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Background Global policymakers have proposed strengthening midwifery regulation to improve access to and quality of care provided by midwives, thereby enhancing maternal healthcare delivery and outcomes. However, quantifying ‘midwifery regulatory environments’ as a construct across countries has been difficult, limiting our ability to evaluate relationships between regulatory environments and key outcomes and hindering actionable steps toward improvement. The Global Midwives’ Associations map survey includes data across five domains of regulation (overarching regulatory policy and legislation; education and qualification; licensure; registration/re-licensure; and scope and conduct of practice). We aimed to use these data to develop a composite index that represents the midwifery regulatory environment in the countries that participated in the survey. Methods To develop our composite Midwifery Regulatory Environment (MRE) Index, we analyzed data from 115 countries in the Global Midwives’ Associations map survey. We identified five different possible scoring characterizations for thirteen regulatory items. Four characterizations used continuous or categorical cumulative scoring and one used multiple individual components scoring. We compared these characterizations using Clarke’s test and descriptive model fit metrics to identify the best fit and performance for three outcomes: maternal mortality ratio, low birthweight prevalence, and stillbirth rate. Results The Aggregated Domain Scoring method, which assigns one point for each of the five essential regulatory domains with activity (possible score range: 0–5), was the best fit and performing characterization for maternal mortality ratio and stillbirth outcomes. The Any-or-None Scoring method, which assigns one point per survey item with regulatory activity (possible score range: 0–13), best fit low birthweight prevalence. Conclusions Our study demonstrates that developing composite characterizations of complex constructs, as exemplified by MRE Index development, can enhance the usability of existing global health datasets. Additionally, it highlights how employing model fit prediction provides a transparent, replicable, and accessible approach for identifying the optimal characterization of the construct based on a specific outcome. Specifically, we found that different characterizations for the MRE Index are preferred for different maternal health outcomes. The MRE Index we have developed stands as a valuable tool for future research exploring relationships between midwifery regulation and maternal health outcomes.

Background South Africa is home to more people living with HIV than any other country, including nearly one in three pregnant women attending antenatal care. Access to antiretroviral therapy (ART) has increased substantially since the start of the national ART program in 2004, with > 95% ART coverage during pregnancy and delivery, and vertical transmission of HIV greatly reduced. However, women who initiate ART during pregnancy are at heightened risk of dropping out of care, particularly after delivery, leading to the potential for viral transmission, morbidity and mortality. It is difficult to evaluate the success of policies of expanded access to ART care, and assess continuity of care, due to the lack of a national longitudinal HIV care database. Also, patient movement between unlinked facilities. For the first time on a national level, we propose to utilize routinely-collected laboratory data to develop and validate a cohort of pregnant women living with HIV in South Africa in a way that is uniquely robust to facility transfer. Methods Using laboratory test data matched to facility type, we will identify entry to antenatal care to build the cohort, then describe key treatment milestones, including 1) engagement in antenatal care, 2) initiation of ART, 3) HIV viremia, and 4) continuity of HIV care in the postpartum period. Second, we will measure the effect of system-wide factors impacting continuity of care among pregnant women. We will assess policies of expanded treatment access on continuity of care using regression-discontinuity analyses. We then will assess mobility and its effect on continuity of care during and after pregnancy. Third, we will identify individual-level risk factors for loss from HIV care in order to develop targeted interventions to improve engagement in HIV care. Discussion This work will create the world’s largest national cohort of pregnant women living with HIV. This novel cohort will be a powerful tool available to policymakers, clinicians and researchers for improving our understanding of engagement in care among pregnant women in South Africa and assessing the performance of the South African national ART program in caring for pregnant women living with HIV. Trial registration N/A (not a clinical trial).

