Assessment of Heat Exposure and Health Outcomes in Rural Populations of Western Kenya by Using Wearable Devices: Observational Case Study.

BACKGROUND: Climate change increasingly impacts health, particularly of rural populations in sub-Saharan Africa due to their limited resources for adaptation. Understanding these impacts remains a challenge, as continuous monitoring of vital signs in such populations is limited. Wearable devices (wearables) present a viable approach to studying these impacts on human health in real time. OBJECTIVE: The aim of this study was to assess the feasibility and effectiveness of consumer-grade wearables in measuring the health impacts of weather exposure on physiological responses (including activity, heart rate, body shell temperature, and sleep) of rural populations in western Kenya and to identify the health impacts associated with the weather exposures. METHODS: We conducted an observational case study in western Kenya by utilizing wearables over a 3-week period to continuously monitor various health metrics such as step count, sleep patterns, heart rate, and body shell temperature. Additionally, a local weather station provided detailed data on environmental conditions such as rainfall and heat, with measurements taken every 15 minutes. RESULTS: Our cohort comprised 83 participants (42 women and 41 men), with an average age of 33 years. We observed a positive correlation between step count and maximum wet bulb globe temperature (estimate 0.06, SE 0.02; P=.008). Although there was a negative correlation between minimum nighttime temperatures and heat index with sleep duration, these were not statistically significant. No significant correlations were found in other applied models. A cautionary heat index level was recorded on 194 (95.1%) of 204 days. Heavy rainfall (>20 mm/day) occurred on 16 (7.8%) out of 204 days. Despite 10 (21%) out of 47 devices failing, data completeness was high for sleep and step count (mean 82.6%, SD 21.3% and mean 86.1%, SD 18.9%, respectively), but low for heart rate (mean 7%, SD 14%), with adult women showing significantly higher data completeness for heart rate than men (2-sided t test: P=.003; Mann-Whitney U test: P=.001). Body shell temperature data achieved 36.2% (SD 24.5%) completeness. CONCLUSIONS: Our study provides a nuanced understanding of the health impacts of weather exposures in rural Kenya. Our study's application of wearables reveals a significant correlation between physical activity levels and high temperature stress, contrasting with other studies suggesting decreased activity in hotter conditions. This discrepancy invites further investigation into the unique socioenvironmental dynamics at play, particularly in sub-Saharan African contexts. Moreover, the nonsignificant trends observed in sleep disruption due to heat expose the need for localized climate change mitigation strategies, considering the vital role of sleep in health. These findings emphasize the need for context-specific research to inform policy and practice in regions susceptible to the adverse health effects of climate change.

Improving performance of hurdle models using rare-event weighted logistic regression: an application to maternal mortality data.

In this paper, performance of hurdle models in rare events data is improved by modifying their binary component. The rare-event weighted logistic regression model is adopted in place of logistic regression to deal with class imbalance due to rare events. Poisson Hurdle Rare Event Weighted Logistic Regression (REWLR) and Negative Binomial Hurdle (NBH) REWLR are developed as two-part models which use the REWLR model to estimate the probability of a positive count and a Poisson or NB zero-truncated count model to estimate non-zero counts. This research aimed to develop and assess the performance of the Poisson and Negative Binomial (NB) Hurdle Rare Event Weighted Logistic Regression (REWLR) models, applied to simulated data with various degrees of zero inflation and to Nairobi county's maternal mortality data. The study data on maternal mortality were pulled from JPHES. The data contain the number of maternal deaths, which is the outcome variable, and other obstetric and demographic factors recorded in MNCH facilities in Nairobi between October 2021 and January 2022. The models were also fit and evaluated based on simulated data with varying degrees of zero inflation. The obtained results are numerically validated and then discussed from both the mathematical and the maternal mortality perspective. Numerical simulations are also presented to give a more complete representation of the model dynamics. Results obtained suggest that NB Hurdle REWLR is the best performing model for zero inflated count data due to rare events.

Second-Line Switch to Dolutegravir for Treatment of HIV Infection.

