Assessment of neonatal respiratory rate variability.

Accurate measurement of respiratory rate (RR) in neonates is challenging due to high neonatal RR variability (RRV). There is growing evidence that RRV measurement could inform and guide neonatal care. We sought to quantify neonatal RRV during a clinical study in which we compared multiparameter continuous physiological monitoring (MCPM) devices. Measurements of capnography-recorded exhaled carbon dioxide across 60-s epochs were collected from neonates admitted to the neonatal unit at Aga Khan University-Nairobi hospital. Breaths were manually counted from capnograms and using an automated signal detection algorithm which also calculated mean and median RR for each epoch. Outcome measures were between- and within-neonate RRV, between- and within-epoch RRV, and 95% limits of agreement, bias, and root-mean-square deviation. Twenty-seven neonates were included, with 130 epochs analysed. Mean manual breath count (MBC) was 48 breaths per minute. Median RRV ranged from 11.5% (interquartile range (IQR) 6.8-18.9%) to 28.1% (IQR 23.5-36.7%). Bias and limits of agreement for MBC vs algorithm-derived breath count, MBC vs algorithm-derived median breath rate, MBC vs algorithm-derived mean breath rate were - 0.5 (- 2.7, 1.66), - 3.16 (- 12.12, 5.8), and - 3.99 (- 11.3, 3.32), respectively. The marked RRV highlights the challenge of performing accurate RR measurements in neonates. More research is required to optimize the use of RRV to improve care. When evaluating MCPM devices, accuracy thresholds should be less stringent in newborns due to increased RRV. Lastly, median RR, which discounts the impact of extreme outliers, may be more reflective of the underlying physiological control of breathing.

Multiparameter Continuous Physiological Monitoring Technologies in Neonates Among Health Care Providers and Caregivers at a Private Tertiary Hospital in Nairobi, Kenya: Feasibility, Usability, and Acceptability Study.

BACKGROUND: Continuous physiological monitoring technologies are important for strengthening hospital care for neonates, particularly in resource-constrained settings, and understanding user perspectives is critical for informing medical technology design, development, and optimization. OBJECTIVE: This study aims to assess the feasibility, usability, and acceptability of 2 noninvasive, multiparameter, continuous physiological monitoring technologies for use in neonates in an African health care setting. METHODS: We assessed 2 investigational technologies from EarlySense and Sibel, compared with the reference Masimo Rad-97 technology through in-depth interviews and direct observations. A purposive sample of health care administrators, health care providers, and caregivers at Aga Khan University Hospital, a tertiary, private hospital in Nairobi, Kenya, were included. Data were analyzed using a thematic approach in NVivo 12 software. RESULTS: Between July and August 2020, we interviewed 12 health care providers, 5 health care administrators, and 10 caregivers and observed the monitoring of 12 neonates. Staffing and maintenance of training in neonatal units are important feasibility considerations, and simple training requirements support the feasibility of the investigational technologies. Key usability characteristics included ease of use, wireless features, and reduced number of attachments connecting the neonate to the monitoring technology, which health care providers considered to increase the efficiency of care. The main factors supporting acceptability included caregiver-highlighted perceptions of neonate comfort and health care respondent technology familiarity. Concerns about the side effects of wireless connections, electromagnetic fields, and mistrust of unfamiliar technologies have emerged as possible acceptability barriers to investigational technologies. CONCLUSIONS: Overall, respondents considered the investigational technologies feasible, usable, and acceptable for the care of neonates at this health care facility. Our findings highlight the potential of different multiparameter continuous physiological monitoring technologies for use in different neonatal care settings. Simple and user-friendly technologies may help to bridge gaps in current care where there are many neonates; however, challenges in maintaining training and ensuring feasibility within resource-constrained health care settings warrant further research. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-035184.

Evaluating the effect of maternal mHealth text messages on uptake of maternal and child health care services in South Africa: a multicentre cohort intervention study.