Retention in HIV care is a challenge in Mozambique. Mozambique's southern provinces have the highest mobility levels of the country. Mobility may result in poorer response to HIV care and treatment initiatives. We conducted a cross-sectional survey to explore the impact of mobility on retention for HIV-positive adults on ART presenting to the clinic in December 2017 and January 2018. Survey data were linked to participant clinical records from the HIV care and treatment program. This study took place in Manhiça District, southern Mozambique. We enrolled self-identified migrants (moved outside of Manhiça District [less than or equal to]12 months prior to survey) and non-migrants, matched by age and sex. 390 HIV-positive adults were included. We found frequent movement: 45% of migrants reported leaving the district 3-5 times over the past 12 months, usually for extended stays. South Africa was the most common destination (71%). Overall, 30% of participants had at least one delay (15-60 days) in ART pick-up and 11% were delayed >60 days, though no significant difference was seen between mobile and non-mobile cohorts. Few migrants accessed care while traveling. Our population of mobile and non-mobile participants showed frequent lapses in ART pick-up. Mobility could be for extended time periods and HIV care frequently did not continue at the destination. Studies are needed to evaluate the impact of Mozambique's approach of providing 3-months ART among mobile populations and barriers to care while traveling, as is better education on how and where to access care when traveling.

While momentum for increasing treatment thresholds is growing, if patients cannot be retained in HIV care from the time of testing positive through long-term adherence to antiretroviral therapy (ART), such strategies may fall short of expected gains. While estimates of retention on ART exist, few cohorts have data on retention from testing positive through long-term ART care. We explored attrition (loss or death) at the Themba Lethu HIV clinic, Johannesburg, South Africa in 3 distinct cohorts enrolled at HIV testing, pre-ART initiation, and ART initiation. Between March 2010 and August 2012 we enrolled 380 patients testing HIV+, 206 initiating pre-ART care, and 185 initiating ART. Of the 380 patients enrolled at testing HIV-positive, 38.7% (95%CI: 33.9-43.7%) returned for eligibility staging within ≤3 months of testing. Of the 206 enrolled at pre-ART care, 84.5% (95%CI: 79.0-88.9%) were ART eligible at their first CD4 count. Of those, 87.9% (95%CI: 82.4-92.2%) initiated ART within 6 months. Among patients not ART eligible at their first CD4 count, 50.0% (95%CI: 33.1-66.9%) repeated their CD4 count within one year of the first ineligible CD4. Among the 185 patients in the ART cohort, 22 transferred out and were excluded from further analysis. Of the remaining 163, 81.0% (95%CI: 74.4-86.5%) were retained in care through two years on treatment. Our findings from a well-resourced clinic demonstrate continual loss from all stages of HIV care and strategies to reduce attrition from all stages of care are urgently needed.

The transition to PEPFAR 2.0 with its focus on country ownership was accompanied by substantial funding cuts. We describe the impact of this transition on HIV care in a large network of HIV clinics in Nigeria. We surveyed 30 comprehensive HIV treatment clinics to assess services supported before (October 2013-September 2014) and after (October 2014-September 2015) the PEPFAR funding policy change, the impact of these policy changes on service delivery areas, and response of clinics to the change. We compared differences in support for staffing, laboratory services, and clinical operations pre- and post-policy change using paired t-tests. We used framework analysis to assess answers to open ended questions describing responses to the policy change. Most sites (83%, n = 25) completed the survey. The majority were public (60%, n = 15) and secondary (68%, n = 17) facilities. Clinics had a median of 989 patients in care (IQR: 543-3326). All clinics continued to receive support for first and second line antiretrovirals and CD4 testing after the policy change, while no clinics received support for other routine drug monitoring labs. We found statistically significant reductions in support for viral load testing, staff employment, defaulter tracking, and prevention services (92% vs. 64%, p = 0.02; 80% vs. 20%, 100% vs. 44%, 84% vs. 16%, respectively, p<0.01 for all) after the policy change. Service delivery was hampered by interrupted laboratory services and reduced wages and staff positions leading to reduced provider morale, and compromised quality of care. Almost all sites (96%) introduced user fees to address funding shortages. Clinics in Nigeria are experiencing major challenges in providing routine HIV services as a result of PEPFAR's policy changes. Funding cutbacks have been associated with compromised quality of care, staff shortages, and reliance on fee-based care for historically free services. Sustainable HIV services funding models are urgently needed.

