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Item Characteristics of HIV-infected adolescents enrolled in a disclosure intervention trial in western Kenya(Taylor & Francis, 2015) Vreeman, Rachel C.; Scanlon, Michael L.; Marete, Irene; Mwangi, Ann; Inui, Thomas S.; McAteer, Carole I.; Nyandiko, Winstone M.; Department of Pediatrics, IU School of MedicineKnowledge of one's own HIV status is essential for long-term disease management, but there are few data on how disclosure of HIV status to infected children and adolescents in sub-Saharan Africa is associated with clinical and psychosocial health outcomes. We conducted a detailed baseline assessment of the disclosure status, medication adherence, HIV stigma, depression, emotional and behavioral difficulties, and quality of life among a cohort of Kenyan children enrolled in an intervention study to promote disclosure of HIV status. Among 285 caregiver-child dyads enrolled in the study, children's mean age was 12.3 years. Caregivers were more likely to report that the child knew his/her diagnosis (41%) compared to self-reported disclosure by children (31%). Caregivers of disclosed children reported significantly more positive views about disclosure compared to caregivers of non-disclosed children, who expressed fears of disclosure related to the child being too young to understand (75%), potential psychological trauma for the child (64%), and stigma and discrimination if the child told others (56%). Overall, the vast majority of children scored within normal ranges on screenings for behavioral and emotional difficulties, depression, and quality of life, and did not differ by whether or not the child knew his/her HIV status. A number of factors were associated with a child's knowledge of his/her HIV diagnosis in multivariate regression, including older age (OR 1.8, 95% CI 1.5-2.1), better WHO disease stage (OR 2.5, 95% CI 1.4-4.4), and fewer reported caregiver-level adherence barriers (OR 1.9, 95% CI 1.1-3.4). While a minority of children in this cohort knew their HIV status and caregivers reported significant barriers to disclosure including fears about negative emotional impacts, we found that disclosure was not associated with worse psychosocial outcomes.Item Contraception use and HIV outcomes among women initiating dolutegravir-containing antiretroviral therapy in Kenya: a retrospective cohort study(Wiley, 2022) Humphrey, John M.; Omodi, Victor; Bernard, Caitlin; Maina, Mercy; Thorne, Julie; Mwangi, Ann; Wools-Kaloustian, Kara; Patel, Rena C.; Medicine, School of MedicineIntroduction: The rollout of dolutegravir (DTG) in low- and middle-income countries was disrupted by a potential association reported with periconceptional DTG exposure among women living with HIV (WLHIV) and infant neural tube defects. This prompted countries to issue interim guidance limiting DTG use among women of reproductive potential to those on effective contraception. Data to understand the potential impact of such guidance on WLHIV are limited. Methods: We conducted a retrospective cohort analysis of WLHIV 15-49 years initiating DTG-containing antiretroviral treatment (ART) in Kenya from 2017 to 2020. We determined baseline effective (oral, injectable or lactational amenorrhea) and very effective (implant, intrauterine device or female sterilization) contraception use among women who initiated DTG before (Group 1) or during (Group 2) the interim guideline period. We defined incident contraception use in each group as the number of contraceptive methods initiated ≤180 days post-guideline (Group 1) or post-DTG initiation (Group 2). We determined the proportions of all women who switched from DTG- to non-nucleoside reverse transcriptase inhibitor (NNRTI)- (efavirenz or nevirapine) containing ART ≤12 months post-DTG initiation, compared their viral suppression (<1000 copies/ml) and conducted multivariable logistic regression to determine factors associated with switching from DTG to NNRTI-containing ART. Results: Among 5155 WLHIV in the analysis (median age 43 years), 89% initiated DTG after transitioning from an NNRTI. Baseline effective and very effective contraception use, respectively, by the group were: Group 1 (12% and 13%) and Group 2 (41% and 35%). Incident contraception use in each group was <5%. Overall, 498 (10%) women switched from DTG to an NNRTI. Viral suppression among those remaining on DTG versus switched to NNRTI was 95% and 96%, respectively (p = 0.63). In multivariable analysis, incident effective and very effective contraception use was not associated with