BACKGROUND: There are high expectations that mobile health (mHealth) strategies will increase uptake of health care services, especially in resource strained settings. Our study aimed to evaluate effects of an mHealth intervention on uptake of maternal health services. METHODS: This was an intervention cohort study conducted at six public antenatal and postnatal care clinics in inner-city Johannesburg, South Africa. The intervention consisted of twice-weekly informative and pregnancy stage-based maternal health information text messages sent to women during pregnancy until their child was one year of age. The intervention arm of 87 mother-infant pairs was compared to a control arm of 90 pairs. Univariate and multivariate analyses were used to compare the probability of the outcome between the two groups. RESULTS: Intervention participants had higher odds of attending all government-recommended antenatal and postnatal visits, all recommended first year vaccinations (OR: 3.2, 95% CI 1.63-6.31) and had higher odds of attending at least the recommended four antenatal visits (OR: 3.21, 95% CI 1.73-5.98). CONCLUSION: We show an improvement in achieving complete maternal-infant continuum of care, providing evidence of a positive impact of informative maternal mHealth messages sent to pregnant women and new mothers. Trial registration ISRCTN, ISRCTN41772986. Registered 13 February 2019-Retrospectively registered, https://www.isrctn.com/ISRCTN41772986.

Effectiveness of an SMS-based maternal mHealth intervention to improve clinical outcomes of HIV-positive pregnant women.

We conducted a retrospective study to investigate the effectiveness of an mHealth messaging intervention aiming to improve maternal health and HIV outcomes. Maternal health SMSs were sent to 235 HIV-infected pregnant women twice per week in pregnancy and continued until the infant's first birthday. The messages were timed to the stage of the pregnancy/infant age and covered maternal health and HIV-support information. Outcomes, measured as antenatal care (ANC) visits, birth outcomes and infant HIV testing, were compared to a control group of 586 HIV-infected pregnant women who received no SMS intervention. Results showed that intervention participants attended more ANC visits (5.16 vs. 3.95, p < 0.01) and were more likely to attend at least the recommended four ANC visits (relative risk (RR): 1.41, 95% confidence interval (CI): 1.15-1.72). Birth outcomes of intervention participants improved as they had an increased chance of a normal vaginal delivery (RR: 1.10, 95% CI: 1.02-1.19) and a lower risk of delivering a low-birth weight infant (<2500 g) (RR: 0.14, 95% CI: 0.02-1.07). In the intervention group, there was a trend towards higher attendance to infant polymerase chain reaction (PCR) testing within six weeks after birth (81.3% vs. 75.4%, p = 0.06) and a lower mean infant age in weeks at HIV PCR testing (9.5 weeks vs. 11.1 weeks, p = 0.14). These results add to the growing evidence that mHealth interventions can have a positive impact on health outcomes and should be scaled nationally following comprehensive evaluation.

Diabetic Myonecrosis of the Axilla: A Novel Case With Severe Clinical Features.

Diabetic myonecrosis is a rare and poorly understood complication of long-standing, inadequately controlled diabetes mellitus. Theoretical mechanisms contributing to the pathophysiology of diabetic myonecrosis include microvascular complications due to advanced glycation end-products, ischemia-reperfusion injuries, and dysregulated coagulation-fibrinolysis activity. Case reports of diabetic myonecrosis most commonly describe diabetic patients with chronically poor glycemic control who experience isolated swelling and severe pain in a unilateral lower limb with no signs of infection or systemic toxicity. Due to the rarity of this condition, there are currently no treatment guidelines. This case describes a 58-year-old male with a history of uncontrolled diabetes who presented with diabetic ketoacidosis with mixed hypovolemic and septic shock. Diabetic myonecrosis was incidentally discovered in the patient's right latissimus dorsi with CT imaging and subsequent surgical exploration. Spontaneous diabetic myonecrosis may mimic several other serious conditions and elicit suboptimal management strategies, particularly in the context of atypical presentations.

