Augmenting maternal clinical cohort data with administrative laboratory dataset linkages: a validation study.

Background: The 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. Methods: We 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 offers us with a deterministic way of performing data linkages without accessing demographic information. In this paper, we quantify the performance metrics of this approach. Results: The 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. Conclusions: The high success rate indicates the reliability of using barcodes for linking data without demographic identifiers. Specimen barcodes are an effective tool for deterministic linking in health data, and may provide a method of creating large, linked data sets without compromising patient confidentiality.

Peripartum mobility and maternal/child separation among women living with HIV in South Africa.

This prospective cohort study investigated the mobility patterns of 200 pregnant and postpartum women living with HIV in South Africa. Participants were enrolled during their third trimester from routine antenatal care near Cape Town, South Africa, and followed for six months postpartum. Quantitative data were collected at enrollment and follow-up. Mobility (self-reported) was common among the participants, despite the brief study period and the concurrent COVID-19 pandemic. While most reported stability in their current residence, 71% had a second main residence, primarily in the Eastern Cape (EC). Participants had a median of two lifetime moves, motivated by work, education, and family life. During the study period, 20% of participants met the study definition of travel (>7 days and >50 km), with trips predominantly to the EC, lasting a median duration of 30 days. Over one-third of participants with other living children reported that these children lived apart from them, with the mother's family being primary caregivers. These findings emphasize the need for targeted interventions to support continuity of care for mobile populations, particularly peripartum women living with HIV. The study contributes valuable insights into mobility dynamics and highlights unique barriers faced by this population, contributing to improved HIV care in resource-limited settings.

Characterizing residential mobility among people with HIV in Tennessee and its impact on HIV care outcomes.

OBJECTIVE: Our objective was to assess the prevalence and patterns of mobility among people with HIV (PWH) in Tennessee and its impact on HIV care outcomes. DESIGN: Retrospective cohort study. METHODS: We combined residential address and HIV surveillance data from PWH in Tennessee from 2016 to 2018. Using Poisson regression, we estimated associations between in-state mobility (change in address or total miles moved) in 1 year and outcomes in the subsequent year; retention: having two CD4 + /HIV RNA values (labs) in a calendar year at least 3 months apart, loss to follow-up (LTFU): having labs at baseline but not the subsequent year, and viral suppression: HIV RNA less than 200 copies/ml. We applied a kernel density estimator to origin-destination address lines to visualize mobility patterns across demographic subgroups. RESULTS: Among 17 428 PWH [median age 45 years (interquartile range; IQR 34-53)], 6564 (38%) had at least one move. Median miles moved was 8.9 (IQR 2.6-143.4)). We observed in-state movement between major cities (Chattanooga, Knoxville, Memphis and Nashville) and out-of-state movement to and from Georgia and Florida. Having at least one in-state move was associated with a decreased likelihood of retention [adjusted relative risk (aRR) = 0.91; 95% confidence interval (CI) 0.88-0.95], and an increased risk of LTFU (aRR = 1.17; 95% CI 1.04-1.31, two to three moves vs. none). Greater distance moved in-state was associated with decreased retention and increased LTFU (aRR = 0.53; 95% CI 0.49-0.58, aRR = 2.52; 95% CI 2.25-2.83, respectively for 1000 vs. 0 miles). There was no association between mobility and viral suppression. CONCLUSION: Mobility is common among PWH in Tennessee and is associated with initial poor engagement in HIV care.

Bringing COVID-19 vaccine to medically underserved populations utilizing a community-guided mobile vaccine program.

Between March 23, 2021, and December 31, 2022, the Mobile Vaccine Program (MVP) vaccinated 5044 individuals from medically-underserved communities in Middle Tennessee identified through and guided by a collaboration of local community agencies. The primary objective of the MVP was to vaccinate individuals for COVID-19 who had barriers to traditional mass vaccine strategies through community-guided strategies and partnerships. Three strategies were developed and implemented with community partners and their affiliated community health workers (CHWs). The strategies included pop-up vaccination clinics at community partner events, CHW-guided door-to-door in-home vaccination, and community partner-initiated homebound referrals for vaccination.

