A national household survey on HIV prevalence and clinical cascade among children aged ≤15 years in Kenya (2018).

We analyzed data from the 2018 Kenya Population-Based HIV Impact Assessment (KENPHIA), a cross-sectional, nationally representative survey, to estimate the burden and prevalence of pediatric HIV infection, identify associated factors, and describe the clinical cascade among children aged < 15 years in Kenya. Interviewers collected information from caregivers or guardians on child's demographics, HIV testing, and treatment history. Blood specimens were collected for HIV serology and if HIV-positive, the samples were tested for viral load and antiretrovirals (ARV). For participants <18 months TNA PCR is performed. We computed weighted proportions with 95% confidence intervals (CI), accounting for the complex survey design. We used bivariable and multivariable logistic regression to assess factors associated with HIV prevalence. Separate survey weights were developed for interview responses and for biomarker testing to account for the survey design and non-response. HIV burden was estimated by multiplying HIV prevalence by the national population projection by age for 2018. Of 9072 survey participants (< 15 years), 87% (7865) had blood drawn with valid HIV test results. KENPHIA identified 57 HIV-positive children, translating to an HIV prevalence of 0.7%, (95% CI: 0.4%-1.0%) and an estimated 138,900 (95% CI: 84,000-193,800) of HIV among children in Kenya. Specifically, children who were orphaned had about 2 times higher odds of HIV-infection compared to those not orphaned, adjusted Odds Ratio (aOR) 2.2 (95% CI:1.0-4.8). Additionally, children whose caregivers had no knowledge of their HIV status also had 2 times higher odds of HIV-infection compared to whose caregivers had knowledge of their HIV status, aOR 2.4 (95% CI: 1.1-5.4)". From the unconditional analysis; population level estimates, 78.9% of HIV-positive children had known HIV status (95% CI: 67.1%-90.2%), 73.6% (95% CI: 60.9%-86.2%) were receiving ART, and 49% (95% CI: 32.1%-66.7%) were virally suppressed. However, in the clinical cascade for HIV infected children, 92% (95% CI: 84.4%-100%) were receiving ART, and of these, 67.1% (95% CI: 45.1%-89.2%) were virally suppressed. The KENPHIA survey confirms a substantial HIV burden among children in Kenya, especially among orphans.

'They can stigmatize you': a qualitative assessment of the influence of school factors on engagement in care and medication adherence among adolescents with HIV in Western Kenya.

School-related factors may influence retention in care and adherence to antiretroviral therapy (ART) among adolescents with human immunodeficiency virus (HIV). We analyzed data from in-depth interviews with 40 adolescents with HIV (aged 14 -19 years), 40 caregivers of adolescents with HIV, and 4 focus group discussions with healthcare workers to evaluate contextual factors affecting adherence to ART and clinic attendance among adolescents, with a focus on the school environment. Informed by Anderson's Model of Health Services Utilization, transcripts were systematically coded and synthesized to identify school-related themes. All groups identified the school environment as a critical barrier to engagement in HIV care and medication adherence for adolescents with HIV. Adolescent participants reported inflexible school schedules and disclosure to school staff as the biggest challenges adhering to clinic appointments and ART. Adolescents described experiencing stigma and discrimination by peers and school staff and would adjust when, where and how often they took ART to avoid inadvertent disclosure. Boarding school students faced challenges because they had limited private space or time. Caregivers were often instrumental in navigating school permissions, including identifying a treatment supporter among school staff. Additional research engaging school staff may guide interventions for schools to reduce stigma and improve adherence and retention.

The development of task sharing policy and guidelines in Kenya.