Developing and testing a clinical care bundle incorporating caffeine citrate to manage apnoea of prematurity in a resource-constrained setting: a mixed methods clinical feasibility study protocol.

BACKGROUND: Apnoea of prematurity (AOP) is a common condition among preterm infants. Methylxanthines, such as caffeine and aminophylline/theophylline, can help prevent and treat AOP. Due to its physiological benefits and fewer side effects, caffeine citrate is recommended for the prevention and treatment of AOP. However, caffeine citrate is not available in most resource-constrained settings (RCS) due to its high cost. Challenges in RCS using caffeine citrate to prevent AOP include identifying eligible preterm infants where gestational age is not always known and the capability for continuous monitoring of vital signs to readily identify apnoea. We aim to develop an evidence-based care bundle that includes caffeine citrate to prevent and manage AOP in tertiary healthcare facilities in Kenya. METHODS: This protocol details a prospective mixed-methods clinical feasibility study on using caffeine citrate to manage apnoea of prematurity in a single facility tertiary-care newborn unit (NBU) in Nairobi, Kenya. This study will include a 4-month formative research phase followed by the development of an AOP clinical-care-bundle prototype over 2 months. In the subsequent 4 months, implementation and improvement of the clinical-care-bundle prototype will be undertaken. The baseline data will provide contextualised insights on care practices within the NBU that will inform the development of a context-sensitive AOP clinical-care-bundle prototype. The clinical care bundle will be tested and refined further during an implementation phase of the quality improvement initiative using a PDSA framework underpinned by quantitative and qualitative clinical audits and stakeholders' engagement. The quantitative component will include all neonates born at gestation age < 34 weeks and any neonate prescribed aminophylline or caffeine citrate admitted to the NBU during the study period. DISCUSSION: There is a need to develop evidence-based and context-sensitive clinical practice guidelines to standardise and improve the management of AOP in RCS. Concerns requiring resolution in implementing such guidelines include diagnosis of apnoea, optimal timing, dosing and administration of caffeine citrate, standardisation of monitoring devices and alarm limits, and discharge protocols. We aim to provide a feasible standardised clinical care bundle for managing AOP in low and middle-income settings.

A survey of barriers and facilitators to caffeine use for apnoea of prematurity in low- and middle-income countries.

BACKGROUND: Despite its associated benefits which include better long-term pulmonary and neurodevelopmental outcome, the use of caffeine for apnoea of prematurity (AoP) has been limited in low- and middle-income countries (LMIC). AIM: To better understand current caffeine use, the barriers and facilitators to its use and perceptions and practices in LMIC which have a disproportionately high burden of prematurity. METHODS: An anonymous online global survey was conducted, targeting healthcare providers working and training in paediatrics and/or neonatology in LMIC. RESULTS: A total of 181 respondents in 16 LMIC were included in the analysis; most were physicians working in publicly-funded urban tertiary hospitals. Most had received training in the use of caffeine for AoP (77%), reported expertise (70%) and confidence (96%) in its use, and had access to caffeine (65%). Caffeine availability was reported to be the greatest barrier (48%) and the greatest facilitator (37%). Other common barriers included cost (31%), access (7%) and policies or guidelines on caffeine use (7%); other common facilitators included policies or guidelines on caffeine use (11%), access (10%), staff/other providers' acceptance of caffeine as an appropriate treatment (9%) and the availability of staff to administer caffeine (8%). Most (79%) noted that access to caffeine was important, 92% agreed that caffeine improves quality of care, and 95% agreed that caffeine improves patient outcome. CONCLUSION: Improving availability and access to low-cost caffeine will be key to increasing caffeine use in LMIC. ABBREVIATIONS: AoP: Apnoea of Prematurity; LMIC: low- and middle-Income countries; REDCap: Research Electronic Data Capture.