In December 2010, the World Health Organization recommended a single Xpert MTB/RIF assay as the initial diagnostic in people suspected of HIV-associated or drug resistant tuberculosis. Few data are available on the impact of this recommendation on patient outcomes. We describe the diagnostic follow-up, clinical characteristics and outcomes of a cohort of tuberculosis suspects screened using a single point-of-care Xpert. Consecutive tuberculosis suspects at a primary care clinic in Johannesburg, South Africa were assessed for tuberculosis using point-of-care Xpert. Sputum smear microscopy and liquid culture were performed as reference standards. Xpert-negatives were evaluated clinically, and further assessed at the discretion of clinicians. Participants were followed for six months. From July-September 2011, 641 tuberculosis suspects were enrolled, of whom 69% were HIV-infected. Eight percent were positive by a single Xpert. Among 116 individuals diagnosed with TB, 66 (57%) were Xpert negative, of which 44 (67%) were empirical or radiological diagnoses and 22 (33%) were Xpert negative/culture-positive. The median time to tuberculosis treatment was 0 days (IQR: 0-0) for Xpert positives, 14 days (IQR: 5-35) for those diagnosed empirically, 14 days (IQR: 7-29) for radiological diagnoses, and 144 days (IQR: 28-180) for culture positives. Xpert negative tuberculosis cases were clinically similar to Xpert positives, including HIV status and CD4 count, and had similar treatment outcomes including mortality and time to antiretroviral treatment initiation. In a high HIV-burden setting, a single Xpert identified less than half of those started on tuberculosis treatment, highlighting the complexity of TB diagnosis even in the Xpert era. Xpert at point-of-care resulted in same day treatment initiation in Xpert-positives, but had no impact on tuberculosis treatment outcomes or mortality.

BackgroundThe use of big data and large language models in healthcare can play a key role in improving patient treatment and healthcare management, especially when applied to large-scale administrative data. A major challenge to achieving this is ensuring that patient confidentiality and personal information is protected. One way to overcome this is by augmenting clinical data with administrative laboratory dataset linkages in order to avoid the use of demographic information.MethodsWe explored an alternative method to examine patient files from a large administrative dataset in South Africa (the National Health Laboratory Services, or NHLS), by linking external data to the NHLS database using specimen barcodes associated with laboratory tests. This provides a deterministic way of performing data linkages without accessing demographic information. In this paper, we quantify the performance metrics of this approach.ResultsThe linkage of the large NHLS data to external hospital data using specimen barcodes achieved a 95% success. Out of the 1200 records in the validation sample, 87% were exact matches and 9% were matches with typographic correction. The remaining 5% were either complete mismatches or were due to duplicates in the administrative data.ConclusionsThe high success rate indicates the reliability of using barcodes for linking data without demographic identifiers. Specimen barcodes are an effective deterministic linkage tool that enable creation of large linked datasets without compromising confidentiality.

Xpert MTB/RIF is recommended by the World Health Organization (WHO) as the initial tuberculosis (TB) diagnostic test in individuals suspected of HIV-associated TB. We sought to evaluate field implementation of Xpert among a cohort of HIV/TB co-infected individuals, including availability, utilization and outcomes. Observational cohort study (patient-level data) and cross-sectional study (site-level Xpert availability data). Data were collected at 30 participating International epidemiologic Databases to Evaluate AIDS (IeDEA) sites in 18 countries from January 2012-January 2016. All patients were HIV-infected and diagnosed with TB, either bacteriologically or clinically, and followed until a determination of TB treatment outcome. We used multivariable modified Poisson regression to estimate adjusted relative risk (RR) and 95% confidence intervals for unfavorable TB treatment outcomes. Most sites (63%) had access to Xpert, either in the clinic (13%), in the same facility (20%) or offsite (30%). Among 2722 HIV/TB patients included, median age was 35.4 years and 41% were female; BMI and CD4 count were low. Overall, most patients (76%) received at least one TB test; 45% were positive. Only 4% of all patients were tested using Xpert: 64% were Xpert-positive, 13% showed rifampicin (RIF) resistance and 30% were extrapulmonary (EPTB) or both pulmonary-EPTB. Treatment outcomes were mostly favorable (77%) and we found little association between Xpert use and an unfavorable TB treatment outcome (RR 1.25, 95%CI: 0.83, 1.90). In this cohort, Xpert utilization was low even though the majority of sites had access to the test. Our findings show the need for expanded implementation and further research exploring barriers to use in low-resource settings.

