IU Indianapolis ScholarWorks :: Browsing by Author "Ayaya, Samuel"

Browsing by Author "Ayaya, Samuel"

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Community Perspectives on Research Consent Involving Vulnerable Children in Western Kenya
(2012-10) Vreeman, Rachel; Kamaara, Eunice; Kamanda, Allan; Ayuku, David; Nyandiko, Winstone; Atwoli, Lukoye; Ayaya, Samuel; Gisore, Peter; Scanlon, Michael; Braitstein, Paula
Involving vulnerable pediatric populations in international research requires culturally appropriate ethical protections. We sought to use mabaraza, traditional East African community assemblies, to understand how a community in western Kenya viewed participation of children in health research and informed consent and assent processes. Results from 108 participants revealed generally positive attitudes towards involving vulnerable children in research, largely because they assumed children would directly benefit. Consent from parents or guardians was understood as necessary for participation while gaining child assent was not. They felt other caregivers, community leaders, and even community assemblies could participate in the consent process. Community members believed research involving orphans and street children could benefit these vulnerable populations, but would require special processes for consent.
Cost-effectiveness of first-line antiretroviral therapy for HIV-infected African children less than 3 years of age
(Ovid Technologies (Wolters Kluwer) - Lippincott Williams & Wilkins, 2015-06-19) Ciaranello, Andrea L.; Doherty, Kathleen; Penazzato, Martina; Lindsey, Jane C.; Harrison, Linda; Kelly, Kathleen; Walensky, Rochelle P.; Essajee, Shaffiq; Losina, Elena; Muhe, Lulu; Wools-Kaloustian, Kara; Ayaya, Samuel; Weinstein, Milton C.; Palumbo, Paul; Freedberg, Kenneth A.; Department of Medicine, IU School of Medicine
BACKGROUND: The International Maternal, Pediatric, and Adolescent Clinical Trials P1060 trial demonstrated superior outcomes for HIV-infected children less than 3 years old initiating antiretroviral therapy (ART) with lopinavir/ritonavir compared to nevirapine, but lopinavir/ritonavir is four-fold costlier. DESIGN/METHODS: We used the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-Pediatric model, with published and P1060 data, to project outcomes under three strategies: no ART; first-line nevirapine (with second-line lopinavir/ritonavir); and first-line lopinavir/ritonavir (second-line nevirapine). The base-case examined South African children initiating ART at age 12 months; sensitivity analyses varied all key model parameters. Outcomes included life expectancy, lifetime costs, and incremental cost-effectiveness ratios [ICERs; dollars/year of life saved ($/YLS)]. We considered interventions with ICERs less than 1× per-capita gross domestic product (South Africa: $7500)/YLS as 'very cost-effective,' interventions with ICERs below 3× gross domestic product/YLS as 'cost-effective,' and interventions leading to longer life expectancy and lower lifetime costs as 'cost-saving'. RESULTS: Projected life expectancy was 2.8 years with no ART. Both ART regimens markedly improved life expectancy and were very cost-effective, compared to no ART. First-line lopinavir/ritonavir led to longer life expectancy (28.8 years) and lower lifetime costs ($41 350/person, from lower second-line costs) than first-line nevirapine (27.6 years, $44 030). First-line lopinavir/ritonavir remained cost-saving or very cost-effective compared to first-line nevirapine unless: liquid lopinavir/ritonavir led to two-fold higher virologic failure rates or 15-fold greater costs than in the base-case, or second-line ART following first-line lopinavir/ritonavir was very ineffective. CONCLUSIONS: On the basis of P1060 data, first-line lopinavir/ritonavir leads to longer life expectancy and is cost-saving or very cost-effective compared to first-line nevirapine. This supports WHO guidelines, but increasing access to pediatric ART is critical regardless of the regimen used.
Impact of Domestic Care Environment on Trauma and Posttraumatic Stress Disorder among Orphans in Western Kenya
(2014-03) Atwoli, Lukoye; Ayuku, David; Hogan, Joseph; Koech, Julius; Vreeman, Rachel C.; Ayaya, Samuel; Braitstein, Paula
Objective The aim of this study was to determine the impact of the domestic care environment on the prevalence of potentially traumatic events (PTEs) and posttraumatic stress disorder (PTSD) among orphaned and separated children in Uasin Gishu County, western Kenya. Methods A total of 1565 (55.5% male) orphaned and separated adolescents aged 10–18 years (mean 13.8 years, sd 2.2), were assessed for PTSD and PTEs including bullying, physical abuse and sexual abuse. In this sample, 746 lived in extended family households, 746 in Charitable Children's Institutions (CCIs), and 73 on the street. Posttraumatic stress symptom (PTSS) scores and PTSD were assessed using the Child PTSD Checklist. Results Bullying was the commonest PTE in all domestic care environments, followed by physical and sexual abuse. All PTEs were commonest among the street youth followed by CCIs. However, sexual abuse was more prevalent in households than in CCIs. Prevalence of PTSD was highest among street youth (28.8%), then households (15.0%) and CCIs (11.5%). PTSS scores were also highest among street youth, followed by CCIs and households. Bullying was associated with higher PTSS scores and PTSD odds than either sexual or physical abuse. Conclusion This study demonstrated differences in distribution of trauma and PTSD among orphaned and separated children in different domestic care environments, with street youth suffering more than those in CCIs or households. Interventions are needed to address bullying and sexual abuse, especially in extended family households. Street youth, a heretofore neglected population, are urgently in need of dedicated mental health services and support.
