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During the COVID-19 pandemic, the need for making testing readily available was recognized as an important factor for individuals to help make informed decisions, including to isolate or seek care, and for policymakers to control transmission. Toward this end, FIND and the Access to COVID-19 Tools Accelerator funded 16 rapid operational research studies and one implementation project in Africa, the Caribbean, and Asia evaluating the utility, acceptability, and feasibility of different community-based SARS-CoV-2 testing approaches. Here, we discuss common factors and challenges encountered during study implementation. We note six key factors essential for success: 1) collaboration and partnerships; 2) buy-in of local stakeholders, including communities; 3) access to affordable supplies; 4) flexible financing; 5) effective approval systems; and 6) a skilled and motivated workforce. We also note various challenges that must be addressed to fully capitalize on these success factors. In particular, ethics committees are often not well equipped to assess operational research during outbreaks. Outbreaks, especially of novel pathogens, are unpredictable, and transmission dynamics are even more likely to change if the pathogen is prone to frequent mutations, such as SARS-CoV-2. Research that aims to evaluate strategies for curbing transmission must hence be easily and swiftly adaptable. This requires flexibility from researchers, funders, staff conducting the studies, and ethics and other approval committees. International guidelines for evaluating operational research protocols in outbreaks are needed to provide timely evidence to enable informed decisions by individuals, communities, and policymakers, thereby reducing both the human and the economic impact of outbreaks.

Background: The outbreak of COVID-19 has caused a setback to the gains achieved in tuberculosis (TB) control by impairing TB diagnosis, delaying treatment initiation and aggravating TB deaths. This study explored the effect of COVID-19 on paediatric TB services provided through the Catalysing Paediatric TB Innovations (CaP-TB) project among caregivers of children receiving TB services and healthcare workers (HCWs) providing TB services in Cameroon and Kenya., Methods: From March to September 2021, in-depth interviews (44) were conducted with caregivers whose children under 5 years had gone through TB services and programme managers (10) overseeing the CaP-TB project. Focus group discussions were conducted with HCWs (07) and community health workers (04) supporting TB care services. Transcripts were coded and analysed by using MAXQDA V.12., Results: The COVID-19 pandemic has caused fear and anxiety among HCWs and caregivers. This fear was motivated by stigma related to COVID-19 and affected the ability to screen patients for TB due to the similarity of symptoms with COVID-19. The health-seeking behaviour of patients was affected, as many caregivers avoided hospitals and those accessing the facilities concealed their sickness due to fear of testing positive or being vaccinated. In addition, COVID-19 mitigation strategies implemented by both government and health facilities to curb the spread of the virus limited patient access to paediatric healthcare services. These included temporary closure of health facilities due to COVID-19 infections among staff, transfer of services to other spaces, spacing out patient appointments and reduced time spent with patients., Conclusions: The outbreak of COVID-19 has induced fear and stigma that affected patients' health-seeking behaviour and provider attitudes towards paediatric TB service delivery. In addition, facility and governmental measures put in place to mitigate COVID-19 impact negatively affected paediatric service delivery. Training for health personnel, timely provision of personal protective equipments and appropriate communication strategies could help mitigate COVID-19 impact on paediatric TB service delivery., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Adolescents and youth living with HIV (AYLHIV) experience worse health outcomes compared to adults. We aimed to understand the experiences of AYLHIV in care in the youth-focused Red-Carpet program in Kenya to assess the quality of service provision and identify programmatic areas for optimization. We conducted focus group discussions among 39 AYLHIV (15-24 years) and structured analysis into four thematic areas. Within the HIV testing theme, participants cited fear of positive results, confidentiality and stigma concerns, and suggested engaging the community and youth in HIV testing opportunities. Within the HIV treatment adherence theme, participants cited forgetfulness, stigma, adverse side effects, lack of family support, and treatment illiteracy as barriers to adherence. Most participants reported positive experiences with healthcare providers and peer support. In terms of the HIV status disclosure theme, AYLHIV cited concerns about their future capacity to conceive children and start families and discussed challenges with understanding HIV health implications and sharing their status with friends and partners. Youth voices informing service implementation are essential in strengthening our capacity to optimize the support for AYLHIV within the community, at schools and healthcare facilities., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Kose et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Despite large numbers of patients accessing antiretroviral treatment (ART) in Kenya, few studies have explored factors associated with virologic failure in Western Kenya, specifically. We undertook a study in Homa Bay County, Kenya to assess the extent of virologic treatment failure and factors associated with it. This was an observational retrospective study conducted from September 2020 to January 2021. Data were abstracted from the records of patients who had been on ART for at least six months at the time of data collection after systematic sampling stratified by age group at ART initiation (0-14 and 15+ years), using probability proportion to the numbers of patients attending the facility. Confirmed viral treatment failure was defined as viral load ≥1000 copies/ml based on two consecutive viral load measurements after at least three months of enhanced adherence counseling. Data were analyzed using descriptive statistics and Cox regression modeling. Of the 2,007 patients sampled, 160 (8.0%) had confirmed virologic treatment failure. Significantly higher virologic treatment failure rates were identified among male patients 78/830 (9.4%) and children 115/782 (14.7%). Factors associated with virologic treatment failure (VTF), were age 0-14 years, adjusted hazard ratio (AHR) 4.42, (95% Confidence Interval [CI], 3.12, 6.32), experience of treatment side effects AHD: 2.43, (95% CI, 1.76, 3.37), attending level 2/3 health facility, AHR: 1.87, (95% CI: 1.29, 2,72), and history of opportunistic infections (OIs), AHR: 1.81, (95% CI, 1.76, 3.37). Children, attendees of level 2/3 health facilities, patients with a history of OIs, and those experiencing treatment side-effects are at risk of VTF. Increased focus on children and adolescents on screening for drug resistance, administration of and adherence to medication, and on effective information and education on side-effects is critical. Additionally, there is need for increased training and support for health care workers at primary level care facilities., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Background: Adolescents living with HIV (ALHIV) experience higher mortality and are more likely to have poor antiretroviral therapy (ART) adherence and unsuppressed viral load (VL) compared to adults. Enhanced adherence counseling (EAC) is a client-centered counseling strategy that aims to identify and address barriers to optimal ART use and can be tailored to the unique needs of adolescents. This study aimed to better understand adherence barriers among ALHIV with suspected treatment failure and their experience with EAC to inform future programming., Methods: A qualitative study was conducted in Homa Bay and Turkana counties, Kenya in 2019 with adolescents and caregivers of children and adolescents living with HIV with suspected treatment failure after ≥6 months on ART and who had received ≥1 EAC sessions. Sixteen focus group discussions (FGDs) were conducted; five FGDs each were held with adolescents 12-14 years (n = 48) and 15-19 years (n = 36). Caregivers (n = 52) participated in six FGDs. Additionally, 17 healthcare workers providing pediatric/adolescent HIV services participated in in-depth interviews. Audio recordings were transcribed and translated from Kiswahili or Dholuo into English and coded using MAXQDA software. Data were thematically analyzed by participant group., Results: Participants identified adolescents' fear of being stigmatized due to their HIV status and their relationship with and level of support provided by caregivers. This underpinned and often undermined adolescents' ART-taking behavior and progress towards more independent medication management. Adolescents were generally satisfied with EAC and perceived it to be important in improving adherence and reducing VL. However, problems were noted with facility-based, individual EAC counseling, including judgmental attitudes of providers and difficulties traveling to and keeping EAC clinic appointments. Participant-suggested improvements to EAC included peer support groups in addition to individual counseling, allowing for greater flexibility in the timing and location of sessions and greater caregiver involvement., Conclusions: The findings provide opportunities to better tailor EAC interventions to promote improved ALHIV adherence and caregiver-supported disease management. Multi-prong EAC interventions that include peer-led and community approaches and target adolescent and caregiver treatment literacy may improve EAC delivery, address issues contributing to poor adherence, and position adolescents to achieve viral suppression., Trial Registration: ClinicalTrials.gov : NCT04915469., (© 2022. The Author(s).)