Smartphone Ownership and Usage Among Pregnant Women Living With HIV in South Africa: Secondary Analysis of CareConekta Trial Data.

BACKGROUND: Mobile health (mHealth) initiatives are increasingly common in low-resource settings, but the appropriateness of smartphone interventions in health care settings is uncertain. More research is needed to establish the appropriateness and feasibility of integrating new mHealth modalities (novel apps and social media apps) in the South African context. OBJECTIVE: In this study, to inform future mHealth interventions, we describe smartphone ownership, preferences, and usage patterns among pregnant women living with HIV in Gugulethu, South Africa. METHODS: We screened pregnant women living with HIV from December 2019 to February 2021 for the CareConekta trial. To be enrolled in the trial, respondents were required to be 18 years of age or older, living with HIV, ≥28 weeks pregnant, and own a smartphone that met the technical requirements of the CareConekta app. In this secondary analysis, we describe mobile phone ownership and sociodemographic characteristics of all women screened for eligibility (n=639), and smartphone use patterns among those enrolled in the trial (n=193). RESULTS: Overall, median age was 31 (IQR 27-35) years. Of the 582 women who owned smartphones, 580 responded to the question about whether or not it was a smartphone, 2 did not. Among those with smartphones, 92% (421/458) of them used the Android operating system of version 5.0 or above, 98% (497/506) of phones had a GPS, and 96% (485/506) of individuals charged their phones less than twice a day. Among women who were enrolled in the trial, nearly all (99%, 190/193) owned the smartphone themselves; however, 14% (26/193) shared their smartphone with someone. In this case, 96% (25/26) reported possessing the phone most of the day. Median duration of ownership of the smartphone was 12 (IQR 5-24) months, median duration with current phone number use was 25 (IQR 12-60) months, and median number of cell phone numbers owned 2 years prior to enrollment in the trial was 2 (IQR 1-2). Receiving (192/193, 99.5%) and making (190/193, 99%) phone calls were among the most common smartphone uses. The least used features were GPS (106/193, 55%) and email (91/193, 47%). WhatsApp was most frequently reported as a favorite app (181/193, 94%). CONCLUSIONS: Smartphone ownership is very common among pregnant women living with HIV in this low-resource, periurban setting. Phone sharing was uncommon, nearly all used the Android system, and phones retained sufficient battery life. These results are encouraging to the development of mHealth interventions. Existing messaging platforms-particularly WhatsApp-are exceedingly popular and could be leveraged for interventions. Findings of moderate smartphone ownership turnover and phone number turnover are considerations for mHealth interventions in similar settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT03836625; https://clinicaltrials.gov/ct2/show/NCT03836625?term=NCT03836625.

The Implementation of a GPS-Based Location-Tracking Smartphone App in South Africa to Improve Engagement in HIV Care: Randomized Controlled Trial.

BACKGROUND: 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. OBJECTIVE: We aimed to describe the feasibility, acceptability, and initial efficacy of using the app in a real-world setting. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT03836625; https://clinicaltrials.gov/ct2/show/NCT03836625. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-4190-x.

The Role of Habit Formation and Automaticity in Diabetes Self-Management: Current Evidence and Future Applications.

PURPOSE OF REVIEW: Diabetes is a chronic condition that requires consistent self-management for optimal health outcomes. People with diabetes are prone to burnout, cognitive burden, and sub-optimal performance of self-management tasks. Interventions that focus on habit formation have the potential to increase engagement by facilitating automaticity of self-management task performance. The purpose of this review is to (1) clarify the conceptualizations of habit formation and behavioral automaticity in the context of health behavior interventions, (2) review the evidence of habit in relation to behaviors relevant to diabetes self-management, and (3) discuss opportunities for incorporating habit formation and automaticity into diabetes self-management interventions. RECENT FINDINGS: Modern habit research describes a habit as a behavior that results over time from an automatic mental process. Automatic behaviors are experienced as cue-dependent, goal-independent, unconscious, and efficient. Habit formation requires context-dependent repetition to form cue-behavior associations. Results of diabetes habit studies are mixed. Observational studies have shown positive associations between habit strength and target self-management behaviors such as taking medication and monitoring blood glucose, as well as glycemic outcomes such as HbA1c. However, intervention studies conducted in similar populations have not demonstrated a significant benefit of habit-forming interventions compared to controls, possibly due to varying techniques used to promote habit formation. Automaticity of self-management behaviors has the potential to minimize the burden associated with performance of self-management tasks and ultimately improve outcomes for people with diabetes. Future studies should focus on refining interventions focused on context-dependent repetition to promote habit formation and better measurement of habit automaticity in diabetes self-management.