BACKGROUND: Data to inform the switch from a ritonavir-boosted protease inhibitor (PI) to dolutegravir in patients living with human immunodeficiency virus (HIV) infection who do not have genotype information and who have viral suppression with second-line therapy containing a ritonavir-boosted PI have been limited. METHODS: In a prospective, multicenter, open-label trial conducted at four sites in Kenya, we randomly assigned, in a 1:1 ratio, previously treated patients without genotype information who had viral suppression while receiving treatment containing a ritonavir-boosted PI to either switch to dolutegravir or continue the current regimen. The primary end point was a plasma HIV type 1 RNA level of at least 50 copies per milliliter at week 48, assessed on the basis of the Food and Drug Administration snapshot algorithm. The noninferiority margin for the between-group difference in the percentage of participants who met the primary end point was 4 percentage points. Safety up to week 48 was assessed. RESULTS: A total of 795 participants were enrolled, with 398 assigned to switch to dolutegravir and 397 assigned to continue taking their ritonavir-boosted PI; 791 participants (397 in the dolutegravir group and 394 in the ritonavir-boosted PI group) were included in the intention-to-treat exposed population. At week 48, a total of 20 participants (5.0%) in the dolutegravir group and 20 (5.1%) in the ritonavir-boosted PI group met the primary end point (difference, -0.04 percentage points; 95% confidence interval, -3.1 to 3.0), a result that met the criterion for noninferiority. No mutations conferring resistance to dolutegravir or the ritonavir-boosted PI were detected at the time of treatment failure. The incidence of treatment-related grade 3 or 4 adverse events was similar in the dolutegravir group and the ritonavir-boosted PI group (5.7% and 6.9%, respectively). CONCLUSIONS: In previously treated patients with viral suppression for whom there were no data regarding the presence of drug-resistance mutations, dolutegravir treatment was noninferior to a regimen containing a ritonavir-boosted PI when the patients were switched from a ritonavir-boosted PI-based regimen. (Funded by ViiV Healthcare; 2SD ClinicalTrials.gov number, NCT04229290.).

Contexts for developing of national essential diagnostics lists. Lessons from a mixed-methods study of existing documents, stakeholders and decision making on tier-specific essential in-vitro diagnostics in African countries.

Since 2019, the WHO recommends the development and implementation of National Essential Diagnostics List (NEDL) to facilitate availability of In-Vitro Diagnostics (IVDs) across the various tiers of the healthcare pyramid, facilities with or without a laboratory on-site. To be effective, the development of NEDL should take into consideration the challenges and opportunities associated with current modalities for organization of tier specific testing services in-country. We conducted a mixed-methods analysis set out to explore available national policies, guidelines and decision-making processes that affect accessibility of diagnostics in African countries; 307 documents from 48 African countries were reviewed and 28 in-depth (group) interviews with 43 key-informants in seven countries were conducted between June and July 2022. Of the 48 countries, Nigeria was the only one with formal NEDL. Twenty-five countries had national test menus (63% outdated, from 2015 or earlier) all specifying tests by laboratory tier (5 including the "community tier"), with additional details on equipment (20), consumables (12), and personnel requirements (11). The most popular criteria to select essential IVDs in the quantitative analysis relate to specificities of the tests, whereas in the qualitative study most mentioned were health care and laboratory contextual factors. Quality assurance and waste management for tests at "community tier" were highlighted as concerns by all the respondents. Additional barriers to implementation included the low decision-making power of Laboratory Directorates within the Ministry of Health, as well as the chronic budgetary gaps for clinical laboratory services and policy and strategic plan development outside of vertical programmes. Four countries out of seven would rather revise their test menus by updating them and add ''community tier", than developing a separate NEDL, the former being considered more operational. This study provides a unique set of practical recommendations to the process of development and effective implementation on NEDL in Africa.

Examining 7 years of implementing quality management systems in medical laboratories in sub-Saharan Africa.

