Efficacy of Single-Dose Albendazole and Albendazole Plus Ivermectin for Soil-Transmitted Helminth Infection in Children in the Peruvian Amazon.

In countries where soil-transmitted helminth (STH) infections are endemic, deworming programs are recommended to reduce morbidity; however, increasing levels of resistance to benzimidazoles are of concern. In an observational study in Peru, we studied the clinical efficacy of 400 mg of albendazole 20 days after treatment among children aged 2-11 years. Of 426 participants who provided samples, 52.3% were infected with a STH, 144 (33.8%) were positive for Ascaris (41.8% light, 50.8% moderate, and 7.4% heavy infections), 147 (34.5%) were positive for Trichuris (75.2% light, 22.5% moderate, and 2.3% heavy infections), and 1.1% were positive for hookworm species (100% light infections). Additional stool samples were examined at 20, 90, and 130 days after the initial treatment. At 20 days post-administration of albendazole, the cure rate (CR) of Ascaris infection was 80.1% (95% CI: 73.5-86.7), and the egg reduction rate (ERR) was 70.8% (95% CI: 57.8-88.7); the CR for Trichuris infection was 27.1% (95% CI: 20.0-34.3), and the ERR was 29.8% (95% CI: -1.40 to 57.5). Among participants with persistent or recurrent infections with Trichuris, the combined therapy of albendazole (400 mg) and ivermectin at 600 µg/dose increased overall CR for Trichuris infection to 75.2% (95% CI: 67.3-83.2%) with an ERR of 84.2% (95% CI: 61.3-93.8%). Albendazole administration alone for the control of STH was associated with high rates of treatment failure, especially for Trichuris. Combined single doses of albendazole and ivermectin was observed to have improved efficacy.

Effect of preterm birth on growth and blood pressure in adulthood in the Pelotas 1993 cohort.

BACKGROUND: Preterm birth has been associated with increased risk of hypertension and cardiovascular disease later in adulthood, attributed to cardiovascular and metabolic alterations in early life. However, there is paucity of evidence from low- and middle-income countries (LMICs). METHODS: We investigated the differences between preterm (<37 weeks gestational age) and term-born individuals in birth length and weight as well as adult (18 and 20 years) height, weight and blood pressure in the Brazilian 1993 Pelotas birth cohort using linear regressions. Analyses were adjusted for the maternal weight at the beginning of pregnancy and maternal education and family income at childbirth. Additional models were adjusted for body mass index (BMI) and birthweight. Separate analyses were run for males and females. The complete sample was analysed with an interaction term for sex. RESULTS: Of the 3585 babies included at birth, 3010 were followed up in adulthood at 22 years. Preterm participants had lower length and weight at birth. This difference remained for male participants in adulthood, but female participants were no shorter than their term counterparts by 18 years of age. At 22 years, females born preterm had lower blood pressures (systolic blood pressure -1.00 mmHg, 95%CI -2.7, 0.7 mmHg; diastolic blood pressure -1.1 mmHg, 95%CI -2.4, 0.3 mmHg) than females born at term. These differences were not found in male participants. CONCLUSIONS: In this Brazilian cohort we found contrasting results regarding the association of preterm birth with blood pressure in young adulthood, which may be unique to an LMIC.

Resistance to single dose albendazole and reinfection with intestinal helminths among children ages 2 to 11 years from the Peruvian Amazon region: a study protocol.

