OBJECTIVES: Previous surveys have demonstrated high rates of early childhood caries (ECC) in the Alaska Native (AN) population of western Alaska. There are many challenges to providing dental care in this road-less Yukon-Kuskokwim Delta region. The regional Tribal Health Organization implemented an electronic dental record (EDR) system in the late 1990s. We explored use of the EDR to establish an oral health surveillance system in children. METHODS: We contracted with EDR software developers to implement calculation of a summary count of decayed (d), missing (m) or filled (f) primary (dmft) score for each individual. We calculated the yearly average dmft scores for 2011-2019 for children aged 3 and 5 years with a comprehensive exam in a given year. We also assessed the number of children undergoing full mouth dental rehabilitation (FMDR). We used US census data population estimates for these age groups to calculate rates. RESULTS: Over the 9-year period, 2,427 3-year-old children (47 percent of all 3-year olds over this period), received a comprehensive exam; increasing from 24 percent in 2011 to 62 percent in 2019. Their average dmft score over the 9-years was 6.4 with a significant annual decline over this period. Seventy percent of AN children who turned 6 between 2015 and 2019 had received at least one FMDR. CONCLUSIONS: An oral health surveillance system has been established in western Alaska using the Electronic Dental Record. High rates of ECC and FMDR were observed. This surveillance system will allow assessments of ECC prevalence and impact of dental interventions.

Alaska Native (AN) people experience higher incidence of, and mortality from, gastric cancer compared to other U.S. populations(1, 2). Compared to the general U.S. population, gastric cancer in AN people occurs at a younger age, is diagnosed at later stages, is more evenly distributed between the sexes, and is more frequently signet-ring or diffuse histology(3). It is known that the prevalence of Helicobacter pylori (Hp) infection, a risk factor for gastric cancer, is high in AN people(4); however, high antimicrobial resistance combined with high reinfection rates in Alaska make treatment at the population level complex(5). In addition, health issues in AN people are uniquely challenging due to the extremely remote locations of many residents. A multiagency workgroup hosted a symposium in Anchorage that brought internationally-recognized experts and local leaders together to evaluate issues around gastric cancer in the AN population. The overall goal of this symposium was to identify the best strategies to combat gastric cancer in the AN population through prevention and early diagnosis.

OBJECTIVE: To assess whether a community water service is associated with the frequency of sugar-sweetened beverages (SSB) consumption, obesity, or perceived health status in rural Alaska. DESIGN: We examined the cross-sectional associations between community water access and frequency of SSB consumption, body mass index categories, and perceived health status using data from the 2013 and 2015 Alaska Behavioral Risk Factor Surveillance System (BRFSS). Participants were categorized by zip code to 'in-home piped water service' or 'no in-home piped water service' based on water utility data. We evaluated the univariable and multivariable (adjusting for age, household income and education) associations between water service and outcomes using log-linear survey-weighted generalized linear models. SETTING: Rural Alaska, USA. SUBJECTS: Eight hundred and eighty-seven adults, aged 25 years and older. RESULTS: In unadjusted models, participants without in-home water reported consuming SSB more often than participants with in-home water (1.46, 95 % CI: 1.06, 2.00). After adjustment for potential confounders, the effect decreased but remained borderline significant (1.29, 95 % CI: 1.00, 1.67). Obesity was not significantly associated with water service but self-reported poor health was higher in those communities without in-home water (1.63, 95 % CI: 1.05, 2.54). CONCLUSIONS: Not having access to in-home piped water could affect behaviours surrounding SSB consumption and general perception of health in rural Alaska.

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 counts at least 250 cells/mul, 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: We conducted a cost-effectiveness analysis of five specific dental interventions to help guide resource allocation. METHODS: We developed a spreadsheet-based tool, from the healthcare payer perspective, to evaluate the cost effectiveness of specific dental interventions that are currently used among Alaska Native children (6-60 months). Interventions included: water fluoridation, dental sealants, fluoride varnish, tooth brushing with fluoride toothpaste, and conducting initial dental exams on children <18 months of age. We calculated the cost-effectiveness ratio of implementing the proposed interventions to reduce the number of carious teeth and full mouth dental reconstructions (FMDRs) over 10 years. RESULTS: A total of 322 children received caries treatments completed by a dental provider in the dental chair, while 161 children received FMDRs completed by a dental surgeon in an operating room. The average cost of treating dental caries in the dental chair was $1,467 ( approximately 258,000 per year); while the cost of treating FMDRs was $9,349 ( approximately 1.5 million per year). All interventions were shown to prevent caries and FMDRs; however tooth brushing prevented the greatest number of caries at minimum and maximum effectiveness with 1,433 and 1,910, respectively. Tooth brushing also prevented the greatest number of FMDRs (159 and 211) at minimum and maximum effectiveness. CONCLUSIONS: All of the dental interventions evaluated were shown to produce cost savings. However, the level of that cost saving is dependent on the intervention chosen.