BACKGROUND: The global critical shortage of health workers prevents expansion of healthcare services and universal health coverage. Like most countries in sub-Saharan Africa, Kenya's healthcare workforce density of 13.8 health workers per 10,000 population falls below the World Health Organization (WHO) recommendation of at least 44.5 doctors, nurses, and midwives per 10,000 population. In response to the health worker shortage, the WHO recommends task sharing, a strategy that can increase access to quality health services. To improve the utilization of human and financial health resources in Kenya for HIV and other essential health services, the Kenya Ministry of Health (MOH) in collaboration with various institutions developed national task sharing policy and guidelines (TSP). To advance task sharing, this article describes the process of developing, adopting, and implementing the Kenya TSP. CASE PRESENTATION: The development and approval of Kenya's TSP occurred from February 2015 to May 2017. The U.S. Centers for Disease Control and Prevention (CDC) allocated funding to Emory University through the United States President's Emergency Plan for AIDS Relief (PEPFAR) Advancing Children's Treatment initiative. After obtaining support from leadership in Kenya's MOH and health professional institutions, the TSP team conducted a desk review of policies, guidelines, scopes of practice, task analyses, grey literature, and peer-reviewed research. Subsequently, a Policy Advisory Committee was established to guide the process and worked collaboratively to form technical working groups that arrived at consensus and drafted the policy. The collaborative, multidisciplinary process led to the identification of gaps in service delivery resulting from health workforce shortages. This facilitated the development of the Kenya TSP, which provides a general orientation of task sharing in Kenya. The guidelines list priority tasks for sharing by various cadres as informed by evidence, such as HIV testing and counseling tasks. The TSP documents were disseminated to all county healthcare facilities in Kenya, yet implementation was stopped by order of the judiciary in 2019 after a legal challenge from an association of medical laboratorians. CONCLUSIONS: Task sharing may increase access to healthcare services in resource-limited settings. To advance task sharing, TSP and clinical practice could be harmonized, and necessary adjustments made to other policies that regulate practice (e.g., scopes of practice). Revisions to pre-service training curricula could be conducted to ensure health professionals have the requisite competencies to perform shared tasks. Monitoring and evaluation can help ensure that task sharing is implemented appropriately to ensure quality outcomes.

Higher prevalence of stunting and poor growth outcomes in HIV-exposed uninfected than HIV-unexposed infants in Kenya.

BACKGROUND: With the growing population of HIV-exposed uninfected (HEU) children globally, it is important to determine population-level growth differences between HEU and HIV-unexposed uninfected (HUU) children. METHODS: We analyzed data from a population-level survey enrolling mother-infant pairs attending 6-week and 9-month immunizations in 140 clinics across Kenya. Weight-for-age (WAZ), length-for-age (LAZ), head circumference-for-age (HCAZ) z-scores and underweight (WAZ < -2), stunting (LAZ < -2), and microcephaly (HCAZ < -2), were compared between HEU and HUU. Correlates of growth faltering and poor growth were assessed using generalized Poisson and linear regression models. RESULTS: Among 2457 infants, 456 (19%) were HEU. Among mothers living with HIV, 64% received antiretroviral therapy (ART) and 22% were on antiretroviral prophylaxis during pregnancy. At 9 months, 72% of HEU and 98% of HUU were breastfeeding. At 6 weeks, HEU had lower mean WAZ (-0.41 vs. -0.09; P < 0.001) and LAZ (-0.99 vs. -0.31; P = 0.001) than HUU. Stunting was higher in HEU than HUU at 6 weeks (34% vs. 18%, P < 0.001) and 9 months (20% vs. 10%, P < 0.001). In multivariable analyses, HEU had lower mean LAZ at 6 weeks (-0.67, 95% confidence interval [CI]: -1.07, -0.26) and 9 months (-0.57, 95% CI: -0.92, -0.21) and HEU had higher stunting prevalence (week-6 adjusted prevalence ratio [aPR]: 1.88, 95% CI: 1.35, 2.63; month-9 aPR: 2.10, 95% CI: 1.41, 3.13). HEU had lower mean head circumference (-0.49, 95% CI: -0.91, -0.07) and higher prevalence of microcephaly (aPR: 2.21, 95% CI: 1.11, 4.41) at 9 months. CONCLUSION: Despite high maternal ART coverage, HEU had poorer growth than HUU in this large population-level comparison. Optimizing breastfeeding practices in HEU may be useful to improve growth.

A clinical decision support system is associated with reduced loss to follow-up among patients receiving HIV treatment in Kenya: a cluster randomized trial.

BACKGROUND: Loss to follow-up (LFTU) among HIV patients remains a major obstacle to achieving treatment goals with the risk of failure to achieve viral suppression and thereby increased HIV transmission. Although use of clinical decision support systems (CDSS) has been shown to improve adherence to HIV clinical guidance, to our knowledge, this is among the first studies conducted to show its effect on LTFU in low-resource settings. METHODS: We analyzed data from a cluster randomized controlled trial in adults and children (aged ≥ 18 months) who were receiving antiretroviral therapy at 20 HIV clinics in western Kenya between Sept 1, 2012 and Jan 31, 2014. Participating clinics were randomly assigned, via block randomization. Clinics in the control arm had electronic health records (EHR) only while the intervention arm had an EHR with CDSS. The study objectives were to assess the effects of a CDSS, implemented as alerts on an EHR system, on: (1) the proportion of patients that were LTFU, (2) LTFU patients traced and successfully linked back to treatment, and (3) time from enrollment on the study to documentation of LTFU. RESULTS: Among 5901 eligible patients receiving ART, 40.6% (n = 2396) were LTFU during the study period. CDSS was associated with lower LTFU among the patients (Adjusted Odds Ratio-aOR 0.70 (95% CI 0.65-0.77)). The proportions of patients linked back to treatment were 25.8% (95% CI 21.5-25.0) and 30.6% (95% CI 27.9-33.4)) in EHR only and EHR with CDSS sites respectively. CDSS was marginally associated with reduced time from enrollment on the study to first documentation of LTFU (adjusted Hazard Ratio-aHR 0.85 (95% CI 0.78-0.92)). CONCLUSION: A CDSS can potentially improve quality of care through reduction and early detection of defaulting and LTFU among HIV patients and their re-engagement in care in a resource-limited country. Future research is needed on how CDSS can best be combined with other interventions to reduce LTFU. Trial registration NCT01634802. Registered at www.clinicaltrials.gov on 12-Jul-2012. Registered prospectively.

