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Background Despite progress to expand access to HIV testing and treatment during pregnancy in Kenya, gaps still remain in prevention of mother-to-child transmission of HIV (PMTCT) services. This study addresses the need for effective and scalable interventions to support women throughout the continuum of care for PMTCT services in low-resource settings. Our research team has successfully implemented the HIV Infant Tracking System (HITSystem), a Web-based, system-level intervention to improve early infant diagnosis (EID) outcomes. Objective This study will expand the scope of the HITSystem to address PMTCT services to bridge the gap between maternal and pediatric HIV services and improve outcomes. This paper describes the intervention development protocol to adapt and pilot an HITSystem version 2.0 to assess acceptability, feasibility, and preliminary PMTCT outcomes in Kenya. Methods This is a 3-year intervention development study to adapt the current HITSystem intervention to support a range of PMTCT outcomes including appointment attendance, antiretroviral therapy (ART) adherence, hospital deliveries, and integration of maternal and pediatric HIV services in low-resource settings. The study will be conducted in 3 phases. Phase 1 will elicit feedback from intervention users (patients and providers) to guide development and refinement of the new PMTCT components and inform optimal implementation. In Phase 2 , we will design and develop the HITSystem 2.0 features to support key PMTCT outcomes guided by clinical content experts and findings from Phase 1. Phase 3 will assess complete PMTCT retention (before, during, and after delivery) using a matched randomized pilot study design in 2 hospitals over 18 months. A total of N=108 HIV-positive pregnant women (n=54 per site) will be enrolled and followed from their first PMTCT appointment until infant HIV DNA Polymerase Chain Reaction testing at the target age of 6 weeks (<7 weeks) postnatal. Results Funding for this study was received in August 2015, enrollment in Phase 1 began in March 2016, and completion of data collection is expected by May 2019. Conclusions This protocol will extend, adapt, and pilot an HITSystem 2.0 version to improve attendance of PMTCT appointments, increase ART adherence and hospital-based deliveries, and prompt EID by 6 weeks postnatal. The HITSystem 2.0 aims to improve the integration of maternal and pediatric HIV services. Trial Registration ClinicalTrials.gov NCT02726607; https://clinicaltrials.gov/ct2/show/NCT02726607 (Archived by WebCite at http://www.webcitation.org/78VraLrOb) International Registered Report Identifier (IRRID) DERR1-10.2196/13268

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BACKGROUND Evidence that text messages can support patient adherence to HIV care is growing. We conducted a pilot study of the HIV Infant Tracking System (HITSystem 2.0), an intervention that includes SMS to patients to support maternal medication adherence, appointment attendance, and hospital-based deliveries during the antenatal period. OBJECTIVE The objective of this study was to qualitatively assess women’s experiences receiving SMS to understand message utility and acceptability with the goal of refining and strengthening the intervention. METHODS As part of an intervention development pilot study, we conducted semi-structured interviews with 33 women living with HIV who received SMS through the HITSystem 2.0 throughout their pregnancy and postpartum period. Interview questions assessed women’s feedback of the SMS, the impact of the SMS on their PMTCT care, and suggestions for improvement. RESULTS Participants described how SMS reinforced existing strategies for medication adherence and served as cues to action for antenatal appointments and hospital-based deliveries. SMS also provided encouragement and enhanced their sense of engagement with their clinical care team. Given the neutral content of the messages, most women reported no concerns about message confidentiality. Recommendations to enhance utility included greater customizability (timing and frequency of messages) and a few women suggested more comprehensive counseling regarding the SMS content to anticipate at the time of enrollment. CONCLUSIONS SMS content was deemed useful and acceptable by pregnant and postpartum women living with HIV and engaged in PMTCT services. Participant recommendations to increase message customization options have been adopted to enhance the intervention. CLINICALTRIAL Trial registration: clinicaltrials.gov, NCT02726607. Registered 01 April 2016. Retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT02726607

UNSTRUCTURED Background: Despite progress to expand access to HIV testing and treatment during pregnancy in Kenya, gaps still remain in prevention of mother-to-child transmission of HIV (PMTCT) services. This study addresses the need for effective and scalable interventions to support women throughout the continuum of care for PMTCT services in low resource settings. Our research team has successfully implemented the HIV Infant Tracking System (HITSystem), a web-based, system-level intervention to improve early infant diagnosis (EID) outcomes. This study will expand the scope of the HITSystem to address PMTCT services to bridge the gap between maternal and pediatric HIV services and improve outcomes. This paper describes the intervention development protocol to adapt and pilot a HITSystem version 2.0 to assess acceptability, feasibility, and preliminary PMTCT outcomes in Kenya. Methods/design: This is a three-year intervention development study to adapt the current HITSystem intervention to support a range of PMTCT outcomes including: retention in care, ART adherence, hospital deliveries, and integration of maternal and pediatric HIV services in low-resource settings. The study will be conducted in three phases. Phase 1 will elicit feedback from intervention users (patients and providers) to guide development and refinement of the new PMTCT components and inform optimal implementation. In Phase 2, we will design and develop the HITSystem 2.0 features to support key PMTCT outcomes guided by clinical content experts and findings from Phase 1. Phase 3 will assess complete PMTCT retention (before, during, and after delivery) using a matched randomized pilot study design in two hospitals over 18-months. A total of n=108 HIV+ pregnant women (n=54 per site) will be enrolled and followed from their first PMTCT appointment until infant HIV DNA PCR testing at the target age of 6 weeks (< 7 weeks) postnatal. Discussion: This protocol will extend, adapt, and pilot a HITSystem 2.0 version to improve attendance of PMTCT appointments, increase ART adherence and hospital-based deliveries, and prompt early infant diagnosis by 6 weeks postnatal. The HITSystem 2.0 aims improve the integration of maternal and pediatric HIV services. Trial registration: ClinicalTrials.gov: NCT02726607. Registered on April 1, 2016.