Evaluation of Sibel's Advanced Neonatal Epidermal (ANNE) wireless continuous physiological monitor in Nairobi, Kenya.

BACKGROUND: Neonatal multiparameter continuous physiological monitoring (MCPM) technologies assist with early detection of preventable and treatable causes of neonatal mortality. Evaluating accuracy of novel MCPM technologies is critical for their appropriate use and adoption. METHODS: We prospectively compared the accuracy of Sibel's Advanced Neonatal Epidermal (ANNE) technology with Masimo's Rad-97 pulse CO-oximeter with capnography and Spengler's Tempo Easy reference technologies during four evaluation rounds. We compared accuracy of heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and skin temperature using Bland-Altman plots and root-mean-square deviation analyses (RMSD). Sibel's ANNE algorithms were optimized between each round. We created Clarke error grids with zones of 20% to aid with clinical interpretation of HR and RR results. RESULTS: Between November 2019 and August 2020 we collected 320 hours of data from 84 neonates. In the final round, Sibel's ANNE technology demonstrated a normalized bias of 0% for HR and 3.1% for RR, and a non-normalized bias of -0.3% for SpO2 and 0.2°C for temperature. The normalized spread between 95% upper and lower limits-of-agreement (LOA) was 4.7% for HR and 29.3% for RR. RMSD for SpO2 was 1.9% and 1.5°C for temperature. Agreement between Sibel's ANNE technology and the reference technologies met the a priori-defined thresholds for 95% spread of LOA and RMSD. Clarke error grids showed that all HR and RR observations were within a 20% difference. CONCLUSION: Our findings suggest acceptable agreement between Sibel's ANNE and reference technologies. Clinical effectiveness, feasibility, usability, acceptability, and cost-effectiveness investigations are necessary for large-scale implementation.

Qualitative study exploring the feasibility, usability and acceptability of neonatal continuous monitoring technologies at a public tertiary hospital in Nairobi, Kenya.

OBJECTIVE: To assess the feasibility, usability and acceptability of two non-invasive, multiparameter, continuous physiological monitoring (MCPM) technologies for use in neonates within a resource-constrained healthcare setting in sub-Saharan Africa. DESIGN: A qualitative study using in-depth interviews and direct observations to describe healthcare professional and caregiver perspectives and experiences with investigational MCPM technologies from EarlySense and Sibel compared with selected reference technologies. SETTING: Pumwani Maternity Hospital is a public, high-volume, tertiary hospital in Nairobi, Kenya. PARTICIPANTS: In-depth interviews were conducted with five healthcare administrators, 12 healthcare providers and 10 caregivers. Direct observations were made of healthcare providers using the technologies on 12 neonates overall. RESULTS: Design factors like non-invasiveness, portability, ease-of-use and ability to measure multiple vital signs concurrently emerged as key themes supporting the usability and acceptability of the investigational technologies. However, respondents also reported feasibility challenges to implementation, including overcrowding in the neonatal unit, lack of reliable access to electricity and computers, and concerns about cost and maintenance needs. To improve acceptability, respondents highlighted the need for adequate staffing to appropriately engage caregivers and dispel misconceptions about the technologies. CONCLUSION: Study participants were positive about the usefulness of the investigational technologies to strengthen clinical care quality and identification of at-risk neonates for better access to timely interventions. These technologies have the potential to improve equity of access to appropriate healthcare services and neonatal outcomes in sub-Saharan African healthcare facilities. However, health system strengthening is also critical to support sustainable uptake of technologies into routine care. TRIAL REGISTRATION NUMBER: NCT03920761.

Clinical feasibility of an advanced neonatal epidermal multiparameter continuous monitoring technology in a large public maternity hospital in Nairobi, Kenya.