Adolescents and youth living with HIV (AYLHIV) are a uniquely vulnerable population facing challenges around adherence, disclosure of HIV status and stigma. Providing school-based support for AYLHIV offers an opportunity to optimize their health and wellbeing. The purpose of this study was to evaluate the feasibility of school-based supportive interventions for AYLHIV in Kenya. From 2016-2019, with funding from ViiV Healthcare, the Elizabeth Glaser Pediatric AIDS Foundation implemented the innovative Red Carpet Program (RCP) for AYLHIV in participating public healthcare facilities and boarding schools in Homa Bay and Turkana Counties in Kenya. In this analysis, we report the implementation of the school-based interventions for AYLHIV in schools, which included: a) capacity building for overall in-school HIV, stigma and sexual and reproductive health education; b) HIV care and treatment support; c) bi-directional linkages with healthcare facilities; and d) psychosocial support (PSS). Overall, 561 school staff and 476 school adolescent health advocates received training to facilitate supportive environments for AYLHIV and school-wide education on HIV, stigma, and sexual and reproductive health. All 87 boarding schools inter-linked to 66 regional healthcare facilities to support care and treatment of AYLHIV. Across all RCP schools, 546 AYLHIV had their HIV status disclosed to school staff and received supportive care within schools, including treatment literacy and adherence counselling, confidential storage and access to HIV medications. School-based interventions to optimize care and treatment support for AYLHIV are feasible and contribute to advancing sexual and reproductive health within schools., Competing Interests: This work was supported with funding by a grant from the Positive Action for Adolescents Programme by ViiV Healthcare UK Ltd. There are no patents, products in development or marketed products to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The authors have declared that no competing interests exist.

Background: HIV testing among adolescents is significantly lower than among adults and many adolescents living with HIV do not know their status. Adolescent perceptions of HIV testing are poorly understood and may negatively affect testing uptake. Using a qualitative design, this study sought to explore perceptions about HIV testing and treatment among adolescents living with HIV and adolescents of unknown HIV status in Lusaka, Zambia and Kenya., Methods: Study participants were adolescents aged 15-19 years old. The adolescents living with HIV were recruited from HIV support groups at health facilities. Adolescents of unknown HIV status were recruited from existing adolescent groups within the community. In both Zambia and Kenya, four focus group discussions (FGDs) were conducted with adolescents living with HIV and four FGDs were conducted with adolescents whose HIV status was unknown, for a total of 16 FDGs. FGDs consisted of 6-12 participants, a moderator, and a note-taker. FGDs were audio-recorded, transcribed, and translated into transcripts. Transcripts were coded in the qualitative analysis software program MAXQDA v. 12. Data reduction and summary tables were generated to help identify themes across the two study population groups. Data were interpreted within the health belief model., Results: Adolescents discussed the challenges of facing a positive HIV test result, including fear of a positive result and need to change their lifestyle, fear of social isolation, and perception of the lost opportunity to achieve future dreams. Most adolescents of unknown status were not as aware of the benefits of learning their HIV status, nor were they aware of the ability to live a long and healthy life on ART. HIV-positive adolescents reported that the messages targeted towards adolescents focus on the need to remain HIV-negative, as opposed to the benefits of knowing one's status. Adolescents described age and requirements for parental permission as a significant limitation in their ability to access HIV testing., Conclusions: Adolescents require more information about the benefits of testing early and the ability to live a long and healthy life on ART. Educating adolescents that HIV testing is a normative behavior among their peers could strengthen HIV testing among adolescents.

Background: Although the World Health Organization recommends HIV-exposed infants receive a 6-week diagnostic test, few receive results by 12 weeks. Point-of-care (POC) early infant diagnosis (EID) may improve timely diagnosis and treatment. This study assesses the impact of routine POC versus laboratory-based EID on return of results by 12 weeks of age., Methods: This was a cluster-randomized stepped-wedge trial in Kenya and Zimbabwe. In each country, 18 health facilities were randomly selected for inclusion and randomized to timing of POC implementation., Findings: Nine thousand five hundred thirty-nine infants received tests: 5115 laboratory-based and 4424 POC. In Kenya and Zimbabwe, respectively, caregivers were 1.29 times [95% confidence interval (CI): 1.27 to 1.30, P < 0.001] and 4.56 times (95% CI: 4.50 to 4.60, P < 0.001) more likely to receive EID results by 12 weeks of age with POC versus laboratory-based EID. POC significantly reduced the time between sample collection and return of results to caregiver by an average of 23.03 days (95% CI: 4.85 to 21.21, P < 0.001) in Kenya and 62.37 days (95% CI: 58.94 to 65.80, P < 0.001) in Zimbabwe. For HIV-infected infants, POC significantly increased the percentage initiated on treatment, from 43.2% to 79.6% in Zimbabwe, and resulted in a nonsignificant increase in Kenya from 91.7% to 100%. The introduction of POC EID also significantly reduced the time to antiretroviral therapy initiation by an average of 17.01 days (95% CI: 9.38 to 24.64, P < 0.001) in Kenya and 56.00 days (95% CI: 25.13 to 153.76, P < 0.001) in Zimbabwe., Conclusions: POC confers significant advantage on the proportion of caregivers receiving timely EID results, and improves time to results receipt and treatment initiation for infected infants. Where laboratory-based EID systems are unable to deliver results to caregivers rapidly, POC should be implemented as part of an integrated testing system.

