Browsing by Author "Mubiana-Mbewe M"
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Item Access to antiretroviral therapy in HIV-infected children aged 0-19 years in the International Epidemiology Databases to Evaluate AIDS (IeDEA) Global Cohort Consortium, 2004-2015: A prospective cohort study.(2018-May) Desmonde S; Tanser F; Vreeman R; Takassi E; Edmonds A; Lumbiganon P; Pinto J; Malateste K; McGowan C; Kariminia A; Yotebieng M; Dicko F; Yiannoutsos C; Mubiana-Mbewe M; Wools-Kaloustian K; Davies MA; Leroy V; Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Somkhele, South Africa.; Richard M. Fairbanks School of Public Health, Indiana University, Indianapolis, Indiana, United States of America.; Inserm U1027, Toulouse III University, Toulouse, France.; Centre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.; Inserm U1219, University of Bordeaux, Bordeaux, France.; Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.; CHU Sylvanus Olympio, Lomé, Togo.; Division of Infectious Diseases, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.; Hopital Gabriel Touré, Bamako, Mali.; Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.; School of Medicine, Universide Federal de Minas Gerais, Belo Horizonte, Brazil.; School of Medicine, Indiana University, Indianapolis, Indiana, United States of America.; Bordeaux School of Public Health, University of Bordeaux, Bordeaux, France.; Khon Kaen University, Khon Kaen, Thailand.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Division of Epidemiology, College of Public Health, Ohio State University, Columbus, Ohio, United States of America.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)INTRODUCTION: Access to antiretroviral therapy (ART) is a global priority. However, the attrition across the continuum of care for HIV-infected children between their HIV diagnosis and ART initiation is not well known. We analyzed the time from enrollment into HIV care to ART initiation in HIV-infected children within the International Epidemiology Databases to Evaluate AIDS (IeDEA) Global Cohort Consortium. METHODS AND FINDINGS: We included 135,479 HIV-1-infected children, aged 0-19 years and ART-naïve at enrollment, between 1 January 2004 and 31 December 2015, in IeDEA cohorts from Central Africa (3 countries; n = 4,948), East Africa (3 countries; n = 22,827), West Africa (7 countries; n = 7,372), Southern Africa (6 countries; n = 93,799), Asia-Pacific (6 countries; n = 4,045), and Latin America (7 countries; n = 2,488). Follow-up in these cohorts is typically every 3-6 months. We described time to ART initiation and missed opportunities (death or loss to follow-up [LTFU]: last clinical visit >6 months) since baseline (the date of HIV diagnosis or, if unavailable, date of enrollment). Cumulative incidence functions (CIFs) for and determinants of ART initiation were computed, with death and LTFU as competing risks. Among the 135,479 children included, 99,404 (73.4%) initiated ART, 1.9% died, 1.4% were transferred out, and 20.4% were lost to follow-up before ART initiation. The 24-month CIF for ART initiation was 68.2% (95% CI: 67.9%-68.4%); it was lower in sub-Saharan Africa-ranging from 49.8% (95% CI: 48.4%-51.2%) in Central Africa to 72.5% (95% CI: 71.5%-73.5%) in West Africa-compared to Latin America (71.0%, 95% CI: 69.1%-72.7%) and the Asia-Pacific (78.3%, 95% CI: 76.9%-79.6%). Adolescents aged 15-19 years and infants <1 year had the lowest cumulative incidence of ART initiation compared to other ages: 62.2% (95% CI: 61.6%-62.8%) and 66.4% (95% CI: 65.7%-67.0%), respectively. Overall, 49.1% were ART-eligible per local guidelines at baseline, of whom 80.6% initiated ART. The following children had lower cumulative incidence of ART initiation: female children (p < 0.01); those aged <1 year, 2-4 years, 5-9 years, and 15-19 years (versus those aged 10-14 years, p < 0.01); those who became eligible during follow-up (versus eligible at enrollment, p < 0.01); and those receiving care in low-income or lower-middle-income countries (p < 0.01). The main limitations of our study include left truncation and survivor bias, caused by deaths of children prior to enrollment, and use of enrollment date as a proxy for missing data on date of HIV diagnosis, which could have led to underestimation of the time between HIV diagnosis and ART initiation. CONCLUSIONS: In this study, 68% of HIV-infected children initiated ART by 24 months. However, there was a substantial risk of LTFU before ART initiation, which may also represent undocumented mortality. In 2015, many obstacles to ART initiation remained, with substantial inequities. More effective and targeted interventions to improve access are needed to reach the target of treating 90% of HIV-infected children with ART.Item Benzathine penicillin G stockouts and other barriers to documented syphilis treatment in pregnancy in Zambia.(2024) Jones AV; Manasyan A; Xue Y; Kapesa H; Mwendafilumba K; Nalwamba L; Mzumara M; Mubiana-Mbewe M; Dionne JA; Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, University of Alabama at Birmingham Hospital, Birmingham, Alabama, United States of America.; Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, United States of America.; Center for Women's Reproductive Health, University of Alabama at Birmingham, University of Alabama at Birmingham Hospital, Birmingham, Alabama, United States of America.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of Pediatrics, University of Alabama at Birmingham, Children's of Alabama Hospital, Birmingham, Alabama, United States of America.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)OBJECTIVE: The prevalence of syphilis in Zambia remains high and is a critical public health concern. The Zambian Ministry of Health recommends universal screening and same-day treatment for syphilis in pregnancy, yet the syphilis screening rate is low, and treatment is poorly documented. The goal of this study was to document syphilis treatment rates and associated factors among pregnant women in care in Zambia. METHODS: This retrospective cohort study included pregnant women diagnosed with syphilis according to rapid plasma reagin (RPR) screening during routine antenatal care (ANC) in Lusaka, Zambia in 2018-2019. The main outcome of interest was lack of documented BPG treatment during pregnancy. Additional information about pregnancy and neonatal outcomes, partner referral for therapy, and facility level stockout data were included. Patient characteristics were compared by treatment status using Pearson Chi-Square Test and logistic regression models were created to estimate the association between individual level-factors, facility type, and lack of BPG treatment. A Cochran-Mantel-Haenszel test was used to evaluate facility-level data with significance set at p<0.05. RESULTS: Among 1,231 pregnant women who screened positive for syphilis at clinic, 643 (52%) lacked documented antibiotic treatment at the facility. BPG was the only antibiotic used to treat syphilis in the cohort and 8% of sex partners had evidence of referral for therapy. Preterm delivery rates were higher in women without documented BPG (43% vs 32%; p = 0.003). In adjusted models, only calendar year and hospital facility type were associated with lack of treatment. At the facility level, annual syphilis screening rates ranged from 37-65% and most (7/10) clinics reported at least one stockout of BPG. CONCLUSION: Treatment rates for syphilis in pregnancy in Zambia were low and BPG medication stockouts at the facility level were common. A consistent supply of BPG at all ANC facilities is needed to facilitate timely treatment and improve birth outcomes.Item Causes of morbidity among HIV-infected children on antiretroviral therapy in primary care facilities in Lusaka, Zambia.