Factors Influencing Influenza and COVID-19 Vaccine Decision-Making in the Post-ICU Period: A Secondary Analysis.

BACKGROUND: The introduction of COVID-19 vaccines exposed volatility and hesitancy around vaccines. Some health care models, including ICU recovery clinics (ICU-RCs), are structured to provide vaccine counseling. However, information regarding provider and patient vaccine conversations is limited in this postacute setting. RESEARCH QUESTION: What factors influence the decision-making process of patients who have survived an ICU stay surrounding influenza and COVID-19 vaccination? STUDY DESIGN AND METHODS: To understand further vaccine perceptions after critical illness, a secondary qualitative thematic analysis was performed using transcripts from a randomized controlled trial designed to develop and refine a telemedicine approach to ICU recovery. Thirty-three ICU-RC visits with 19 adult patients and 13 caregivers were conducted within 12 weeks of hospital discharge. The analysis was guided by the theory of planned behavior (TPB). RESULTS: Five themes were elicited from the data. The first four themes arose from the TPB: (1) behavioral and attitudinal beliefs (not being susceptible to the flu, concerns about the COVID-19 vaccine causing fertility issues, and not being tested enough), (2) normative beliefs (everyone they know is getting the influenza vaccine so they are, too), (3) control vaccine beliefs (patients are more likely to get the COVID-19 vaccine if it is easy to obtain), and (4) intention to vaccinate. Another theme not related to the TPB arose and could contribute to vaccine intent and behavior: (5) health team engagement with patients and caregivers (allowing for ICU clinicians to correct vaccine misinformation in real time). INTERPRETATION: Using the information learned in our study, the period after critical illness or other acute illness events may be an especially fruitful target for designing an action plan for improving public trust in vaccines and improving overall completion rates; however, further research is needed. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03926533; URL: www.clinicaltrials.gov.

Cohort profile: CareConekta: a pilot study of a smartphone application to improve engagement in postpartum HIV care in South Africa.

PURPOSE: Pregnant and postpartum women living with HIV in South Africa are at high risk of dropping out of care, particularly after delivery. Population mobility may contribute to disruptions in HIV care, and postpartum women are known to be especially mobile. To improve engagement in HIV care during the peripartum period, we developed CareConekta, a smartphone application (app) that uses GPS coordinates to characterise mobility and allow for real-time intervention. We conducted a randomised controlled pilot study to assess feasibility, acceptability and initial efficacy of the app intervention to improve engagement in HIV care. This cohort profile describes participant enrolment and follow-up, describes the data collected and provides participant characteristics. PARTICIPANTS: We enrolled 200 pregnant women living with HIV attending routine antenatal care at the Gugulethu Midwife Obstetric Unit in Cape Town, South Africa. Eligible women must have owned smartphones that met the app's technical requirements. Seven participants were withdrawn near enrolment, leaving 193 in the cohort. FINDINGS TO DATE: Data were collected from detailed participant questionnaires at enrolment and follow-up (6 months after delivery), as well as GPS data from the app, and medical records. Follow-up is complete; initial analyses have explored smartphone ownership, preferences and patterns of use among women screened for eligibility and those enrolled in the study. FUTURE PLANS: Additional planned analyses will characterise mobility in the population using the phone GPS data and participant self-reported data. We will assess the impact of mobility on engagement in care for the mother and infant. We also will describe the acceptability and feasibility of the study, including operational lessons learnt. By linking this cohort to the National Health Laboratory Service National HIV Cohort in South Africa, we will continue to assess engagement in care and mobility outcomes for years to come. Collaborations are welcome. TRIAL REGISTRATION NUMBER: NCT03836625.