Background: Children living with HIV remain undiagnosed due to missed opportunities along the prevention of mother-to-child HIV transmission cascade. This study addresses programmatic gaps in the cascade by describing pregnancy and HIV-related services received by mothers of children newly identified as HIV-positive through active case finding., Methods: This was a prospective observational cohort (2017-2018) of HIV-positive children <15 years of age newly diagnosed at study facilities and/or surrounding communities in Kenya and Uganda. At enrollment, caregivers were interviewed about maternal and child health and HIV history. Child medical and laboratory information was abstracted at two months post-diagnosis. Descriptive summary statistics were calculated; associations between selected factors and child age at HIV diagnosis were evaluated using generalized estimating equations., Results: 174 HIV-positive children (median age 2.4 years) were enrolled. Among maternal caregivers, 110/132 (83.3%) attended antenatal care and 60 (45.5%) reported testing HIV-negative in antenatal care. Of 41 and 56 women known to be HIV-positive during pregnancy and breastfeeding respectively, 17 (41.5%) and 15 (26.8%) did not receive antiretroviral drugs. Despite known maternal HIV-positive status during pregnancy, 39% of these children were not diagnosed until after two years of age; children were diagnosed at younger ages in Uganda (p = 0.0074) and if mother was the caregiver (p<0.0001). The most common HIV testing points identifying children were outpatient (44.3%) and maternal/child health departments (29.9%). Nearly all children initiated antiretroviral therapy within two weeks of diagnosis., Conclusions: Multiple missed opportunities for HIV prevention and delays in HIV testing of HIV-exposed children were identified in newly diagnosed children. Findings support critical prevention messaging and retesting of HIV-negative women during pregnancy and breastfeeding, strengthening HIV treatment initiation and follow-up systems and interventions to ensure HIV-positive women receive lifelong antiretroviral therapy throughout the cascade, and broader implementation of community case finding so children not engaged in care receive testing services., Competing Interests: The authors have declared that no competing interests exist.

Background: Tuberculosis is among the top-10 causes of mortality in children with more than 1 million children suffering from TB disease annually worldwide. The main challenge in young children is the difficulty in establishing an accurate diagnosis of active TB. The INPUT study is a stepped-wedge cluster-randomized intervention study aiming to assess the effectiveness of integrating TB services into child healthcare services on TB diagnosis capacities in children under 5 years of age., Methods: Two strategies will be compared: i) The standard of care, offering pediatric TB services based on national standard of care; ii) The intervention, with pediatric TB services integrated into child healthcare services: it consists of a package of training, supportive supervision, job aids, and logistical support to the integration of TB screening and diagnosis activities into pediatric services. The design is a cluster-randomized stepped-wedge of 12 study clusters in Cameroon and Kenya. The sites start enrolling participants under standard-of-care and will transition to the intervention at randomly assigned time points. We enroll children aged less than 5 years with a presumptive diagnosis of TB after obtaining caregiver written informed consent. The participants are followed through TB diagnosis and treatment, with clinical information prospectively abstracted from their medical records. The primary outcome is the proportion of TB cases diagnosed among children < 5 years old attending the child healthcare services. Secondary outcomes include: number of children screened for presumptive active TB; diagnosed; initiated on TB treatment; and completing treatment. We will also assess the cost-effectiveness of the intervention, its acceptability among health care providers and users, and fidelity of implementation., Discussion: Study enrolments started in May 2019, enrolments will be completed in October 2020 and follow up will be completed by June 2021. The study findings will be disseminated to national, regional and international audiences and will inform innovative approaches to integration of TB screening, diagnosis, and treatment initiation into child health care services., Trial Resistration: NCT03862261, initial release 12 February 2019.

Introduction: We determine the level of adherence to the revised Kenya early infant diagnosis (EID) algorithm during implementation of a point-of-care (POC) EID project., Methods: Data before (August 2016 to July 2017) and after (August 2017 to July 2018) introduction of POC EID were collected retrospectively from the national EID database and registers for 33 health facilities. We assessed the number of HIV-infected infants who underwent confirmatory testing and received baseline viral load test and proportion of infants with an initial negative result who had a subsequent test., Results and Discussion: Significantly higher number of infants accessed confirmatory testing (94.2% versus 38.6%; P < .0001) with POC EID. Baseline viral load test and follow-up testing at 6 months, although higher with POC EID, were not significantly different from the pre-POC EID intervention period., Conclusion: The POC EID implementation has the potential to increase proportion of infants who receive confirmatory testing, thus reducing the risk of false-positive results.

Background: Admission to Intensive Care Units (ICU) exposures family members to a new environment, advanced monitoring systems and aggressive treatments. This is coupled with the critical condition of the patient being admitted in ICU. In such times of stress and crisis, families have varying experiences as they navigate the ICU journey. These happen more or less in chronological phases., Aim: This review sought to describe the experiences of family members of patients admitted in adult ICUs., Data Sources: Four electronic databases (PubMed, Embase, Scopus and Web of Science) were searched, using keywords and free-text words., Methods: Curation of the review question involved problem identification, a scoping search, developing a search strategy, evaluation, data analysis, and reporting. Freehand search in reference lists of eligible articles was also done to obtain potentially eligible articles published in English language between 2007 and 2018. Studies were included if they reported on family members' experiences in adult ICUs. This review conforms to the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA)., Results: Upon completion of the screening process, 28 studies were included. Most studies were conducted in the United States while no study was identified from Africa. We report on 717 family members. Family members' experience of the ICU journey falls into three main themes: (i) Floating, (ii) Probing and (iii) Continuity or Closure., Conclusion: As healthcare technology advances, the ICU environment consequently needs to evolve. As such, healthcare providers will need to adjust their practice, support and consider the patients' family as the other part of the patient and members of the care team in order to meet their expectations. Further research highlighting family members' experience of the ICU journey in Africa is needed., (© 2019 Nordic College of Caring Science.)

