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The HIV Infant Tracking System (HITSystem) is an eHealth intervention to improve early infant diagnosis (EID) through alerts to providers and text messages to mothers. This study explored mothers' experiences receiving standard and HITSystem-enhanced EID services to assess perceived intervention benefits, acceptability, and opportunities for improvement. This qualitative study was embedded within a cluster-randomized control trial to evaluate the HITSystem at six Kenyan government hospitals (3 intervention, 3 control). We conducted semi-structured interviews with 137 mothers attending EID follow-up visits. Compared to control sites, participants at HITSystem sites described enhanced EID quality; HITSystem-generated texts informed them of result availability and retesting needs, provided cues-to-action for clinic attendance, and engendered opportunities for patient support. They described improved EID efficiency through shorter waiting periods for results and fewer hospital visits. Participants reported high satisfaction with EID and acceptability of text messages; however, modifications to ensure text delivery, increase repeat testing reminders, include low literacy content options, and provide encouraging messages were suggested. These user experience data suggest improvements in EID at HITSystem sites when compared with control sites.

Background: As many as 40% of the 1 million children living with HIV (CLHIV) receiving antiretroviral treatment (ART) in resource limited settings have not achieved viral suppression (VS). Kenya has a large burden of pediatric HIV with nearly 140,000 CLHIV. Feasible, scalable, and cost-effective approaches to ensure VS in CLHIV are urgently needed. The goal of this study is to determine the feasibility and impact of point-of-care (POC) viral load (VL) and targeted drug resistance mutation (DRM) testing to improve VS in children on ART in Kenya. Methods: We are conducting a randomized controlled study to evaluate the use of POC VL and targeted DRM testing among 704 children aged 1–14 years on ART at health facilities in western Kenya. Children are randomized 1:1 to intervention (higher frequency POC VL and targeted DRM testing) vs. control (standard-of-care) arms and followed for 12 months. Our primary outcome is VS (VL

Background Tuberculosis (TB) screening in Prevention of Mother-To-Child Transmission (PMTCT) programs is important to improve TB detection, prevention and treatment. Methods As part of a national PMTCT program evaluation, mother-infant pairs attending 6-week and 9-month immunization visits were enrolled at 141 maternal and child health clinics throughout Kenya. Clinics were selected using population-proportion-to-size sampling with oversampling in a high human immunodeficiency virus (HIV) prevalence region. The World Health Organization (WHO) TB symptom screen was administered to HIV-infected mothers, and associations with infant cofactors were determined. Results Among 498 HIV-infected mothers, 165 (33%) had a positive TB symptom screen. Positive maternal TB symptom screen was associated with prior TB (P = 0.04). Women with a positive TB symptom screen were more likely to have an infant with HIV infection (P = 0.02) and non-specific TB symptoms, including cough (P = 0.003), fever (P = 0.05), and difficulty breathing (P = 0.01). TB exposure was reported by 11% of the women, and 15% of the TB-exposed women received isoniazid preventive therapy. Conclusions Postpartum HIV-infected mothers frequently had a positive TB symptom screen. Mothers with a positive TB symptom screen were more likely to have infants with HIV or non-specific TB symptoms. Integration of maternal TB screening and prevention into PMTCT programs may improve maternal and infant outcomes.

Rationale Early Infant Diagnosis (EID) is critical to timely identification of HIV and rapid treatment initiation for infants found to be infected. Completing the EID cascade involves a series of age-specific tests between birth and 18 months and can be challenging for mother- infant pairs in low-resource settings. Even prior to recent increases in Kenya's testing recommendations, approximately 22% of mother-infant pairs enrolled in EID were lost to follow-up. As EID cascades become increasingly complex, identifying strategies to maximize retention becomes even more essential. Despite ongoing health system improvements, we still lack a framework for understanding the individual-level, psychosocial processes underlying EID completion—insight that could be essential for shaping strategies to support patients and close gaps in retention. Objective Our objective was to explain individual-level processes that lead to EID completion among mothers who successfully completed the EID cascade. Methods Using qualitative methods informed by grounded theory, we conducted 65 interviews with Kenyan mothers who completed EID. Results We identified three themes related to completion: (1) Negative motivation, from the consequences of infant infection, fear of postnatal transmission, and burden of maternal failure; (2) Positive motivation, from achieving a final goal, responding to provider support, and maximizing infant health; and (3) Overcoming challenges, through resolve/resiliency, planning/privatizing and rejecting stigma/leveraging support. Conclusion Overall, the EID cascade served as a framing process for women to secure an identity as a good mother. Successful EID completion was the product of a strong motivational foundation channeled into strategies to surmount persistent challenges. Participant accounts of overcoming challenges highlight their resiliency as well as the outstanding need to address financial, logistical, and social barriers to care. Future EID programs may capitalize on these findings by affirming patients' quest for identity control, leveraging positive motivators, and expanding peer support structures to help mothers feel connected throughout the cascade.