Associations of Sociodemographic and Clinical Factors with Late Presentation for Early Infant HIV Diagnosis (EID) Services in Kenya.

BACKGROUND: Understanding the missed opportunities in early infant HIV testing within the PMTCT program is essential to address any gaps. The study set out to describe the clinical and sociodemographic characteristics of the infants presenting late for early infant diagnosis in Kenya. METHODS: We abstracted routinely collected clinical and sociodemographic characteristics, in a cross-sectional study, on all HIV-infected infants with a positive polymerase chain reaction (PCR) test from 1,346 President's Emergency Plan for AIDS Relief (PEPFAR) supported health facilities for the period October 2016 to September 2018. We used multivariate logistic regression to examine the association of sociodemographic and clinical characteristics with late (>2 months after birth) presentation for infant HIV testing. RESULTS: Of the 4,011 HIV-infected infants identified, the median infant age at HIV diagnosis was 3 months [interquartile range (IQR), 1-16 months], and two-thirds [2,669 (66.5%)] presented late for infant HIV testing. Factors that were associated with late presentation for infant testing were: maternal ANC non-attendance, adjusted odds ratio (aOR) 1.41 (95% confidence interval (CI) 1.18 -1.69); new maternal HIV diagnosis, aOR 1.45, (95%CI 1.24 -1.7); and lack of maternal antiretroviral therapy(ART), aOR 1.94, (95% CI 1.64 - 2.30). There was a high likelihood of identifying HIV-infected infants among infants who presented for medical services in the outpatient setting (aOR 18.9; 95% CI 10.2 - 34.9) and inpatient setting (aOR 12.2; 95% CI 6.23-23.9) compared to the infants who presented late in maternity. CONCLUSION AND GLOBAL HEALTH IMPLICATIONS: Gaps in early infant HIV testing suggest the need to increase maternal pre-pregnancy HIV diagnosis, timely antenatal care, early infant diagnosis services, early identification of mothers who seroconvert during pregnancy or breastfeeding and improved HIV screening in outpatient and inpatient settings. Early referral from the community and access to health facilities should be strengthened by the implementation of national PMTCT guidelines.

Factors Associated with Loss to Follow-Up Among Patients Receiving HIV Treatment in Nairobi, Kenya.

We investigated factors associated with loss to follow-up (LTFU) in 24 urban health facilities in Nairobi, Kenya. We conducted a retrospective analysis of routinely collected data to assess factors associated with LTFU in the period October 1, 2016, to June 30, 2017. LTFU was defined as no antiretroviral therapy (ART) refill for ≥90 days and no documentation of transfer, death, or treatment cessation in the patient chart, and if no lapse of ≥90 days between ART refills, patients were considered retained in care. Multivariable logistic regression modeling was used to compute odds ratios and 95% confidence interval (CI) for LTFU. Our analysis included 633 individuals who were LTFU and 13,098 individuals retained in care. Most participants (69.6%) were women, and median age was 33.0 years (interquartile range, 27.2-38.3 years). Median ART duration was shorter among those LTFU (0.4 years) than retained patients (2.5 years, p < .0001). Being male [adjusted odds ratio (aOR) 1.30; 95% CI: 1.04-1.63, p = .02], transferring into facilities while already receiving ART (aOR 11.58; 95% CI: 8.23-16.29, p < .0001), and having a shorter ART duration (<6 months) were associated with increased odds of LTFU. Patients who transferred into a facility while already receiving ART had the highest adjusted odds of being LTFU compared with those retained in care. In this urban and highly mobile population, transferring into facilities while already receiving ART was strongly associated with LTFU. Focusing programming efforts on patients transferring between urban clinics to identify reasons for transfer and potential barriers to treatment adherence could help improve patient outcomes. Supplementary case management and support may be needed to promote a seamless transition and ensure uninterrupted engagement in HIV care and treatment.