BACKGROUND: Deworming programs aimed at reducing morbidity and mortality from geohelminth infections are common in many countries where these infections are endemic, but data demonstrating increasing levels of resistance to albendazole and mebendazole are causes for concern. Studies to evaluate the clinical efficacy of deworming programs are critical to maintain high infection control goals. METHODS: We propose to assess the clinical efficacy of Peruvian national guidelines for deworming programs in a prospective observational study conducted in the Amazon River basin area near Iquitos, Peru. Major outcomes to be evaluated include (1) albendazole resistance of intestinal helminths (trichuriasis, ascariasis, hookworm), and (2) frequency of reinfection with intestinal helminths 4 months after treatment with albendazole. Children ages 2-11 years from the Belén District of Iquitos will be identified based on a community census. Following parental informed consent, demographic data, weight, and height will be recorded and a stool specimen for parasitological exam by direct observation and Kato-Katz concentration method, and helminthic egg counts will be collected prior to administration of albendazole, following Peruvian national guidelines. Follow-up stool specimens examined in the same manner will be collected at 20 days, 90 days, and 100 days following initial administration of albendazole, and based on parasites found repeat treatment will be administered in accordance with national guidelines. Real-time multiplex qPCR will be performed on helminth positive samples collected prior to initial deworming and on helminth-positive specimens detected on day 15-20. A total sample size of 380 participants was calculated based on total population in the target group and prevalence estimates of helminth infections and clinical resistance based on recent data. DISCUSSION: Data from observational clinical efficacy studies are important to guide geohelminth infection control programs. Trial registration https://www.researchregistry.com/ . Identification number: researchregistry7736; Registered retrospectively March 13, 2022; https://www.researchregistry.com/browse-the-registry#home/registrationdetails/622e024cf06132001e3327bf/.

Knowledge, attitudes, and practices of cervical cancer prevention and pap smears in two low-income communities in Lima, Peru.

BACKGROUND: Cervical cancer is a leading cause of death among Peruvian women. Barriers at multiple levels impact effective screening and treatment, including a lack of knowledge about cervical cancer and how regular screening can reduce morbidity and mortality through earlier detection. The aim of this study is to assess knowledge, attitudes, and practices regarding cervical cancer and its prevention in the peri-urban communities of Oasis and Pampas in southern Lima, Peru that can be used to inform future campaigns about cervical cancer prevention. METHODS: A cross-sectional survey that included several open-ended questions was administered to women in Pampas and Oasis between 2015 and 2016 to evaluate the knowledge, attitudes, and practices regarding cervical cancer and Pap smears. RESULTS: In total, 224 women were interviewed. Knowledge about cervical cancer and Pap smears was high, and attitudes were predominantly positive among most participants. Most participants knew how often they should get Pap smears (89.7%), when to begin seeking screening (74.6%), knew the price of a Pap smear (61.9%), and felt Pap smears were important for their health (70.1%). About one third (29.5%) of premenopausal women reported receiving a Pap smear in the last year. However, open ended questions revealed some knowledge gaps around Pap smears, as well as some stigma associated to Human Papilloma Virus (HPV) infection. CONCLUSION: Although knowledge of cervical cancer prevention was generally high and perceptions were positive among women in peri-urban Peruvian communities, our findings revealed there is a need for education on HPV infection prevalence among sexually active individuals to reduce stigma. Future research should focus on exploring experiences with follow-up and treatment associated with abnormal Pap smears, as well as perspectives from health authorities and professionals about barriers in the early detection and treatment process for cervical cancer.

Cross-sectional study of dengue-related knowledge, attitudes and practices in Villa El Salvador, Lima, Peru.