Clinically feasible multiparameter continuous physiological monitoring technologies are needed for use in resource-constrained African healthcare facilities to allow for early detection of critical events and timely intervention for major morbidities in high-risk neonates. We conducted a prospective clinical feasibility study of a novel multiparameter continuous physiological monitoring technology in neonates at Pumwani Maternity Hospital in Nairobi, Kenya. To assess feasibility, we compared the performance of Sibel's Advanced Neonatal Epidermal (ANNE) technology to reference technologies, including Masimo's Rad-97 pulse CO-oximeter with capnography technology for heart rate (HR), respiratory rate (RR), and oxygen saturation (SpO2) measurements and Spengler's Tempo Easy non-contact infrared thermometer for temperature measurements. We evaluated key performance criteria such as up-time, clinical event detection performance, and the agreement of measurements compared to those from the reference technologies in an uncontrolled, real-world setting. Between September 15 and December 15, 2020, we collected and analyzed 503 h of ANNE data from 109 enrolled neonates. ANNE's up-time was 42 (11%) h more for HR, 77 (25%) h more for RR, and 6 (2%) h less for SpO2 compared to the Rad-97. However, ANNE's ratio of up-time to total attached time was less than Rad-97's for HR (0.79 vs 0.86), RR (0.68 vs. 0.79), and SpO2 (0.69 vs 0.86). ANNE demonstrated adequate performance in identifying high and low HR and RR and high temperature events; however, showed relatively poor performance for low SpO2 events. The normalized spread of limits of agreement were 8.4% for HR and 52.2% for RR and the normalized root-mean-square deviation was 4.4% for SpO2. Temperature agreement showed a spread of limits of agreement of 2.8 °C. The a priori-identified optimal limits were met for HR and temperature but not for RR or SpO2. ANNE was clinically feasible for HR and temperature but not RR and SpO2 as demonstrated by the technology's up-time, clinical event detection performance, and the agreement of measurements compared to those from the reference technologies.

Evaluation of a contactless neonatal physiological monitor in Nairobi, Kenya.

BACKGROUND: Globally, 2.5 million neonates died in 2018, accounting for 46% of under-5 deaths. Multiparameter continuous physiological monitoring (MCPM) of neonates allows for early detection and treatment of life-threatening health problems. However, neonatal monitoring technology is largely unavailable in low-resource settings. METHODS: In four evaluation rounds, we prospectively compared the accuracy of the EarlySense under-mattress device to the Masimo Rad-97 pulse CO-oximeter with capnography reference device for heart rate (HR) and respiratory rate (RR) measurements in neonates in Kenya. EarlySense algorithm optimisations were made between evaluation rounds. In each evaluation round, we compared 200 randomly selected epochs of data using Bland-Altman plots and generated Clarke error grids with zones of 20% to aid in clinical interpretation. RESULTS: Between 9 July 2019 and 8 January 2020, we collected 280 hours of MCPM data from 76 enrolled neonates. At the final evaluation round, the EarlySense MCPM device demonstrated a bias of -0.8 beats/minute for HR and 1.6 breaths/minute for RR, and normalised spread between the 95% upper and lower limits of agreement of 6.2% for HR and 27.3% for RR. Agreement between the two MCPM devices met the a priori-defined threshold of 30%. The Clarke error grids showed that all observations for HR and 197/200 for RR were within a 20% difference. CONCLUSION: Our research indicates that there is acceptable agreement between the EarlySense and Masimo MCPM devices in the context of large within-subject variability; however, further studies establishing cost-effectiveness and clinical effectiveness are needed before large-scale implementation of the EarlySense MCPM device in neonates. TRIAL REGISTRATION NUMBER: NCT03920761.

Clinical feasibility of a contactless multiparameter continuous monitoring technology for neonates in a large public maternity hospital in Nairobi, Kenya.