Piperaquine Pharmacokinetics during Intermittent Preventive Treatment for Malaria in Pregnancy.

Dihydroartemisinin-piperaquine (DP) is a long-acting artemisinin combination treatment that provides effective chemoprevention and has been proposed as an alternative antimalarial drug for intermittent preventive therapy in pregnancy (IPTp). Several pharmacokinetic studies have shown that dose adjustment may not be needed for the treatment of malaria in pregnancy with DP. However, there are limited data on the optimal dosing for IPTp. This study aimed to evaluate the population pharmacokinetics of piperaquine given as IPTp in pregnant women. Pregnant women were enrolled in clinical trials conducted in Kenya and Indonesia and treated with standard 3-day courses of DP, administered in 4- to 8-week intervals from the second trimester until delivery. Pharmacokinetic blood samples were collected for piperaquine drug measurements before each treatment round, at the time of breakthrough symptomatic malaria, and at delivery. Piperaquine population pharmacokinetic properties were investigated using nonlinear mixed-effects modeling with a prior approach. In total, data from 366 Kenyan and 101 Indonesian women were analyzed. The pharmacokinetic properties of piperaquine were adequately described using a flexible transit absorption (n = 5) followed by a three-compartment disposition model. Gestational age did not affect the pharmacokinetic parameters of piperaquine. After three rounds of monthly IPTp, 9.45% (95% confidence interval [CI], 1.8 to 26.5%) of pregnant women had trough piperaquine concentrations below the suggested target concentration (10.3 ng/ml). Translational simulations suggest that providing the full treatment course of DP at monthly intervals provides sufficient protection to prevent malaria infection. Monthly administration of DP has the potential to offer optimal prevention of malaria during pregnancy. (This study has been registered at ClinicalTrials.gov under identifier NCT01669941 and in the ISRCTN under number ISRCTN34010937.).

"They Just Tell Me to Abstain:" Variable Access to and Uptake of Sexual and Reproductive Health Services Among Adolescents Living With HIV in Kenya.

Background: To improve holistic care for adolescents living with HIV (ALHIV), including integration of sexual and reproductive health services (SRHS), the Kenya Ministry of Health implemented an adolescent package of care (APOC). To inform optimized SRH service delivery, we sought to understand the experiences with SRHS for ALHIV, their primary caregivers, and health care workers (HCWs) following APOC implementation. Methods: We completed a mixed methods evaluation to characterize SRHS provided and personal experiences with access and uptake using surveys conducted with facility managers from 102 randomly selected large HIV treatment facilities throughout Kenya. Among a subset of 4 APOC-trained facilities in a high burden county, we conducted in-depth interviews (IDIs) with 40 ALHIV and 40 caregivers of ALHIV, and 4 focus group discussions (FGDs) with HCWs. Qualitative data was analyzed using thematic analysis. Facility survey data was analyzed using descriptive statistics. Results: Of 102 surveyed facilities, only 56% reported training in APOC and 12% reported receiving additional adolescent-related SRHS training outside of APOC. Frequency of condom provision to ALHIV varied, with 65% of facilities providing condoms daily and 11% never providing condoms to ALHIV. Family planning (FP) was provided to ALHIV daily in 60% of facilities, whereas 14% of facilities reported not providing any FP services to ALHIV. Screening and treatment for STIs for adolescents were provided at all clinics, with 67% providing STI services daily. Three key themes emerged characterizing experiences with adolescent SRHS access and uptake: (1) HCWs were the preferred source for SRH information, (2) greater adolescent autonomy was a facilitator of SRH discussions with HCWs, and (3) ALHIV had variable access to and limited uptake of SRHS within APOC-trained health facilities. The primary SRHS reported available to ALHIV were abstinence and condom use education. There was variable access to FP, condoms, pregnancy and STI testing, and partner services. Adolescents reported limited utilization of SRHS beyond education. Conclusions: Our results indicate a gap in SRHS offered within APOC trained facilities and highlight the importance of adolescent autonomy when providing SRHS and further HCW training to improve SRHS integration within HIV care for ALHIV.

Male partner antenatal clinic attendance is associated with increased uptake of maternal health services and infant BCG immunization: a national survey in Kenya.

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

Noncommunicable disease burden among HIV patients in care: a national retrospective longitudinal analysis of HIV-treatment outcomes in Kenya, 2003-2013.

