Browsing by Author "Fowler, G. Mary"

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    Comparative effects of three methods of promoting breastfeeding among human immunodeficiency virus–infected women in Uganda
    (International Health, 2018) Fowler, G. Mary
    The objective of this study was to evaluate the comparative effects of three breastfeeding promotion interventions on the duration of exclusive breastfeeding (EBF) and any breastfeeding (BF) among human immunodeficiency virus (HIV)-infected women in Uganda. Methods Between February 2012 and February 2013, 218 HIV-infected pregnant mothers were randomly assigned to (A) standard care (n=73), (B) enhanced family/peer support (n=72) or (C) enhanced nutrition education (n=73). Results The prevalence (%) of EBF/BF did not differ between intervention arms at the sixth (A, 85/92; B, 84/91; C, 87/89) and ninth (A, 17/91; B, 18/89; C, 16/87) postpartum month assessments (p>0.05). However, the risk of early BF cessation differed between intervention arms depending on the mother’s level of formal education (p=0.04). Among women with no formal education, the risk of early BF cessation was 88% (adjusted hazard ratio [aHR] 0.12 [95% confidence interval {CI} 0.05–0.30]) and 93% (aHR 0.07 [95% CI 0.03–0.18]) lower in arms B and C, respectively, than in arm A (p<0.01). HIV status disclosure to a partner was associated with a higher risk of early EBF (p=0.03) and BF (p=0.04) cessation. Conclusions In resource-limited settings, enhanced (vs standard care) EBF promotion interventions may not differentially influence EBF but reduce the risk of early BF cessation among women with no formal education. Targeted enhanced interventions among women with no formal education and a mother’s partner may be critical to reducing the risk of early EBF/BF cessation.
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    Contraceptive Use and Pregnancy Incidence among VOICE Participants in Uganda.
    (AIDS Research and Human Retroviruses,, 2014) Fowler, G. Mary
    Background: Vitamin D (VitD) is an endogenous immunomodulator that could protect from HIV-1 infection. We recently found that high levels of VitD and its receptor are associated with natural resistance to HIV-1 infection; up-regulation of the anti-inflammatory cytokine IL-10, and the induction of defensins in mucosa might be part of the mechanisms involved in this association. However, several other molecules might be involved in this protection. Methods: To further explore this issue, a case-control study using samples of 58 HIV-1-exposed but seronegative (HESN) individuals, and 59 non-exposed healthy controls (HCs) was carried out. mRNA relative units (RU) of APOBEC3G, ELAFIN, TRIM5alfa, SAMHD1 and Catelicidin in peripheral blood mononuclear cells (PBMCs), oral and genital mucosa were quantified by qRT-PCR. Circulating VitD and mRNA levels of VDR were previously reported and used for correlations. Results: HESNs had significantly higher mRNA RU of the antiviral molecules APOBEC3G and ELAFIN in PBMCs and SAMHD1 and Catelicidin in oral mucosa compared to HCs. Positive correlation between VDR and ELAFIN mRNA in PBMCs of HESNs was found. Conclusions: These results suggest at high levels of APOBEC3G, ELAFIN, SAMHD1, and Catelicidin are associated with natural resistance to HIV-1 infection. VitD may be upregulating the expression of ELAFIN as observed for other anti-HIV-1 molecules. However, further studies are required to define causal associations.
