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Background: At-birth and point-of-care (POC) testing can expedite early infant diagnosis of HIV and improve infant outcomes. Guided by the Consolidated Framework for Implementation Research (CFIR), this study describes the implementation of an at-birth POC testing pilot from the perspective of implementing providers and identifies the factors that might support and hinder the scale up of these promising interventions., Methods: We conducted 28 focus group discussions (FGDs) with 48 providers across 4 study sites throughout the course of a pilot study assessing the feasibility and impact of at-birth POC testing. FGDs were audio-recorded, transcribed, and analyzed for a priori themes related to CFIR constructs. This qualitative study was nested within a larger study to pilot and evaluate at-birth and POC HIV testing., Results: Out of the 39 CFIR constructs, 30 were addressed in the FGDs. While all five domains were represented, major themes revolved around constructs related to intervention characteristics, inner setting, and outer setting. Regarding intervention characteristics, the advantages of at-birth POC (rapid turnaround time resulting in improved patient management and enhanced patient motivation) were significant enough to encourage provider uptake and enthusiasm. Challenges at the intervention level (machine breakdown, processing errors), inner settings (workload, limited leadership engagement, challenges with access to information), and outer setting (patient-level challenges, limited engagement with outer setting stakeholders) hindered implementation, frustrated providers, and resulted in missed opportunities for testing. Providers discussed how throughout the course of the study adaptations to implementation (improved channels of communication, modified implementation logistics) were made to overcome some of these challenges. To improve implementation, providers cited the need for enhanced training and for greater involvement among stakeholders outside of the implementing team (i.e., other clinicians, hospital administrators and implementing partners, county and national health officials). Despite provider enthusiasm for the intervention, providers felt that the lack of engagement from leadership within the hospital and in the outer setting would preclude sustained implementation outside of a research setting., Conclusion: Despite demonstrated feasibility and enthusiasm among implementing providers, the lack of outer setting support makes sustained implementation of at-birth POC testing unlikely at this time. The findings highlight the multi-dimensional aspect of implementation and the need to consider facilitators and barriers within each of the five CFIR domains., Trial Registration: ClinicalTrials.gov, NCT03435887 . Retrospectively registered on 19 February 2020., (© 2021. The Author(s).)

Background: Prevention of mother-to-child HIV transmission (PMTCT) services in Kenya can be strengthened through the delivery of relevant and culturally appropriate SMS messages., Methods: This study reports on the results of focus groups conducted with pre and postnatal women living with HIV (5 groups, n = 40) and their male partners (3 groups, n = 33) to elicit feedback and develop messages to support HIV+ women's adherence to ART medication, ANC appointments and a facility-based birth. The principles of message design informed message development., Results: Respondents wanted ART adherence messages that were low in verbal immediacy (ambiguous), came from an anonymous source, and were customized in timing and frequency. Unlike other studies, low message immediacy was prioritized over customization of message content. For retention, participants preferred messages with high verbal immediacy-direct appointment reminders and references to the baby-sent infrequently from a clinical source., Conclusion: Overall, participants favored content that was brief, cheerful, and emotionally appealing., (© 2021. The Author(s).)

Background: Early infant diagnosis among human immunodeficiency virus (HIV)-exposed infants is a critical component of prevention of mother-to-child transmission programs. Barriers to early infant diagnosis include poor uptake, low retention at designated re-testing intervals, delayed test results, passive systems of communication, and poor linkage to treatment. This study will evaluate the HIV Infant Tracking System (HITSystem), an eHealth intervention that streamlines communication and accountability between the key early infant diagnosis stakeholders: HIV+ mothers and their HIV-exposed infants, healthcare providers, and central laboratory personnel. It is hypothesized that the HITSystem will significantly improve early infant diagnosis retention at 9 and 18 months postnatal and the timely provision of services., Methods/design: Using a phased cluster-randomized controlled trial design, we will evaluate the impact of the HITSystem on eight primary benchmarks in the 18-month long cascade of care for early infant diagnosis. Study sites are six government hospitals in Kenya matched on geographic region, resource level, and patient volume. Early infant diagnosis outcomes of mother-infant dyads (n = 120 per site) at intervention hospitals (n = 3) where the HITSystem is deployed at baseline will be compared to the matched control sites providing standard care. After allowing for sufficient time for enrollment and 18-month follow-up of dyads, the HITSystem will be deployed at the control sites in the end of Year 3. Primary outcomes are retention among mother-infant dyads, initiation of antiretroviral therapy among HIV-infected infants, and the proportion of services delivered within the optimal time window indicated by national and study guidelines. Satisfaction interviews with participants and providers will inform intervention improvements. Cost-effectiveness analyses will be conducted to inform the sustainability of the HITSystem. Hypothesized outcomes include significantly higher retention throughout the 18-month early infant diagnosis process, significantly more services provided on-time at intervention sites, and a potential savings to the healthcare system., Discussion: This study will evaluate the public health impact of the HITSystem to improve critical early infant diagnosis outcomes in low-resource settings. Cost-effectiveness analyses will inform the feasibility of scale-up in other settings., Trial Registration: ClinicalTrials.gov: NCT02072603.