switching. Conclusions: Baseline, but not incident, effective contraception use was higher during the interim guideline period compared to before it, suggesting women already using effective contraception were preferentially selected to initiate DTG after the guideline was released. These findings reveal challenges in the implementation of policy which ties antiretroviral access to contraceptive use. Future guidance should capture nuances of contraception decision-making and support women's agency to make informed decisions.Item A Cross-Sectional Study of Disclosure of HIV Status to Children and Adolescents in Western Kenya(2014-01) Vreeman, Rachel C; Scanlon, Michael L; Mwangi, Ann; Turissini, Matthew; Ayaya, Samuel O; Tenge, Constance; Nyandiko, Winstone MIntroduction Disclosure of HIV status to children is essential for disease management but is not well characterized in resource-limited settings. This study aimed to describe the prevalence of disclosure and associated factors among a cohort of HIV-infected children and adolescents in Kenya. Methods We conducted a cross-sectional study, randomly sampling HIV-infected children ages 6–14 years attending 4 HIV clinics in western Kenya. Data were collected from questionnaires administered by clinicians to children and their caregivers, supplemented with chart review. Descriptive statistics and disclosure prevalence were calculated. Univariate analyses and multivariate logistic regression were performed to assess the association between disclosure and key child-level demographic, clinical and psychosocial characteristics. Results Among 792 caregiver-child dyads, mean age of the children was 9.7 years (SD = 2.6) and 51% were female. Prevalence of disclosure was 26% and varied significantly by age; while 62% of 14-year-olds knew their status, only 42% of 11-year-olds and 21% of 8-year-olds knew. In multivariate regression, older age (OR 1.49, 95%CI 1.35–1.63), taking antiretroviral drugs (OR 2.27, 95%CI 1.29–3.97), and caregiver-reported depression symptoms (OR 2.63, 95%CI 1.12–6.20) were significantly associated with knowing one’s status. Treatment site was associated with disclosure for children attending one of the rural clinics compared to the urban clinic (OR 3.44, 95%CI 1.75–6.76). Conclusions Few HIV-infected children in Kenya know their HIV status. The likelihood of disclosure is associated with clinical and psychosocial factors. More data are needed on the process of disclosure and its impact on children.Item Development, Assessment, and Outcomes of a Community-Based Model of Antiretroviral Care in Western Kenya Through a Cluster-Randomized Control Trial(Wolters Kluwer, 2021-06-01) Goodrich, Suzanne; Siika, Abraham; Mwangi, Ann; Nyambura, Monicah; Naanyu, Violet; Yiannoutsos, Constantin; Spira, Thomas; Bateganya, Moses; Toroitich-Ruto, Cathy; Otieno-Nyunya, Boaz; Wools-Kaloustian, Kara; Medicine, School of MedicineObjective: To develop and assess an alternative care model using community-based groups for people living with HIV and facilitate by lay personnel. Methods: Geographic locations in the Academic Model Providing Access to Healthcare Kitale clinic catchment were randomized to standard of care versus a community-based care group (ART Co-op). Adults stable on antiretroviral therapy and virally suppressed were eligible. Research Assistant-led ART Co-ops met in the community every 3 months. Participants were seen in the HIV clinic only if referred. CD4 count and viral load were measured in clinic at enrollment and after 12 months. Retention, viral suppression, and clinic utilization were compared between groups using χ2, Fisher exact, and Wilcoxon rank sum tests. Results: At 12 months, there were no significant differences in mean CD4 count or viral load suppression. There was a significant difference in patient retention in assigned study group between the intervention and control group (81.6% vs 98.6%; P < 0.001), with a number of intervention patients withdrawing because of stigma, relocation, pregnancy, and work conflicts. All participants, however, were retained in an HIV care program for the study duration. The median number of clinic visits was lower for the intervention group than that for the control group (0 vs 3; P < 0.001). Conclusions: Individuals retained in a community-based HIV care model had clinical outcomes equivalent to those receiving clinic-based care. This innovative model of HIV care addresses the problems of insufficient health care personnel and patient retention barriers, including time, distance, and cost to attend