Search

This cross-sectional study of 3212 pregnant women assessed the field performance, acceptability, and feasibility of two dual HIV/syphilis rapid diagnostic tests, the Chembio DPP HIV-syphilis Assay and the SD Bioline HIV/syphilis Duo in antenatal clinics. Sensitivity and specificity for HIV and syphilis were calculated compared to the rapid Determine HIV-1/2 with Uni-Gold to confirm positive results for HIV and the Treponema pallidum particle agglutination assay for syphilis. RPR titers ≥1:4 were used to define active syphilis detection. Acceptability and feasibility were assessed using self-reported questionnaires. For Chembio, the HIV sensitivity was 90.6% (95%CI = 87.4, 93.0) and specificity was 97.2% (95%CI = 96.2, 97.8); syphilis sensitivity was 68.6% (95%CI = 61.9, 74.6) and specificity was 98.5% (95%CI = 97.8, 98.9). For SD Bioline, HIV sensitivity was 89.4% (95%CI = 86.1, 92.0) and specificity was 96.3% (95%CI = 95.3, 97.1); syphilis sensitivity was 66.2% (95%CI = 59.4, 72.4) and specificity was 97.2% (95%CI = 96.4, 97.9). Using the reference for active syphilis, syphilis sensitivity was 84.7% (95%CI = 76.1, 90.6) for Chembio and 81.6% (95%CI = 72.7, 88.1) for SD Bioline. Both rapid diagnostic tests were assessed as highly acceptable and feasible. In a field setting, the performance of both rapid diagnostic tests was comparable to other published field evaluations and each was rated highly acceptable and feasible. These findings can be used to guide further research and proposed scale up in antenatal clinic settings. [ABSTRACT FROM AUTHOR]

Background: Improved primary health care is needed in developing countries to effectively manage the growing burden of hypertension. Our objective was to evaluate hypertension management in Zambian rural primary care clinics using process and outcome indicators to assess the screening, monitoring, treatment and control of high blood pressure.Methods: Better Health Outcomes through Mentoring and Assessment (BHOMA) is a 5-year, randomized stepped-wedge trial of improved clinical service delivery underway in 46 rural Zambian clinics. Clinical data were collected as part of routine patient care from an electronic medical record system, and reviewed for site performance over time according to hypertension related indicators: screening (blood pressure measurement), management (recorded diagnosis, physical exam or urinalysis), treatment (on medication), and control. Quantitative data was used to develop guides for qualitative in-depth interviews, conducted with health care providers at a proportional sample of half (20) of clinics. Qualitative data was iteratively analyzed for thematic content.Results: From January 2011 to December 2014, 318,380 visits to 46 primary care clinics by adults aged ≥ 25 years with blood pressure measurements were included. Blood pressure measurement at vital sign screening was initially high at 89.1% overall (range: 70.1-100%), but decreased to 62.1% (range: 0-100%) by 48 months after intervention start. The majority of hypertensive patients made only one visit to the clinics (57.8%). Out of 9022 patients with at least two visits with an elevated blood pressure, only 49.3% had a chart recorded hypertension diagnosis. Process indicators for monitoring hypertension were <10% and did not improve with time. In in-depth interviews, antihypertensive medication shortages were common, with 15/20 clinics reporting hydrochlorothiazide-amiloride stockouts. Principal challenges in hypertension management included 1) equipment and personnel shortages, 2) provider belief that multiple visits were needed before official management, 3) medication stock-outs, leading to improper prescriptions and 4) poor patient visit attendance.Conclusions: Our findings suggest that numerous barriers stand in the way of hypertension diagnosis and management in Zambian primary health facilities. Future work should focus on performance indicator development and validation in low resource contexts, to facilitate regular and systematic data review to improve patient outcomes.Trial Registration: ClinicalTrials.gov, Identifier NCT01942278 . Date of Registration: September 2013. [ABSTRACT FROM AUTHOR]