BACKGROUND: Over the last decade, the Kenyan HIV treatment program has grown exponentially, with improved survival among people living with HIV (PLHIV). In the same period, noncommunicable diseases (NCDs) have become a leading contributor to disease burden. We sought to characterize the burden of four major NCDs (cardiovascular diseases, cancer, chronic respiratory diseases and diabetes mellitus) among adult PLHIV in Kenya. METHODS: We conducted a nationally representative retrospective medical chart review of HIV-infected adults aged ≥15 years enrolled in HIV care in Kenya from October 1, 2003 through September 30, 2013. We estimated proportions of four NCD categories among PLHIV at enrollment into HIV care, and during subsequent HIV care visits. We compared proportions and assessed distributions of co-morbidities using the Chi-Square test. We calculated NCD incidence rates and their confidence intervals in assessing cofactors for developing NCDs. RESULTS: We analyzed 3170 records of HIV-infected patients; 2115 (66.3%) were from women. Slightly over half (51.1%) of patient records were from PLHIVs aged above 35 years. Close to two-thirds (63.9%) of PLHIVs were on ART. Proportion of any documented NCD among PLHIV was 11.5% (95% confidence interval [CI] 9.3, 14.1), with elevated blood pressure as the most common NCD 343 (87.5%) among PLHIV with a diagnosed NCD. Despite this observation, only 17 (4.9%) patients had a corresponding documented diagnosis of hypertension in their medical record. Overall NCD incidence rates for men and women were (42.3 per 1000 person years [95% CI 35.8, 50.1] and 31.6 [95% CI 27.7, 36.1], respectively. Compared to women, the incidence rate ratio for men developing an NCD was 1.3 [95% CI 1.1, 1.7], p = 0.0082). No differences in NCD incidence rates were seen by marital or employment status. At one year of follow up 43.8% of PLHIV not on ART had been diagnosed with an NCD compared to 3.7% of patients on ART; at five years the proportions with a diagnosed NCD were 88.8 and 39.2% (p < 0.001), respectively. CONCLUSIONS: PLHIV in Kenya have a high prevalence of NCD diagnoses. In the absence of systematic, effective screening, NCD burden is likely underestimated in this population. Systematic screening and treatment for NCDs using standard guidelines should be integrated into HIV care and treatment programs in sub-Saharan Africa.

Disclosure and Clinical Outcomes Among Young Adolescents Living With HIV in Kenya.

PURPOSE: Informing adolescents of their own HIV infection is critical as the number of adolescents living with HIV increases. We assessed the association between HIV disclosure and retention in care and mortality among adolescents aged 10-14 years in Kenya's national program. METHODS: We abstracted routinely collected patient-level data for adolescents enrolled into HIV care in 50 health facilities from November 1, 2004, through March 31, 2010. We defined disclosure as any documentation that the adolescent had been fully or partially made aware of his or her HIV status. We compared weighted proportions for categorical variables using χ2 and weighted logistic regression to identify predictors of HIV disclosure; we estimated the probability of LTFU using Kaplan-Meier methods and dying using Cox regression-based test for equality of survival curves. RESULTS: Of the 710 adolescents aged 10-14 years analyzed; 51.3% had severe immunosuppression, 60.3% were in WHO stage 3 or 4, and 36.6% were aware of their HIV status. Adolescents with HIV-infected parents, histories of opportunistic infections (OIs), and enrolled in support groups were more likely to be disclosed to. At 36 months, disclosure was associated with lower mortality [1.5% (95% CI .6%-4.1%) versus 5.4% (95% CI 3.6.6%-8.0%, p < .001)] and lower LTFU [6.2% (95% CI 3.0%-12.6%) versus 33.9% (95% CI 27.3%-41.1%) p < .001]. CONCLUSIONS: Only one third of HIV-infected Kenyan adolescents in treatment programs had been told they were infected, and knowing their HIV status was associated with reduced LTFU and mortality. The disclosure process should be systematically encouraged and organized for HIV-infected adolescents.

Preexposure Prophylaxis for Human Immunodeficiency Virus (HIV) Prevention Among HIV-uninfected Pregnant Women: Estimated Coverage Using Risk-based Versus Regional Prevalence Approaches.

Antenatal register data from 62 clinics in 5 regions of Kenya were used to estimate women with human immunodeficiency virus (HIV) risk (partner HIV status, syphilis). With individual risk-guided preexposure prophylaxis (PrEP) offer in all regions, 39% of pregnant women would be offered PrEP nationally. Offering PrEP to all women in high-prevalence regions reached 26% of the pregnant women.