clinic, and has the potential for wider implementation.Item First-Line Antiretroviral Treatment Failure in East African Children(East African Medical Association, 2021) Marete, Irene; Mwangi, Ann; Brown, Steven; Wools-Kaloustian, Kara; Yiannoutsos, Constantin; Abuogi, Lisa; Lyamuya, Rita; Ngonyani, Kapella; Achieng, Marion; Apaka, Cosmas; Rotich, Elyne; Ayaya, Samuel; Medicine, School of MedicineObjectives: To describe the incidence of antiretroviral treatment failure and associated factors in a pediatric clinical cohort within the East African International epidemiology Databases to Evaluate AIDS (EA-IeDEA) consortium. Design: A retrospective cohort study. Clinical treatment failure was defined as advancement in clinical WHO stage, or CDC class at least 24 weeks after initiation of treatment. Immunological failure was defined as developing or returning to the following age-related immunological thresholds after at least 24 weeks on treatment; CD4 count of <200 or CD4%<10% for children aged 2-5 years and CD4 count of < 100 for a child aged > 5years. Setting: The study utilized the electronic medical records of HIV-infected pediatric patients enrolled into the EA-IeDEA consortium clinics from January 2005 to August 2012. Results: A total of 5927 children were included in the analysis. The estimated cumulative incidence of clinical ART treatment failure at one year and four years post ART initiation was11.5% and 31% respectively, while that of immunological treatment failure was at 3% and 22.5% respectively. The main factors associated with clinical failure were advanced clinical stage at ART-initiation, year started ART and residing in a rural area. Factors associated with immunological failure were male gender and age of the child at ART-initiation. Only 6% of those identified as having clinical treatment failure were switched to second line treatment during the four years of follow-up. Conclusion: The probability of clinical and immunologic failure was relatively high and increased with time.Item PREVALENCE of psychiatric morbidity in a community sample in Western Kenya(BioMed Central, 2017-01-18) Kwobah, Edith; Epstein, Steve; Mwangi, Ann; Litzelman, Debra; Atwoli, Lukoye; Department of Medicine, IU School of MedicineBACKGROUND: About 25% of the worldwide population suffers from mental, neurological and substance use disorders but unfortunately, up to 75% of affected persons do not have access to the treatment they need. Data on the magnitude of the mental health problem in Kenya is scarce. The objectives of this study were to establish the prevalence and the socio-demographic factors associated with mental and substance use disorders in Kosirai division, Nandi County, Western Kenya. METHODS: This was a cross sectional descriptive study in which participants were selected by simple random sampling. The sampling frame was obtained from a data base of the population in the study area developed during door-to-door testing and counseling exercises for HIV/AIDS. Four hundred and twenty consenting adults were interviewed by psychologists using the Mini International Neuropsychiatric Interview Version 7 for Diagnostic and Statistical Manual 5th Edition and a researcher-designed social demographic questionnaire. RESULTS: One hundred and ninety one (45%) of the participants had a lifetime diagnosis of at least one of the mental disorders. Of these, 66 (15.7%) had anxiety disorder, 53 (12.3%) had major depressive disorder; 49 (11.7%) had alcohol and substance use disorder. 32 (7.6%) had experienced a psychotic episode and 69 (16.4%) had a life-time suicidal attempt. Only 7 (1.7%) had ever been diagnosed with a mental illness. Having a mental condition was associated with age less than 60 years and having a medical condition. CONCLUSION: A large proportion of the community has had a mental disorder in their lifetime and most of these conditions are undiagnosed and therefore not treated. These findings indicate a need for strategies that will promote diagnosis and treatment of community members with psychiatric disorders. In order to screen more people for mental illness, we recommend further research to evaluate a strategy similar to the home based counseling and testing for HIV and the use of simple screening tools.Item A semiparametric method for the analysis of outcomes during a gap in HIV care under incomplete outcome ascertainment(De Gruyter, 2020-09) Bakoyannis, Giorgos; Diero, Lameck; Mwangi, Ann; Wools-Kaloustian, Kara K.; Yiannoutsos, Constantin T.; Biostatistics, School of Public HealthObjectives: Estimation of