BACKGROUND: Achievement of ISO15189 accreditation demonstrates competency of a laboratory to conduct testing. Three programmes were developed to facilitate achievement of accreditation in low- and middle-income countries: Strengthening Laboratory Management Towards Accreditation (SLMTA), Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) and Laboratory Quality Stepwise Implementation (LQSI). OBJECTIVE: To determine the level of accreditation and associated barriers and facilitators among medical laboratories in the WHO-AFRO region by 2020. METHODS: A desk review of SLIPTA and SLMTA databases was conducted to identify ISO15189-accredited medical laboratories between January 2013 and December 2020. Data on access to the LQSI tool were extracted from the WHO database. Facility and country characteristics were collected for analysis as possible enablers of accreditation. The chi-square test was used to analyse differences with level of significance set at <0.05. RESULTS: A total of 668 laboratories achieved accreditation by 2020 representing a 75% increase from the number in 2013. Accredited laboratories were mainly in South Africa (n = 396; 55%) and Kenya (n = 106; 16%), two countries with national accreditation bodies. About 16.9% (n = 113) of the accredited laboratories were registered for the SLIPTA programme and 26.6% (n = 178) for SLMTA. Approximately 58,217 LQSI users were registered by December 2020. Countries with a higher UHC index for access to HIV care and treatment, higher WHO JEE scores for laboratory networks, a larger number of registered LQSI users, with national laboratory policy/strategic plans and PEPFAR-priority countries were more likely to have an accredited laboratory. Of the 475 laboratories engaged in the SLIPTA programme, 154 attained ≥4 SLIPTA stars (ready to apply for accreditation) and 113 achieved ISO 15189 accreditation, with 96 enrolled into the SLMTA programme. Lower-tier laboratories were less likely to achieve accreditation than higher-tier laboratories (7.7% vs. 30%) (p < 0.001). The probability of achieving ISO 15189 accreditation (19%) was highest during the first 24 months after enrolment into the SLIPTA programme. CONCLUSION: To sustainably anchor quality improvement initiatives at facility level, national approaches including access to a national accreditation authority, adoption of national quality standards and regulatory frameworks are required.

Do Common Beans (Phaseolus vulgaris L.) Promote Good Health in Humans? A Systematic Review and Meta-Analysis of Clinical and Randomized Controlled Trials.

The common bean is a nutrient-dense food empirically known to have beneficial effects on human health. Many studies have looked at the effects of "pulses" on different health issues, providing general overviews of the importance of each pulse in health studies. This study systematically reviews and provides meta-analyses of the effect of bean extract as a supplement or whole bean on four health issues (cardiovascular diseases, diabetes mellitus, obesity, and cancers) from a dissection of clinical and randomized controlled trials using human subjects. A digital search in PubMed and Google ScholarTM resulted in 340 articles, with only 23 peer-reviewed articles matching our inclusion criteria. Findings indicated that common beans reduced LDL cholesterol by 19 percent, risk of cardiovascular disease (CVD) by 11 percent, and coronary heart disease (CHD) by 22 percent. Besides this, we noted variances in the literature on cancer findings, with some authors stating it reduced the proliferation of some kinds of tumor cells and reduced the growth of polyps, while others did not specifically examine cancers but the predisposing factors alone. However, diabetes studies indicated that the postprandial glucose level at the peak of 60 min for common bean consumers was low (mean difference = -2.01; 95% CI [-4.6, -0.63]), but the difference between the treated and control was not significant, and there was a high level of heterogeneity among studies (I2 = 98%). Only obesity studies indicated a significantly high level of weight gain among control groups (mean difference = 1.62; 95% CI [0.37, 2.86]). There is a need for additional clinical trials using a standardized measure to indicate the real effect of the common bean on health.

Managing laboratory waste from HIV-related molecular testing: Lessons learned from African countries.

Waste generated from HIV viral load (VL) testing contains potentially hazardous guanidinium thiocyanate (GTC). GTC is toxic to humans and can pollute waters and harm aquatic life if not disposed of appropriately. We assessed gaps in waste management (WM) policies, regulations and practices through a self-assessment scorecard and an online survey questionnaire among 11 African countries participating in a laboratory systems strengthening community of practice and receiving technical assistance to scale-up VL testing. We identified solutions from national stakeholders, technical agencies, and manufacturers to inform interventions for improving WM. Nine of 11 countries did not have WM policies/guidelines in place. Most Countries reported disposing liquid chemical waste into the sewer. Nine countries prioritised the development of policies as a multi-sectoral approach in the short term. High-temperature incineration through cement factory kilns was identified as an effective, inexpensive and high-capacity disposal option for GTC-containing waste in the short term. A long-term consideration with funding from governments and donors were infrastructural investments for conventional high-temperature incineration where cement factory kilns are unavailable/inaccessible. Adequate WM of GTC-containing waste through available funding could provide the necessary impetus to establish comprehensive WM systems addressing all types of healthcare waste through a multisectoral approach.

