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.

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.

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.

72 weeks post-partum follow-up of dolutegravir versus efavirenz initiated in late pregnancy (DolPHIN-2): an open-label, randomised controlled study.

BACKGROUND: Late initiation of antiretrovirals in pregnancy is associated with increased risk of perinatal transmission and higher infant mortality. We report the final 72-week postpartum results for efficacy and safety of dolutegravir-based compared with efavirenz-based regimens in mothers and infants. METHODS: DolPHIN-2 was a randomised, open-label trial. Pregnant women in South Africa and Uganda aged at least 18 years, with untreated but confirmed HIV infection and an estimated gestation of at least 28 weeks, initiating antiretroviral therapy in third trimester were eligible for inclusion. Eligible women were randomly assigned (1:1) to receive either dolutegravir-based (50 mg dolutegravir, 300 mg tenofovir disoproxil fumarate, and either 200 mg emtricitabine in South Africa or 300 mg lamivudine in Uganda) or efavirenz-based (fixed dose combination 600 mg tenofovir disoproxil fumarate plus either emtricitabine in South Africa or lamivudine in Uganda) therapy. The primary efficacy outcome was the time to a viral load of less than 50 copies per mL measured at 6, 12, 24, 48, and 72 weeks postpartum with a Cox model adjusting for viral load and CD4 cell count. Safety endpoints were summarised by the number of women and infants with events. This trial is registered with ClinicalTrials.gov, NCT03249181. FINDINGS: Between Jan 23 and Aug 15, 2018, 280 women were screened for inclusion, of whom 268 (96%) women were randomly assigned: 133 (50%) to the efavirenz group and 135 (50%) to the dolutegravir group. 250 (93%; 125 [50%] in the efavirenz group and 125 [50%] in the dolutegravir group) women were included in the intention-to-treat analysis of efficacy. Median time to viral load of less than 50 copies per mL was 4·1 weeks (IQR 4·0-5·1) in the dolutegravir group compared with 12·1 weeks (10·7-13·3) in the efavirenz group (adjusted hazard ratio [HR] 1·93 [95% CI 1·5-2·5]). At 72 weeks postpartum, 116 (93%) mothers in the dolutegravir group and 114 (91%) in the efavirenz group had a viral load of less than 50 copies per mL. Of 57 (21%) mothers with a severe adverse event, three (2%) in the dolutegravir group and five (4%) in the efavirenz group were related to the drug (dolutegravir drug-related events were one woman each with suicidal ideation, suicide attempt, herpes zoster meningitis; efavirenz drug-related events were one woman each with suicide attempt and liver cirrhosis, and three people with drug-induced liver injury). Of 136 (56%) infants in whom severe adverse events were recorded, none were related to the study drugs. In addition to the three infant HIV infections detected at birth in the dolutegravir group that have been previously reported, an additional transmission in the efavirenz group occurred during breastfeeding despite optimal maternal viral suppression and serial negative infant tests in the first year of life. INTERPRETATION: Dolutegravir was safe and well tolerated, supporting updated WHO treatment recommendations in pregnant and breastfeeding women. Infant HIV transmissions can occur during breastfeeding despite persistently undetectable maternal viral load highlighting the need for continued infant testing. FUNDING: Unitaid.

Cervical dysplasia and high-risk human papillomavirus infections among HIV-infected and HIV-uninfected adolescent females in South Africa.

BACKGROUND: HIV-infected adolescents may be at higher risk for high-grade cervical lesions than HIV-uninfected adolescents. The purpose of this study was to compare the prevalence of high-risk HPV (HR-HPV) infections and Pap smear abnormalities between these two groups. METHODS: In this cross-sectional study, we compared the HPV DNA and Pap smear results between 35 HIV-infected and 50 HIV-uninfected adolescents in order to determine the prevalence of HR-HPV genotypes and cervical cytological abnormalities. Comparisons were made using Pearson χ (2) and independent-samples t-tests analyses, and associations between demographic and behavioral characteristics and HPV infections were examined. RESULTS: HIV-infected participants were more likely to be infected with any HPV (88.6% versus 48.0%; P < 0.001) and with at least one HR-HPV (60.0% versus 24.0%; P = 0.001), and to have multiple concurrent HPV infections (68.6% versus 22.0%; P < 0.001). HPV 16 and 18 were relatively underrepresented among HR-HPV infections. Abnormal Pap test results were more common among HIV-infected participants (28.8% versus 12.0%; P = 0.054). A history of smoking was associated with HR-HPV infection. CONCLUSIONS: HIV-infected adolescents have an increased risk of infection with HR-HPV and of Pap test abnormalities. The majority of HR-HPV infections among our participants would not be prevented by the currently available vaccinations against HPV.