Multiparameter continuous physiological monitoring (MCPM) technologies are critical in the clinical management of high-risk neonates; yet, these technologies are frequently unavailable in many African healthcare facilities. We conducted a prospective clinical feasibility study of EarlySense's novel under-mattress MCPM technology in neonates at Pumwani Maternity Hospital in Nairobi, Kenya. To assess feasibility, we compared the performance of EarlySense's technology to Masimo's Rad-97 pulse CO-oximeter with capnography technology for heart rate (HR) and respiratory rate (RR) measurements using up-time, clinical event detection performance, and accuracy. Between September 15 and December 15, 2020, we collected and analyzed 470 hours of EarlySense data from 109 enrolled neonates. EarlySense's technology's up-time per neonate was 2.9 (range 0.8, 5.3) hours for HR and 2.1 (range 0.9, 4.0) hours for RR. The difference compared to the reference was a median of 0.6 (range 0.1, 3.1) hours for HR and 0.8 (range 0.1, 2.9) hours for RR. EarlySense's technology identified high HR and RR events with high sensitivity (HR 81%; RR 83%) and specificity (HR 99%; RR 83%), but was less sensitive for low HR and RR (HR 0%; RR 14%) although maintained specificity (HR 100%; RR 95%). There was a greater number of false negative and false positive RR events than false negative and false positive HR events. The normalized spread of limits of agreement was 9.6% for HR and 28.6% for RR, which met the a priori-identified limit of 30%. EarlySense's MCPM technology was clinically feasible as demonstrated by high percentage of up-time, strong clinical event detection performance, and agreement of HR and RR measurements compared to the reference technology. Studies in critically ill neonates, assessing barriers and facilitators to adoption, and costing analyses will be key to the technology's development and potential uptake and scale-up.

Identification of thresholds for accuracy comparisons of heart rate and respiratory rate in neonates.

Background: Heart rate (HR) and respiratory rate (RR) can be challenging to measure accurately and reliably in neonates. The introduction of innovative, non-invasive measurement technologies suitable for resource-constrained settings is limited by the lack of appropriate clinical thresholds for accuracy comparison studies. Methods: We collected measurements of photoplethysmography-recorded HR and capnography-recorded exhaled carbon dioxide across multiple 60-second epochs (observations) in enrolled neonates admitted to the neonatal care unit at Aga Khan University Hospital in Nairobi, Kenya. Trained study nurses manually recorded HR, and the study team manually counted individual breaths from capnograms. For comparison, HR and RR also were measured using an automated signal detection algorithm. Clinical measurements were analyzed for repeatability. Results: A total of 297 epochs across 35 neonates were recorded. Manual HR showed a bias of -2.4 (-1.8%) and a spread between the 95% limits of agreement (LOA) of 40.3 (29.6%) compared to the algorithm-derived median HR. Manual RR showed a bias of -3.2 (-6.6%) and a spread between the 95% LOA of 17.9 (37.3%) compared to the algorithm-derived median RR, and a bias of -0.5 (1.1%) and a spread between the 95% LOA of 4.4 (9.1%) compared to the algorithm-derived RR count. Manual HR and RR showed repeatability of 0.6 (interquartile range (IQR) 0.5-0.7), and 0.7 (IQR 0.5-0.8), respectively. Conclusions: Appropriate clinical thresholds should be selected a priori when performing accuracy comparisons for HR and RR. Automated measurement technologies typically use median values rather than counts, which significantly impacts accuracy. A wider spread between the LOA, as much as 30%, should be considered to account for the observed physiological nuances and within- and between-neonate variability and different averaging methods. Wider adoption of thresholds by data standards organizations and technology developers and manufacturers will increase the robustness of clinical comparison studies.

The Mobile Alliance for Maternal Action Text Message-Based mHealth Intervention for Maternal Care in South Africa: Qualitative User Study.