Timing of HIV diagnosis relative to pregnancy and postpartum HIV care continuum outcomes among Latin American women, 2000 to 2017.

BACKGROUND: HIV incidence among women of reproductive age and vertical HIV transmission rates remain high in Latin America. We, therefore, quantified HIV care continuum barriers and outcomes among pregnant women living with HIV (WLWH) in Latin America. METHODS: WLWH (aged ≥16 years) enrolling at Caribbean, Central and South America network for HIV epidemiology (CCASAnet) sites from 2000 to 2017 who had HIV diagnosis, pregnancy and delivery dates contributed. Logistic regression produced adjusted odds ratios (aOR) and 95% confidence intervals (CI) for retention in care (≥2 visits ≥3 months apart) and virological suppression (viral load <200 copies/mL) 12 months after pregnancy outcome. Cumulative incidences of loss to follow-up (LTFU) postpartum were estimated using Cox regression. Evidence of HIV status at pregnancy confirmation was the exposure. Covariates included pregnancy outcome (born alive vs. others); AIDS diagnosis prior to delivery; CD4, age, HIV-1 RNA and cART regimen at first delivery and CCASAnet country. RESULTS: Among 579 WLWH, median postpartum follow-up was 4.34 years (IQR 1.91, 7.35); 459 (79%) were HIV-diagnosed before pregnancy confirmation, 445 (77%) retained in care and 259 (45%) virologically suppressed at 12 months of postpartum. Cumulative incidence of LTFU was 21% by 12 months and 40% by five years postpartum. Those HIV-diagnosed during pregnancy had lower odds of retention (aOR = 0.58, 95% CI: 0.35 to 0.97) and virological suppression (aOR = 0.50, 95% CI: 0.31 to 0.82) versus those HIV-diagnosed before. CONCLUSION: HIV diagnosis during pregnancy was associated with poorer 12-month retention and virological suppression. Young women should be tested and linked to HIV care earlier to narrow these disparities.

Patterns of mobility and its impact on retention in care among people living with HIV in the Manhiça District, Mozambique.

INTRODUCTION: 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. METHODS: 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 ≤12 months prior to survey) and non-migrants, matched by age and sex. RESULTS: 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. CONCLUSION: 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.

Attitudes Toward a Proposed GPS-Based Location Tracking Smartphone App for Improving Engagement in HIV Care Among Pregnant and Postpartum Women in South Africa: Focus Group and Interview Study.

BACKGROUND: Peripartum women living with HIV in South Africa are at high risk of dropping out of care and are also a particularly mobile population, which may impact their engagement in HIV care. With the rise in mobile phone use worldwide, there is an opportunity to use smartphones and GPS location software to characterize mobility in real time. OBJECTIVE: The aim of this study was to propose a smartphone app that could collect individual GPS locations to improve engagement in HIV care and to assess potential users' attitudes toward the proposed app. METHODS: We conducted 50 in-depth interviews (IDIs) with pregnant women living with HIV in Cape Town and Johannesburg, South Africa, and 6 focus group discussions (FGDs) with 27 postpartum women living with HIV in Cape Town. Through an open-ended question in the IDIs, we categorized "positive," "neutral," or "negative" reactions to the proposed app and identified key quotations. For the FGD data, we grouped the text into themes, then analyzed it for patterns, concepts, and associations and selected illustrative quotations. RESULTS: In the IDIs, the majority of participants (76%, 38/50) responded favorably to the proposed app. Favorable comments were related to the convenience of facilitated continued care, a sense of helpfulness on the part of the researchers and facilities, and the difficulties of trying to maintain care while traveling. Among the 4/50 participants (8%) who responded negatively, their comments were primarily related to the individual's responsibility for their own health care. The FGDs revealed four themes: facilitating connection to care, informed choice, disclosure (intentional or unintentional), and trust in researchers. CONCLUSIONS: Women living with HIV were overwhelmingly positive about the idea of a GPS-based smartphone app to improve engagement in HIV care. Participants reported that they would welcome a tool to facilitate connection to care when traveling and expressed trust in researchers and health care facilities. Within the context of the rapid increase of smartphone use in South Africa, these early results warrant further exploration and critical evaluation following real-world experience with the app.