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    Effects of chronic health conditions on school adaptation
    (Paediatrics research,, 1984) Fowler, G. Mary
    This study of children with chronic health conditions (CHC) assessed the relationship of demographic and health variables to school achievement and absenteeism. From July 1982 to June 1983 data were collected in 11 subspeciality clinics on 270 children followed at a tertiary care center. Academic performance and days absent for the prior year were obtained from schools. Physicians rated subjects' activity limitation. The CHC group was 61% male, 68% white, mean age 12 years. Children with cystic fibrosis, arthritis, sickle cell disease, hemophilia, and spina bifida averaged the most days absent (>20), while those with chronic lung and cardiac conditions averaged the least (10). Total CHC achievement scores were well below the state average (53rd vs. 63rd percentile). Group scores were highest for general hematology, hemophilia, chronic bowel and lung. Scores were lowest for epilepsy (39th), sickle cell (24th), and spina bifida (21st), and these groups had the highest rates of repeated grades and special services. Overall CHC group achievement was unrelated to school absence. A stepwise regression model related demographic and health variables to log of days absent and achievement scores. Achievement was correlated with socioeconomic status, race, grade failure, and type of CHC (r2=.44; p=.0001) while school absence was mainly related to health variables (activity limitation, number of clinic visits, specific CHC) and female sex (r2=.17; p=.0001). For CHC children, demographic factors were important predictors of academic performance. CHC children of low socioeconomic status were at double jeopardy for poor school achievement.
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    Epidemiology of HIV and AIDS among Adolescents and Young Adults in the United States
    (Journal of Adolescent Health, 2006) Fowler, G. Mary
    Purpose: To describe the current status of the human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) epidemic among adolescents and young adults in the United States. Despite reported declines in sexual risk behaviors among adolescents in the past decade, little has been published about the epidemiology of HIV and AIDS among adolescents and young adults in the United States. Methods: We analyzed cases of HIV or AIDS diagnosed among persons aged 13 to 24 years and reported to the national HIV/AIDS Reporting System. We used AIDS cases diagnosed from 1985 through 2003 from the 50 states, the District of Columbia, and the U.S. trusts and territories, and we used HIV cases diagnosed in 2003 from 32 states and the U.S. Virgin Islands. We present five-year trends in HIV diagnoses from 1999 through 2003 from 33 surveillance areas that have stable name-based HIV reporting. The data were adjusted for reporting delays and unreported risk factors. Results: At the end of 2003, 7074 adolescents and young adults, aged 13 to 24 years at the time of diagnosis, were living with AIDS in the United States. Of these, 63% were aged 20 to 24 years. AIDS rates were highest among black persons (63 per 100,000) and youth living in the South (22 per 100,000) and Northeast (18 per 100,000). Among females, the number of diagnosed HIV cases decreased from 1611 cases in 1999 to 1454 in 2003. Among males, the number increased significantly from 1763 in 1999 to 2443 in 2003. The observed increase in the number of HIV diagnoses among males was driven by an increase in HIV diagnoses among young men who have sex with men. Conclusions: National case surveillance data for persons aged 13 to 24 years revealed that the burden of HIV and AIDS falls most heavily upon the Southern region of the United States and disproportionately upon black and Hispanic youth. The observed increases in the number of HIV cases among men who have sex with men are congruent with recent reports that suggest a resurgence of HIV among these young men. Our findings highlight the need for intensified HIV prevention efforts within minority communities and among men who have sex with men as well as strengthened efforts to encourage at-risk youth to get tested for HIV. © 2006 Society for Adolescent Medicine. All rights reserved
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    Growth in HIV-infected children receiving antiretroviral therapy at a pediatric infectious diseases clinic in Uganda
    (Mary Ann Liebert, Inc., 2008) Fowler, G. Mary
    Antiretroviral therapy (ART) improves growth and survival of HIV-infected individuals. We designed a retrospective cohort study to assess clinical factors associated with growth in HIV-infected children on ART in Uganda between July 2003 and March 2006. Height and weight measurements taken pre- and post-ART initiation for at least 6 months were age- and gender-standardized to CDC 2000 reference. We analyzed medical records of 749 children receiving ART. Descriptive and logistic regression analyses were conducted to identify covariates associated with risk of either stunting or being underweight. Longitudinal regression analysis with a mixed model using autoregressive covariance structure was used to compare change in height and weight before and after initiation of ART. The mean age of the study population at first visit was 7.5 years. Mean height-for-age, weight-for-age, and weight-for-height percentiles at first visit were 8.6, 7.7, and 7.9, respectively. At last visit mean height-for-age, weight-for-age, and weight-for-height percentiles were 8.6, 13.3, and 13.8, respectively. Baseline weight-for-age z score of 1 or more was protective against stunting (odds ratio [OR] 0.25, confidence interval [CI] 0.18–0.35) while baseline height-for-age z score of 1 or more was protective against becoming underweight (OR 0.75, CI 0.63–0.88). Children in World Health Organization (WHO) stages II, III, and IV at baseline were 1.5 times more likely to become underweight (OR 1.51, CI 1.07–2.14). Initiation of ART resulted in improvement in mean standardized weight-for-age z score and weight-for-age percentiles (p < 0.001). Weight-for-age percentile and z score improved significantly after initiation of ART. This pediatric population gained weight more rapidly than height after initiation of ART.