BACKGROUND: Using mobile technology to support health care (mobile health [mHealth]) has been shown to improve health outcomes across a multitude of health specialties and across the world. Exploring mHealth user experiences can aid in understanding how and why an intervention was successful. The Mobile Alliance for Maternal Action (MAMA) was a free maternal mHealth SMS text messaging service that was offered to pregnant women in Johannesburg, South Africa, with the goal of improving maternal, fetal, and infant health outcomes. We conducted focus group discussions with MAMA users to learn about their experiences with the program. OBJECTIVE: The aim of this qualitative study was to gather opinions of participants of the MAMA maternal mHealth service regarding health care atmosphere, intervention use, and intervention feedback. METHODS: Prenatal and postnatal women (N=15) from public antenatal and postnatal care sites in central Johannesburg who were receiving free maternal health text messages (MAMA) participated in 3 focus group discussions. Predefined discussion topics included personal background, health care system experiences, MAMA program recruitment, acceptability, participant experiences, and feedback. RESULTS: The feedback regarding experiences with the health system were comprised of a few reports of positive experiences and many more reports of negative experiences such as long wait times, understaffed facilities, and poor service. Overall acceptability for the maternal text message intervention was high. Participants reflected that the messages were timely, written clearly, and felt supportive. Participants also reported sharing messages with friends and family. CONCLUSIONS: These findings suggest that maternal mHealth interventions delivered through text messages can provide timely, relevant, useful, and supportive information to pregnant women and new mothers especially in settings where there may be mistrust of the health care system.

Improving Linkage to and Retention in Care in Newly Diagnosed HIV-Positive Patients Using Smartphones in South Africa: Randomized Controlled Trial.

BACKGROUND: South Africa provides free antiretroviral therapy for almost 5 million people living with HIV, but only 71% of the eligible people are on treatment, representing a shortfall in the care cascade, especially among men and youth. Many developing countries have expanded access to smartphones; success in health apps raises the possibility of improving this cascade. OBJECTIVE: SmartLink is a health app for Android smartphones providing HIV-related laboratory results, information, support, and appointment reminders to engage and link patients to care. This study aimed to evaluate the ability of SmartLink to improve linkage to care for HIV-positive smartphone owners. METHODS: This study was a multisite randomized controlled trial in Johannesburg. The intervention arm received the app (along with referral to a treatment site) and the control arm received the standard of care (referral alone). Linkage to care was confirmed by an HIV-related blood test reported on the National Health Laboratory Service database between 2 weeks and 8 months after initiation. RESULTS: A total of 345 participants were recruited into the study; 64.9% (224/345) of the participants were female and 44.1% (152/345) were aged less than 30 years. In addition, 46.7% (161/345) were employed full time, 95.9% (331/345) had at least secondary school education, and 35.9% (124/345) were from Zimbabwe. Linkage to care between 2 weeks and 8 months was 48.6% (88/181) in the intervention arm versus 45.1% (74/164) in the control (P=.52) and increased to 64.1% (116/181) and 61.0% (100/164) (P=.55), respectively, after the initial 8-month period. Moreover, youth aged 18 to 30-years showed a statistically significant 20% increase in linkage to care for the intervention group. CONCLUSIONS: Youth aged less than 30 years have been historically difficult to reach with traditional interventions, and the SmartLink app provides a proof of concept that this population reacts to mobile health interventions that engage patients in HIV care. TRIAL REGISTRATION: ClinicalTrials.gov NCT02756949; https://clinicaltrials.gov/ct2/show/NCT02756949 (Archived by WebCite at http://www.webcitation.org/6z1GTJCNW).

Forecasting the Value for Money of Mobile Maternal Health Information Messages on Improving Utilization of Maternal and Child Health Services in Gauteng, South Africa: Cost-Effectiveness Analysis.