OBJECTIVES: To describe and quantify the dengue-related knowledge, attitudes and practices of residents in an urban shantytown in Lima, Peru. DESIGN/SETTING: A cross-sectional survey of adults between 18 and 80 years living in approximately 120 blocks in Oasis, an urban shantytown situated in the low-to-middle income district of Villa El Salvador in Southern Lima. The survey was adapted from an existing survey previously used in Iquitos, Peru, and included questions relating to knowledge of dengue symptoms, transmission, prevention and current mosquito control practices. PARTICIPANTS: A total of 240 surveys were completed with 80% of respondents being female and approximately 50% of all respondents describing themselves as housewives. RESULTS: Although 97.9% of respondents had heard of dengue, only 6.2% of people knew someone who had experienced the disease. Approximately half (54.2%) of the respondents knew dengue was transmitted by mosquitoes and 51.7% were able to identify fever and one other correct symptom of dengue. Female sex was significantly associated with greater symptom knowledge (OR 2.22, 95% CI 1.08 to 4.72) and prevention knowledge (OR 2.12, 95% CI 1.06 to 4.21). Past or current higher education attendance was significantly associated with symptom knowledge (OR 2.56, 95% CI 1.25 to 5.44) and transmission knowledge (OR 3.46, 95% CI 1.69 to 7.57). Knowledge of dengue was not significantly associated with carrying out practices to control mosquitoes (OR 1.76, 95% CI 0.87 to 3.54). CONCLUSIONS: This population demonstrated baseline dengue knowledge. However, this was incomplete and substantially less when compared with endemic areas. Given the sporadic nature of dengue transmission in Lima, it is not surprising that knowledge of the disease was not associated with carrying out practices to reduce mosquitoes. However, as dengue transmission in Lima is likely to increase, understanding how best to improve public knowledge of the disease and how to translate this into appropriate community action will be a key public health consideration.

Assessing the Implementation of a Behavior Change Intervention: Process Evaluation of a Stepped-Wedge Cluster Randomized Controlled Trial for Newborn Health.

Maternal and under five-year-old mortality rates have reduced in the last two decades globally due to concerted effort, yet newborn deaths remain unacceptably prevalent. Behavior change is an important component of interventions to address newborn health problems in low-income countries. In Cambodia, maternal and newborn mortality has markedly decreased, and continued improvements will allow the country to achieve further reduction in newborn morbidity. The results of an implementation study of the Newborn Care and Infection Control Initiative using process evaluation are presented to provide insight into the trial implementation and context of the program that may have contributed to intervention results. The study utilized a mixed method process to explore the context, mechanisms, and implementation of intervention components: training of village health support group volunteers to provide home visits, training of midwives on infection prevention and control around the perinatal period, counseling on newborn care, and provision of training materials for counseling and intervention. Implementation was evaluated through quantitative and qualitative data collection including surveys, observation, semi-structured interviews, focus groups, and visual media. Descriptive statistics summarized the quantitative data and thematic analysis was used to explore the qualitative data. The evaluation identified several factors that might have influenced the outcomes of the trial: continuity of health center staff communication, timing and ability to complete home visits, and training quality. Additional support for parents in the perinatal period, preferably provided at the community level, will contribute to further improvement in health outcomes for newborns in this area. Researchers in this context should consider mechanisms to improve the coordination of health facility staff counseling while providing support and resources to ensure home visits to families with newborns are made on time. Attention to staffing, training, and quality of newborn health interventions is critical in planning for the scaling-up of newborn health programming.

A Linked Community and Health Facility Intervention to Improve Newborn Health in Cambodia: the NICCI Stepped-Wedge Cluster-Randomized Controlled Trial.

BACKGROUND: Newborn mortality in Cambodia remains high, with sepsis and complications of delayed care-seeking important contributing factors. Intervention study objectives were to improve infection control behavior by staff in health centers; improve referral of sick newborns; increase recognition of danger signs, and prompt care-seeking at an appropriate health facility; and appropriate referral for sick newborns by mothers and families of newborn infants. METHODS: The stepped-wedge cluster-randomized controlled trial took place in rural Cambodia from February 2015 to November 2016. Sixteen clusters consisted of public health center catchment areas serving the community. The intervention included health center staff training and home visits to mothers by community health volunteers within 24 hours of birth and on days 3 and 7 after delivery, including assessment of newborns for danger signs and counselling mothers. The trial participants included women who had recently delivered a newborn who were visited in their homes in the first week, as well as health center staff and community volunteers who were trained in newborn care. Women in their last trimester of pregnancy greater than 18 years of age were recruited and were blinded to their group assignment. Mothers and caregivers (2494) received counseling on handwashing practices, breastfeeding, newborn danger signs, and prompt, appropriate referral to facilities. RESULTS: Health center staff in the intervention group had increased likelihood of hand washing at recommended key moments when compared with the control group, increased knowledge of danger signs, and higher recall of at least three hygiene messages. Of mother/caregiver participants at 14 days after delivery, women in the intervention group were much more likely to know at least three danger signs and to have received messages on care-seeking compared with controls. CONCLUSIONS: The intervention improved factors understood to be associated with newborn survival and health. Well-designed training, followed by regular supervision, enhanced the knowledge and self-reported behavior of health staff and health volunteers, as well as mothers' own knowledge of newborn danger signs. However, further improvement in newborn care, including care-seeking for illness and handwashing among mothers and families, will require additional involvement from broader stakeholders in the community.