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    HIV monoclonal antibodies
    (PLoS Med, 2014) Fowler, G. Mary
    While formula feeding is recommended for HIV-infected mothers in industrialized countries, breastfeeding is the cornerstone of infant survival in many low-resource countries. In such settings, the World Health Organization (WHO) recommends that HIV-infected mothers should breastfeed for 12 months with concurrent infant or maternal ARV prophylaxis to reduce transmission risk [2]. However, new reports suggest that weaning prior to age 18 months is associated with elevated morbidity and mortality among HIV-exposed, uninfected children even in clinical trial settings [4]. Additionally, the use of ARV prophylaxis by mother or infant during breastfeeding can reduce but does not eliminate transmission risk and relies on strict adherence to daily drug administration. Breakthrough infections at rates as high as 2–5% by age six months and 6% by age 12 months have been observed in breastfeeding infants of HIV-infected mothers who have been provided with triple ARV drug therapy during pregnancy and breastfeeding [4],[6].
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    Multicountry validation of SAMBA - a novel molecular point-of-care test for HIV-1 detection in resource-limited setting
    (Wolters Kluwer Health, Inc, 2017) Fowler, G. Mary
    Introduction: Early diagnosis of HIV-1 infection and the prompt initiation of antiretroviral therapy are critical to achieving a reduction in the morbidity and mortality of infected infants. The Simple AMplification-Based Assay (SAMBA) HIV-1 Qual Whole Blood Test was developed specifically for early infant diagnosis and prevention of mother-to-child transmission programs implemented at the point-of-care in resource-limited settings. Methods: We have evaluated the performance of this test run on the SAMBA I semiautomated platform with fresh whole blood specimens collected from 202 adults and 745 infants in Kenya, Uganda, and Zimbabwe. Results were compared with those obtained with the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) HIV-1 assay as performed with fresh whole blood or dried blood spots of the same subjects, and discrepancies were resolved with alternative assays. Results: The performance of the SAMBA and CAP/CTM assays evaluated at 5 laboratories in the 3 countries was similar for both adult and infant samples. The clinical sensitivity, specificity, positive predictive value, and negative predictive value for the SAMBA test were 100%, 99.2%, 98.7%, and 100%, respectively, with adult samples, and 98.5%, 99.8%, 99.7%, and 98.8%, respectively, with infant samples. Discussion: Our data suggest that the SAMBA HIV-1 Qual Whole Blood Test would be effective for early diagnosis of HIV-1 infection in infants at point-of-care settings in sub-Saharan Africa.