Approximately 20% of rural Alaskan homes lack in-home piped water; residents haul water to their homes. The limited quantity of water impacts the ability to meet basic hygiene needs. We assessed rates of infections impacted by water quality (waterborne, e.g. gastrointestinal infections) and quantity (water-washed, e.g. skin and respiratory infections) in communities transitioning to in-home piped water. Residents of four communities consented to a review of medical records 3 years before and after their community received piped water. We selected health encounters with ICD-9CM codes for respiratory, skin and gastrointestinal infections. We calculated annual illness episodes for each infection category after adjusting for age. We obtained 5,477 person-years of observation from 1032 individuals. There were 9,840 illness episodes with at least one ICD-9CM code of interest; 8,155 (83%) respiratory, 1,666 (17%) skin, 241 (2%) gastrointestinal. Water use increased from an average 1.5 gallons/capita/day (g/c/d) to 25.7 g/c/d. There were significant (P-value < 0.05) declines in respiratory (16, 95% confidence interval (CI): 11-21%), skin (20, 95%CI: 10-30%), and gastrointestinal infections (38, 95%CI: 13-55%). We demonstrated significant declines in respiratory, skin and gastrointestinal infections among individuals who received in-home piped water. This study reinforces the importance of adequate quantities of water for health.

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.

OBJECTIVE: To identify factors associated with repeat pregnancy subsequent to an index pregnancy among women living with HIV (WLWH) in western Kenya who were enrolled in a 24-month phase-II clinical trial of triple-ART prophylaxis for prevention of mother-to-child transmission, and to contextualize social and cultural influences on WLWH's reproductive decision making. METHODS: A mixed-methods approach was used to examine repeat pregnancy within a 24 month period after birth. Counselor-administered questionnaires were collected from 500 WLWH. Forty women (22 with a repeat pregnancy; 18 with no repeat pregnancy) were purposively selected for a qualitative interview (QI). Simple and multiple logistic regression analyses were performed for quantitative data. Thematic coding and saliency analysis were undertaken for qualitative data. RESULTS: Eighty-eight (17.6%) women had a repeat pregnancy. Median maternal age was 23 years (range 15-43 years) and median gestational age at enrollment was 34 weeks. In multiple logistic regression analyses, living in the same compound with a husband (adjusted odds ratio (AOR): 2.33; 95% confidence interval (CI): 1.14, 4.75) was associated with increased odds of repeat pregnancy (p ≤ 0.05). Being in the 30-43 age group (AOR: 0.25; 95% CI: 0.07, 0.87), having talked to a partner about family planning (FP) use (AOR: 0.53; 95% CI: 0.29, 0.98), and prior usage of FP (AOR: 0.45; 95% CI: 0.25, 0.82) were associated with a decrease in odds of repeat pregnancy. QI findings centered on concerns about modern contraception methods (side effects and views that they 'ruined the womb') and a desire to have the right number of children. Religious leaders, family, and the broader community were viewed as reinforcing cultural expectations for married women to have children. Repeat pregnancy was commonly attributed to contraception failure or to lack of knowledge about post-delivery fertility. CONCLUSIONS: In addition to cultural context, reproductive health programs for WLWH may need to address issues related to living circumstances and the possibility that reproductive-decision making may extend beyond the woman and her partner.

We estimated HIV prevalence and identified correlates of HIV infection among 1106 men and women aged 16-34 years residing in Kisumu, Kenya. Demographic, sexual, and other behavioural data were collected using audio computer-assisted self-interview in conjunction with a medical examination, real-time parallel rapid HIV testing, and laboratory testing for pregnancy, gonorrhoea, chlamydia, syphilis, and herpes simplex virus type 2. Multivariate logistic regression was used to identify variables associated with prevalent HIV infection by gender. Overall HIV prevalence was 12.1%. HIV prevalence among women (17.1%) was approximately two and one half times the prevalence among men (6.6%). Odds of HIV infection in men increased with age (aOR associated with one year increase in age = 1.21, CI = 1.07-1.35) and were greater among those who were uncircumcised (aOR = 4.42, CI = 1.41-13.89) and those who had an herpes simplex virus type 2 positive (aOR = 3.13, CI = 1.12-8.73) test result. Odds of prevalent HIV infection among women also increased with age (aOR associated with one year increase in age = 1.16, CI = 1.04-1.29). Women who tested herpes simplex virus type 2 positive had more than three times the odds (aOR = 3.85, CI = 1.38-10.46) of prevalent HIV infection compared with those who tested herpes simplex virus type 2 negative. Tailored sexual health interventions and programs may help mitigate HIV age and gender disparities.