the cascade of HIV care is essential for evaluating care and treatment programs, informing policy makers and assessing targets such as 90-90-90. A challenge to estimating the cascade based on electronic health record concerns patients "churning" in and out of care. Correctly estimating this dynamic phenomenon in resource-limited settings, such as those found in sub-Saharan Africa, is challenging because of the significant death under-reporting. An approach to partially recover information on the unobserved deaths is a double-sampling design, where a small subset of individuals with a missed clinic visit is intensively outreached in the community to actively ascertain their vital status. This approach has been adopted in several programs within the East Africa regional IeDEA consortium, the context of our motivating study. The objective of this paper is to propose a semiparametric method for the analysis of competing risks data with incomplete outcome ascertainment. Methods: Based on data from double-sampling designs, we propose a semiparametric inverse probability weighted estimator of key outcomes during a gap in care, which are crucial pieces of the care cascade puzzle. Results: Simulation studies suggest that the proposed estimators provide valid estimates in settings with incomplete outcome ascertainment under a set of realistic assumptions. These studies also illustrate that a naïve complete-case analysis can provide seriously biased estimates. The methodology is applied to electronic health record data from the East Africa IeDEA Consortium to estimate death and return to care during a gap in care. Conclusions: The proposed methodology provides a robust approach for valid inferences about return to care and death during a gap in care, in settings with death under-reporting. Ultimately, the resulting estimates will have significant consequences on program construction, resource allocation, policy and decision making at the highest levels.Item Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) in western Kenya: a study protocol of a cluster randomized trial(BioMed Central, 2019-09-09) Mercer, Tim; Njuguna, Benson; Bloomfield, Gerald S.; Dick, Jonathan; Finkelstein, Eric; Kamano, Jemima; Mwangi, Ann; Naanyu, Violet; Pastakia, Sonak D.; Valente, Thomas W.; Vedanthan, Rajesh; Akwanalo, Constantine; Medicine, School of MedicineBACKGROUND: Hypertension is a major risk factor for cardiovascular disease (CVD), yet treatment and control rates for hypertension are very low in low- and middle-income countries (LMICs). Lack of effective referral networks between different levels of the health system is one factor that threatens the ability to achieve adequate blood pressure control and prevent CVD-related morbidity. Health information technology and peer support are two strategies that have improved care coordination and clinical outcomes for other disease entities in other settings; however, their effectiveness and cost-effectiveness in strengthening referral networks to improve blood pressure control and reduce CVD risk in low-resource settings are unknown. METHODS/DESIGN: We will use the PRECEDE-PROCEED framework to conduct transdisciplinary implementation research, focused on strengthening referral networks for hypertension in western Kenya. We will conduct a baseline needs and contextual assessment using a mixed-methods approach, in order to inform a participatory, community-based design process to fully develop a contextually and culturally appropriate intervention model that combines health information technology and peer support. Subsequently, we will conduct a two-arm cluster randomized trial comparing 1) usual care for referrals vs 2) referral networks strengthened with our intervention. The primary outcome will be one-year change in systolic blood pressure. The key secondary clinical outcome will be CVD risk reduction, and the key secondary implementation outcomes will include referral process metrics such as referral appropriateness and completion rates. We will conduct a mediation analysis to evaluate the influence of changes in referral network characteristics on intervention outcomes, a moderation analysis to evaluate the influence of baseline referral network characteristics on the effectiveness of the intervention, as well as a process evaluation using the Saunders framework. Finally, we will analyze the incremental cost-effectiveness of the intervention relative to usual care, in terms of costs per unit decrease in systolic blood pressure, per percentage change in CVD risk score, and per