Short Communication: Reduced Nevirapine Concentrations Among HIV-Positive Women Receiving Mefloquine for Intermittent Preventive Treatment for Malaria Control During Pregnancy.

Clinical trials demonstrated intermittent preventive treatment in pregnancy with mefloquine (MQ) reduced malaria rates among pregnant women, yet an unexpected higher risk of mother-to-child transmission (MTCT) of HIV among HIV-positive women receiving MQ has also been observed. To determine if interactions between antiretroviral drugs (ARVs) and MQ could contribute to the increased MTCT observed in women receiving MQ, we performed a retrospective cross-sectional analysis of ARV plasma concentrations in peripheral blood (maternal plasma) and cord blood (cord plasma) collected at delivery from 186 mothers participating in a randomized clinical trial of MQ (n = 102) compared with placebo (n = 84) in Kenya. Plasma zidovudine (AZT), lamivudine (3TC), and nevirapine (NVP) concentrations were measured by high-performance liquid chromatography-tandem mass spectrometry. Although only 4% (7/186) reported not using these ARVs, AZT, 3TC, and NVP were all below the limit of detection in 44% of maternal plasma and 42% of cord plasma samples, and proportions were similar between the two study arms. Median concentrations of AZT and 3TC were not significantly lower in the MQ arm compared with the placebo arm for maternal plasma and cord plasma (p > .05). However, median NVP concentrations were significantly lower in the MQ study arm compared with the placebo study arm in both maternal plasma (1,597 ng/mL vs. 2,353 ng/mL, Mann-Whitney Rank Sum, p = .023) and cord plasma (2,038 ng/mL vs. 2,434 ng/mL, p = .048). Reduced NVP concentrations in maternal and cord plasma of women receiving MQ suggest MQ may affect NVP metabolism for both mother and infant. These results highlight the need to evaluate potential drug-drug interactions between candidate antimalarials and ARVs for use in pregnant women.

Prevalence and correlates of non-disclosure of maternal HIV status to male partners: a national survey in Kenya.

BACKGROUND: Prevention of mother-to-child HIV transmission (PMTCT) programs usually test pregnant women for HIV without involving their partners. Non-disclosure of maternal HIV status to male partners may deter utilization of PMTCT interventions since partners play a pivotal role in decision-making within the home including access to and utilization of health services. METHODS: Mothers attending routine 6-week and 9-month infant immunizations were enrolled at 141 maternal and child health (MCH) clinics across Kenya from June-December 2013. The current analysis was restricted to mothers with known HIV status who had a current partner. Multivariate logistic regression models adjusted for marital status, relationship length and partner attendance at antenatal care (ANC) were used to determine correlates of HIV non-disclosure among HIV-uninfected and HIV-infected mothers, separately, and to evaluate the relationship of non-disclosure with uptake of PMTCT interventions. All analyses accounted for facility-level clustering, RESULTS: Overall, 2522 mothers (86% of total study population) met inclusion criteria, 420 (17%) were HIV-infected. Non-disclosure of HIV results to partners was higher among HIV-infected than HIV-uninfected women (13% versus 3% respectively, p < 0.001). HIV-uninfected mothers were more likely to not disclose their HIV status to male partners if they were unmarried (adjusted odds ratio [aOR] = 3.79, 95% CI: 1.56-9.19, p = 0.004), had low (≤KSH 5000) income (aOR = 1.85, 95% CI: 1.00-3.14, p = 0.050), experienced intimate partner violence (aOR = 3.65, 95% CI: 1.84-7.21, p < 0.001) and if their partner did not attend ANC (aOR = 4.12, 95% CI: 1.89-8.95, p < 0.001). Among HIV-infected women, non-disclosure to male partners was less likely if women had salaried employment (aOR = 0.42, 95%CI: 0.18-0.96, p = 0.039) and each increasing year of relationship length was associated with decreased likelihood of non-disclosure (aOR = 0.90, 95% CI: 0.82-0.98, p = 0.015 for each year increase). HIV-infected women who did not disclose their HIV status to partners were less likely to uptake CD4 testing (aOR = 0.32, 95% CI: 0.15-0.69, p = 0.004), to use antiretrovirals (ARVs) during labor (OR = 0.38, 95% CI 0.15-0.97, p = 0.042), or give their infants ARVs (OR = 0.08, 95% CI 0.02-0.31, p < 0.001). CONCLUSION: HIV-infected women were less likely to disclose their status to partners than HIV-uninfected women. Non-disclosure was associated with lower use of PMTCT services. Facilitating maternal disclosure to male partners may enhance PMTCT uptake.

Spatial-temporal trend for mother-to-child transmission of HIV up to infancy and during pre-Option B+ in western Kenya, 2007-13.