(2009-Oct) Mubiana-Mbewe M; Bolton-Moore C; Banda Y; Chintu N; Nalubamba-Phiri M; Giganti M; Guffey MB; Sambo P; Stringer EM; Stringer JS; Chi BH; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)OBJECTIVES: To describe the pattern of incident illness in children after initiation of antiretroviral therapy (ART) in a large public health sector programme in Lusaka, Zambia. METHODS: Systematic chart review to retrospectively extract data from medical records of children (i.e. <15 years) initiating ART in the Lusaka, Zambia public sector. Incident conditions were listed separately and then grouped according to broad categories. Predictors for incident diagnoses were determined using univariate and multivariable analysis. RESULTS: Between May 2004 and June 2006, 1705 HIV-infected children initiated ART. Of these, 1235 (72%) had their medical records reviewed. Median age at ART initiation was 77 months and 554 (45%) were females. Eight hundred and forty-one (68%) children had an incident condition during this period, with a median time of occurrence of 64 days from ART initiation. Twenty-eight incident conditions were documented. When categorized, the most common were mucocutaneous conditions [incidence rate (IR): 70.6 per 100 child-years, 95% CI: 64.5-77.2] and upper respiratory tract infection (IR: 70.1 per 100 child-years; 95% CI: 64.0-76.7). Children with severe immunosuppression (i.e. CD4 < 10%) were more likely to develop lower respiratory tract infection (16.3%vs. 10.2%; P = 0.003) and mucocutaneous conditions (43.9% vs. 35.3%; P = 0.005) than those with CD4 > or = 10%. CONCLUSION: There is a high incidence of new illness after ART initiation, emphasizing the importance of close monitoring during this period. Early initiation of ART and use of antimicrobial prophylaxis may also help to reduce the occurrence of such co-morbidities.Item Causes of stillbirth, neonatal death and early childhood death in rural Zambia by verbal autopsy assessments.(2011-Jul) Turnbull E; Lembalemba MK; Guffey MB; Bolton-Moore C; Mubiana-Mbewe M; Chintu N; Giganti MJ; Nalubamba-Phiri M; Stringer EM; Stringer JS; Chi BH; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)OBJECTIVES: To describe specific causes of the high rates of stillbirth, neonatal death and early child childhood death in Zambia. METHODS: We conducted a household-based survey in rural Zambia. Socio-demographic and delivery characteristics were recorded, alongside a maternal HIV test. Verbal autopsy questionnaires were administered to elicit mortality-related information and independently reviewed by three experienced paediatricians who assigned a cause and contributing factor to death. For this secondary analysis, deaths were categorized into: stillbirths (foetal death ≥28 weeks of gestation), neonatal deaths (≤28 days) and early childhood deaths (>28 days to <2 years). RESULTS: Among 1679 households, information was collected on 148 deaths: 34% stillbirths, 26% neonatal and 40% early childhood deaths. Leading identifiable causes of stillbirth were intrauterine infection (26%) and birth asphyxia (18%). Of 32 neonatal deaths, 38 (84%) occurred within the first week of life, primarily because of infections (37%) and prematurity (34%). The majority of early childhood deaths were caused by suspected bacterial infections (82%). HIV prevalence was significantly higher in mothers who reported an early childhood death (44%) than mothers who did not (17%; P < 0.01). Factors significantly associated with mortality were lower socio-economic status (P < 0.01), inadequate water or sanitation facilities (P < 0.01), home delivery (P = 0.04) and absence of a trained delivery attendant (P < 0.01). CONCLUSION: We provide community-level data about the causes of death among children under 2 years of age. Infectious etiologies for mortality ranked highest. At a public health level, such information may have an important role in guiding prevention and treatment strategies to address perinatal and early childhood mortality.Item Clinical outcomes and CD4 cell response in children receiving antiretroviral therapy at primary health care facilities in Zambia.(2007-Oct-24) Bolton-Moore C; Mubiana-Mbewe M; Cantrell RA; Chintu N; Stringer EM; Chi BH; Sinkala M; Kankasa C; Wilson CM; Wilfert CM; Mwango A; Levy J; Abrams EJ; Bulterys M; Stringer JS; Centre for Infectious Disease Research in Zambia, Lusaka.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)CONTEXT: The Zambian Ministry of Health provides pediatric antiretroviral therapy (ART) at primary care clinics in Lusaka, where, despite scale-up of perinatal prevention efforts, many children are already infected with the human immunodeficiency virus (HIV). OBJECTIVE: To report early clinical and immunologic outcomes of children enrolled in the pediatric treatment program. DESIGN, SETTING, AND PATIENTS: Open cohort assessment using routinely collected clinical and outcome data from an electronic medical record system in use at 18 government primary health facilities in Lusaka, Zambia. Care was provided primarily by nurses and clinical officers ("physician extenders" akin to physician assistants in the United States). Patients were children (<16 years of age) presenting for HIV care between May 1, 2004, and June 29, 2007. INTERVENTION: Three-drug ART (zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz) for children who met national treatment criteria. MAIN OUTCOME MEASURES: Survival, weight gain, CD4 cell count, and hemoglobin response. RESULTS: After enrollment of 4975 children into HIV care, 2938 (59.1%) started ART. Of those initiating ART, the median age was 81 months (interquartile range, 36-125), 1531 (52.1%) were female, and 2087 (72.4%) with World Health Organization stage information were in stage III or IV. At the time of analysis, 158 children (5.4%) had withdrawn from care and 382 (13.0%) were at least 30 