Background: Hypertension constitutes a growing burden of illness in developing countries like Zambia. Adequately screening and treating hypertension could greatly reduce the complications of stroke and coronary disease. Our objective was to determine the prevalence of hypertension and identify current treatment practices among adult patients presenting for routine care to rural health facilities in the Better Health Outcomes through Mentoring and Assessments (BHOMA) project.Methods: We conducted a retrospective analysis of routinely collected clinical data from 46 rural government clinics in Zambia. Our analysis cohort comprised patients ≥ 25 years with recorded blood pressure measurements, who sought care at primary health centers. Consistent with prior research, in our primary analysis, we only included data from first visits. Hypertension was defined as a systolic blood pressure ≥140 mmHg, or diastolic blood pressure ≥90 mmHg, or reported use of antihypertensive medication. A sensitivity analysis was performed using median blood pressure for individuals with multiple visits.Results and Discussion: From January 2011 to December 2014, 116,130 first visits by adult patients met eligibility criteria. The crude prevalence of hypertension by onsite measurement or reported use of antihypertensive medication was 23.1% [95% CI: 22.8-23.3] (23.6% in females, 22.3% in males). The age standardized prevalence of hypertension across participating sites was 28.0 [95% CI: 27.7-28.3] (29.7% in females, 25.8% in males). Sensitivity analysis revealed a similar prevalence using data from all visits. Only 5.6% of patients had a diagnosis of hypertension documented in their medical record. Among patients with hypertension, only 18.0% had any antihypertensive drug prescribed, with nifedipine (8.9%), furosemide (8.3%), and propranolol (2.4%) as the most common.Conclusions: Age standardized prevalence of hypertension in rural primary health clinics in Zambia was high compared to other studies in rural Africa; however, we diagnosed hypertension with only one measurement and this may have biased our findings. Future efforts to improve hypertension control should focus on population preventive care and primary healthcare provider education on individual management. [ABSTRACT FROM AUTHOR]

Background: Mobile health (m-health) utilizes widespread access to mobile phone technologies to expand health services. Community health workers (CHWs) provide first-level contact with health facilities; combining CHW efforts with m-health may be an avenue for improving primary care services. As part of a primary care improvement project, a pilot CHW program was developed using a mobile phone-based application for outreach, referral, and follow-up between the clinic and community in rural Zambia. Materials and Methods: The program was implemented at six primary care sites. Computers were installed at clinics for data entry, and data were transmitted to central servers. In the field, using a mobile phone to send data and receive follow-up requests, CHWs conducted household health surveillance visits, referred individuals to clinic, and followed up clinic patients. Results: From January to April 2011, 24 CHWs surveyed 6,197 households with 33,304 inhabitants. Of 15,539 clinic visits, 1,173 (8%) had a follow-up visit indicated and transmitted via a mobile phone to designated CHWs. CHWs performed one or more follow-ups on 74% (n =871) of active requests and obtained outcomes on 63% (n =741). From all community visits combined, CHWs referred 840 individuals to a clinic. Conclusions: CHWs completed all planned aspects of surveillance and outreach, demonstrating feasibility. Components of this pilot project may aid clinical care in rural settings and have potential for epidemiologic and health system applications. Thus, m-health has the potential to improve service outreach, guide activities, and facilitate data collection in Zambia. [ABSTRACT FROM AUTHOR]

Introduction: Zambia's under-resourced public health system will not be able to deliver on its health-related Millennium Development Goals without a substantial acceleration in mortality reduction. Reducing mortality will depend not only upon increasing access to health care but also upon improving the quality of care that is delivered. Our project proposes to improve the quality of clinical care and to improve utilization of that care, through a targeted quality improvement (QI) intervention delivered at the facility and community level. Description of implementation: The project is being carried out 42 primary health care facilities that serve a largely rural population of more than 450,000 in Zambia's Lusaka Province. We have deployed six QI teams to implement consensus clinical protocols, forms, and systems at each site. The QI teams define new clinical quality expectations and provide tools needed to deliver on those expectations. They also monitor the care that is provided and mentor facility staff to improve care quality. We also engage community health workers to actively refer and follow up patients. Evaluation design: Project implementation occurs over a period of four years in a stepped expansion to six randomly selected new facilities every three months. Three annual household surveys will determine population estimates of age-standardized mortality and under-5 mortality in each