Incidence of World Health Organization stage 3 and 4 events, tuberculosis and mortality in untreated, HIV-infected children enrolling in care before 1 year of age: an IeDEA (International Epidemiologic Databases To Evaluate AIDS) East Africa regional analysis
(Ovid Technologies (Wolters Kluwer) - Lippincott Williams & Wilkins, 2014-06) Ciaranello, Andrea; Lu, Zhigang; Ayaya, Samuel; Losina, Elena; Musick, Beverly; Vreeman, Rachel; Freedberg, Kenneth A.; Abrams, Elaine J.; Dillabaugh, Lisa; Doherty, Katie; Ssali, John; Yiannoutsos, Constantin T.; Wools-Kaloustian, Kara; Department of Pediatrics, IU School of Medicine
BACKGROUND: Few studies have reported CD4%- and age-stratified rates of World Health Organization Stage 3 (WHO3) events, World Health Organization Stage 4 (WHO4) events, tuberculosis (TB) and mortality in HIV-infected infants before initiation of antiretroviral therapy. METHODS: HIV-infected children enrolled before 1 year of age in the International Epidemiologic Databases to Evaluate AIDS East Africa region (October 1, 2002, to November, 2008) were included. We estimated incidence rates of earliest clinical event (WHO3, WHO4 and TB), before antiretroviral therapy initiation per local guidelines, stratified by current age (< or ≥6 months) and current CD4% (<15%, 15-24%, ≥25%). CD4%-stratified mortality rates were estimated separately for children who did not experience a clinical event ("background" mortality) and for children who experienced an event, including "acute" mortality (≤30 days post event) and "later" mortality (>30 days post event). RESULTS: Among 847 children (median enrollment age: 4.8 months; median pre-antiretroviral therapy follow up: 10.8 months; 603 (71%) with ≥1 CD4% recorded), event rates were comparable for those aged <6 and ≥6 months. Current CD4% was associated with risk of WHO4 events for children <6 months of age and with all evaluated events for children ≥6 months old (P < 0.05). "Background" mortality was 3.7-8.4/100 person-years (PY). "Acute" mortality (≤30 days post event) was 33.8/100 PY (after TB) and 41.1/100 PY (after WHO3 or WHO4). "Later" mortality (>30 days post event) ranged by CD4% from 4.7 to 29.1/100 PY. CONCLUSIONS: In treatment-naïve, HIV-infected infants, WHO3, WHO4 and TB events were common before and after 6 months of age and led to substantial increases in mortality. Early infant HIV diagnosis and treatment are critically important, regardless of CD4%.
Models of care for orphaned and separated children and upholding children’s rights: cross-sectional evidence from western Kenya
(2014-04) Embleton, Lonnie; Ayuku, David; Kamanda, Allan; Atwoli, Lukoye; Ayaya, Samuel; Vreeman, Rachel; Nyandiko, Winstone; Gisore, Peter; Koech, Julius; Braitstein, Paula
Background Sub-Saharan Africa is home to approximately 55 million orphaned children. The growing orphan crisis has overwhelmed many communities and has weakened the ability of extended families to meet traditional care-taking expectations. Other models of care and support have emerged in sub-Saharan Africa to address the growing orphan crisis, yet there is a lack of information on these models available in the literature. We applied a human rights framework using the United Nations Convention on the Rights of the Child to understand what extent children’s basic human rights were being upheld in institutional vs. community- or family-based care settings in Uasin Gishu County, Kenya. Methods The Orphaned and Separated Children’s Assessments Related to their Health and Well-Being Project is a 5-year cohort of orphaned children and adolescents aged ≤18 year. This descriptive analysis was restricted to baseline data. Chi-Square test was used to test for associations between categorical /dichotomous variables. Fisher’s exact test was also used if some cells had expected value of less than 5. Results Included in this analysis are data from 300 households, 19 Charitable Children’s Institutions (CCIs) and 7 community-based organizations. In total, 2871 children were enrolled and had baseline assessments done: 1390 in CCI’s and 1481 living in households in the community. We identified and described four broad models of care for orphaned and separated children, including: institutional care (sub-classified as ‘Pure CCI’ for those only providing residential care, ‘CCI-Plus’ for those providing both residential care and community-based supports to orphaned children , and ‘CCI-Shelter’ which are rescue, detention, or other short-term residential support), family-based care, community-based care and self-care. Children in institutional care (95%) were significantly (p < 0.0001) more likely to have their basic material needs met in comparison to those in family-based care (17%) and institutions were better able to provide an adequate standard of living. Conclusions Each model of care we identified has strengths and weaknesses. The orphan crisis in sub-Saharan Africa requires a diversity of care environments in order to meet the needs of children and uphold their rights. Family-based care plays an essential role; however, households require increased support to adequately care for children.