days late for follow-up. Of the remaining 2398 children receiving ART, 198 (8.3%) died over 3018 child-years of follow-up (mortality rate, 6.6 deaths per 100 child-years; 95% confidence interval [CI], 5.7-7.5); of these deaths, 112 (56.6%) occurred within 90 days of therapy initiation (early mortality rate, 17.4/100 child-years; post-90-day mortality rate, 2.9/100 child-years). Mortality was associated with CD4 cell depletion, lower weight-for-age, younger age, and anemia in multivariate analysis. The mean CD4 cell percentage at ART initiation among the 1561 children who had at least 1 repeat measurement was 12.9% (95% CI, 12.5%-13.3%) and increased to 23.7% (95% CI, 23.1%-24.3%) at 6 months, 27.0% (95% CI, 26.3%-27.6%) at 12 months, 28.0% (95% CI, 27.2%-28.8%) at 18 months, and 28.4% (95% CI, 27.4%-29.4%) at 24 months. CONCLUSIONS: Care provided by clinicians such as nurses and clinical officers can result in good outcomes for HIV-infected children in primary health care settings in sub-Saharan Africa. Mortality during the first 90 days of therapy is high, pointing to a need for earlier intervention.Item Contraceptive use among HIV-infected women and men receiving antiretroviral therapy in Lusaka, Zambia: a cross-sectional survey.(2016-May-12) Hancock NL; Chibwesha CJ; Bosomprah S; Newman J; Mubiana-Mbewe M; Sitali ES; Bolton-Moore C; Mbwili-Muleya C; Chi BH; Centre for Infectious Disease Research in Zambia, PO Box 34681, 5032 Great North Road, Lusaka, Zambia.; Department of Obstetrics and Gynecology, UNC Global Women's Health, University of North Carolina School of Medicine, 3009 Old Clinic Building, Campus, Box 7577, Chapel Hill, NC, 27599-7577, USA.; Centre for Infectious Disease Research in Zambia, PO Box 34681, 5032 Great North Road, Lusaka, Zambia. NancyLHancock@gmail.com.; Department of Obstetrics and Gynecology, UNC Global Women's Health, University of North Carolina School of Medicine, 3009 Old Clinic Building, Campus, Box 7577, Chapel Hill, NC, 27599-7577, USA. NancyLHancock@gmail.com.; Lusaka District Community Health Office, Ministry of Community Development, Mother and Child Health, PO Box 50827, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND: Family planning (FP) is an essential health service and an important part of comprehensive HIV care. However, there is limited information about the contraceptive needs of people living with HIV in sub-Saharan Africa, which in turn has hampered efforts to expand and integrate FP services into existing HIV programs. METHODS: We performed a cross-sectional survey to determine FP prevalence and predictors among HIV-positive women and men attending 18 public antiretroviral therapy (ART) clinics in Lusaka, Zambia. Trained peer counselors administered the 10-question survey to those seeking care for five days at each of the target sites. RESULTS: From February to April 2014, we surveyed 7,046 HIV-infected patients receiving routine HIV services. Use of modern contraception was reported by 69 % of female ART patients and 79 % of male ART patients. However, highly effective contraceptive use and dual method use were low among women (38 and 25 %, respectively) and men (19 and 14 %, respectively). HIV disclosure status (adjusted odds ratio (AOR) = 4.91, 95 % confidence interval (CI) = 3.32-7.24 for women, AOR = 3.58, 95 % CI = 2.39-5.38 for men) and sexual activity in the last 6 months (AOR = 5.80, 95 % CI = 4.51-7.47 for women, AOR = 6.24, 95 % CI = 3.51-11.08 for men) were associated with modern contraceptive use in multivariable regression. Most respondents said they would access FP services if made available within ART clinic. CONCLUSIONS: While FP-ART integration may be a promising strategy for increasing FP service uptake, such services must focus on assessing sexual activity and advocating for dual method use to increase effective contraceptive use and prevent unintended pregnancies.Item Development and validation of a novel scale for antiretroviral therapy readiness among pregnant women in urban Zambia with newly diagnosed HIV infection.(2023-Apr-06) Mubiana-Mbewe M; Bosomprah S; Saroj RK; Kadota J; Koyuncu A; Thankian K; Vinikoor MJ; Department of Biostatistics, School of Public Health, University of Ghana, Accra, Ghana.; Centre for Infectious Diseases Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia. Mwangelwa.Mbewe@cidrz.org.; Department of Medicine, University of Alabama at Birmingham, Birmingham, USA.; Centre for Infectious Diseases Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia.; UCSF Center for Tuberculosis and Division of Pulmonary and Critical Care Medicine San Francisco General Hospital, University of California, San Francisco, CA, USA.; Department of Gender Studies, University of Zambia, Lusaka, Zambia.; Department of Epidemiology, Johns Hopkins University, Maryland, USA.; School of Computational and Integrative Sciences, Jawaharlal Nehru University, New Delhi, 110067, India.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND: Women who are newly diagnosed with HIV infection during pregnancy may not be ready to immediately initiate lifelong antiretroviral therapy (ART; called Option B +) as is recommended. Lack of "readiness" drives early disengagement from care and undermines prevention of HIV transmission to infants. Several studies have shown high early attrition of women initiating ART in pregnancy. Although poor ART uptake and adherence have been attributed to various factors including stigma, disclosure issues and structural issues, there is no standard way of determining which pregnant woman will face challenges and therefore need additional support. We developed and validated a novel ART readiness tool in Lusaka, Zambia. METHODS: The aim of this study was to develop and validate a tool that could be used to assess how ready a newly diagnosed pregnant woman living with HIV would be to initiate ART on the day of diagnosis. Using a mixed method design, we conducted this study in three public-setting health facilities in Lusaka, Zambia. Informed by qualitative research and literature review, we identified 27 candidate items. We assessed content validity using expert and target population judgment approaches. We administered the 27-item questionnaire to 454 newly diagnosed pregnant women living with HIV, who were enrolled into a randomized trial (trials number NCT02459678). We performed item reduction analysis and used Cronbach's alpha coefficient of 0.70 as threshold for reliability. RESULTS: A total of 454 pregnant women living with HIV enrolled in the study between March 2017 and December 2017; 452 had complete data for analysis. The correlation coefficient between the 27 items on the completed ART readiness scale ranged from 0.31 to 0.70 while item discrimination index ranged from -0.01 to 2.38. Sixteen items were selected for the final scale, representing three domains, which we classified as "internalized and anticipated HIV stigma", "partner support" and "anticipated structural barriers". CONCLUSION: We developed and validated a tool that could be used to assess readiness of newly diagnosed women living with HIV to initiate ART. This ART readiness tool could allow clinics to tailor limited resources to pregnant women living with HIV needing additional support to initiate and remain on ART.Item Duration of cART Before Delivery and Low Infant Birthweight Among HIV-Infected Women in Lusaka, Zambia.