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PLOS Medicine editors Beryne Odeny and Callam Davidson report from the Consortium of Universities for Global Health conference., Competing Interests: The authors’ individual competing interests are at http://journals.plos.org/plosmedicine/s/staff-editors. PLOS is funded partly through manuscript publication charges, but the PLOS Medicine Editors are paid a fixed salary (their salaries are not linked to the number of papers published in the journal).

Beryne Odeny discusses PLOS Medicine's Special Issue on early cancer detection and minimal residual disease., Competing Interests: The author’s individual competing interests are at http://journals.plos.org/plosmedicine/s/staff-editors. PLOS is funded partly through manuscript publication charges, but the PLOS Medicine Editors are paid a fixed salary (their salaries are not linked to the number of papers published in the journal).

Beryne Odeny discusses strategies to improve equity in health care and health research., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: The author’s individual competing interests are at http://journals.plos.org/plosmedicine/s/staff-editors. PLOS is funded partly through manuscript publication charges, but the PLOS Medicine Editors are paid a fixed salary (their salaries are not linked to the number of papers published in the journal).

Beryne Odeny reports from the CUGH 2021 virtual conference., Competing Interests: The author’s individual competing interests are at http://journals.plos.org/plosmedicine/s/staff-editors. PLOS is funded partly through manuscript publication charges, but the PLOS Medicine Editors are paid a fixed salary (their salaries are not linked to the number of papers published in the journal).

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 < 1000 copies/mL) 12 months after enrollment by study arm. Secondary outcomes include time to VS and the impact of targeted DRM testing on VS. In addition, key informant interviews with patients and providers will generate an understanding of how the POC VL intervention functions. Finally, we will model the cost-effectiveness of POC VL combined with targeted DRM testing., Discussion: This study will provide critical information on the impact of POC VL and DRM testing on VS among CLHIV on ART in a resource-limited setting and directly address the need to find approaches that maximize VS among children on ART., Trials Registration: NCT03820323., (© 2020 The Authors. Published by Elsevier Inc.)

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., (Copyright © 2020. Published by Elsevier Ltd.)

Background: At-birth and point-of-care (POC) HIV testing are emerging strategies to streamline infant HIV diagnosis and expedite ART initiation for HIV-positive infants. The purpose of this qualitative study was to evaluate factors influencing the provision and acceptance of at-birth POC testing among both HIV care providers and parents of HIV-exposed infants in Kenya., Methods: We conducted semi-structured interviews with 26 HIV care providers and 35 parents of HIV-exposed infants (including 23 mothers, 6 fathers, and 3 mother-father pairs) at four study hospitals prior to POC implementation. An overview of best available evidence related to POC was presented to participants prior to each interview. Interviews probed about standard EID services, perceived benefits and risk of at-birth and POC testing, and suggested logistics of providing at-birth and POC. Interviews were audio recorded, translated (if necessary), and transcribed verbatim. Using the Transdisciplinary Model of Evidence Based Practice to guide analysis, transcripts were coded based on a priori themes related to environmental context, patient characteristics, and resources., Results: Most providers (24/26) and parents (30/35) held favorable attitudes towards at-birth POC testing. The potential for earlier results to improve infant care and reduce parental anxiety drove preferences for at-birth POC testing. Parents with unfavorable views towards at-birth POC testing preferred standard testing at 6 weeks so that mothers could heal after birth and have time to bond with their newborn before-possibly-learning that their child was HIV-positive. Providers identified lack of resources (shortage of staff, expertise, and space) as a barrier., Discussion: While overall acceptability of at-birth POC testing among HIV care providers and parents of HIV-exposed infants may facilitate uptake, barriers remain. Applying a task-shifting approach to implementation and ensuring providers receive training on at-birth POC testing may mitigate provider-related challenges. Comprehensive counseling throughout the antenatal and postpartum periods may mitigate patient-related challenges., Competing Interests: The authors have declared that no competing interests exist.

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: Male partner antenatal clinic (ANC) attendance may improve maternal uptake of maternal child health (MCH) services., Methods: We conducted a cross-sectional survey of mother-infant pairs attending week-6 or month-9 infant immunizations at 120 high-volume MCH clinics throughout Kenya. Clinics were selected using probability proportionate to size sampling. Women were interviewed using structured questionnaires and clinical data was verified using MCH booklets. Among married women, survey-weighted logistic regression models accounting for clinic-level clustering were used to compare outcomes by male ANC attendance and to identify its correlates., Results: Among 2521 women attending MCH clinics and had information on male partner ANC attendance, 2141 (90%) were married of whom 806 (35%) had male partners that attended ANC. Among married women, male partner ANC attendance was more frequent among women with higher education, women who requested their partners to attend ANC, had male partners with higher education, did not report partner violence, and had disclosed their HIV status (p < 0·001 for each). Additionally, male ANC attendance was associated with higher uptake of ANC visits [adjusted Odds Ratio (AOR) = 1·67, 95% confidence interval (CI) 1·36-2·05,], skilled delivery (AOR = 2·00, 95% CI 1·51-2·64), exclusive breastfeeding (AOR = 1·70, 95% CI 1·00-2·91), infant Bacille Calmette Guerin (BCG) immunization (AOR = 3·59, 95% CI 1·00-12·88), and among HIV-infected women, antiretroviral drugs (aOR = 6·16, 95% CI 1·26-30·41)., Conclusion: Involving male partners in MCH activities amplifies benefits of MCH services by engaging partner support for maternal uptake of services.

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., (©Sarah Finocchario-Kessler, May Maloba, Melinda Brown, Brad Gautney, Kathy Goggin, Catherine Wexler, Natabhona Mabachi, Beryne Odeny, Silas Lagat, Sharon Koech, Jacinda K Dariotis, Thomas A Odeny. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.06.2019.)

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 < 0.001). HIV-uninfected mothers were more likely to not disclose their HIV status to male partners if they were unmarried (adjusted odds ratio [aOR] = 3.79, 95% CI: 1.56-9.19, p = 0.004), had low (≤KSH 5000) income (aOR = 1.85, 95% CI: 1.00-3.14, p = 0.050), experienced intimate partner violence (aOR = 3.65, 95% CI: 1.84-7.21, p < 0.001) and if their partner did not attend ANC (aOR = 4.12, 95% CI: 1.89-8.95, p < 0.001). Among HIV-infected women, non-disclosure to male partners was less likely if women had salaried employment (aOR = 0.42, 95%CI: 0.18-0.96, p = 0.039) and each increasing year of relationship length was associated with decreased likelihood of non-disclosure (aOR = 0.90, 95% CI: 0.82-0.98, p = 0.015 for each year increase). HIV-infected women who did not disclose their HIV status to partners were less likely to uptake CD4 testing (aOR = 0.32, 95% CI: 0.15-0.69, p = 0.004), to use antiretrovirals (ARVs) during labor (OR = 0.38, 95% CI 0.15-0.97, p = 0.042), or give their infants ARVs (OR = 0.08, 95% CI 0.02-0.31, p < 0.001)., Conclusion: HIV-infected women were less likely to disclose their status to partners than HIV-uninfected women. Non-disclosure was associated with lower use of PMTCT services. Facilitating maternal disclosure to male partners may enhance PMTCT uptake.

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-month z-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 using t-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.