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-naive, 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+.

In Kenya, HIV-1 viral load monitoring is commonly performed with the Cobas Amplicor using plasma specimens. Interest is growing in transitioning to real-time PCR (RT-PCR), such as the Cobas Ampliprep/Cobas TaqMan (CAP/CTM), using dried blood spots (DBS). Before implementation, direct evaluation of the two assays using DBS field specimens is required. This study compares the sensitivity, specificity, negative and positive predictive values (NPV and PPV, respectively), concordance, and agreement between HIV-1 viral load measurements using plasma and DBS specimens obtained from 512 HIV-1-infected pregnant females enrolled in the Kisumu Breastfeeding Study and tested with the Cobas Amplicor and CAP/CTM assays. The sensitivity and NPV of viral load detection in DBS specimens were higher with CAP/CTM (sensitivity, 100%; 95% confidence interval [CI], 99.1 to 100.0%; NPV, 100%; 95% CI, 59.0 to 100.0%) than the Cobas Amplicor (sensitivity, 96.6%; 95% CI, 94.3 to 98.1%; NPV, 58.8%; 95% CI, 40.7 to 75.4%). The PPVs were comparable between both assays when using DBS. The specificity of viral load detection in DBS specimens was lower with CAP/CTM (77.8%; 95% CI, 40.0 to 97.2%) than that of the Cobas Amplicor (95.2%; 95% CI, 76.2 to 99.9%). Good concordance and agreement were observed when paired plasma and DBS specimens were tested with both assays. Lower specificity with the CAP/CTM is likely due to proviral HIV-1 DNA amplification and lower detection limits with RT-PCR. However, the CAP/CTM has better sensitivity and higher throughput than the Cobas Amplicor. These findings suggest that DBS may be a suitable alternative to plasma when using RT-PCR, which could increase access to viral load monitoring in resource-limited settings.

We compared adverse events among breastfeeding neonates born to Kenyan mothers receiving triple-antiretroviral therapy including either nevirapine or nelfinavir. Nevirapine-exposed infants had an absolute increase in risk for 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 breastfeeding are viable options where alternatives to breast milk are not safe, affordable, or feasible.

BACKGROUND: Health benefits and survival of an exclusively breastfed infant is dependent on the mother's health; thus the need for antiretroviral (ARV) intervention for PMTCT. Achieving maternal health benefits from these regimens requires adherence to the treatments and close monitoring. We evaluated virologic, immunologic responses and adherence among women receiving maternal triple antiretroviral prophylaxis consisting of lamivudine/zidovudine and nevirapine or nelfinavir in the Kisumu Breastfeeding Study. METHODS: We analyzed baseline demographic data, trends in CD4+ count and viral load (VL) at enrollment (32-34 weeks gestation), delivery, 14 and 24 weeks postpartum among 434 women who remained in the study at 24 weeks postpartum. Adherence rates were determined using pill counts reinforced by self-report and drug calendar. We dichotomized adherence as ≥95% versus <95%. RESULTS: Among the 434 women, 84% (n=366) had adherence ≥95%. Women with undetectable VL (<400 copies/ml) increased from 6% at baseline to 79% and women with CD4+ count <250cells/mcL decreased from 23% (100) at baseline to 5% (22) at 24 weeks postpartum. In discrete-survival model, time to achieving VL suppression was associated with baseline VL <5.0 log copies/ml, parity ≥2, and use of nelfinavir versus nevirapine-based ARV. Association between undetectable VL with duration of therapy (p<0.0001); and adherence with suppression of VL (p=0.001) was observed. CONCLUSIONS: High baseline VL and short exposure to ARVs for PMTCT are risk factors for failing to achieve undetectable VL. These findings support the new WHO guidelines for early initiation of ARV prophylaxis for PMTCT for maximal reduction of maternal VL.

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.

Antiretroviral drugs cross from maternal plasma to breast milk and from breast milk to the infant in different concentrations. We measured concentrations of nelfinavir and its active metabolite (M8) in maternal plasma and breast milk from women and in dried blood spots collected from their infants at delivery and postnatal weeks 2, 6, 14, and 24 in the Kisumu Breastfeeding Study, Kisumu, Kenya. Nelfinavir-based antiretroviral regimens given to mothers as PMTCT do not expose the breastfeeding infant to biologically significant concentrations of nelfinavir or M8.