(2016-Apr-15) Bengtson AM; Chibwesha CJ; Westreich D; Mubiana-Mbewe M; Vwalika B; Miller WC; Mapani M; Musonda P; Pettifor A; Chi BH; *Department of Epidemiology, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina; †Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; ‡Department of Obstetrics and Gynecology, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina; §Department of Public Health, University of Zambia School of Medicine, Lusaka, Zambia; and ‖Department of Medicine, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)OBJECTIVE: To estimate the association between duration of combination antiretroviral therapy (cART) during pregnancy and low infant birthweight (LBW), among women ≥37 weeks of gestation. DESIGN: We conducted a retrospective cohort study of HIV-infected women who met eligibility criteria based on CD4 count ≤350 but had not started cART at entry into antenatal care. Our cohort was restricted to births that occurred ≥37 weeks of gestation. METHODS: We used Poisson models with robust variance estimators to estimate risk ratios (RRs) and 95% confidence intervals (CIs). RESULTS: Of 50,765 HIV-infected women with antenatal visits between January 2009 and September 2013, 4474 women met the inclusion criteria. LBW occurred in 302 pregnancies (7%). Nearly two-thirds of women (62%) eligible to initiate cART never started treatment. Overall, 14% were on cART for ≤8 weeks, 22% for 9-20 weeks, and 2% for 21-36 weeks. There was no evidence of an increased risk of LBW for women receiving cART for ≤8 weeks (RR = 1.22; 95% CI: 0.77 to 1.91), 9-20 weeks (RR = 1.23; 95% CI: 0.82 to 1.83), or 21-36 weeks (RR = 0.87; 95% CI: 0.22 to 3.46), compared with women who never initiated treatment. These findings were consistent across several sensitivity analyses. CONCLUSIONS: Longer duration of cART was not associated with poor fetal growth among term pregnancies in our cohort. However, the relationship between cART and adverse pregnancy outcomes remains complicated. Continued work is required to investigate causality. An understanding cART's impact on adverse pregnancy outcomes is essential as cART becomes the cornerstone of preventing mother-to-child transmission programs globally.Item Effect of Enhanced Adherence Package on Early ART Uptake Among HIV-Positive Pregnant Women in Zambia: An Individual Randomized Controlled Trial.(2021-Mar) Mubiana-Mbewe M; Bosomprah S; Kadota JL; Koyuncu A; Kusanathan T; Mweebo K; Musokotwane K; Mulenga PL; Chi BH; Vinikoor MJ; Centre for Infectious Disease Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia. Mwangelwa.Mbewe@cidrz.org.; Department of Biostatistics, School of Public Health, University of Ghana, Accra, Ghana.; Department of Medicine, University of Alabama at Birmingham, Birmingham, USA.; Division of Pulmonary and Critical Care Medicine, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, USA.; Department of Gender Studies, University of Zambia, Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia.; Prevention, Care and Treatment Branch, U.S. Centers for Disease Control and Prevention, Lusaka, Zambia.; Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.; Directorate of Public Health, Zambian Ministry of Health, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)We evaluated the effect of an option B-plus Enhanced Adherence Package (BEAP), on early ART uptake in a randomized controlled trial. HIV-positive, ART naïve pregnant women in Lusaka, Zambia, were randomized to receive BEAP (phone calls/home visits, additional counseling, male partner engagement and missed-visit follow-up) versus standard of care (SOC). The primary outcome was initiating and remaining on ART at 30 days. Analysis was by intention to treat (ITT) using logistic regression. Additional per protocol analysis was done. We enrolled 454 women; 229 randomized to BEAP and 225 to SOC. Within 30 days of eligibility, 445 (98.2%) initiated ART. In ITT analysis, 82.5% BEAP versus 80.4% SOC participants reached primary outcome (crude relative risk [RR] 1.03; 95% confidence interval [CI] 0.91-1.16; Wald test statistic = 0.44; p-value = 0.66). In per protocol analysis, (92 participants (40.2%) excluded), 91.9% BEAP versus 80.4% SOC participants reached primary outcome (crude RR 1.14; 95% CI 1.02-1.29; Wald test statistic = 2.23; p-value = 0.03). Early ART initiation in pregnancy was nearly universal but there was early drop out suggesting need for additional adherence support.This trial was registered at ClinicalTrials.gov (trials number NCT02459678) on May 14, 2015.Item Effect on growth of exposure to maternal antiretroviral therapy in breastmilk versus extended infant nevirapine prophylaxis among HIV-exposed perinatally uninfected infants in the PROMISE randomized trial.(2021) Stranix-Chibanda L; Tierney C; Pinilla M; George K; Aizire J; Chipoka G; Mallewa M; Naidoo M; Nematadzira T; Kusakara B; Violari A; Mbengeranwa T; Njau B; Fairlie L; Theron G; Mubiana-Mbewe M; Khadse S; Browning R; Fowler MG; Siberry GK; FHI 360, Durham, NC, United States of America.; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States of America.; University of North Carolina Project, Lilongwe, Malawi.; Johns Hopkins University School of Medicine, Baltimore, MD, United States of America.; University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe.; Office of HIV/AIDS, United States Agency for International Development, Washington, DC, United States of America.; Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research in the Department of Biostatistics, Boston, MA, United States of America.; Department of Obstetrics and Gynaecology, Stellenbosch University, Cape Town, South Africa.; Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.; Perinatal HIV Research Unit, Johannesburg, South Africa.; Makerere University-Johns Hopkins University Research Programme, Kampala, Uganda.; University of KwaZulu-Natal, Centre Aids Prevention Research South Africa (CAPRISA), Durban, South Africa.; College of Medicine-Johns Hopkins University Project, Blantyre, Malawi.; University of Zimbabwe Faculty of Medicine and Health Sciences, Child and Adolescent Health Unit, Harare, Zimbabwe.; Department of Obstetrics and Gynaecology, BJ Government Medical College, Pune, India.; Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MD, United States of America.; Kilimanjaro Christian Medical Center, Moshi, United Republic of Tanzania.