Mobile health interventions are common in public health settings in Africa, and our preliminary work showed that smartphones are increasing in South Africa. We developed a novel smartphone app-CareConekta-that used GPS location data to characterize personal mobility to improve engagement in HIV care among pregnant and postpartum women living with HIV in South Africa. The app also used the user's location to map nearby clinics. We aimed to describe the feasibility, acceptability, and initial efficacy of using the app in a real-world setting. We conducted a prospective randomized controlled trial at a public sector clinic near Cape Town, South Africa. We enrolled 200 pregnant (third trimester) women living with HIV who owned a smartphone that met the required specifications. All participants installed the app, designed to collect 2 GPS heartbeats per day to geolocate the participant within a random 1-km fuzzy radius (for privacy). We randomized (1:1) participants to a control arm to receive the app with no additional support or an intervention arm to receive supportive phone calls, WhatsApp (Meta Platforms, Inc) messages, or both from the study team when traveling >50 km from the study area for >7 days. In addition to mobility data collected daily through the phone, participants completed questionnaires at enrollment and follow-up (approximately 6 months post partum). A total of 7 participants were withdrawn at enrollment or shortly after because of app installation failure (6/200, 3%) or changing to an unsuitable phone (1/200, 0.50%). During the study period, no participant's smartphone recorded at least 1 heartbeat per day, which was our primary feasibility measure. Of the 171 participants who completed follow-up, only half (91/171, 53.2%) reported using the same phone as that used at enrollment, with the CareConekta app still installed on the phone and GPS usually enabled. The top reasons reported for the lack of heartbeat data were not having mobile data, uninstalling the app, and no longer having a smartphone. Acceptability measures were positive, but participants at follow-up demonstrated a lack of understanding of the app's purpose and function. The clinic finder was a popular feature. Owing to the lack of consistent GPS heartbeats throughout the study, we were unable to assess the efficacy of the intervention. Several key challenges impeded our study feasibility. Although the app was designed to reverse bill participants for any data use, the lack of mobile data was a substantial barrier to our study success. Participants reported purchasing WhatsApp data, which could not support the app. Problems with the web-based dashboard meant that we could not consistently monitor mobility. Our study provides important lessons about implementing an ambitious GPS-based study under real-world conditions in a limited-resource setting. ClinicalTrials.gov NCT03836625; https://clinicaltrials.gov/ct2/show/NCT03836625. RR2-10.1186/s13063-020-4190-x.

Background South Africa is home to the world’s largest antiretroviral therapy program but sustaining engagement along the HIV care continuum has proven challenging in the country and throughout the wider region. Population mobility is common in South Africa, but there are important research gaps in describing this mobility and its impact on engagement in HIV care. Postpartum women and their infants in South Africa are known to be at high risk of dropping out of HIV care after delivery and are frequently mobile. Methods In 2017, we developed a beta version of a smartphone application (app) - CareConekta - that detects a user’s smartphone location to allow for prospective characterization of mobility. Now we will adapt and test CareConekta to conduct essential formative work on mobility and evaluate an intervention - the CareConekta app plus text notifications and phone calls and/or WhatsApp messages - to facilitate engagement in HIV care during times of mobility. During the 3-year project period, our first objective is to evaluate the feasibility, acceptability, and initial efficacy of using CareConekta as an intervention to improve engagement in HIV care. Our second objective is to characterize mobility among South African women during the peripartum period and its impact on engagement in HIV care. We will enroll 200 eligible pregnant women living with HIV and receiving care at the Gugulethu Midwife Obstetric Unit in Cape Town, South Africa. Discussion This work will provide critical information about mobility during the peripartum period and the impact on engagement in HIV care. Simultaneously, we will pilot test an intervention to improve engagement with rigorously assessed outcomes. If successful, CareConekta offers tremendous potential as a research and service tool that can be adapted and evaluated in multiple geographic regions, study contexts, and patient populations. Trial registration ClinicalTrials.gov: NCT03836625 . Registered on 8 February 2019.