disability-adjusted life year saved. DISCUSSION: This study will provide evidence for the implementation of innovative strategies for strengthening referral networks to improve hypertension control in LMICs. If effective, it has the potential to be a scalable model for health systems strengthening in other low-resource settings worldwide.Item The Prevalence of Disclosure of HIV Status to HIV-Infected Children in Western Kenya(Oxford University Press, 2013) Turissini, Matthew L.; Nyandiko, Winstone M.; Ayaya, Samuel O.; Marete, Irene; Mwangi, Ann; Chemboi, Victor; Warui, Lucy; Vreeman, Rachel C.; Pediatrics, School of MedicineBackground: As antiretroviral therapy (ART) allows the world's 2.3 million human immunodeficiency virus (HIV)-infected children to grow and thrive, these children need to be informed of their HIV status. Neither the prevalence of disclosure to children nor its impact has been evaluated in most resource-limited settings. Methods: We conducted a prospective assessment of a random sample of HIV-infected children ages 6-14 years enrolled in HIV care at a large referral clinic in Eldoret, Kenya. Clinicians administered questionnaires to children and caregivers independently at routine clinic visits to assess disclosure status, ART adherence, stigma, and depression. Children's demographic and clinical characteristics were extracted from chart review. We calculated descriptive statistics and performed logistic regression to assess the association between disclosure and other characteristics. Results: Two hundred seventy children-caregiver dyads completed questionnaires. The mean child age was 9.3 years (standard deviation 2.6); 49% were male, and 42% were orphans. 11.1% of children had been informed of their HIV status (N = 30). Of those under 10 years, 3.3% knew their status, whereas 9.2% of 10- to 12-year-olds and 39.5% of 13- to 14-year-olds knew they had HIV. Only age was significantly associated with disclosure status in both bivariate analyses (P < .0001) and multiple logistic regression (odds ratio 1.67, 95% confidence interval 1.36-2.05) when considering social demographics, disease stage variables, adherence, stigma measures, and depression. Conclusions: Rates of informing children in western Kenya of their HIV status are low, even among older children. Guiding families through developmentally appropriate disclosure processes should be a key facet of long-term pediatric HIV management.Item Trends Over Time for Adolescents Enrolling in HIV Care in Kenya, Tanzania, and Uganda From 2001–2014(Wolters Kluwer, 2018-10) Apondi, Edith; Humphrey, John M.; Sang, Edwin; Mwangi, Ann; Keter, Alfred; Musick, Beverly S.; Nalugoda, Fred K.; Ssali, John; Bukusi, Elizabeth; Yiannoutsos, Constantin T.; Wools-Kaloustian, Kara; Ayaya, Samuel; Medicine, School of MedicineBackground: The data needed to understand the characteristics and outcomes, over time, of adolescents enrolling in HIV care in East Africa are limited. Setting: Six HIV care programs in Kenya, Tanzania, and Uganda. Methods: This retrospective cohort study included individuals enrolling in HIV care as younger adolescents (10–14 years) and older adolescents (15–19 years) from 2001–2014. Descriptive statistics were used to compare groups at enrollment and antiretroviral therapy (ART) initiation over time. The proportion of adolescents was compared with the total number of individuals aged 10 years and older enrolling over time. Competing-risk analysis was used to estimate 12-month attrition after enrollment/pre-ART initiation; post-ART attrition was estimated by Kaplan–Meier method. Results: A total of 6344 adolescents enrolled between 2001 and 2014. The proportion of adolescents enrolling among all individuals increased from 2.5% (2001–2004) to 3.9% (2013–2014, P < 0.0001). At enrollment, median CD4 counts in 2001–2004 compared with 2013–2014 increased for younger (188 vs. 379 cells/mm3, P < 0.0001) and older (225 vs. 427 cells/mm3, P < 0.0001) adolescents. At ART initiation, CD4 counts increased for younger (140 vs. 233 cells/mm3, P < 0.0001) and older (64 vs. 323 cells/mm3, P < 0.0001) adolescents. Twelve-month attrition also increased for all adolescents both after enrollment/pre-ART initiation (4.7% vs. 12.0%, P < 0.001) and post-ART initiation (18.7% vs. 31.2%, P < 0.001). Conclusions: Expanding HIV services and ART coverage was likely associated with earlier adolescent enrollment and ART initiation but also with higher attrition rates before and after ART initiation. Interventions are needed to promote retention in care among adolescents.