Background: Despite considerable efforts to prevent HIV and other sexually transmitted infections (STI) among female sex workers (FSW), other sexual and reproductive health (SRH) needs, such preventing unintended pregnancies, among FSW have received far less attention. Programs targeting FSW with comprehensive, accessible services are needed to address their broader SRH needs. This study tested the effectiveness of an intervention to increase dual contraceptive method use to prevent STIs, HIV and unintended pregnancy among FSW attending services in drop-in centers (DIC) in two cities in Kenya. The intervention included enhanced peer education, and routine screening for family planning (FP) needs plus expanded non-condom FP method availability in the DIC., Methods: We conducted a two-group, pre-/posttest, quasi-experimental study with 719 FSW (360 intervention group, 359 comparison group). Participants were interviewed at baseline and 6 months later to examine changes in condom and non-condom FP method use., Results: The intervention had a significant positive effect on non-condom, FP method use (OR = 1.38, 95%CI (1.04, 1.83)), but no effect on dual method use. Consistent condom use was reported to be high; however, many women also reported negotiating condom use with both paying and non-paying partners as difficult or very difficult. The strongest predictor of consistent condom use was partner type (paying versus non-paying/emotional); FSW reported both paying and non-paying partners also influence non-condom contraceptive use. Substantial numbers of FSW also reported experiencing sexual violence by both paying and non-paying partners., Conclusions: Self-reported difficulties with consistent condom use and the sometimes dangerous conditions under which they work leave FSW vulnerable to unintended pregnancy STIs/HIV. Adding non-barrier FP methods to condoms is crucial to curb unintended pregnancies and their potential adverse health, social and economic consequences. Findings also highlight the need for additional strategies beyond condoms to reduce HIV and STI risk among FSW., Trial Registration: Clinicaltrials.gov NCT01957813., Competing Interests: The authors have declared that no competing interests exist.

Background: People living with HIV (PLHIV) often face barriers in accessing quality and comprehensive HIV care, including stigma and discrimination, which results in poor retention and viral non-suppression. Peer-led interventions can help address these barriers. In Kenya, peer educators (PEs) are PLHIV who support other PLHIV to adhere to clinic schedules and antiretroviral medication uptake. In spite of their status as role models and their key role in supporting clients receiving HIV care and treatment, little is known about the characteristics and treatment outcomes of PEs themselves, specifically viral suppression., Methods: This is a retrospective descriptive analysis of program data on treatment outcomes of PEs engaged in active patient support activities between October 2010 and January 2017. All eligible PEs from 140 health facilities located in 23 counties of Kenya were included in the study. Data from 230 PEs were abstracted from the electronic medical records, patient files, and registers between June and August 2017. Study variables included key sociodemographic characteristics (sex, marital status, and age), duration on antiretroviral therapy (ART), WHO clinical staging, baseline CD4 count, current antiretroviral regimen and uptake of isoniazid preventive therapy (IPT). The outcome variable was viral suppression, defined as a viral load <1000 copies/ml., Results: Overall, 173/230 (75%) of the PEs were female, 144/230 (63%) were married, and median age (LQ, UQ) was 38.5 (33.0, 42.0) years. The PEs had been on ART for a median (LQ, UQ) duration of 76.0 (37.0, 105.0) months. Six months IPT completion was high at 97%. Of the 222 (97%) PEs with an up-to-date viral load taken within the last one year, 211 (95%) were virally suppressed., Conclusion: Our study showed that peer educators actively engaged in patient support activities have achieved high viral suppression rates., Competing Interests: The authors have declared that no competing interests exist.

Background: For HIV-infected pregnant and breastfeeding women, antiretroviral therapy (ART) is known to reduce the mother's risk of passing the infection to her child. However, concerns remain about possible associations between various components of different ART regimens and adverse fetal and infant outcomes. As part of a clinical trial in western Kenya for the prevention of mother-to-child transmission (PMTCT) of HIV, pregnant women received one of two different ART regimens., Methods: The original PMTCT study conducted in Kenya enrolled 522 HIV-infected, ART-naive pregnant women. These women were assigned to receive an ART regimen that included either nevirapine, a nonnucleoside reverse transcriptase inhibitor (NNRTI), or nelfinavir, a protease inhibitor. This substudy involves 384 women from the original study who had baseline CD4 cell counts at least 250 cells/μl, and compares the risks of adverse fetal and infant outcomes between the two ART regimens., Results: There were 386 live births (including multiples) and 7 (1.8%) stillbirths. Among live births, there were 67 preterm deliveries, 37 low-birth weight infants, and 14 infant deaths by 6 months. There were no statistically significant differences between the two ART regimens for any of the reported adverse outcomes., Conclusion: Although these data do not show significant differences between the NNRTI-based or protease inhibitor-based regimens in serious adverse fetal and infant outcomes, more studies need to be done and careful vigilance is needed to ensure infant safety.

Objective: Unsuccessful linkage to care and treatment increases adolescent HIV-related morbidity and mortality. This study evaluated the effect of a novel adolescent and youth Red Carpet Program (RCP) on the timing and outcomes of linkage to care., Design: A prepost implementation evaluation of the pilot RCP program., Settings: Healthcare facilities (HCFs) and schools in Homa Bay County, Kenya., Study Participants: HIV-infected adolescents (15-19 years) and youth (20-21 years)., Interventions: RCP provided fast-track peer-navigated services, peer counseling, and psychosocial support at HCFs and schools in six Homa Bay subcounties in 2016. RCP training and sensitization was implemented in 50 HCFs and 25 boarding schools., Main Outcome Measures: New adolescent and youth HIV diagnosis, linkage to and retention in care and treatment., Results: Within 6 months of program rollout, 559 adolescents and youths (481 women; 78 men) were newly diagnosed with HIV (15-19 years n = 277; 20-21 years, n = 282). The majority (n = 544; 97.3%) were linked to care, compared to 56.5% at preimplementation (P < 0.001). All (100.0%; n = 559) adolescents and youths received peer counseling and psychosocial support, and the majority (n = 430; 79.0%) were initiated on treatment. Compared to preimplementation, the proportion of adolescents and youths who were retained on treatment increased from 66.0 to 90.0% at 3 months (P < 0.001), and from 54.4 to 98.6% at 6 months (P < 0.001)., Conclusion: Implementation of RCP was associated with significant improvement in linkage to and early retention in care among adolescent and youth. The ongoing study will fully assess the efficacy of this linkage-to-care approach.