community before, during, and after implementation. Surveys will also provide measures of childhood vaccine coverage, pregnancy care utilization, and general adult health. Health facility surveys will assess coverage of primary health interventions and measures of health system effectiveness. Discussion: The patient-provider interaction is an important interface where the community and the health system meet. Our project aims to reduce population mortality by substantially improving this interaction. Our success will hinge upon the ability of mentoring and continuous QI to improve clinical service delivery. It will also be critical that once the quality of services improves, increasing proportions of the population will recognize their value and begin to utilize them. [ABSTRACT FROM AUTHOR]

Background: The Global Resilience Oral Workshops (GROW) Free and Strong programs take a strengths-based, positive youth development (PYD) approach to promoting thriving. Through both prevention (GROW Strong) and intervention (GROW Free) exercises, these programs aim to build character and emotional resilience while also lowering unhealthy alcohol use.To meaningfully assess the impact of the GROW programs on health and PYD, ecologically and psychometrically valid measures of character strengths were needed, with a focus on the strengths of hope, forgiveness, spirituality, prudence, and self-control (self-regulation) promoted by GROW.We tested a series of exploratory and confirmatory factor analyses of these five key constructs using two samples: a school-based youth sample enrolled in GROW Strong (n = 460; Mage = 15.04 years, SDage = 1.21; 53.0% female); and a community-based adult sample enrolled in GROW Free (n = 457; Mage = 20.60 years, SDage = 1.88; 49.7% female); both enrolled using a waitlist-control design.Measures demonstrated strong invariance across specific subgroups present in the data sets, with differences emerging across ages, urban/rural locations, and baseline study conditions.To meaningfully document PYD programs and character development in the majority world, measurement models must be theory-predicated, robust, and empirically validated for the specific context. The results provide evidence for such a measure that will be useful in future intervention studies promoting character strengths to address unhealthy alcohol use in Zambia.Objective: The Global Resilience Oral Workshops (GROW) Free and Strong programs take a strengths-based, positive youth development (PYD) approach to promoting thriving. Through both prevention (GROW Strong) and intervention (GROW Free) exercises, these programs aim to build character and emotional resilience while also lowering unhealthy alcohol use.To meaningfully assess the impact of the GROW programs on health and PYD, ecologically and psychometrically valid measures of character strengths were needed, with a focus on the strengths of hope, forgiveness, spirituality, prudence, and self-control (self-regulation) promoted by GROW.We tested a series of exploratory and confirmatory factor analyses of these five key constructs using two samples: a school-based youth sample enrolled in GROW Strong (n = 460; Mage = 15.04 years, SDage = 1.21; 53.0% female); and a community-based adult sample enrolled in GROW Free (n = 457; Mage = 20.60 years, SDage = 1.88; 49.7% female); both enrolled using a waitlist-control design.Measures demonstrated strong invariance across specific subgroups present in the data sets, with differences emerging across ages, urban/rural locations, and baseline study conditions.To meaningfully document PYD programs and character development in the majority world, measurement models must be theory-predicated, robust, and empirically validated for the specific context. The results provide evidence for such a measure that will be useful in future intervention studies promoting character strengths to address unhealthy alcohol use in Zambia.Method: The Global Resilience Oral Workshops (GROW) Free and Strong programs take a strengths-based, positive youth development (PYD) approach to promoting thriving. Through both prevention (GROW Strong) and intervention (GROW Free) exercises, these programs aim to build character and emotional resilience while also lowering unhealthy alcohol use.To meaningfully assess the impact of the GROW programs on health and PYD, ecologically and psychometrically valid measures of character strengths were needed, with a focus on the strengths of hope, forgiveness, spirituality, prudence, and self-control (self-regulation) promoted by GROW.We tested a series of exploratory and confirmatory factor analyses of these five key constructs using two samples: a school-based youth sample enrolled in GROW Strong (n = 460; Mage = 15.04 years, SDage = 1.21; 