INTRODUCTION: Using spatial-temporal analyses to understand coverage and trends in elimination of mother-to-child transmission of HIV (e-MTCT) efforts may be helpful in ensuring timely services are delivered to the right place. We present spatial-temporal analysis of seven years of HIV early infant diagnosis (EID) data collected from 12 districts in western Kenya from January 2007 to November 2013, during pre-Option B+ use. METHODS: We included in the analysis infants up to one year old. We performed trend analysis using extended Cochran-Mantel-Haenszel stratified test and logistic regression models to examine trends and associations of infant HIV status at first diagnosis with: early diagnosis (<8 weeks after birth), age at specimen collection, infant ever having breastfed, use of single dose nevirapine, and maternal antiretroviral therapy status. We examined these covariates and fitted spatial and spatial-temporal semiparametric Poisson regression models to explain HIV-infection rates using R-integrated nested Laplace approximation package. We calculated new infections per 100,000 live births and used Quantum GIS to map fitted MTCT estimates for each district in Nyanza region. RESULTS: Median age was two months, interquartile range 1.5-5.8 months. Unadjusted pooled positive rate was 11.8% in the seven-years period and declined from 19.7% in 2007 to 7.0% in 2013, p < 0.01. Uptake of testing ≤8 weeks after birth was under 50% in 2007 and increased to 64.1% by 2013, p < 0.01. By 2013, the overall standardized MTCT rate was 447 infections per 100,000 live births. Based on Bayesian deviance information criterion comparisons, the spatial-temporal model with maternal and infant covariates was best in explaining geographical variation in MTCT. DISCUSSION: Improved EID uptake and reduced MTCT rates are indicators of progress towards e-MTCT. Cojoined analysis of time and covariates in a spatial context provides a robust approach for explaining differences in programmatic impact over time. CONCLUSION: During this pre-Option B+ period, the prevention of mother to child transmission program in this region has not achieved e-MTCT target of ≤50 infections per 100,000 live births. Geographical disparities in program achievements may signify gaps in spatial distribution of e-MTCT efforts and could indicate areas needing further resources and interventions.

Non-disclosure to male partners and incomplete PMTCT regimens associated with higher risk of mother-to-child HIV transmission: a national survey in Kenya.

Health worker experience and community support may be higher in high HIV prevalence regions than low prevalence regions, leading to improved prevention of mother-to-child HIV transmission (PMTCT) programs. We evaluated 6-week and 9-month infant HIV transmission risk (TR) in a high prevalence region and nationally. Population-proportionate-to-size sampling was used to select 141 clinics in Kenya, and mobile teams surveyed mother-infant pairs attending 6-week and 9-month immunizations. HIV DNA testing was performed on HIV-exposed infants. Among 2521 mother-infant pairs surveyed nationally, 2423 (94.7%) reported HIV testing in pregnancy or prior diagnosis, of whom 200 (7.4%) were HIV-infected and 188 infants underwent HIV testing. TR was 8.8% (4.0%-18.3%) in 6-week and 8.9% (3.2%-22.2%) in 9-month cohorts including mothers with HIV diagnosed postpartum, of which 53% of infant infections were due to previously undiagnosed mothers. Of 276 HIV-exposed infants in the Nyanza survey, TR was 1.4% (0.4%-5.3%) at 6-week and 5.1% (2.5%-9.9%) at 9-months. Overall TR was lower in Nyanza, high HIV region, than nationally (3.3% vs. 7.2%, P = 0.02). HIV non-disclosure to male partners and incomplete ARVs were associated with TR in both surveys [aOR = 12.8 (3.0-54.3); aOR = 5.6 (1.2-27.4); aOR = 4.5 (1.0-20.0), aOR = 2.5, (0.8-8.4), respectively]. TR was lower in a high HIV prevalence region which had better ARV completion and partner HIV disclosure, possibly due to programmatic efficiencies or community/peer/partner support. Most 9-month infections were among infants of mothers without prior HIV diagnosis. Strategies to detect incident or undiagnosed maternal infections will be important to achieve PMTCT.

High Prevalence of Abacavir-associated L74V/I Mutations in Kenyan Children Failing Antiretroviral Therapy.

A survey of 461 HIV-infected Kenyan children receiving antiretroviral therapy found 143 (31%) failing virologically. Drug resistance mutations were found in 121; 37 had L74V/I mutations, with 95% receiving abacavir (ABC)-containing regimens. L74V/I was associated with current ABC usage (P = 0.0001). L74V/I may be more prevalent than previously realized in children failing ABC-containing regimens, even when time on treatment has been short. Ongoing rigorous pediatric drug resistance surveillance is needed.