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND: Malnutrition is highly prevalent in HIV-exposed perinatally uninfected infants (HEUs) increasing the risk of morbidity and mortality throughout the life course. We set out to compare the effect of postnatal exposure to maternal antiretroviral therapy (mART) in breastmilk versus infant Nevirapine prophylaxis (iNVP) on somatic growth of HEUs in the randomized PROMISE trial. METHODS AND FINDINGS: We randomized 2431 mothers with HIV and their 2444 HEUs from six African countries and India 6-14 days after delivery to mART or iNVP for prevention of breastmilk HIV transmission. The mART regimen contained tenofovir/emtricitabine (99%) plus lopinavir/ritonavir. Infant growth parameters were compared at postnatal week 10, 26, 74 and 104 using World Health Organization (WHO) z-scores for length-for-age (LAZ), weight-for-age (WAZ), and head circumference-for-age (HCAZ). Week 26 LAZ was the primary endpoint measure. Student T-tests compared mean LAZ, WAZ, and HCAZ; estimated mean and 95% confidence interval (CI) are presented. Maternal and infant baseline characteristics were comparable between study arms. The estimated median breastfeeding duration was 70 weeks. After a mean follow-up of 88 weeks, mean LAZ and WAZ were below the WHO reference population mean at all timepoints, whereas mean HCAZ was not. The mART and iNVP arms did not differ for the primary outcome measure of LAZ at week 26 (p-value = 0.39; estimated mean difference (95%CI) of -0.05 (-0.18, 0.07)) or any of the other secondary growth outcome measures or timepoints (all p-values≥0.16). Secondary analyses of the primary outcome measure adjusting for week 0 LAZ and other covariates did not change these results (all p-values≥0.09). However, infants assigned to mART were more likely to have stunting compared to iNVP infants at week 26 (odds ratio (95% CI): 1.28 (1.05, 1.57)). CONCLUSIONS: In HEUs, growth effects from postnatal exposure to mART compared to iNVP were comparable for measures on length, weight and head circumference with no clinically relevant differences between the groups. Despite breastfeeding into the second year of life, length and weight were below reference population means at all ages in both arms. Further investment is needed to optimize postnatal growth of infants born to women with HIV. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number NCT01061151.Item Effects of preterm birth, maternal ART and breastfeeding on 24-month infant HIV-free survival in a randomized trial.(2024-Jul-15) Dadabhai S; Chou VB; Pinilla M; Chinula L; Owor M; Violari A; Moodley D; Stranix-Chibanda L; Matubu TA; Chareka GT; Theron G; Kinikar AA; Mubiana-Mbewe M; Fairlie L; Bobat R; Mmbaga BT; Flynn PM; Taha TE; McCarthy KS; Browning R; Mofenson LM; Brummel SS; Fowler MG; Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Soweto.; Department of Paediatrics and Child Health, University of KwaZulu-Natal, Durban, South Africa.; National Institute of Allergy and Infectious Diseases/NIH, Rockville, MD.; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.; Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; St. Jude Children's Research Hospital, Memphis, TN.; B.J. Government Medical College, Department of Paediatrics, Pune, India.; Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.; Elizabeth Glaser Pediatric AIDS Foundation, Washington DC, USA.; MU-JHU Research Collaboration; Upper Mulago Hill Road, Kampala, Uganda.; Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.; Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg.; University of North Carolina Project Malawi, Tidziwe Centre, Lilongwe, Malawi.; Centre for Infectious Disease Research in Zambia, George CRS, Lusaka, Zambia.; Centre for the AIDS Programme of Research in South Africa and School of Clinical Medicine, University of KwaZulu Natal, Congella, South Africa.; Kamuzu University of Health Sciences-Johns Hopkins Research Project, Blantyre, Malawi.; Child, Adolescent and Women's Health Department, Faculty of Medicine and Health Sciences, University of Zimbabwe, Avondale.; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health.; Kilimanjaro Christian Medical Centre, Kilimanjaro Clinical Research Institute and Kilimanjaro Christian Medical University College/Kilimanjaro CRS, Moshi, Tanzania.; University of Zimbabwe Clinical Trials Research Centre, Belgravia, Harare, Zimbabwe.; FHI 360, Durham, NC.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND: IMPAACT 1077BF/FF (PROMISE) compared the safety/efficacy of two HIV antiretroviral therapy (ART) regimens to zidovudine (ZDV) alone during pregnancy for HIV prevention. PROMISE found an increased risk of preterm delivery (<37 weeks) with antepartum triple ART (TDF/FTC/LPV+r or ZDV/3TC/LPV+r) compared with ZDV alone. We assessed the impact of preterm birth, breastfeeding, and antepartum ART regimen on 24-month infant survival. METHODS: We compared HIV-free and overall survival at 24 months for liveborn infants by gestational age, time-varying breastfeeding status, and antepartum ART arm at 14 sites in Africa and India. Kaplan-Meier survival probabilities and Cox proportional hazards ratios were estimated. RESULTS: Three thousand four hundred and eighty-two live-born infants [568 (16.3%) preterm and 2914 (83.7%) term] were included. Preterm birth was significantly associated with lower HIV-free survival [0.85; 95% confidence interval (CI) 0.82-0.88] and lower overall survival (0.89; 95% CI 0.86-0.91) versus term birth (0.96; 95% CI 0.95-0.96). Very preterm birth (<34 weeks) was associated with low HIV-free survival (0.65; 95% CI 0.54-0.73) and low overall survival (0.66; 95% CI 0.56-0.74). Risk of HIV infection or death at 24 months was higher with TDF-ART than ZDV-ART (adjusted hazard ratio 2.37; 95% CI 1.21-4.64). Breastfeeding initiated near birth decreased risk of infection or death at 24 months (adjusted hazard ratio 0.05; 95% CI 0.03-0.08) compared with not breastfeeding. CONCLUSION: Preterm birth and antepartum TDF-ART were associated with lower 24-month HIV-free survival compared with term birth and ZDV-ART. Any breastfeeding strongly promoted HIV-free survival, especially if initiated close to birth. Reducing preterm birth and promoting infant feeding with breastmilk among HIV/antiretroviral drug-exposed infants remain global health priorities.Item Growth patterns of infants with in- utero HIV and ARV exposure in Cape Town, South Africa and Lusaka, Zambia.