53.0% female); and a community-based adult sample enrolled in GROW Free (n = 457; Mage = 20.60 years, SDage = 1.88; 49.7% female); both enrolled using a waitlist-control design.Measures demonstrated strong invariance across specific subgroups present in the data sets, with differences emerging across ages, urban/rural locations, and baseline study conditions.To meaningfully document PYD programs and character development in the majority world, measurement models must be theory-predicated, robust, and empirically validated for the specific context. The results provide evidence for such a measure that will be useful in future intervention studies promoting character strengths to address unhealthy alcohol use in Zambia.Results: The Global Resilience Oral Workshops (GROW) Free and Strong programs take a strengths-based, positive youth development (PYD) approach to promoting thriving. Through both prevention (GROW Strong) and intervention (GROW Free) exercises, these programs aim to build character and emotional resilience while also lowering unhealthy alcohol use.To meaningfully assess the impact of the GROW programs on health and PYD, ecologically and psychometrically valid measures of character strengths were needed, with a focus on the strengths of hope, forgiveness, spirituality, prudence, and self-control (self-regulation) promoted by GROW.We tested a series of exploratory and confirmatory factor analyses of these five key constructs using two samples: a school-based youth sample enrolled in GROW Strong (n = 460; Mage = 15.04 years, SDage = 1.21; 53.0% female); and a community-based adult sample enrolled in GROW Free (n = 457; Mage = 20.60 years, SDage = 1.88; 49.7% female); both enrolled using a waitlist-control design.Measures demonstrated strong invariance across specific subgroups present in the data sets, with differences emerging across ages, urban/rural locations, and baseline study conditions.To meaningfully document PYD programs and character development in the majority world, measurement models must be theory-predicated, robust, and empirically validated for the specific context. The results provide evidence for such a measure that will be useful in future intervention studies promoting character strengths to address unhealthy alcohol use in Zambia.Conclusions: The Global Resilience Oral Workshops (GROW) Free and Strong programs take a strengths-based, positive youth development (PYD) approach to promoting thriving. Through both prevention (GROW Strong) and intervention (GROW Free) exercises, these programs aim to build character and emotional resilience while also lowering unhealthy alcohol use.To meaningfully assess the impact of the GROW programs on health and PYD, ecologically and psychometrically valid measures of character strengths were needed, with a focus on the strengths of hope, forgiveness, spirituality, prudence, and self-control (self-regulation) promoted by GROW.We tested a series of exploratory and confirmatory factor analyses of these five key constructs using two samples: a school-based youth sample enrolled in GROW Strong (n = 460; Mage = 15.04 years, SDage = 1.21; 53.0% female); and a community-based adult sample enrolled in GROW Free (n = 457; Mage = 20.60 years, SDage = 1.88; 49.7% female); both enrolled using a waitlist-control design.Measures demonstrated strong invariance across specific subgroups present in the data sets, with differences emerging across ages, urban/rural locations, and baseline study conditions.To meaningfully document PYD programs and character development in the majority world, measurement models must be theory-predicated, robust, and empirically validated for the specific context. The results provide evidence for such a measure that will be useful in future intervention studies promoting character strengths to address unhealthy alcohol use in Zambia. [ABSTRACT FROM AUTHOR]

Importance: Accurate assessment of gestational age (GA) is essential to good pregnancy care but often requires ultrasonography, which may not be available in low-resource settings. This study developed a deep learning artificial intelligence (AI) model to estimate GA from blind ultrasonography sweeps and incorporated it into the software of a low-cost, battery-powered device., Objective: To evaluate GA estimation accuracy of an AI-enabled ultrasonography tool when used by novice users with no prior training in sonography., Design, Setting, and Participants: This prospective diagnostic accuracy study enrolled 400 individuals with viable, single, nonanomalous, first-trimester pregnancies in Lusaka, Zambia, and Chapel Hill, North Carolina. Credentialed sonographers established the "ground truth" GA via transvaginal crown-rump length measurement. At random follow-up visits throughout gestation, including