Warming the postpartum body as a form of postnatal care: An ethnographic study of medical injections and traditional health practices in Cambodia.

Postpartum care is a critical element for ensuring survival and health of mothers and newborns but is often inadequate in low- and middle-income countries due to barriers to access and resource constraints. Newly delivered mothers and their families often rely on traditional forms of postnatal care rooted in social and cultural customs or may blend modern and traditional forms of care. This ethnographic study sought to explore use of biomedical and traditional forms of postnatal care. Data were collected through unstructured observation and in-depth interviews with 15 mothers. Participants reported embracing traditional understandings of health and illness in the post-partum period centered on heating the body through diet, steaming, and other applications of heat, yet also seeking injections from private health care providers. Thematic analysis explored concepts related to transitioning forms of postnatal care, valuing of care through different lenses, and diverse sources of advice on postnatal care. Mothers also described concurrent use of both traditional medicine and biomedical postnatal care, and the importance of adhering to cultural traditions of postnatal care for future health. Maternal and newborn health are closely associated with postnatal care, so ensuring culturally appropriate and high-quality care must be an important priority for stakeholders including understand health practices that are evolving to include injections.

Micronutrient powder use in Arequipa, Peru: Barriers and enablers across multiple levels.

In Peru, nearly half of children aged 6-36 months were diagnosed with anaemia in 2017. To address this disease, the Peruvian Ministry of Health implemented a national programme in 2014, distributing free micronutrient powders (MNPs) to all children of this age. However, rates of childhood anaemia remain high. The aim of this study was to explore factors at all levels of the Social-Ecological Model that affect MNP use and adherence in Arequipa, an Andean city with childhood anaemia rates higher than the national average. We conducted in-depth interviews with 20 health personnel and 24 caregivers and 12 focus group discussions with 105 caregivers. We identified numerous barriers, including negative side effects (constipation, vomiting, and diarrhoea), poor taste of MNP, lack of familial and peer support for its use, insufficient informational resources provided by the health system, and limited human resources that constricted health personnel abilities to implement MNP programming successfully. Facilitators identified included concern about the long-term effects of anaemia, support from organizations external to the health system, well-coordinated care within the health system, and provision of resources by the Ministry of Health. We found that community or organizational and societal factors were key to limited MNP use and adherence, specifically the limited time health personnel have to address caregivers' doubts during appointments and the lack of informational resources outside of these appointments. Potential policy implications could be to increase informational resources available outside of individualized counselling by strengthening existing collaborations with community organizations, increasing media coverage, and providing group counselling.

Neonatal Sepsis Epidemiology in a Rural Province in Southeastern Cambodia, 2015-2017.

Neonatal sepsis is the second most prevalent cause of neonatal deaths in low- and middle-income countries, and many countries lack epidemiologic data on the local causes of neonatal sepsis. During April 2015-November 2016, we prospectively collected 128 blood cultures from neonates admitted with clinical sepsis to the provincial hospital in Takeo, Cambodia, to describe the local epidemiology. Two percent (n = 3) of positive blood cultures identified were Gram-negative bacilli (GNB) and were presumed pathogens, whereas 10% (n = 13) of positive blood cultures identified were likely contaminants, consistent with findings in other published studies. No group B Streptococcus was identified in any positive cultures. The presence of GNB as the primary pathogens could help influence local treatment guidelines.