Sharing genetic test results with family members of BRCA, PALB2, CHEK2, and ATM carriers.

OBJECTIVE: This study explored motivators and challenges/barriers to sharing personal genetic test results (GTR) with family members (FM). METHODS: Semi-structured, in-depth interviews were conducted with 62 women who had a pathogenic or likely pathogenic (P/LP) variant in aBRCA, PALB2, CHEK2, or ATM gene. Selective qualitative data analysis focused on eliciting motivators and challenges/barriers identified by participants when sharing their GTR with FM. RESULTS: Motivators to sharing personal GTR with FM included: health protection and prevention; moral obligation; decisional empowerment; familial ties; written resources; and contextualization for a familial cause for cancer. Challenges/barriers to family sharing included: concern for FM reactions; complexities of information; lack of closeness; perceived relevance; and emotional impact. CONCLUSIONS: All motivators and challenges/barriers were identified across BRCA and non-BRCA carriers, demonstrating commonalities in family sharing of GTR among high- to moderate-penetrance hereditary BC (breast cancer) genes. Despite challenges/barriers, participants disclosed their GTR with most close FM, yet restrictions in communication and/or strain on the timing, manner of disclosing, and strategies used varied across certain FM. PRACTICE IMPLICATIONS: These findings offer healthcare providers and researchers preliminary practical implications for broadly improving family sharing interventions across P/LP variants in BC risk genes by demonstrating important elements to include in family sharing letters.

Family communication of genetic test results among women with inherited breast cancer genes.

Identification of inherited breast cancer may guide care. These benefits can be amplified through communication of genetic test results with at-risk family members and subsequent family testing (FT). Females with a pathogenic/likely pathogenic (P/LP) variant in BRCA1/2, PALB2, CHEK2, and/or ATM were surveyed about family communication (FC) of genetic test results and FT. Comparisons were made across genes. The 235 participants with P/LP variants (186 BRCA1/2, 28 PALB2, 15 CHEK2, and 6 ATM) had a median age of 54 and most were non-Hispanic whites (89%) with a prior breast cancer diagnosis (61%). When controlling for other variables, FC was higher among younger participants (p<.0001), those with high FC self-efficacy (p=.019), and those with P/LP variants in BRCA1/2 compared to PALB2 (p =.040) and ATM/CHEK2 (p =.032). Higher rates of FC and FT were also observed among female relatives and relatives of closer kinship. Overall 94% of participants would find one or more resources helpful with FC and 70% reported using FC resources when telling family members about their genetic test result. The three most commonly used resources included the following: (a) a family sharing letter (38%); (b) printed materials (30%); and (c) web-based information (23%). Among the 86% who spoke with a genetic counselor (GC), 93% were given at least one FC resource and the three most common resources GCs provided to participants overlapped with the resources participants would find helpful and those that were used. Our results suggest lower FC and FT rates among women with P/LP variants in genes other than BRCA1/2, the reasons for which should be evaluated in future studies. As more data to refine cancer risks and management are generated across these other inherited breast cancer genes, strategies to improve FC and FT are needed to amplify the benefits of genetic testing.

The South African National HIV Pregnancy Cohort: evaluating continuity of care among women living with HIV.

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).

Cancer risk management among female BRCA1/2, PALB2, CHEK2, and ATM carriers.