(2022-Jan-10) Nyemba DC; Kalk E; Vinikoor MJ; Madlala HP; Mubiana-Mbewe M; Mzumara M; Moore CB; Slogrove AL; Boulle A; Davies MA; Myer L; Powis K; Centre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa. dorothy.nyemba@uct.ac.za.; Centre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.; Ukwanda Centre for Rural Health, Faculty of Medicine & Health Sciences, Stellenbosch University, Worcester, South Africa.; Department of Internal Medicine and Pediatrics, Massachusetts General Hospital, Boston, MA, USA.; Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, MA, USA.; Western Cape Government: Health, Cape Town, South Africa.; Division of Epidemiology & Biostatistics, Faculty of Health Sciences, School of Public Health and Family Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa. dorothy.nyemba@uct.ac.za.; Department of Paediatrics & Child Health, Faculty of Medicine & Health Sciences, Stellenbosch University, Worcester, South Africa.; Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Division of Epidemiology & Biostatistics, Faculty of Health Sciences, School of Public Health and Family Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND: Infants born HIV-exposed yet remain uninfected (HEU) are at increased risk of poorer growth and health compared to infants born HIV-unexposed (HU). Whether maternal antiretroviral treatment (ART) in pregnancy ameliorates this risk of poorer growth is not well understood. Furthermore, whether risks are similar across high burden HIV settings has not been extensively explored. METHODS: We harmonized data from two prospective observational studies conducted in Cape Town, South Africa, and Lusaka, Zambia, to compare weight-for-age (WAZ), length-for-age (LAZ) and weight-for-length (WLZ) Z-scores between infants who were HEU and HU, converting infant anthropometric measures using World Health Organisation Growth Standards adjusted for age and sex. Linear mixed effects models were fit to identify risk factors for differences in anthropometrics at 6-10 weeks and 6 months by infant HIV exposures status and by timing of exposure to maternal ART, either from conception or later in gestation. RESULTS: Overall 773 mother-infant pairs were included across two countries: women living with HIV (WLHIV), 51% (n = 395) with 65% on ART at conception and 35% initiating treatment in pregnancy. In linear mixed effects models, WAZ and WLZ at 6-10 weeks were lower among infants who were HEU vs HU [β = - 0.29 (95% CI: - 0.46, - 0.12) and [β = - 0.42 (95% CI: - 0.68, - 0.16)] respectively after adjusting for maternal characteristics and infant feeding with a random intercept for country. At 6 months, LAZ was lower [β = - 0.28 CI: - 0.50, - 0.06)] among infants who were HEU, adjusting for the same variables, with no differences in WAZ and WLZ. Within cohort evaluations identified different results with higher LAZ among infants who were HEU from Zambia at 6-10 weeks, [β = + 0.34 CI: + 0.01, + 0.68)] and lower LAZ among infants who were HEU from South Africa [β = - 0.30 CI: - 0.59, - 0.01)] at 6 months, without other anthropometric differences at either site. CONCLUSION: Infant growth trajectories differed by country, highlighting the importance of studying contextual influences on outcomes of infants who were HEU.Item Identifying barriers to ART initiation and adherence: An exploratory qualitative study on PMTCT in Zambia.(2022) Kanguya T; Koyuncu A; Sharma A; Kusanathan T; Mubanga M; Chi BH; Vinikoor MJ; Mubiana-Mbewe M; University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.; Department of Gender Studies, University of Zambia, Lusaka, Zambia.; Centre for Infectious Diseases Research in Zambia, Lusaka, Zambia.; University of Alabama at Birmingham, Birmingham, Alabama, United States of America.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND: Though antiretroviral therapy (ART) is widely available, HIV positive pregnant women in Zambia are less likely to start and remain on therapy throughout pregnancy and after delivery. This study sought to understand readiness to start ART among HIV pregnant women from the perspectives of both women and men in order to suggest more holistic programs to support women to continue life-long ART after delivery. METHODS: We conducted a qualitative study with HIV positive pregnant women before and after ART initiation, and men with female partners, to understand readiness to start lifelong ART. We conducted 28 in-depth interviews among women and 2 focus group discussions among male partners. Data were transcribed verbatim and analyzed in NVivo 12 using thematic analysis. Emerging themes from the data were organized using the social ecological framework. RESULTS: Men thought of their female partners as young and needing their supervision to initiate and stay on ART. Women agreed that disclosure and partner support were necessary preconditions to ART initiation and adherence and, expressed fear of divorce as a prominent barrier to disclosure. Maternal love and desire to look after one's children instilled a sense of responsibility among women which motivated them to overcome individual, interpersonal and health system level barriers to initiation and adherence. Women preferred adherence strategies that were discrete, the effectiveness of which, depended on women's intrinsic motivation. CONCLUSION: The results support current policies in Zambia to encourage male engagement in ART care. To appeal to male partners, messaging on ART should be centered on emphasizing the importance of male involvement to ensure women remain engaged in ART care. Programs aimed at supporting postpartum ART adherence should design messages that appeal to both men's role in couples' joint decision-making and women's maternal love as motivators for adherence.Item Impact of the Umoyo mother-infant pair model on HIV-positive mothers' social support, perceived stigma and 12-month retention of their HIV-exposed infants in PMTCT care: evidence from a cluster randomized controlled trial in Zambia.(2019-Aug-15) Phiri SC; Mudhune S; Prust ML; Haimbe P; Shakwelele H; Chisenga T; Mubiana-Mbewe M; Mzumara M; McCarthy E; Prescott MR; Center for Infectious Disease Research in Zambia, Lusaka, Zambia.; Clinton Health Access Initiative, Lusaka, Zambia. sydnyhill@gmail.com.; Clinton Health Access Initiative, Lusaka, Zambia.; Ministry of Health Zambia, Lusaka, Zambia.; Clinton Health Access Initiative, Boston, MA, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND: Public health systems in resource-constrained settings have a critical role to play in the elimination of HIV transmission but are often financially constrained. This study is an evaluation of a mother-infant-pair model called "Umoyo," which was designed to be low cost and scalable in a public health system. Facilities with the Umoyo model dedicate a clinic day to provide services to only HIV-exposed infants (HEIs) and their mothers. Such models are in operation with reported success in Zambia but have not been rigorously tested. This work establishes whether the Umoyo