Impact of Routine Point-of-Care Versus Laboratory Testing for Early Infant Diagnosis of HIV: Results From a Multicountry Stepped-Wedge Cluster-Randomized Controlled Trial.

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.

Strengthening Existing Laboratory-Based Systems vs. Investing in Point-of-Care Assays for Early Infant Diagnosis of HIV: A Model-Based Cost-Effectiveness Analysis.

BACKGROUND: To improve early infant HIV diagnosis (EID) programs, options include replacing laboratory-based tests with point-of-care (POC) assays or investing in strengthened systems for sample transport and result return. SETTING: We used the CEPAC-Pediatric model to examine clinical benefits and costs of 3 EID strategies in Zimbabwe for infants 6 weeks of age. METHODS: We examined (1) laboratory-based EID (LAB), (2) strengthened laboratory-based EID (S-LAB), and (3) POC EID (POC). LAB/S-LAB and POC assays differed in sensitivity (LAB/S-LAB 100%, POC 96.9%) and specificity (LAB/S-LAB 99.6%, POC 99.9%). LAB/S-LAB/POC algorithms also differed in: probability of result return (79%/91%/98%), time until result return (61/53/1 days), probability of initiating antiretroviral therapy (ART) after positive result (52%/71%/86%), and total cost/test ($18.10/$30.47/$30.71). We projected life expectancy (LE) and average lifetime per-person cost for all HIV-exposed infants. We calculated incremental cost-effectiveness ratios (ICERs) from discounted (3%/year) LE and costs in $/year-of-life saved (YLS), defining cost effective as an ICER <$580/YLS (reflecting programs providing 2 vs. 1 ART regimens). In sensitivity analyses, we varied differences between S-LAB and POC in result return probability, result return time, ART initiation probability, and cost. RESULTS: For infants who acquired HIV, LAB/S-LAB/POC led to projected one-year survival of 67.3%/69.9%/75.6% and undiscounted LE of 21.74/22.71/24.49 years. For all HIV-exposed infants, undiscounted LE was 63.35/63.38/63.43 years, at discounted lifetime costs of $200/220/240 per infant. In cost-effectiveness analysis, S-LAB was an inefficient use of resources; the ICER of POC vs. LAB was $830/YLS. CONCLUSIONS: Current EID programs will attain greater benefit from investing in POC EID rather than strengthening laboratory-based systems.

Burden of prehypertension among adults in Kenya: a retrospective analysis of findings from the Healthy Heart Africa (HHA) Programme.

BACKGROUND: Hypertension is the leading risk factor for mortality globally. African countries, including Kenya, have a high and rising prevalence of hypertension. Prehypertension is associated with an increased risk of progression to overt hypertension and a higher risk of cardiovascular disease and mortality. Despite this, little is documented on the prevalence and distribution of prehypertension in sub-Saharan Africa. This study sought to estimate the overall burden of prehypertension in Kenyan adults enrolled in a large hypertension control programme, Healthy Heart Africa. The distribution and determinants of prehypertension in the sample were explored as secondary objectives. METHODS: This was a post hoc analysis of cross-sectional data obtained from population-level blood pressure (BP) screening of adults aged ≥18 years in the community and ambulatory care facilities in 17/47 sub-national administrative units in Kenya. All participants with a complete record for systolic and diastolic BP were included. Descriptive analyses were performed for sociodemographic characteristics. Pearson's chi-square test was used to assess differences in categorical variables. Multivariate logistic regression analysis was performed to identify factors independently associated with prehypertension. RESULTS: Of 5,985,185 participant records that were included in the analysis, 34% were men (mean age: 45 [SD 2.9] years). The majority (63%) lived in rural Kenya. The prevalence of prehypertension was 54.5% and that of hypertension was 20.8%. Characteristics that were independently associated with prehypertension (adjusted odds ratio [95% CI]) included male sex (1.23 [±0.0023], p <  0.001 for all age groups > 25 years) and rural residence (1.60 [±0.023], p <  0.001). CONCLUSIONS: Approximately one in every two Kenyan adults has prehypertension. This calls for urgent development and roll-out of a national BP screening and control programme. It also provides a strong basis for the formulation of multisectoral national policies that will ensure implementation of evidence-based, low-cost public health interventions geared towards primary prevention of hypertension, especially in population groups that are traditionally considered at low risk, such as young adults and rural residents.