Nutritional Status of Orphaned and Separated Children and Adolescents Living in Community and Institutional Environments in Uasin Gishu County, Kenya
(2013-07) Braitstein, Paula; Ayaya, Samuel; Nyandiko, Winstone M.; Kamanda, Allan; Koech, Julius; Gisore, Peter; Atwoli, Lukoye; Vreeman, Rachel C.; Duefield, Corey; Ayuku, David O.
Objective To describe the nutritional status of orphaned and separated children and adolescents (OSCA) living in households in the community (HH), on the street, and those in institutional environments in western Kenya. Methods The study enrolled OSCA from 300 randomly selected households (HH), 19 Charitable Children’s Institutions (CCIs), and 100 street-involved children. Measures of malnutrition were standardized with Z-scores using World Health Organization criteria; Z-scores ≤-2 standard deviations (sd) were moderate-severe malnutrition. Data were analyzed using multivariable logistic regression adjusting for child age, sex, HIV status, whether the child had been hospitalized in the previous year, time living with current guardian, and intra-household clustering for adequacy of diet and moderate-severe malnutrition. Results Included are data from 2862 participants (1337 in CCI’s, 1425 in HH’s, and 100 street youth). The population was 46% female with median age at enrolment of 11.1 years. Only 4.4% of households and institutions reported household food security; 93% of children in HH reported an adequate diet vs. 95% in CCI’s and 99% among street youth. After adjustment, OSCA in HH were less likely to have an adequate diet compared to those in CCI’s (AOR 0.4, 95% CI 0.2–1.0). After adjustment, there were no differences between the categories of children on weight-for-age, weight-for-height, or BMI-for-age. Children living in HH (AOR 2.6, 95% CI: 2.0–3.4) and street youth (AOR: 5.9, 95% CI: 3.6–9.5) were more likely than children in CCI’s to be low height-for-age. Conclusion OSCA in HH are less likely to have an adequate diet compared to children in CCI’s. They and street children are more likely to be moderately-severely low height-for-age compared to children in CCI’s, suggesting chronic malnutrition among them.
A qualitative study using traditional community assemblies to investigate community perspectives on informed consent and research participation in western Kenya
(2012-09) Vreeman, Rachel; Kamaara, Eunice; Kamanda, Allan; Ayuku, David; Nyandiko, Winstone; Atwoli, Lukoye; Ayaya, Samuel; Gisore, Peter; Scanlon, Michael; Braitstein, Paula
Background International collaborators face challenges in the design and implementation of ethical biomedical research. Evaluating community understanding of research and processes like informed consent may enable researchers to better protect research participants in a particular setting; however, there exist few studies examining community perspectives in health research, particularly in resource-limited settings, or strategies for engaging the community in research processes. Our goal was to inform ethical research practice in a biomedical research setting in western Kenya and similar resource-limited settings. Methods We sought to use mabaraza, traditional East African community assemblies, in a qualitative study to understand community perspectives on biomedical research and informed consent within a collaborative, multinational research network in western Kenya. Analyses included manual, progressive coding of transcripts from mabaraza to identify emerging central concepts. Results Our findings from two mabaraza with 108 community members revealed that, while participants understood some principles of biomedical research, they emphasized perceived benefits from participation in research over potential risks. Many community members equated health research with HIV testing or care, which may be explained in part by the setting of this particular study. In addition to valuing informed consent as understanding and accepting a role in research activities, participants endorsed an increased role for the community in making decisions about research participation, especially in the case of children, through a process of community consent. Conclusions Our study suggests that international biomedical research must account for community understanding of research and informed consent, particularly when involving children. Moreover, traditional community forums, such as mabaraza in East Africa, can be used effectively to gather these data and may serve as a forum to further engage communities in community consent and other aspects of research.