Objective: Female sex workers (FSWs) need access to contraceptive services, yet programs often focus on HIV prevention and less on the broader sexual and reproductive health needs of FSWs. We aimed to identify barriers to accessing contraceptive services among FSWs and preferences for contraceptive service delivery options among FSWs and health care providers (HCPs) in order to inform a service delivery intervention to enhance access to and use of contraceptives for FSWs in Kenya., Study Design: Twenty focus group discussions were conducted with FSWs and HCPs in central Kenya., Results: Three barriers were identified that limited the ability of FSWs to access contraceptive services: (1) an unsupportive clinic infrastructure, which consisted of obstructive factors such as long wait times, fees, inconvenient operating hours and perceived compulsory HIV testing; (2) discriminatory provider-client interactions, where participants believed negative and differential treatment from female and male staff members impacted FSWs' willingness to seek medical services; and (3) negative partner influences, including both nonpaying and paying partners. Drop-in centers followed by peer educators and health care facilities were identified as preferred service delivery options., Conclusions: FSWs may not be able to regularly access contraceptive services until interpersonal (male partners) and structural (facilities and providers) barriers are addressed. Alternative delivery options, such as drop-in centers coupled with peer educators, may be an approach worth evaluating., Implications Statement: An unsupportive clinic infrastructure, discriminatory provider-client interactions and negative partner influences are barriers to FSWs accessing the contraception services they need. Alternative service delivery options, such integrating contraceptive service delivery at drop-in centers designed for FSWs and information delivery through peer educators, might provide improved access and better service quality to FSWs seeking contraception., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: The prevalence of anaemia during pregnancy is estimated to be 35-75% in sub-Saharan Africa and is associated with an increased risk of maternal mortality. We evaluated the frequency and factors associated with anaemia in HIV-infected women undergoing antiretroviral (ARV) therapy for prevention of mother-to-child transmission (PMTCT) enrolled in The Kisumu Breastfeeding Study 2003-2009., Methods: Maternal haematological parameters were monitored from 32 to 34 weeks of gestation to 2 years post-delivery among 522 enrolled women. Clinical and laboratory assessments for causes of anaemia were performed, and appropriate management was initiated. Anaemia was graded using the National Institutes of Health Division of AIDS 1994 Adult Toxicity Tables. Data were analysed using SAS software, v 9.2. The Wilcoxon two-sample rank test was used to compare groups. A logistic regression model was fitted to describe the trend in anaemia over time., Results: At enrolment, the prevalence of any grade anaemia (Hb < 9.4 g/dl) was 61.8%, but fell during ARV therapy, reaching a nadir (7.4%) by 6 months post-partum. A total of 41 women (8%) developed severe anaemia (Hb < 7 g/dl) during follow-up; 2 (4.9%) were hospitalised for blood transfusion, whereas 3 (7.3%) were transfused while hospitalised (for delivery). The greatest proportion of severe anaemia events occurred around delivery (48.8%; n = 20). Anaemia (Hb ≥ 7 and < 9.4 g/dl) at enrolment was associated with severe anaemia at delivery (OR 5.87; 95% CI: 4.48, 7.68, P < 0.01). Few cases of severe anaemia coincided with clinical malaria (24.4%; n = 10) and helminth (7.3%; n = 3) infections., Conclusion: Resolution of anaemia among most participants during study follow-up was likely related to receipt of ARV therapy. Efforts should be geared towards addressing common causes of anaemia in HIV-infected pregnant women, prioritising initiation of ARV therapy and management of peripartum blood loss., (© 2016 John Wiley & Sons Ltd.)

Background: Anemia results in increased morbidity and mortality, underscoring the need to better understand its pathophysiology amongst HIV-exposed and infected children in sub-Saharan Africa, the region where most infant HIV exposure and infections occur., Methods: This analysis used samples obtained from children in the Kisumu Breastfeeding Study (KiBS). KiBS was a longitudinal phase IIB, open-label, one-arm clinical trial, designed to investigate the safety, tolerability and effectiveness of a maternal triple-antiretroviral (ARV) regimen for prevention of mother-to-child transmission (PMTCT) of HIV, during late pregnancy and early infancy while breastfeeding. Blood samples from 482 children were obtained at birth, 2, 6, 10 and 14 weeks and 6, 9, 12, 18 and 24 months. Severity of anemia was graded using the NIH Division of AIDS (DAIDS) toxicity tables. We describe the proportion of children with anemia and anomalies in red blood cell parameters at various time points over 24 months and compare rates of anemia between HIV-infected and HIV-uninfected children and by mothers' ARV regimen and infant malaria infection., Results: The proportion of children with anemia significantly increased after the breastfeeding period in both HIV-infected and HIV-uninfected children with higher proportion among HIV-infected children compared to HIV-uninfected children (RR: 1.72; CI: 1.22-2.44, p = 0.002). Maternal triple-antiretroviral regimen was not associated with infant anemia (p = 0.11). There was no significant difference in mean hemoglobin between HIV-uninfected children with and without malaria at each time point except at 24 months., Conclusion: A relatively lower proportion of children with severe anemia during the breastfeeding period suggest that exposure to mother's triple antiretroviral combinations through breast milk, posed minimal risk of hematologic toxicity.

Background: Absolute neutrophil counts (ANCs) are lower in East African adults. To assess the impact of lower ANCs, we reviewed data from HIV-infected Kenyan women receiving antiretroviral therapy antepartum and postpartum., Methods: The Kisumu Breastfeeding Study (KiBS) participants received an antiretroviral regimen from 34 weeks' gestation through 6 months postpartum. Measured ANCs and subsequent illnesses were reviewed. Adverse events (AEs) potentially attributable to neutropenia were identified, and ANCs were graded using the 2004 Division of AIDS table for Grading the Severity of AEs., Results: Among 478 women with ≥1 postpartum ANC measured, 298 (62.1%) women met criteria for an AE (<1.3 × 10(9) cells/L). Of those, 38 (12.5%) women experienced a nonlife-threatening illness potentially attributable to neutropenia., Conclusion: More than half of KiBS women met criteria for neutropenia. The mild clinical experience of most participants with low ANCs supports that these values might be typical for this population and may not result in adverse clinical sequelae., (© The Author(s) 2013.)