Performances of serological parallel and serial testing algorithms were analyzed using a combination of three ELISA and three rapid tests for the confirmation of HIV infection. Each was assessed individually for their sensitivity and specificity on a blinded panel of 769 retrospective sera of known HIV status. Western blot was used as a confirmatory assay for discordant results. Subsequently, one parallel and one serial testing algorithm were assessed on a new panel of 912 HIV-positive and negative samples. Individual evaluation of the ELISAs and rapid tests indicated a sensitivity of 100% for all assays except Uni-Gold with 99.7%. The specificities ranged from 99.1% to 99.4% for rapid assays and from 97.5% to 99.1% for ELISAs. A parallel and serial testing algorithms using Enzygnost and Vironostika, and Determine followed by Uni-Gold respectively, showed 100% sensitivity and specificity. The cost for testing 912 samples was US$4.74 and US$ 1.9 per sample in parallel and serial testing respectively. Parallel or serial testing algorithm yielded a sensitivity and specificity of 100%. This alternative algorithm is reliable and reduces the occurrence of both false negatives and positives. The serial testing algorithm was more cost effective for diagnosing HIV infections in this population.

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. TRIAL REGISTRATION: ClinicalTrials.gov NCT00146380 Please see later in the article for the Editors' Summary.

Alaska Native people have suffered disproportionately from previous influenza pandemics. We evaluated 3 separate syndromic data sources to determine temporal and geographic patterns of spread of 2009 pandemic influenza A H1N1 (pH1N1) in Alaska, and reviewed records from persons hospitalized with pH1N1 disease in 3 areas in Alaska to characterize clinical and epidemiologic features of disease in Alaskans. A wave of pH1N1 disease swept through Alaska beginning in most areas in August or early September. In rural regions, where Alaska Native people comprise a substantial proportion of the population, disease occurred earlier than in other regions. Alaska Native people and Asian/Pacific Islanders (A/PI) were 2-4 times more likely to be hospitalized than whites. Alaska Native people and other minorities remain at high risk for early and substantial morbidity from pandemic influenza episodes. These findings should be integrated into plans for distribution and use of vaccine and antiviral agents.

Quality medical laboratory services are an integral part of routine health care, medical research, and public health systems. Despite this vital role, quality laboratory services in Africa are scarce. The crucial need for expanding quality laboratory services throughout sub-Saharan Africa is especially critical because of the region's burden of disease. Fortunately, several plans from supporting international partners are underway to help strengthen laboratory infrastructure in this region. A key component of these initiatives is the enforcement of quality assurance services through accreditation by international standards such as the International Organization for Standardization (ISO) 15189. However, acquisition and maintenance of these standards are a significant challenge, especially in resource-limited settings. The most common limiting factors can include funding, government support, equipment, training opportunities, and poor procurement infrastructure. In this article, we discuss the challenges and benefits accrued in pursuing and sustaining ISO 15189 accreditation for the Kenya Medical Research Institute/Centre for Disease Control HIV-Research Laboratory in Kisumu, Kenya.

In the Kisumu Breastfeeding Study (KiBS), prevention of mother-to-child HIV transmission study, highly active antiretroviral therapy (HAART) is provided from 34 weeks gestation, through delivery to six months postpartum. The study recommends that women practice exclusive breastfeeding for six months, then wean abruptly. We sought to explore factors such as, education, family support, cultural norms, and sources of information about perinatal HIV transmission, which may influence a mother's decision to comply or not comply with the study's recommendation to stop breastfeeding when HAART is discontinued. We used semi-structured interviews of a purposive sample of 18 mothers participating in the KiBS. By interviewing 10 mothers who stopped breastfeeding and eight mothers who continued, it was possible to examine how different factors may have affected the groups of participants. All participants stated that it was not traditional to stop breastfeeding at six months. Participants who stopped breastfeeding reported more family support, were more educated, and were more likely to disclose their HIV status. Participants who continued breastfeeding more often expressed concern about stigma. Participants learned about mother-to-child transmission from clinics, churches, community groups, and other HIV-positive mothers. This substudy suggests that family support, education, and cultural norms are important factors that may influence a mother's decision regarding breastfeeding cessation. Thus, counseling and family support may play integral roles in the promotion of early breastfeeding cessation.

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 ([Formula: see text] and [Formula: see text], respectively); however, during the weaning period, there were no differences in the frequency of diarrhea between cohorts ([Formula: see text]). 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.