"Knocking on Doors that Don't Open": experiences of caregivers of children living with disabilities in Iquitos and Lima, Peru.

Background: More than one billion people worldwide live with a disability. Despite advances in recognising inequalities experienced by people with disabilities, barriers to services and stigmatisation still exist. The aims of this study were to explore: (1) perceptions and experiences of services specifically available to people with disabilities and their caregivers and (2) the perception of disability. Methods: In-depth interviews were conducted with 20 caregivers of persons with a disability and 14 key informants in two cities in Peru; Lima and Iquitos. The social-ecological model was used as a framework to analyse and present data, stratifying the key barriers and opportunities at each level. Results: At the individual level, interviewees reported a lack of support at the time of diagnosis, poor coping strategies, and communicated their desire for, and willingness to participate in support groups if they were established. On the community level, education and awareness were reportedly lacking and acts of discrimination and stigmatisation were common. Participants described opportunities for community-level campaigns to increase exposure and awareness of disability rights and inclusion. A dissatisfaction with government programmes was reported, as services were not available to everyone, in part due to geographical and socio-economic barriers. Conclusions: The main findings were the lack of emotional, informational, and tangible support available to caregivers of people with disabilities, often exacerbated by lower socio-economic status; a lack of transparency of care pathways available to people with disabilities; and a lack of visibility of people with disability in both Lima and Iquitos. Implications for Rehabilitation Support groups could offer additional support to caregivers of people with disabilities in Lima, mitigating existing gaps in services for people with disabilities, and their families. Education campaigns implemented on a community level could start to curb discrimination and stigmatisation of people with disabilities in Lima and Iquitos. A national census with inclusive language and methodology specifically designed to capture the percentage of the population currently living with a disability would give a real indication of what services are needed in Peru. The provision of clear, publically available routes of attention would assist caregivers and families to access services for people with disabilities.

Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age.

Probiotics are increasingly used for diarrhea, but studies under the Food and Drug Administration and Investigational New Drug program are few. We conducted a phase-one placebo-controlled study of Lactobacillus reuteri DSM 17938 under Investigational New Drug program in 60 children 2-5 years of age (41 L. reuteri, 19 placebos) in a resource-constrained community in Peru. No differences in objective data on adverse events were noted, although some differences based on subjective parental reports for fever and diarrhea were seen.

"Zika is everywhere": A qualitative exploration of knowledge, attitudes and practices towards Zika virus among women of reproductive age in Iquitos, Peru.

Zika virus was reported in the rainforest city of Iquitos, Peru in 2016. The potential associations between Zika and fetal neurological disorders were reported extensively in the media regarding neighboring Brazil, and led to great concern about the impact Zika could have on people's health in Iquitos when it arrived. The aim of this study was to explore the knowledge, attitudes, and preventative practices related to Zika virus and its transmission among women of childbearing age in Iquitos, Peru. Six focus group discussions with 46 women of ages 20-35 from an Iquitos district with confirmed Zika cases were conducted to explore: 1) knowledge of Zika transmission, its symptoms, and treatment, 2) attitudes regarding Zika, including perceptions of risk for and severity of Zika, and 3) preventative practices, including awareness of health promotion activities. Participants were knowledgeable about Zika symptoms and knew it was transmitted by mosquitoes, and about half had heard about the association between Zika and microcephaly, but most lacked knowledge about the associated neurological disorders in adults, its sexual transmission, and ways to prevent infection. They expressed concern for pregnant women exposed to the virus and the impact on the fetus. Participants felt at risk of contracting the Zika virus, yet had not changed preventive practices, possibly in part because their perception of the severity of this disease was low. This study reveals knowledge gaps that could be addressed via health promotion messages that might improve prevention practices to help community members protect themselves from Zika virus during this outbreak.

Delays in seeking and receiving health care services for pneumonia in children under five in the Peruvian Amazon: a mixed-methods study on caregivers' perceptions.