Background: The levonorgestrel intrauterine system (LNG IUS) may become the next long-acting contraceptive to be introduced in public sector programs of resource-poor countries. Whereas service provision for subdermal implants and intrauterine devices is growing, little is known about how the LNG IUS might fit in., Study Design: We conducted a cohort study of 313 women in Kenya who were 6-12 weeks postpartum when they started using these methods: subdermal implant (205), LNG IUS (93), and copper intrauterine device (15). Participants returned for visits at 6 and 12 months to share information on bleeding patterns, side effects, satisfaction, and continued use of the products. We used Kaplan-Meier techniques to estimate method continuation rates and chi-square tests of association to identify differences in experiences with the methods., Results: The 12-month continuation rate for the LNG IUS was 89.1 (95% confidence interval [CI] = 86.9-94.9) and statistically equivalent to that of the subdermal implant (91.8: 95% CI = 80.6-94.0). Nearly 87% of LNG IUS users were very satisfied with the method at 6 months compared to 75% of implant users; this gap closed somewhat at 12 months as satisfaction levels of implant users rose. At 12 months 78% of LNG IUS users felt that their bleeding pattern was highly acceptable compared with about 66% of implant users., Conclusions: This study found that the LNG IUS compared favorably to the subdermal implant in terms of satisfaction levels and continued use. The LNG IUS will provide another long-acting option for postpartum women., Implications: The LNG IUS may soon be purchased by international donor agencies for use in public sector programs in sub-Saharan Africa and other resource-poor countries. The results of this study suggest that the product will be successful in future introduction activities., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: In 2012, the World Health Organization (WHO) amended their 2010 guidelines for women receiving limited duration, triple-antiretroviral drug regimens during pregnancy and breastfeeding for prevention of mother-to-child transmission of HIV (tARV-PMTCT) (Option B) to include the option to continue lifelong combination antiretroviral therapy (cART) (Option B+). We evaluated clinical and CD4 outcomes in women who had received antiretrovirals for prevention of mother-to-child transmission and then discontinued antiretrovirals 6-months postpartum., Methods and Findings: The Kisumu Breastfeeding Study, 2003-2009, was a prospective, non-randomized, open-label clinical trial of tARV-PMTCT in ARV-naïve, Kenyan women. Women received tARV-PMTCT from 34 weeks' gestation until 6-months postpartum when women were instructed to discontinue breastfeeding. Women with CD4 count (CD4) <250cells/mm3 or WHO stage III/IV prior to 6-months postpartum continued cART indefinitely. We estimated the change in CD4 after discontinuing tARV-PMTCT and the adjusted relative risk [aRR] for factors associated with declines in maternal CD4. We compared maternal and infant outcomes following weaning-when tARV-PMTCT discontinued-by maternal ARV status through 24-months postpartum. Compared with women who continued cART, discontinuing antiretrovirals was associated with infant HIV transmission and death (10.1% vs. 2.4%; P = 0.03). Among women who discontinued antiretrovirals, CD4<500 cells/mm3 at either initiation (21.8% vs. 1.5%; P = 0.002; aRR: 9.8; 95%-confidence interval [CI]: 2.4-40.6) or discontinuation (36.9% vs. 8.3%; P<0.0001; aRR: 4.4; 95%-CI: 1.9-5.0) were each associated with increased risk of women requiring cART for their own health within 6 months after discontinuing., Conclusions: Considering the serious health risks to the woman's infant and the brief reprieve from cART gained by stopping, every country should evaluate the need for and feasibility to implement WHO Option B+ for PMTCT. Evaluating CD4 at antiretroviral initiation or 6-months postpartum can identify pregnant women who would most benefit from continuing cART in settings unable to implement WHO Option B+.

Background: Sino-implant (II) is a two-rod subcutaneous contraceptive implant used up to 4 years, containing 150 mg of levonorgestrel. We conducted two observational studies of Sino-implant (II) to evaluate its performance in routine service delivery settings., Methods: We enrolled 1326 women age 18-44 who had Sino-implant (II) inserted at clinics in Pakistan and Kenya. Women were followed-up using either an active or passive follow-up scheme in each study. Study outcomes were: one-year cumulative pregnancy and discontinuation rates; rates of insertion and removal complications; adverse event and side effect rates; reasons for discontinuation; and implant acceptability and satisfaction with clinic services., Results: A total of 754 women returned for at least one follow-up visit. The overall Pearl pregnancy rate was 0.4 per 100 woman-years [95% confidence interval (CI) 0.1, 0.9] resulting from 1 confirmed post-insertion pregnancy in Kenya and 4 in Pakistan. Country-specific Pearl rates were 0.2 (95% CI 0.0, 0.9) in Kenya and 0.6 (95% CI 0.2, 1.6) in Pakistan. The total cumulative 12-month probability of removal was 7.6% (95% CI 6.1, 9.1), with country-specific removal probabilities of 3.7% in Kenya (95% CI 2.1, 5.3) and 10.8% in Pakistan (95% CI 8.5, 13.2). Four serious adverse events occurred in Kenya and none occurred in Pakistan; one SAE (an ectopic pregnancy) was possibly related to Sino-implant (II). Most women in both countries said they would recommend the implant to others., Conclusion: The results from these studies reveal high effectiveness and favorable safety and acceptability during the first year of use of Sino-implant., Implication: The favorable Sino-implant (II) findings from Kenya and Pakistan provide further evidence from disparate regions that Sino-implant (II) is safe, effective and acceptable during routine service delivery., (Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The levonorgestrel intrauterine system (LNG IUS) was developed over 30 years ago, but the product is currently too expensive for widespread use in many developing countries. In Kenya, one organization has received donated commodities for 5 years, providing an opportunity to assess impact and potential future role of the product., Methods: We reviewed service statistics on insertions of the LNG IUS, copper intrauterine device (IUD), and subdermal implant from 15 mobile outreach teams during the 2011 calendar year. To determine the impact of the LNG IUS introduction, we analyzed changes in uptake and distribution of the copper IUD and subdermal implant by comparing periods of time when the LNG IUS was available with periods when it was not available. In addition, we interviewed 27 clinicians to assess their views of the product and of its future role., Results: When the LNG IUS was not available, intrauterine contraception accounted for 39% of long-acting method provision. The addition of the LNG IUS created a slight rise in intrauterine contraception uptake (to 44%) at the expense of the subdermal implant, but the change was only marginally significant (P = .08) and was largely attributable to the copper IUD. All interviewed providers felt that the LNG IUS would increase uptake of long-acting methods, and 70% felt that the noncontraceptive benefits of the product are important to clients., Conclusions: The LNG IUS was well-received among providers and family planning clients in this population in Kenya. Although important changes in service statistics were not apparent from this analysis (perhaps due to the small quantity of LNG IUS that was available), provider enthusiasm for the product was high. This finding, above all, suggests that a larger-scale introduction effort would have strong support from providers and thus increase the chances of success. Adding another proven and highly acceptable long-acting contraceptive technology to the method mix could have important reproductive health impact.