model would improve 12-month retention of HEIs. METHODS: A cluster randomized trial including 28 facilities was conducted across two provinces of Zambia to investigate the impact on 12-month retention of HEIs in care. These facilities were offering Prevention of Mother-to-Child-Transmission (PMTCT) services and supported by the same implementing partner. Randomization was achieved by use of the covariate-constrained optimization technique. Secondary outcomes included the impact of Umoyo clinics on social support and perceived HIV stigma among mothers. For each of the outcomes, a difference-in-difference analysis was conducted at the facility level using the unweighted t test. RESULTS: From 13 control (12-month retention at endline: 45%) and 11 intervention facilities (12-month retention at endline: 33%), it was found that Umoyo clinics had no impact on 12-month retention of HEIs in the t test (- 11%; 99% CI - 40.1%, 17.2%). Regarding social support and stigma, the un-weighted t test showed no impact though sensitivity tests showed that Umoyo had an impact on increasing social support (0.31; 99% CI 0.08, 0.54) and reducing perceived stigma from health care workers (- 0.27; 99% CI - 0.46, - 0.08). CONCLUSION: The Umoyo approach of having a dedicated clinic day for HEIs and their mothers did not improve retention of HEIs though there are indications that it can increase social support among mothers and reduce stigma. Without further support to the underlying health system, based on the evidence generated through this evaluation, the Umoyo clinic day approach on its own is not considered an effective intervention to increase retention of HIV-exposed infants. TRIAL REGISTRATION: Pan African Clinical Trial Registry, ID: PACTR201702001970148 . Prospectively registered on 13 January 2017.Item Implementation and Operational Research: Distance From Household to Clinic and Its Association With the Uptake of Prevention of Mother-to-Child HIV Transmission Regimens in Rural Zambia.(2015-Nov-01) Escamilla V; Chibwesha CJ; Gartland M; Chintu N; Mubiana-Mbewe M; Musokotwane K; Musonda P; Miller WC; Stringer JS; Chi BH; *Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL; †Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; ‡Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC; §Institute for Global Health, Vanderbilt University, Nashville, TN; ‖Society for Family Health, Lusaka, Zambia; ¶Zambian Ministry of Community Development and Mother-Child Health, Lusaka, Zambia; #Department of Public Health, University of Zambia School of Medicine, Lusaka, Zambia; **Division of Infectious Diseases, Department of Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC; ††Department of Epidemiology, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC; and ‡‡Currently at Departments of Medicine and Pediatrics, Massachusetts General Hospital; Boston, MA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND: In rural settings, HIV-infected pregnant women often live significant distances from facilities that provide prevention of mother-to-child transmission (PMTCT) services. METHODS: We offered universal maternal combination antiretroviral regimens in 4 pilot sites in rural Zambia. To evaluate the impact of services, we conducted a household survey in communities surrounding each facility. We collected information about HIV status and antenatal service utilization from women who delivered in the past 2 years. Using household Global Positioning System coordinates collected in the survey, we measured Euclidean (i.e., straight line) distance between individual households and clinics. Multivariable logistic regression and predicted probabilities were used to determine associations between distance and uptake of PMTCT regimens. RESULTS: From March to December 2011, 390 HIV-infected mothers were surveyed across four communities. Of these, 254 (65%) had household geographical coordinates documented. One hundred sixty-eight women reported use of a PMTCT regimen during pregnancy including 102 who initiated a combination antiretroviral regimen. The probability of PMTCT regimen initiation was the highest within 1.9 km of the facility and gradually declined. Overall, 103 of 145 (71%) who lived within 1.9 km of the facility initiated PMTCT versus 65 of 109 (60%) who lived farther away. For every kilometer increase, the association with PMTCT regimen uptake (adjusted odds ratio: 0.90, 95% confidence interval: 0.82 to 0.99) and combination antiretroviral regimen uptake (adjusted odds ratio: 0.88, 95% confidence interval: 0.80 to 0.97) decreased. CONCLUSIONS: In this rural African setting, uptake of PMTCT regimens was influenced by distance to health facility. Program models that further decentralize care into remote communities are urgently needed.Item Nonvirologic algorithms for predicting HIV infection among HIV-exposed infants younger than 12 weeks of age.(2013-Feb) Chi BH; Limbada MI; Giganti MJ; Li MS; Bweupe M; Musonda P; Bubala P; Mubiana-Mbewe M; Chintu NT; Bolton-Moore C; Stringer JS; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia. bchi@cidrz.org; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND: Early initiation of antiretroviral therapy has been shown to reduce mortality among perinatally HIV-infected infants, but availability of virologic testing remains limited in many settings. METHODS: We collected cross-sectional data from mother-infant pairs in three primary care clinics in Lusaka, Zambia, to develop predictive models for HIV infection among infants younger than 12 weeks of age. We evaluated algorithm performance for all possible combinations of selected characteristics using an iterative approach. In primary analysis, we identified the model with the highest combined sensitivity and specificity. RESULTS: Between July 2009 and May 2011, 822 eligible HIV-infected mothers and their HIV-exposed infants were enrolled; of these, 44 (5.4%) infants had HIV diagnosed. We evaluated 382,155,260 different characteristic combinations for predicting infant HIV infection. The algorithm with the highest combined sensitivity and specificity required 5 of the following 7 characteristic thresholds: infant CD8 percentage >22; infant CD4 percentage ≤44; infant weight-for-age Z score ≤0; infant CD4 ≤1600 cells/µL; infant CD8 >2200 cells/µL; maternal CD4 ≤600 cells/µL; and mother not currently using antiretroviral therapy for HIV treatment. This combination had a sensitivity of 90.3%, specificity of 78.4%, positive predictive value of 22.4%, negative predictive value of 99.2% and area under the curve of 0.844. CONCLUSION: Predicting HIV infection in HIV-exposed infants in this age group is difficult using clinical and immunologic characteristics. Expansion of polymerase chain reaction capacity in resource-limited settings remains urgently needed.Item Pediatric HIV-HBV Coinfection in Lusaka, Zambia: Prevalence and Short-Term Treatment Outcomes.