablets. These tablets are not readily available in low-resource settings where the burden of HIV is highest. We did nested pharmacokinetic substudies in patients enrolled in the ODYSSEY-trial to evaluate simplified dosing in children with HIV.

Changes in Bone Mineral Density During and After Lactation in Ugandan Women With HIV on Tenofovir-Based Antiretroviral Therapy.

Antiretroviral therapy (ART) in people living with human immunodeficiency virus (HIV) is associated with bone loss, but data are limited in lactation, when physiological bone mineral mobilization is occurring. This research charted changes in areal bone mineral density (aBMD) during and after lactation in Ugandan women with HIV (WWH) initiated onto ART in pregnancy, compared to women without HIV (REF). One-hundred WWH on tenofovir-based ART and 100 REF were enrolled in pregnancy.

Recommendations for treating life-threatening Kaposi sarcoma during pregnancy in HIV-positive women in low income countries.

In areas of high HIV and human herpes virus 8 prevalence, life-threatening forms of Kaposi sarcoma (KS) can occur in HIV-positive women during pregnancy. Treating KS in pregnancy must balance both the well-being of the mother with the health of the fetus, yet data and recommendations on the best treatment approach for KS during pregnancy are limited. Without effective treatment, which can be difficult to obtain in low income countries (LICs), the mother and infant are at risk for poor outcomes.

Disseminated cysticercosis and Kaposi sarcoma in a child with HIV/AIDS: A case report.

Background: Clinical manifestations of extraneural infection with the pork tapeworm Taenia solium typically affect the muscles, eyes, alimentary canal, and/or subcutaneous tissues. Children living with HIV are at increased risk for more widespread and severe manifestations of food-borne opportunistic infections, including T. solium, due to fluctuating levels of immunosuppression.

Impact of sickle cell disease on presentation and progression of paediatric HIV: a retrospective cohort study.

Objectives: HIV and sickle cell disease (SCD) are significant causes of morbidity and mortality in sub-Saharan Africa. Given their separate roles in immune dysregulation, our objective was to characterise the impact that SCD has on the presentation and progression of paediatric HIV.

Methods: The study was a retrospective cohort study (study period 2004-2018).

Pretreatment HIV drug resistance predicts accumulation of new mutations in ART-naïve Ugandan children.

Aim: To assess the prevalence of pretreatment drug resistance (PDR) and its association with virologic outcomes after 24 weeks of antiretroviral therapy (ART), within an urban cohort of Ugandan children.

Methods: Prospective observational study. Baseline and 24-week assessments of viral load (VL) and genotypic drug resistance to nucleoside reverse transcriptase inhibitors (NRTI) and non-nucleoside reverse transcriptase inhibitors (NNRTI) were performed.

Risk factors for mortality and management of children with complicated severe acute malnutrition at a tertiary referral hospital in Malawi.

Background: Severe acute malnutrition (SAM) is a major cause of childhood mortality in resource-limited settings. The relationship between clinical factors and adherence to the 'WHO 10 Steps' and mortality in children with SAM is not fully understood.

Methods: Data from an ongoing prospective observational cohort study assessing admission characteristics, management patterns and clinical outcome in children aged 6-36 months admitted to a tertiary hospital in Malawi from September 2018 to September 2019 were analysed.

Point-of-Care Testing to Guide Treatment and Estimate Risk Factors for Sexually Transmitted Infections in Adolescents and Young People With Human Immunodeficiency Virus in Eswatini.

Background: The World Health Organization (WHO) estimates 127 million new cases of (CT), 87 million new cases of (NG), and 156 million new cases of (TV) each year, which corresponds to 355 (219-606), 303 (216-468), and 243 (97.6-425) thousand disability-adjusted life-years. In low-resource settings, however, sexually transmitted infections (STIs) are treated syndromically and many individuals with asymptomatic infection may be missed, especially adolescents and young adults with human immunodeficiency virus (HIV).

The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi.

Background: Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs. There is an urgent need for evidence-based, cost-effective, and scalable interventions to improve maternal adherence and retention that can be feasibly implemented in overburdened health systems. Brief video-based interventions are a promising but underutilized approach to this crisis.

Childhood malnutrition within the indigenous Wayuú children of northern Colombia.

Malnutrition contributes to nearly half of all preventable deaths in children under the age of five. While the burden of disease is heaviest in Sub-Saharan Africa, South, and Southeast Asia, malnutrition in Latin America remains high, especially within indigenous communities. This study evaluates the prevalence of malnutrition and its relationship with access to healthcare resources within 172 indigenous Wayuú communities in La Guajira, Colombia.

Improving Pediatric Academic Global Health Collaborative Research and Agenda Setting: A Mixed-Methods Study.

Academic global health collaborations have the potential to improve joint understanding of health issues in low- and middle-income countries (LMICs). Our objective was to elucidate perceptions of benefits and challenges of academic global health collaborations as well as areas for improving collaborative research conducted in LMICs. This cross-sectional, mixed-methods study surveyed investigators' perceptions of benefits and challenges of pediatric academic global health collaborations.