Unsafe abortion accounts for 35% of maternal mortality in Kenya. Post-abortion care (PAC) reduces maternal death and provides an opportunity to prevent unwanted pregnancies. Few studies have documented how the receipt of PAC services varies by client age. In this study, descriptive data were collected from clients, providers and eight health facilities in Kenya's Central and Nairobi provinces to examine receipt of PAC services by client age, client satisfaction and provider attitudes. Delivery of PAC treatment, pain management, HIV and STI services and violence screening did not vary by age. However, fewer youth between the ages of 15 and 24 received a contraceptive method compared with adult clients (35% versus 48%; p=0.02). Forty-nine per cent of youth reported not using a family planning method due to fears of infertility, side-effects or lack of knowledge compared with 22% of adults. Additional efforts are needed in Kenya to bolster the family planning services that young PAC clients receive and increase the uptake of contraception.

Background: The levonorgestrel intrauterine system (LNG IUS) may become more available in the public sector of resource-poor countries, but it is unclear what product features might be attractive to users and what factors will influence uptake., Study Design: We recruited 671 women in Kenya who were seeking contraception at 6-12 weeks postpartum and gave them an opportunity to try the LNG IUS. We asked why they did or did not choose it, relative to the alternative options. χ² tests of association were done to examine participant characteristics and decision-making associated with choice., Results: Participants chose the following methods: LNG IUS (16%), injectable (36%), subdermal implant (30%), progestin-only pills (15%) and copper intrauterine device (IUD) (3%). Reasons for not choosing the LNG IUS included fear of pain/injury/discomfort (34%), modesty issues regarding insertion (33%) and fear of hormonal/health side effects (31%). Nearly a third of LNG IUS acceptors said they would have chosen a short-acting method if the LNG IUS were not available, and only 21% would have chosen the copper IUD., Conclusions: The LNG IUS could be an ideal method for increasing uptake of long-acting methods among recent postpartum women. Product attributes and comparisons to other contraceptive options are important factors in decision-making. Even among women comfortable with intrauterine contraception, great distinctions and preferences are apparent. Addressing specific misconceptions and fears with better information can help women make the best personal choices., (Copyright © 2013 Elsevier Inc. All rights reserved.)

We compared adverse events among breast-feeding neonates born to Kenyan mothers receiving triple-antiretroviral therapy, including either nevirapine or nelfinavir. Nevirapine-exposed infants had an absolute increase in the risk of rash but no significant risk differences for hepatotoxicity or high-risk hyperbilirubinemia compared with nelfinavir-exposed infants. From an infant-safety perspective, nevirapine-based regimens given during pregnancy and breast-feeding are viable options where alternatives to breast milk are not safe, affordable or feasible.

Background: Few studies have evaluated the risk of nevirapine (NVP)-associated hepatotoxicity among HIV-infected pregnant women with a CD4 count ≥250 cells/mm(3)., Methods: We enrolled HIV-infected pregnant Kenyan women who initiated triple antiretroviral therapy (ART) at 34 weeks gestation. We compared the rates of severe hepatotoxicity (grades 3-4 hepatotoxicity) and rash-associated hepatotoxicity (rash with ≥grade 2 hepatotoxicity) with NVP and nelfinavir (NFV), respectively., Results: We initiated triple ART in 522 pregnant women; severe hepatotoxicity and rash-associated hepatotoxicity occurred in 14 (3%) and 9 (2%) women, respectively. Women who initiated NVP had higher rates of severe hepatotoxicity (5% vs 1%; P = .03) and rash-associated hepatotoxicity (4% vs 0%; P = .003) when compared with NFV. Among women who initiated NVP (n = 254), a baseline CD4 count ≥250 cells/mm(3) was not associated with severe hepatotoxicity (5% vs 3%; P = .52) or rash-associated hepatotoxicity (4% vs 3%; P = .69)., Conclusion: Nevirapine use but not CD4 count ≥250 cells/mm(3) was associated with hepatotoxicity.

Youth attending voluntary counseling and HIV testing (VCT) services often have unmet need for contraception. Integrated family planning (FP) and HIV services can address dual HIV and unintended pregnancy prevention needs. However, little is known about which VCT service characteristics, such as quality of care, strength of FP-HIV service integration, and youth-friendliness, affect contraceptive behavior. This study explores the facility- and provider-level characteristics that may be associated with same day uptake or intention to use contraception after a VCT visit, and contraceptive use three months later among youth clients, controlling for client characteristics. This was a descriptive study conducted in 20 integrated VCT clinics across Kenya. Data collection included 20 structured clinic observations, 349 baseline interviews with male and female clients aged 15-24 after their VCT visit plus 277 follow-up interviews with clients three months later, and interviews with 46 providers who served the clients at the study clinics. Client, provider, and structured observation data were linked and multi-level logistic path models were used for analyses. Results revealed little evidence of specific service characteristics being associated with contraceptive behavior. However, VCT providers were not routinely screening for risk of unintended pregnancy or counseling on contraception. Results are likely a reflection of suboptimal integrated services. The clinics were serving youth with unmet contraceptive need and therefore integrated services should be strengthened overall to ensure no missed opportunities.