Time to First-Line ART Failure and Time to Second-Line ART Switch in the IeDEA Pediatric Cohort
(Wolters Kluwer, 2018-06-01) Wools-Kaloustian, Kara; Marete, Irene; Ayaya, Samuel; Sohn, Annette H.; Nguyen, Lam Van; Li, Shanshan; Leroy, Valériane; Musick, Beverly S.; Newman, Jamie E.; Edmonds, Andrew; Davies, Mary-Ann; Tanoh Eboua, François; Obama, Marie-Thérèse; Yotebieng, Marcel; Sawry, Shobna; Mofenson, Lynne M.; Yiannoutsos, Constantin T.; Medicine, School of Medicine
BACKGROUND: Globally, 49% of the estimated 1.8 million children living with HIV are accessing antiretroviral therapy (ART). There are limited data concerning long-term durability of first-line ART regimens and time to transition to second-line. METHODS: Children initiating their first ART regimen between 2 and 14 years of age and enrolled in one of 208 sites in 30 Asia-Pacific and African countries participating in the Pediatric International Epidemiology Databases to Evaluate AIDS consortium were included in this analysis. Outcomes of interest were: first-line ART failure (clinical, immunologic, or virologic), change to second-line, and attrition (death or loss to program ). Cumulative incidence was computed for first-line failure and second-line initiation, with attrition as a competing event. RESULTS: In 27,031 children, median age at ART initiation was 6.7 years. Median baseline CD4% for children ≤5 years of age was 13.2% and CD4 count for those >5 years was 258 cells per microliter. Almost all (94.4%) initiated a nonnucleoside reverse transcriptase inhibitor; 5.3% a protease inhibitor, and 0.3% a triple nucleoside reverse transcriptase inhibitor-based regimen. At 1 year, 7.7% had failed and 14.4% had experienced attrition; by 5 years, the cumulative incidence was 25.9% and 29.4%, respectively. At 1 year after ART failure, 13.7% had transitioned to second-line and 11.2% had experienced attrition; by 5 years, the cumulative incidence was 31.6% and 25.9%, respectively. CONCLUSIONS: High rates of first-line failure and attrition were identified in children within 5 years after ART initiation. Of children meeting failure criteria, only one-third were transitioned to second-line ART within 5 years.
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 Medicine
Background: 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.
Untangling the Relationship Between Antiretroviral Therapy Use and Incident Pregnancy: A Marginal Structural Model Analysis Using Data From 47,313 HIV-Positive Women in East Africa
(Ovid Technologies (Wolters Kluwer) - Lippincott Williams & Wilkins, 2016-07-01) Elul, Batya; Wools-Kaloustian, Kara K.; Wu, Yingfeng; Musick, Beverly S.; Nuwagaba-Biribonwoha, Harriet; Nash, Denis; Ayaya, Samuel; Bukusi, Elizabeth; Okong, Pius; Otieno, Juliana; Wabwire, Deo; Kambugu, Andrew; Yiannoutsos, Constantin T.; Department of Medicine, IU School of Medicine
BACKGROUND: Scale-up of triple-drug antiretroviral therapy (ART) in Africa has transformed the context of childbearing for HIV-positive women and may impact pregnancy incidence in HIV programs. METHODS: Using observational data from 47,313 HIV-positive women enrolled at 26 HIV clinics in Kenya and Uganda between 2001 and 2009, we calculated the crude cumulative incidence of pregnancy for the pre-ART and on-ART periods. The causal effect of ART use on incident pregnancy was assessed using inverse probability weighted marginal structural models, and the relationship was further explored in multivariable Cox models. RESULTS: Crude cumulative pregnancy incidence at 1 year after enrollment/ART initiation was 4.0% and 3.9% during the pre-ART and on-ART periods, respectively. In marginal structural models, ART use was not significantly associated with incident pregnancy [hazard ratio = 1.06; 95% confidence interval (CI): 0.99 to 1.12]. Similarly, in Cox models, there was no significant relationship between ART use and incident pregnancy (cause-specific hazard ratio: 0.98; 95% CI: 0.91 to 1.05), but effect modification was observed. Specifically, women who were pregnant at enrollment and on ART had an increased risk of incident pregnancy compared to those not pregnant at enrollment and not on ART (cause-specific hazard ratio: 1.11; 95% CI: 1.01 to 1.23). CONCLUSIONS: In this large cohort, ART initiation was not associated with incident pregnancy in the general population of women enrolling in HIV care but rather only among those pregnant at enrollment. This finding further highlights the importance of scaling up access to lifelong treatment for pregnant women.

Browsing by Author "Ayaya, Samuel"

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