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    Noninferiority of a Task-Shifting HIV Care an Treatment Model Using Peer Counselors and Nurses Among Ugandan Women Initiated on ART: Evidence From a Randomized Trial
    (Lippincott Williams & Wilkins, 2013) Fowler, G. Mary
    Objective: To assess the noninferiority of a task-shifting HIV treatment model relying on peer counselors and nurses compared with a physician-centered model among HIV-1-positive women initiated on antiretroviral therapy (ART) at a prevention of motherto-child transmission clinic in Mulago Hospital, Uganda. Methods: HIV-1-infected ART eligible naive women were randomized to either nurse–peer (intervention) or doctor–counselor (standard model) arm. The primary endpoint was virologic success defined attaining a viral load , 400 RNA copies per milliliter 6–12 months after ART initiation. Noninferiority was defined as the lower 95% confidence limit for the difference in proportions with virologic success being less than 10%. Secondary outcomes included immunologic success (mean CD4 count increase from baseline) and pill count. Results: Data on 85 participants were analyzed (n = 45 in the intervention and n = 40 in the standard model). The proportion of participants with virologic success was similar in the standard and intervention models [91% versus 88% respectively; difference, 3%; 95% confidence interval (CI): 211% to 12%]. Probability of viral detection at 6–12 months’ time point was similar in the 2 models(log-rank test P = 0.73). Immunologic and pill count indicators were also similar in the intervention and standard models, with mean CD4 increase of 217 versus 206 cells per microliter (difference, 11; 95% CI: 260 to 82 cells/mL) and pill counts of 99.8% versus 99.7% (difference, 0.0; 95% CI: 25% to 5%) respectively. Conclusions: Nurses and peer counselors were not inferior in providing ART follow-up care to postpartum women, an approach that may help deliver treatment to many more HIV-infected people.
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    Short Communication:
    (The Johns Hopkins Medical Institutions,, 2009) Fowler, G. Mary
    Use of single dose nevirapine (sdNVP) to prevent HIV mother-to-child transmission is associated with the emergence of NVP resistance in many infants who are HIV infected despite prophylaxis. We combined results from four clinical trials to analyze predictors of NVP resistance in sdNVP-exposed Ugandan infants. Samples were tested with the ViroSeq HIV Genotyping System and a sensitive point mutation assay (LigAmp, for detection of K103N, Y181C, and G190A). NVP resistance was detected at 6–8 weeks in 36 (45.0%) of 80 infants using ViroSeq and 33 (45.8%) of 72 infants using LigAmp. NVP resistance was more frequent among infants who were infected in utero than among infants who were diagnosed with HIV infection after birth by 6–8 weeks of age. Detection of NVP resistance at 6–8 weeks was not associated with HIV subtype (A vs. D), pre-NVP maternal viral load or CD4 cell count, infant viral load at 6–8 weeks, or infant sex. NVP resistance was still detected in some infants 6–12 months after sdNVP exposure. In this study, in utero HIV infection was the only factor associated with detection of NVP resistance in infants 6–8 weeks after sdNVP exposure.
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    Short Communication: In Utero HIV Infection Is Associated with an Increased Risk of Nevirapine Resistance in Ugandan Infants Who Were Exposed to Perinatal Single Dose Nevirapine
    (Mary Ann Liebert, Inc, 2009) Fowler, G. Mary
    Use of single dose nevirapine (sdNVP) to prevent HIV mother-to-child transmission is associated with the emergence of NVP resistance in many infants who are HIV infected despite prophylaxis. We combined results from four clinical trials to analyze predictors of NVP resistance in sdNVP-exposed Ugandan infants. Samples were tested with the ViroSeq HIV Genotyping System and a sensitive point mutation assay (LigAmp, for detection of K103N, Y181C, and G190A). NVP resistance was detected at 6–8 weeks in 36 (45.0%) of 80 infants using ViroSeq and 33 (45.8%) of 72 infants using LigAmp. NVP resistance was more frequent among infants who were infected in utero than among infants who were diagnosed with HIV infection after birth by 6–8 weeks of age. Detection of NVP resistance at 6–8 weeks was not associated with HIV subtype (A vs. D), pre-NVP maternal viral load or CD4 cell count, infant viral load at 6–8 weeks, or infant sex. NVP resistance was still detected in some infants 6–12 months after sdNVP exposure. In this study, in utero HIV infection was the only factor associated with detection of NVP resistance in infants 6–8 weeks after sdNVP exposure.