BACKGROUND: Limited evidence exists on the value for money of mHealth information programs in low resource settings. OBJECTIVE: This study sought to model the incremental cost-effectiveness of gradually scaling up text messaging services to pregnant women throughout Gauteng province, South Africa from 2012 to 2017. METHODS: Data collection occurred as part of a retrospective study in 6 health centers in Gauteng province. Stage-based short message service (SMS) text messages on maternal health were sent to pregnant women twice per week during pregnancy and continued until the infant's first birthday. Program costs, incremental costs to users, and the health system costs for these women were measured along with changes in the utilization of antenatal care visits and childhood immunizations and compared with those from a control group of pregnant women who received no SMS text messages. Incremental changes in utilization were entered into the Lives Saved Tool and used to forecast lives saved and disability adjusted life years (DALYs) averted by scaling up program activities over 5 years to reach 60% of pregnant women across Gauteng province. Uncertainty was characterized using one-way and probabilistic uncertainty analyses. RESULTS: Five-year program costs were estimated to be US $1.2 million, 17% of which were incurred by costs on program development and 31% on SMS text message delivery costs. Costs to users were US $1.66 to attend clinic-based services, nearly 90% of which was attributed to wages lost. Costs to the health system included provider time costs to register users (US $0.08) and to provide antenatal care (US $4.36) and postnatal care (US $3.08) services. Incremental costs per DALY averted from a societal perspective ranged from US $1985 in the first year of implementation to US $200 in the 5th year. At a willingness-to-pay threshold of US $2000, the project had a 40% probability of being cost-effective in year 1 versus 100% in all years thereafter. CONCLUSIONS: Study findings suggest that delivering SMS text messages on maternal health information to pregnant and postpartum women may be a cost-effective strategy for bolstering antenatal care and childhood immunizations, even at very small margins of coverage increases. Primary data obtained prospectively as part of more rigorous study designs are needed to validate modeled results.

Improving Linkage to HIV Care Through Mobile Phone Apps: Randomized Controlled Trial.

BACKGROUND: In HIV treatment program, gaps in the "cascade of care" where patients are lost between diagnosis, laboratory evaluation, treatment initiation, and retention in HIV care, is a well-described challenge. Growing access to internet-enabled mobile phones has led to an interest in using the technology to improve patient engagement with health care. OBJECTIVE: The objectives of this trial were: (1) to assess whether a mobile phone-enabled app could provide HIV patients with laboratory test results, (2) to better understand the implementation of such an intervention, and (3) to determine app effectiveness in improving linkage to HIV care after diagnosis. METHODS: We developed and tested an app through a randomized controlled trial carried out in several primary health care facilities in Johannesburg. Newly diagnosed HIV-positive patients were screened, recruited, and randomized into the trial as they were giving a blood sample for initial CD4 staging. Trial eligibility included ownership of a phone compatible with the app and access to the internet. Trial participants were followed for a minimum of eight months to determine linkage to HIV care indicated by an HIV-related laboratory test result. RESULTS: The trial outcome results are being prepared for publication, but here we describe the significant operational and technological lessons provided by the implementation. Android was identified as the most suitable operating system for the app, due to Android functionality and communication characteristics. Android also had the most significant market share of all smartphone operating systems in South Africa. The app was successfully developed with laboratory results sent to personal smartphones. However, given the trial requirements and the app itself, only 10% of screened HIV patients successfully enrolled. We report on issues such as patient eligibility, app testing in a dynamic phone market, software installation and compatibility, safe identification of patients, linkage of laboratory results to patients lacking unique identifiers, and present lessons and potential solutions. CONCLUSIONS: The implementation challenges and lessons of this trial may assist future similar mHealth interventions to avoid some of the pitfalls. Ensuring sufficient expertise and understanding of the programmatic needs by the software developer, as well as in the implementation team, with adequate and rapid piloting within the target groups, could have led to better trial recruitment. However, the majority of screened patients were interested in the study, and the app was installed successfully in patients with suitable smartphones, suggesting that this may be a way to engage patients with their health care data in future. TRIAL REGISTRATION: ClinicalTrials.gov NCT02756949; https://clinicaltrials.gov/ct2/show/NCT02756949 (Archived by WebCite at http://www.webcitation.org/6z1GTJCNW).