Background: Effective strategies are needed for the prevention of mother-to-child HIV transmission (PMTCT) in resource-limited settings. The Kisumu Breastfeeding Study was a single-arm open label trial conducted between July 2003 and February 2009. The overall aim was to investigate whether a maternal triple-antiretroviral regimen that was designed to maximally suppress viral load in late pregnancy and the first 6 mo of lactation was a safe, well-tolerated, and effective PMTCT intervention., Methods and Findings: HIV-infected pregnant women took zidovudine, lamivudine, and either nevirapine or nelfinavir from 34-36 weeks' gestation to 6 mo post partum. Infants received single-dose nevirapine at birth. Women were advised to breastfeed exclusively and wean rapidly just before 6 mo. Using Kaplan-Meier methods we estimated HIV-transmission and death rates from delivery to 24 mo. We compared HIV-transmission rates among subgroups defined by maternal risk factors, including baseline CD4 cell count and viral load. Among 487 live-born, singleton, or first-born infants, cumulative HIV-transmission rates at birth, 6 weeks, and 6, 12, and 24 mo were 2.5%, 4.2%, 5.0%, 5.7%, and 7.0%, respectively. The 24-mo HIV-transmission rates stratified by baseline maternal CD4 cell count <500 and ≥500 cells/mm(3) were 8.4% (95% confidence interval [CI] 5.8%-12.0%) and 4.1% (1.8%-8.8%), respectively (p = 0.06); the corresponding rates stratified by baseline maternal viral load <10,000 and ≥10,000 copies/ml were 3.0% (1.1%-7.8%) and 8.7% (6.1%-12.3%), respectively (p = 0.01). None of the 12 maternal and 51 infant deaths (including two second-born infants) were attributed to antiretrovirals. The cumulative HIV-transmission or death rate at 24 mo was 15.7% (95% CI 12.7%-19.4%)., Conclusions: This trial shows that a maternal triple-antiretroviral regimen from late pregnancy through 6 months of breastfeeding for PMTCT is safe and feasible in a resource-limited setting. These findings are consistent with those from other trials using maternal triple-antiretroviral regimens during breastfeeding in comparable settings.

Background: Nevirapine and lamivudine given to mothers are transmitted to infants via breastfeeding in quantities sufficient to have biologic effects on the virus; this may lead to an increased risk of a breastfed infant's development of resistance to maternal antiretrovirals. The Kisumu Breastfeeding Study (KiBS), a single-arm open-label prevention of mother-to-child HIV transmission (PMTCT) trial, assessed the safety and efficacy of zidovudine, lamivudine, and either nevirapine or nelfinavir given to HIV-infected women from 34 wk gestation through 6 mo of breastfeeding. Here, we present findings from a KiBS trial secondary analysis that evaluated the emergence of maternal ARV-associated resistance among 32 HIV-infected breastfed infants., Methods and Findings: All infants in the cohort were tested for HIV infection using DNA PCR at multiple study visits during the 24 mo of the study, and plasma RNA viral load for all HIV-PCR-positive infants was evaluated retrospectively. Specimens from mothers and infants with viral load >1,000 copies/ml were tested for HIV drug resistance mutations. Overall, 32 infants were HIV infected by 24 mo of age, and of this group, 24 (75%) infants were HIV infected by 6 mo of age. Of the 24 infants infected by 6 mo, nine were born to mothers on a nelfinavir-based regimen, whereas the remaining 15 were born to mothers on a nevirapine-based regimen. All infants were also given single-dose nevirapine within 48 hours of birth. We detected genotypic resistance mutations in none of eight infants who were HIV-PCR positive by 2 wk of age (specimens from six infants were not amplifiable), for 30% (6/20) at 6 wk, 63% (14/22) positive at 14 wk, and 67% (16/24) at 6 mo post partum. Among the 16 infants with resistance mutations by 6 mo post partum, the common mutations were M184V and K103N, conferring resistance to lamivudine and nevirapine, respectively. Genotypic resistance was detected among 9/9 (100%) and 7/15 (47%) infected infants whose mothers were on nelfinavir and nevirapine, respectively. No mutations were detected among the eight infants infected after the breastfeeding period (age 6 mo)., Conclusions: Emergence of HIV drug resistance mutations in HIV-infected infants occurred between 2 wk and 6 mo post partum, most likely because of exposure to maternal ARV drugs through breast milk. Our findings may impact the choice of regimen for ARV treatment of HIV-infected breastfeeding mothers and their infected infants.

To reduce mother-to-child transmission of human immunodeficiency virus (HIV) in resource-poor settings, the World Health Organization recommends exclusive breast-feeding for 6 months, followed by rapid weaning if replacement feeding is affordable, feasible, available, safe, and sustainable. In the Kisumu Breastfeeding Study (trial registration: Clinicaltrials.gov identifier NCT00146380), infants of HIV-infected mothers who received antiretroviral therapy experienced high rates of diarrhea at weaning. To address this problem, mothers in the Kisumu Breastfeeding Study were given safe water storage vessels, hygiene education, and bleach for household water treatment. We compared the incidence of diarrhea in infants enrolled before (cohort A) and after (cohort B) implementation of the intervention. Cohort B infants experienced less diarrhea than cohort A infants, before and after weaning (P < .001 and P = .047, respectively); however, during the weaning period, there were no differences in the frequency of diarrhea between cohorts (P = 0.89). Testing of stored water in cohort B homes indicated high adherence (monthly range, 80%-95%) to recommended chlorination practices. Among infants who were weaned early, provision of safe water may be insufficient to prevent weaning-associated diarrhea.

There are limited data describing the concentrations of zidovudine, lamivudine, and nevirapine in nursing infants as a result of transfer via breast milk. The Kisumu Breastfeeding Study is a phase IIb open-label trial of prenatal, intrapartum, and postpartum maternal treatment with zidovudine, lamivudine, and nevirapine from 34 weeks of gestation to 6 months postpartum. In a pharmacokinetic substudy, maternal plasma, breast milk, and infant dried blood spots were collected for drug assay on the day of delivery and at 2, 6, 14, and 24 weeks after delivery. Sixty-seven mother-infant pairs were enrolled. The median concentrations in breast milk of zidovudine, lamivudine, and nevirapine during the study period were 14 ng/ml, 1,214 ng/ml, and 4,546 ng/ml, respectively. Zidovudine was not detectable in any infant plasma samples obtained after the day of delivery, while the median concentrations in infant plasma samples from postpartum weeks 2, 6, and 14 were 67 ng/ml, 32 ng/ml, and 24 ng/ml for lamivudine and 987 ng/ml, 1,032 ng/ml, and 734 ng/ml for nevirapine, respectively. Therefore, lamivudine and nevirapine, but not zidovudine, are transferred to infants via breast milk in biologically significant concentrations. The extent and effect of infant drug exposure via breast milk must be well understood in order to evaluate the benefits and risks of maternal antiretroviral use during lactation.