PURPOSE: Identification of inherited breast cancer may guide cancer risk management. We sought to compare risk management practices across women with inherited breast cancer genes. METHODS: Females with a pathogenic/likely pathogenic (P/LP) variant in BRCA1/2, PALB2, CHEK2, and/or ATM were surveyed about cancer risk management. Comparisons were made across genes. RESULTS: The 235 participants with P/LP variants (186 BRCA1/2, 28 PALB2, 15 CHEK2, and 6 ATM) had a median age of 54 and 61% had a prior breast cancer diagnosis. For women with P/LP variants in BRCA1/2, PALB2, and ATM/CHEK2, bilateral mastectomy (BM) rates were 79%, 61%, and 52%, and bilateral oophorectomy (BO) rates were 89%, 30%, and 37%, respectively. Among women with P/LP variants in PALB2 and ATM/CHEK2, 27% of those who had a BO had a family history of ovarian cancer. Contralateral mastectomy rates for women with P/LP variants in PALB2 and ATM/CHEK2 with unilateral breast cancer were 60% and 58%, and BM rates for those without breast cancer were 57% and 29%, respectively. CONCLUSION: These findings suggest high rates of both contralateral mastectomies among those with unilateral breast cancer and BM among those without a breast cancer diagnosis across women with P/LP variants in high and moderate penetrance breast cancer genes. BO was also often utilized for risk reduction across these women. These findings suggest potential overtreatment through risk-reducing surgery, and highlight the importance of promoting guideline-adherent, risk-appropriate care.

CareConekta: study protocol for a randomized controlled trial of a mobile health intervention to improve engagement in postpartum HIV care in South Africa.

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.

Attrition of HIV-positive children from HIV services in low and middle-income countries.

INTRODUCTION: Identification and retention of HIV-positive children in HIV services is essential to ensure optimal health outcomes. This systematic review and meta-analysis examines the magnitude of attrition [loss to follow-up (LTFU) and death) of HIV-positive children from HIV services in low and middle-income countries (LMICs). METHODS: We performed a comprehensive multidatabase search of original studies reporting retention/attrition data for HIV-positive children in LMICs through April 2016. Outcomes included LTFU, death, and overall attrition (LTFU + death) at intervals up to 60 months of follow-up. At least two authors determined study eligibility, performed data extraction, and made quality assessments. We used random-effects meta-analytic methods to aggregate effect sizes and perform meta-regression analyses. RESULTS: We identified 3040 unique studies; 91 met eligibility criteria and were included in the analysis. This represents 147 129 HIV-positive children; most were from Africa (83%). LTFU definitions varied widely, with significant variability in outcomes across studies. Most attrition occurred in the first 6 months of follow-up, increasing to 23% by 36 months. HIV-positive children receiving antiretroviral therapy (ART) had significantly better retention in care than those not on ART. Studies that performed case-finding/tracing for those LTFU had better retention in care up to 24 months of follow-up. CONCLUSIONS: These findings underscore the high attrition of children from HIV services in LMICs. Early ART initiation and decentralized patient support services (e.g. tracing for those LTFU) have potential to improve retention in care. Implementation research and resources are urgently needed to improve retention among this vulnerable population.

Effect of PEPFAR funding policy change on HIV service delivery in a large HIV care and treatment network in Nigeria.

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.

Acceptability of Interventions to Improve Engagement in HIV Care Among Pregnant and Postpartum Women at Two Urban Clinics in South Africa.

INTRODUCTION: Pregnant women initiating antiretroviral therapy (ART) in sub-Saharan Africa have been shown to have sub-optimal engagement in care, particularly after delivery, and interventions to improve engagement in care for this unique population are urgently needed. METHODS: We enrolled 25 pregnant women living with HIV at each of two large antenatal clinics in Johannesburg and Cape Town, South Africa (n = 50), and conducted in-depth interviews. We assessed participants' reported acceptability of the following proposed interventions to improve engagement in care and retention monitoring data systems: financial incentives, educational toys, health education, combined maternal/infant visits, cell phone text reminders, mobility tracking, fingerprint/biometric devices, and smartcards. RESULTS: Acceptability overall for interventions was high, with mixed responses for some interventions. Overall themes identified included (i) the intersection of individual and facility responsibility for a patient's health, (ii) a call for more health education, (iii) issues of disclosure and concerns about privacy, and (iv) openness to interventions that could improve health systems. DISCUSSION: These findings provide insight into the preferences and concerns of potential users of interventions to improve engagement in HIV care for pregnant women, and support the development of tools that specifically target this high-risk group.