Point-of-Care Early Infant Diagnosis Improves Adherence to the Testing Algorithm in Kenya.

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.

Prevalence, incidence and correlates of HSV-2 infection in an HIV incidence adolescent and adult cohort study in western Kenya.

BACKGROUND: Herpes simplex virus type 2 (HSV-2) infections are associated with increased risk of HIV transmission. We determined HSV-2 prevalence, incidence and associated risk factors, incidence among persons with indeterminate results, and prevalence of HSV-2/HIV co-infection among young adults (18-34 years) and adolescents (16-17 years) enrolled in an HIV incidence cohort study in western Kenya. METHODS: Participants (n = 1106; 846 adults) were screened and those HIV-1 negative were enrolled and followed-up quarterly for one year. HSV-2 was assessed using the Kalon enzyme immunoassay. HSV-2 incidence was calculated separately among HSV-2 seronegative participants and those indeterminate at baseline. Logistic regression was used to estimate the odds of HSV-2 infection and Poisson regression was used to assess HSV-2 incidence and associated factors. RESULTS: Overall, HSV-2 prevalence was 26.6% [95% confidence interval (CI): 23.9-29.4] and was higher in adults (31.5% [95% CI: 28.3-34.9]) than adolescents (10.7% [95% CI: 7.1-15.3]). Factors associated with prevalent HSV-2 included female gender, increasing age, HIV infection, history of sexually transmitted infection, low level of education, multiple sexual partners, and being married, divorced, separated or widowed. Overall HSV-2 incidence was 4.0 per 100 person-years (/100PY) 95% CI: 2.7-6.1 and was higher in adults (4.5/100PY) and females (5.1/100PY). In multivariable analysis only marital status was associated with HSV-2 incidence. Among 45 participants with indeterminate HSV-2 results at baseline, 22 seroconverted, resulting in an incidence rate of 53.2 /100PY [95% CI: 35.1-80.9]. Inclusion of indeterminate results almost doubled the overall incidence rate to 7.8 /100 PY [95% CI: 5.9-10.5]. Prevalence of HIV/HSV-2 co-infection was higher in female adults than female adolescents (17.1 [95% CI: 13.6-21.0] versus 3.4 [95% CI: 1.1-7.8]). CONCLUSION: The high incidence rate among persons with indeterminate results underscores the public health concerns for HSV-2 spread and underreporting of the HSV-2 burden. Careful consideration is needed when interpreting HSV-2 serology results in these settings.

Establishment of reference intervals during normal pregnancy through six months postpartum in western Kenya.

BACKGROUND: Pregnancy is associated with changes in hematological and biochemistry values, yet there are no African reference intervals for clinical management of pregnant women. We sought to 1) develop laboratory reference intervals during pregnancy and up to 24 weeks postpartum and 2) determine the proportion of women in a previous clinical trial who would be misclassified as having out-of-range values using reference intervals from a United States (U.S.) population. METHODS AND FINDINGS: This was a longitudinal sub-study of 120 clinically healthy, HIV-uninfected, self-selected pregnant women seeking antenatal care services at either of two public hospitals in western Kenya. Blood specimens were obtained from consented women at gestational ages 28 and 36 weeks and at 2, 6, 14 and 24 weeks postpartum. Median and 95% reference intervals were calculated for immune-hematological and biochemistry parameters and compared to reference intervals from a Kenyan and United States (U.S.) population, using Wilcoxon tests. Differences with p≤0.05 were considered significant. Some hematological parameters, including hemoglobin and neutrophils showed significant variations compared to reference intervals for non-pregnant women. Hemoglobin values were significantly lower during pregnancy but were comparable to the values in non-pregnant women by 6 weeks postpartum. CD4, CD8 and platelets were significantly elevated in early postpartum but declined gradually, reaching normal levels by 24 weeks postpartum. Using the new hemoglobin reference levels from this study to estimate prevalence of 'out of range' values in a prior Kisumu research cohort of pregnant/postpartum women, resulted in 0% out of range values, in contrast to 96.3% using US non-pregnant reference values. CONCLUSION: There were substantial differences in U.S. and Kenyan values for immune-hematological parameters among pregnant/postpartum women, specifically in red blood cell parameters in late pregnancy and 2 weeks postpartum. Use of U.S. reference intervals markedly increases likelihood of out of range values, highlighting the need for suitable locally developed reference intervals.