a primary evaluation window from 14 0/7 weeks' to 27 6/7 weeks' gestation, novice users obtained blind sweeps of the maternal abdomen using the AI-enabled device (index test) and credentialed sonographers performed fetal biometry with a high-specification machine (study standard)., Main Outcomes and Measures: The primary outcome was the mean absolute error (MAE) of the index test and study standard, which was calculated by comparing each method's estimate to the previously established GA and considered equivalent if the difference fell within a prespecified margin of ±2 days., Results: In the primary evaluation window, the AI-enabled device met criteria for equivalence to the study standard, with an MAE (SE) of 3.2 (0.1) days vs 3.0 (0.1) days (difference, 0.2 days [95% CI, -0.1 to 0.5]). Additionally, the percentage of assessments within 7 days of the ground truth GA was comparable (90.7% for the index test vs 92.5% for the study standard). Performance was consistent in prespecified subgroups, including the Zambia and North Carolina cohorts and those with high body mass index., Conclusions and Relevance: Between 14 and 27 weeks' gestation, novice users with no prior training in ultrasonography estimated GA as accurately with the low-cost, point-of-care AI tool as credentialed sonographers performing standard biometry on high-specification machines. These findings have immediate implications for obstetrical care in low-resource settings, advancing the World Health Organization goal of ultrasonography estimation of GA for all pregnant people., Trial Registration: ClinicalTrials.gov Identifier: NCT05433519.

Background: Women with HIV face an increased risk of preterm birth. 17 alpha-hydroxyprogesterone caproate (17P) has been shown in some trials to reduce early delivery among women with a history of spontaneous preterm birth. We investigated whether 17P would reduce this risk among women with HIV., Methods: We did a randomised, double-blind, placebo-controlled trial in pregnant women with HIV at the University Teaching Hospital and Kamwala District Health Centre in Lusaka, Zambia. Eligible patients were women aged 18 years or older with confirmed HIV-1 infection, viable intrauterine singleton pregnancy at less than 24 weeks of gestation, and were receiving or intending to commence antiretroviral therapy during pregnancy. Exclusion criteria were major uterine or fetal anomaly; planned or in situ cervical cerclage; evidence of threatened miscarriage, preterm labour, or ruptured membranes at screening; medical contraindication to 17P; previous participation in the trial; or history of spontaneous preterm birth. Eligible participants provided written informed consent and were randomly assigned (1:1) to receive 250 mg intramuscular 17P or placebo once per week, starting between 16 and 24 weeks of gestation until delivery, stillbirth, or reaching term (37 weeks). Participants and study staff were masked to assignment, except for pharmacy staff who did random assignment and prepared injections but did not interact with participants. The primary outcome was a composite of delivery before 37 weeks or stillbirth at any gestational age. Patients attended weekly visits for study drug injections and antenatal care. We estimated the absolute and relative difference in risk of the primary outcome and safety events between treatment groups by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03297216, and is complete., Findings: Between Feb 7, 2018 and Jan 13, 2020, we assessed 1042 women for inclusion into the study. 242 women were excluded after additional assessments, and 800 eligible patients were enrolled and randomly assigned to receive intramuscular 17P (n=399) or placebo (n=401). Baseline characteristics were similar between groups. Adherence to study drug injections was 98% in both groups, no patients were lost to follow-up, and the final post-partum visit was on Aug 6, 2020. 36 (9%) of 399 participants assigned to 17P had preterm birth or stillbirth, compared with 36 (9%) of 401 patients assigned to placebo (risk difference 0·1, 95% CI -3·9 to 4·0; relative risk 1·0, 95% CI 0·6 to 1·6; p=0·98). Intervention-related adverse events were reported by 140 (18%) of 800 participants and occurred in similar proportions in both randomisation groups. No serious adverse events were reported., Interpretation: Although 17P seems to be safe and acceptable to participants, available data do not support the use of the drug to prevent preterm birth among women whose risk derives solely from HIV infection. The low risk of preterm birth in both randomisation groups warrants further investigation., Funding: US National Institutes of Health and the Bill and Melinda Gates Foundation., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)