Gaps in Adolescent Engagement in Antenatal Care and Prevention of Mother-to-Child HIV Transmission Services in Kenya.

BACKGROUND: Rates of pregnancy and HIV infection are high among adolescents. However, their engagement in prevention of mother-to-child HIV transmission (PMTCT) services is poorly characterized. We compared engagement in the PMTCT cascade between adult and adolescent mothers in Kenya. METHODS: We conducted a nationally representative cross-sectional survey of mother-infant pairs attending 120 maternal child health clinics selected by probability proportionate to size sampling, with a secondary survey oversampling HIV-positive mothers in 30 clinics. Antenatal care (ANC) attendance, HIV testing, and antiretroviral (ARV) use were compared between adolescent (age ≤19 years) and adult mothers using χ tests and logistic regression. RESULTS: Among 2521 mothers, 278 (12.8%) were adolescents. Adolescents were less likely than adults to be employed (16.5% vs. 37.9%), married (66.1% vs. 88.3%), have intended pregnancy (40.5% vs. 58.6%), or have disclosed their HIV status (77.5% vs. 90.7%) (P < 0.01 for all). Adolescents were less likely than adults to attend ≥4 ANC visits (35.2% vs. 45.6%, P = 0.002). This effect remained significant when adjusting for employment, household crowding, pregnancy intention, gravidity, and HIV status [adjusted odds ratio (95% confidence interval) = 0.54 (0.37 to 0.97), P = 0.001]. Among 2359 women without previous HIV testing, 96.1% received testing during pregnancy; testing levels did not differ between adolescents and adults. Among 288 HIV-positive women not on antiretroviral therapy before pregnancy, adolescents were less likely than adults to be on ARVs (65.0% vs. 85.8%, P = 0.01) or to have infants on ARVs (85.7% vs. 97.7%, P = 0.005). CONCLUSIONS: Adolescent mothers had poorer ANC attendance and uptake of ARVs for PMTCT. Targeted interventions are needed to improve retention of this vulnerable population in the PMTCT cascade.

Rates and Predictors of Non-Adherence to Antiretroviral Therapy among HIV-Positive Individuals in Kenya: Results from the Second Kenya AIDS Indicator Survey, 2012.

INTRODUCTION: Understanding the levels and associated factors of non-adherence to antiretroviral therapy (ART) is crucial in designing interventions to improve adherence and health outcomes of ART. We assessed non-adherence to ART among HIV-infected persons reporting ART use in a nationally representative survey in Kenya. METHODS: The Kenya AIDS Indicator Survey 2012 was a population-based, household survey of persons aged 18 months-64 years conducted in 2012-2013. Self-reported information was collected on demographics, sexual behaviour, HIV status, and ART use. Blood was collected for HIV testing, and if HIV infected, CD4 and viral load testing. HIV-positive specimens were tested for the presence of antiretroviral (ARV) drugs using a qualitative ARV assay using liquid chromatography-tandem mass spectrometry. HIV-positive persons who reported receiving ART but did not have the ARV biomarker present were defined as being non-adherent to their ARV medication. We restricted our analysis to HIV-infected persons aged 15-64 years who reported receiving ART and had laboratory-confirmed results from ARV testing. Multivariate logistic regression was used to identify variables associated with non-adherence. RESULTS: A total of 648 (5.6%; CI 4.9-6.3) tested HIV-positive of whom 559 (86.3%) had sufficient volume of blood to be tested for ARV drugs. Of those, 271 (47.7%; CI 41.8-53.6) self-reported HIV-positive status during the interview and 186 (69.1%; CI 62.2-76.0) of those reported taking ART. The ARV biomarker was absent in 18 of 186 individuals (9.4%; CI 4.9-13.8) who thus were defined as being non-adherent to ART. Non-adherence was associated with being aged 15-29 years (AOR 8.39; CI 2.26-31.22, p = 0.002) compared to aged 30-64 years, rural residence (AOR 5.87; CI 1.39-25.61, p = 0.016) compared with urban residence and taking recreational drugs in the past 30 days (AOR 5.89; CI 1.30-26.70, p = 0.022). CONCLUSION: Overall, less than 10% of Kenyans aged 15-64 years on ART were not adhering to their HIV medication, highlighting the success of the Kenyan national ART program. Our findings, however, point to the need for targeted interventions particularly for young persons, those in rural areas to improve adherence outcomes, as well as delivery of treatment programs that include psychosocial support as a preventative measure to minimize substance abuse and the risk of treatment failure.