Viral and Host Characteristics of Recent and Established HIV-1 Infections in Kisumu based on a Multiassay Approach.

Integrated approaches provide better understanding of HIV/AIDS epidemics. We optimised a multiassay algorithm (MAA) and assessed HIV incidence, correlates of recent infections, viral diversity, plus transmission clusters among participants screened for Kisumu Incidence Cohort Study (KICoS1) (2007-2009). We performed BED-CEIA, Limiting antigen (LAg) avidity, Biorad avidity, and viral load (VL) tests on HIV-positive samples. Genotypic analyses focused on HIV-1 pol gene. Correlates of testing recent by MAA were assessed using logistic regression model. Overall, 133 (12%, 95% CI: 10.2-14.1) participants were HIV-positive, of whom 11 tested recent by MAA (BED-CEIA OD-n < 0.8 + LAg avidity OD-n < 1.5 + VL > 1000 copies/mL), giving an incidence of 1.46% (95% CI: 0.58-2.35) per year. This MAA-based incidence was similar to longitudinal KICoS1 incidence. Correlates of testing recent included sexually transmitted infection (STI) treatment history (OR = 3.94, 95% CI: 1.03-15.07) and syphilis seropositivity (OR = 10.15, 95% CI: 1.51-68.22). Overall, HIV-1 subtype A (63%), D (15%), C (3%), G (1%) and recombinants (18%), two monophyletic dyads and intrinsic viral mutations (V81I, V81I/V, V108I/V and K101Q) were observed. Viral diversity mirrored known patterns in this region, while resistance mutations reflected likely non-exposure to antiretroviral drugs. Management of STIs may help address ongoing HIV transmission in this region.

Prevalence of reproductive tract infections and the predictive value of girls' symptom-based reporting: findings from a cross-sectional survey in rural western Kenya.

OBJECTIVES: Reproductive tract infections (RTIs), including sexually acquired, among adolescent girls is a public health concern, but few studies have measured prevalence in low-middle-income countries. The objective of this study was to examine prevalence in rural schoolgirls in Kenya against their reported symptoms. METHODS: In 2013, a survey was conducted in 542 adolescent schoolgirls aged 14-17 years who were enrolled in a menstrual feasibility study. Vaginal self-swabbing was conducted after girls were interviewed face-to-face by trained nurses on symptoms. The prevalence of girls with symptoms and laboratory-confirmed infections, and the sensitivity, specificity, positive and negative predictive values of symptoms compared with laboratory results, were calculated. RESULTS: Of 515 girls agreeing to self-swab, 510 answered symptom questions. A quarter (24%) reported one or more symptoms; most commonly vaginal discharge (11%), pain (9%) or itching (4%). Laboratory tests confirmed 28% of girls had one or more RTI. Prevalence rose with age; among girls aged 16-17 years, 33% had infections. Bacterial vaginosis was the most common (18%), followed by Candida albicans (9%), Chlamydia trachomatis (3%), Trichomonas vaginalis (3%) and Neisseria gonorrhoeae (1%). Reported symptoms had a low sensitivity and positive predictive value. Three-quarters of girls with bacterial vaginosis and C. albicans, and 50% with T. vaginalis were asymptomatic. CONCLUSIONS: There is a high prevalence of adolescent schoolgirls with RTI in rural Kenya. Public efforts are required to identify and treat infections among girls to reduce longer-term sequelae but poor reliability of symptom reporting minimises utility of symptom-based diagnosis in this population. TRIAL REGISTRATION NUMBER: ISRCTN17486946.

Anaemia in HIV-infected pregnant women receiving triple antiretroviral combination therapy for prevention of mother-to-child transmission: a secondary analysis of the Kisumu breastfeeding study (KiBS).

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.

Anemia and Red Blood Cell Abnormalities in HIV-Infected and HIV-Exposed Breastfed Infants: A Secondary Analysis of the Kisumu Breastfeeding Study.

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.