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 (

Background Pregnant and postpartum women living with HIV (WLHIV) are a priority population for virologic monitoring and efforts to ensure viral suppression to reduce the risk for vertical-transmission and poor maternal health outcomes. Few studies have examined the role of parity on viral suppression during periconception in WLHIV. Methods We present data from the ongoing Opt4Mamas study which enrolled pregnant women with HIV on antiretroviral therapy between March and November 2019 attending antenatal care in five public health facilities in Kisumu County, Kenya. We evaluated associations between various sociodemographic and psychosocial factors and periconception viral suppression (< 40 copies/mL) within 12 months of study enrollment. We conducted univariate and multivariate logistic regressions, calculating odds ratios (OR) and 95% confidence intervals (CI). Results Among 497 women enrolled, mean age 29.9 years, 301 (61%) had viral load results available within 12 months of study enrollment. Viral loads were available a median of 18 days from conception (interquartile range 71 days before to 90 days after conception), and 237 women (79%) were virally suppressed. The majority (90%) of women were on a non-nucleoside reverse transcriptase inhibitor and 23 (9%) were on a protease inhibitor-containing regimen. In univariate analysis, women younger than 25 and primigravida women were less likely to be virally suppressed (OR 0.31, 95% CI [0.16 - 0.60] and OR 0.25, 95% CI [0.11 - 0.61] respectively; Table 1). The relationship between primigravida and periconception viral suppression is modified by age and duration on ART. Primigravida women who were younger than 25 years or who had less than 1 year of ART had significantly reduced odds of achieving viral suppression in the past year compared to primigravida women who were older or who had more experience taking ART (OR 0.09, 95%CI [0.03-0.31] and OR 0.09, 95%CI [0.02-0.48] respectively; Table 2). Table 1: Comparison of Pregnant Women with HIV by Periconception Viral Suppression Table 2: Interaction Effects with Primigravida Status Conclusion Risk factors for non-suppression around the time of conception in WLHIV include primigravida status, which is modified by age and duration on ART. Interventions targeting viral suppression among WLHIV leading up to their first pregnancy are needed, particularly among those who are newly initiated onto ART or younger age. Disclosures All Authors: No reported disclosures

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.

Background Prevention of mother-to-child HIV transmission (PMTCT) programs usually test pregnant women for HIV without involving their partners. Non-disclosure of maternal HIV status to male partners may deter utilization of PMTCT interventions since partners play a pivotal role in decision-making within the home including access to and utilization of health services. Methods Mothers attending routine 6-week and 9-month infant immunizations were enrolled at 141 maternal and child health (MCH) clinics across Kenya from June–December 2013. The current analysis was restricted to mothers with known HIV status who had a current partner. Multivariate logistic regression models adjusted for marital status, relationship length and partner attendance at antenatal care (ANC) were used to determine correlates of HIV non-disclosure among HIV-uninfected and HIV-infected mothers, separately, and to evaluate the relationship of non-disclosure with uptake of PMTCT interventions. All analyses accounted for facility-level clustering, Results Overall, 2522 mothers (86% of total study population) met inclusion criteria, 420 (17%) were HIV-infected. Non-disclosure of HIV results to partners was higher among HIV-infected than HIV-uninfected women (13% versus 3% respectively, p

Exclusive breastfeeding (EBF) means giving only breast milk to an infant. Although it is the optimal mode of feeding for infants younger than 6 months, its prevalence is low in HIV-endemic regions. Extensive promotion of EBF for 6 months in prevention of mother-to-child HIV transmission (PMTCT) programs could inadvertently result in stigma due to women's perceived association of EBF with HIV infection. In this qualitative study, we describe how stigma impacts the uptake of EBF among HIV-positive and -negative women.Pregnant and postpartum women and their male partners were recruited to participate in a total of 22 focus group discussions (FGDs). Transcripts were analyzed using ATLAS.ti. Codes were identified both a priori and inductively using the open coding approach. Major themes and subthemes were identified.There was a broad and strong consensus among some FGD participants that HIV-related stigma was a barrier to EBF. EBF was perceived as a practice for HIV-positive women. Thus, fear of discrimination deterred both HIV-positive and -negative women from EBF. However, with health education, peer counselor, and male partner support, some women were able to breastfeed exclusively regardless of opposing social norms.Stigma related to HIV poses a formidable barrier to EBF in HIV-endemic regions. There is an urgent need to widely target all women with EBF information and support EBF practices regardless of maternal HIV infection status. The lessons learned from this study indicate that vertical programs can hinder promotion of infant health interventions and therefore negatively affect child survival.

Background. Tenofovir disoproxil fumarate (TDF) is commonly used in antiretroviral treatment (ART) and preexposure prophylaxis regimens. We evaluated the relationship of prenatal TDF use and growth outcomes among Kenyan HIV-exposed uninfected (HEU) infants.Materials and Methods.We included PCR-confirmed HEU infants enrolled in a cross-sectional survey of mother-infant pairs conducted between July and December 2013 in Kenya. Maternal ART regimen during pregnancy was determined by self-report and clinic records. Six-week and 9-monthz-scores for weight-for-age (WAZ), weight-for-length (WLZ), length-for-age (LAZ), and head circumference-for-age (HCAZ) were compared among HEU infants with and without TDF exposure usingt-tests and multivariate linear regression models.Results.Among 277 mothers who received ART during pregnancy, 63% initiated ART before pregnancy, of which 89 (32%) used TDF. No differences in birth weight (3.0 kg versus 3.1 kg,p=0.21) or gestational age (38 weeks versus 38 weeks,p=0.16) were detected between TDF-exposed and TDF-unexposed infants. At 6 weeks, unadjusted mean WAZ was lower among TDF-exposed infants (−0.8 versus −0.4,p=0.03), with a trend towards association in adjusted analyses (p=0.06). There were no associations between prenatal TDF use and WLZ, LAZ, and HCAZ in 6-week or 9-month infant cohorts.Conclusion.Maternal TDF use did not adversely affect infant growth compared to other regimens.