BACKGROUND: Delays in receiving adequate care for children suffering from pneumonia can be life threatening and have been described associated with parents' limited education and their difficulties in recognizing the severity of the illness. The "three delays" was a model originally proposed to describe the most common determinants of maternal mortality, but has been adapted to describe delays in the health seeking process for caregivers of children under five. This study aims to explore the caregivers' perceived barriers for seeking and receiving health care services in children under five years old admitted to a referral hospital for community-acquired pneumonia in the Peruvian Amazon Region using the three-delays model framework. METHODS: There were two parts to this mixed-method, cross-sectional, hospital-based study. First, medical charts of 61 children (1 to 60 months old) admitted for pneumonia were reviewed, and clinical characteristics were noted. Second, to examine health care-seeking decisions and actions, as well as associated delays in the process of obtaining health care services, we interviewed 10 of the children's caregivers. RESULTS: Half of the children in our study were 9 months old or less. Main reasons for seeking care at the hospital were cough (93%) and fever (92%). Difficulty breathing and fast breathing were also reported in more than 60% of cases. In the interviews, caregivers reported delays of 1 to 14 days to go to the closest health facility. Factors perceived as causes for delays in deciding to seek care were apparent lack of skills to recognize signs and symptoms and of confidence in the health system, and practicing self-medication. No delays in reaching a health facility were reported. Once the caregivers reached a health facility, they perceived lack of competence of medical staff and inadequate treatment provided by the primary care physicians. CONCLUSION: According to caregivers, the main delays to get health care services for pneumonia among young children were identified in the initial decision of caregivers to seek healthcare and in the health system to provide it. Specific interventions targeted to main barriers may be useful for reducing delays in providing appropriate health care for children with pneumonia.

Use of Camphor and Essential Oil Balms for Infants in Cambodia.

Balms and oils containing terpenic compounds, such as camphor, menthol and eucalyptus, are potentially toxic, and numerous reports of adverse events stemming from their use in infants and young children have been published. During qualitative research on newborn practices in rural Cambodia, these products were found to be commonly applied to the skin of newborns and infants and available in most households. Parents and caregivers of infants in Cambodia and other settings where use of camphor- and menthol-containing products are common should be educated on the risks of these to prevent child morbidity and potential mortality.

Interdisciplinary Postdoctoral Training in Global Health Through a Novel Joint Project for Trainees from Diverse Disciplines: Benefits, Risks, and Observations.

Postdoctoral training programs are usually highly individualized arrangements between trainees and a limited number of senior mentors in their field, an approach that contrasts with current trends in public health education that promote interdisciplinary training to spur innovation. Herein, we describe an alternative model for postdoctoral training for a group of fellows from distinct disciplines. Fellows work with mentors from diverse fields to create a joint research project or a group of complementary projects, with the goal of developing a new device, intervention, or innovation to address a global health problem. The perceived benefits, challenges, and limitations of this team approach to interdisciplinary postdoctoral training are presented.

Newborn Care in the Home and Health Facility: Formative Findings for Intervention Research in Cambodia.

Global coverage and scale up of interventions to reduce newborn mortality remains low, though progress has been achieved in improving newborn survival in many low-income settings. An important factor in the success of newborn health interventions, and moving to scale, is appropriate design of community-based programs and strategies for local implementation. We report the results of formative research undertaken to inform the design of a newborn health intervention in Cambodia. Information was gathered on newborn care practices over a period of three months using multiple qualitative methods of data collection in the primary health facility and home setting. Analysis of the data indicated important gaps, both at home and facility level, between recommended newborn care practices and those typical in the study area. The results of this formative research have informed strategies for behavior change and improving referral of sick infants in the subsequent implementation study. Collection and dissemination of data on newborn care practices from settings such as these can contribute to efforts to advance survival, growth and development of newborns for intervention research, and for future newborn health programming.

Newborn Infection Control and Care Initiative for health facilities to accelerate reduction of newborn mortality (NICCI): study protocol for a randomized controlled trial.

BACKGROUND: Newborn health is a key issue in addressing the survival of children under five years old, particularly in low and middle income countries, and the evidence base for newborn health interventions continues to evolve. Over the last decade, maternal and under five-year-old mortality and morbidity rates have been successfully reduced in Cambodia, but newborn health has lagged behind. Evidence suggests that an important proportion of newborn mortality both globally and in Cambodia is attributable to infections and sepsis. While initiatives are being implemented to address some causes of newborn illness (related to pre-term birth and asphyxia), a country-level approach to reducing infections has not been formulated. The Newborn Infection Control and Care Initiative (NICCI) is a community and health facility linked intervention to improve health outcomes for newborns. METHODS/DESIGN: The present study applies a cluster randomized trial, using a stepped wedge design, to assess the impact of a package intervention on newborn health. The intervention components include addressing infection control in the perinatal period in health facilities, promoting infection prevention and control practices in health center and home environments, and improving the timeliness of referrals for newborns with suspected infections to appropriate health facilities, by linking families to the medical system through a network of community based volunteers who will make home visits to families in the first week of a newborn's life. DISCUSSION: The NICCI trial is designed to complement and enhance the Cambodian Ministry of Health strategies and objectives for maternal and newborn care. Results of the study will help to inform policy and the possible scale-up of newborn health interventions in the country. TRIAL REGISTRATION: This trial was registered with Clinicaltrials.gov (identifier: NCT02271737) on 5 October 2014.

A Controlled Study of Tuberculosis Diagnosis in HIV-Infected and Uninfected Children in Peru.

BACKGROUND: Diagnosing tuberculosis in children is challenging because specimens are difficult to obtain and contain low tuberculosis concentrations, especially with HIV-coinfection. Few studies included well-controls so test specificities are poorly defined. We studied tuberculosis diagnosis in 525 children with and without HIV-infection. METHODS AND FINDINGS: 'Cases' were children with suspected pulmonary tuberculosis (n = 209 HIV-negative; n = 81 HIV-positive) and asymptomatic 'well-control' children (n = 200 HIV-negative; n = 35 HIV-positive). Specimens (n = 2422) were gastric aspirates, nasopharyngeal aspirates and stools analyzed by a total of 9688 tests. All specimens were tested with an in-house hemi-nested IS6110 PCR that took <24 hours. False-positive PCR in well-controls were more frequent in HIV-infection (P≤0.01): 17% (6/35) HIV-positive well-controls versus 5.5% (11/200) HIV-negative well-controls; caused by 6.7% (7/104) versus 1.8% (11/599) of their specimens, respectively. 6.7% (116/1719) specimens from 25% (72/290) cases were PCR-positive, similar (P>0.2) for HIV-positive versus HIV-negative cases. All specimens were also tested with auramine acid-fast microscopy, microscopic-observation drug-susceptibility (MODS) liquid culture, and Lowenstein-Jensen solid culture that took ≤6 weeks and had 100% specificity (all 2112 tests on 704 specimens from 235 well-controls were negative). Microscopy-positivity was rare (0.21%, 5/2422 specimens) and all microscopy-positive specimens were culture-positive. Culture-positivity was less frequent (P≤0.01) in HIV-infection: 1.2% (1/81) HIV-positive cases versus 11% (22/209) HIV-negative cases; caused by 0.42% (2/481) versus 4.7% (58/1235) of their specimens, respectively. CONCLUSIONS: In HIV-positive children with suspected tuberculosis, diagnostic yield was so low that 1458 microscopy and culture tests were done per case confirmed and even in children with culture-proven tuberculosis most tests and specimens were false-negative; whereas PCR was so prone to false-positives that PCR-positivity was as likely in specimens from well-controls as suspected-tuberculosis cases. This demonstrates the importance of control participants in diagnostic test evaluation and that even extensive laboratory testing only rarely contributed to the care of children with suspected TB. TRIAL REGISTRATION: This study did not meet Peruvian and some other international criteria for a clinical trial but was registered with the ClinicalTrials.gov registry: ClinicalTrials.gov NCT00054769.