(2015-Dec) Peebles K; Nchimba L; Chilengi R; Bolton Moore C; Mubiana-Mbewe M; Vinikoor MJ; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.; Department of Pediatrics, University Teaching Hospital, Lusaka, Zambia.; Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA peebles.kathryn@gmail.com.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)Hepatitis B virus (HBV) is endemic in Africa, where it may occur as an HIV coinfection. Data remain limited on HIV-HBV epidemiology in Africa, particularly in children. Using programmatic data from pediatric HIV clinics in Lusaka, Zambia during 2011-2014, we analyzed the prevalence of chronic HBV coinfection (defined as a single positive hepatitis B surface antigen [HBsAg] test) and its impact on immune recovery and liver enzyme elevation (LEE) during the first year of antiretroviral therapy. Among 411 children and adolescents, 10.4% (95% confidence interval, 7.6-14.1) had HIV-HBV. Coinfected patients were more likely to have World Health Organization stage 3/4, LEE and CD4 <14% at care entry (all p < 0.05). During treatment, CD4 increases and LEE incidence were similar by HBsAg status. HBsAg positivity decreased (11.8% vs. 6.6%; p = 0.24) following HBV vaccine introduction. These findings support screening pediatric HIV patients in Africa for HBV coinfection. Dedicated cohorts are needed to assess long-term outcomes of coinfection.Item Reaching the third 95 using community ART delivery models.(2022-Jan) Mubiana-Mbewe M; Centre for Infectious Disease in Zambia, Lusaka, Zambia. Electronic address: mwangelwa.mbewe@cidrz.org.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)Item Slow Acceptance of Universal Antiretroviral Therapy (ART) Among Mothers Enrolled in IMPAACT PROMISE Studies Across the Globe.(2019-Sep) Stranix-Chibanda L; Brummel S; Pilotto J; Mutambanengwe M; Chanaiwa V; Mhembere T; Kamateeka M; Aizire J; Masheto G; Chamanga R; Maluwa M; Hanley S; Joao E; Theron G; Nevrekar N; Nyati M; Santos B; Aurpibul L; Mubiana-Mbewe M; Oliveira R; Anekthananon T; Mlay P; Angelidou K; Tierney C; Ziemba L; Coletti A; McCarthy K; Basar M; Chakhtoura N; Browning R; Currier J; Fowler MG; Flynn P; Instituto of Pediatrics Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.; Kilimanjaro Christian Medical Centre, Moshi, Tanzania.; Harvard T.H. Chan School of Public Health, Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.; Centre Aids Prevention Research South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.; Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, USA.; University of Zimbabwe College of Health Sciences, Paediatrics and Child Health, Harare, Zimbabwe. lstranix@uzchs-ctrc.org.; College of Medicine - Johns Hopkins Research Project, Blantyre, Malawi.; University of North Carolina Project, Lilongwe, Malawi.; University of Zimbabwe College of Health Sciences - Clinical Trials Research Centre, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe.; Department of Infectious Diseases, St Jude Children's Research Hospital, Memphis, TN, USA.; Perinatal HIV Research Unit, Johannesburg, South Africa.; Division of Infectious Diseases, University of California Los Angeles, Los Angeles, USA.; Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research in the Department of Biostatistics, Boston, USA.; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, USA.; Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.; Department of Obstetrics and Gynaecology, Stellenbosch University, Cape Town, South Africa.; FHI 360, IMPAACT Operations Center, Durham, NC, USA.; University of Zimbabwe College of Health Sciences - Clinical Trials Research Centre, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe. lstranix@uzchs-ctrc.org.; Frontier Science and Technology Research Foundation, Amherst, USA.; Department of Infectious Diseases, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, USA.; Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, China.; Hospital Nossa Senhora da Conceicao, Porto Alegre, Brazil.; Laboratorio de AIDS e Imunologia Molecular - Fiocruz, Hospital Geral de Nova Iguacu, Rio de Janeiro, Brazil.; Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.; Department of Obstetrics and Gynaecology, BJ Government Medical College, Pune, India.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)The PROMISE trial enrolled asymptomatic HIV-infected pregnant and postpartum women not eligible for antiretroviral treatment (ART) per local guidelines and randomly assigned proven antiretroviral strategies to assess relative efficacy for perinatal prevention plus maternal/infant safety and maternal health. The START study subsequently demonstrated clear benefit in initiating ART regardless of CD4 count. Active PROMISE participants were informed of results and women not receiving ART were strongly recommended to immediately initiate treatment to optimize their own health. We recorded their decision and the primary reason given for accepting or rejecting the universal ART offer after receiving the START information. One-third of participants did not initiate ART after the initial session, wanting more time to consider. Six sessions were required to attain 95% uptake. The slow uptake of universal ART highlights the need to prepare individuals and sensitize communities regarding the personal and population benefits of the "Treat All" strategy.Item Stunting and growth velocity of adolescents with perinatally acquired HIV: differential evolution for males and females. A multiregional analysis from the IeDEA global paediatric collaboration.(2019-Nov) Jesson J; Schomaker M; Malasteste K; Wati DK; Kariminia A; Sylla M; Kouadio K; Sawry S; Mubiana-Mbewe M; Ayaya S; Vreeman R; McGowan CC; Yotebieng M; Leroy V; Davies MA; Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, OH, USA.; Department of Child Health and Paediatrics, School of Medicine, College of Health Sciences, Moi University, Eldoret, Kenya.; Sanglah Hospital, Bali, Indonesia.; Ryan White Center for Pediatric Infectious Disease and Global Health, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.; Vanderbilt University School of Medicine, Nashville, TN, USA.; The Kirby Institute, UNSW, Sydney, Australia.; University of Cape Town, Centre for Infectious Disease Epidemiology and Research, Cape Town, South Africa.; Hopital Gabriel Touré, Bamako, Mali.; Harriet Shezi Children's Clinic, Chris Hani Baragwanath Academic Hospital, Soweto, South Africa.; Faculty of Health Scences, Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.; CIRBA, Abidjan, Côte d'Ivoire.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Inserm U1219, Bordeaux Population Health Center, Université de Bordeaux, Bordeaux, France.; Medical Informatics and Technology, Institute of Public Health, UMIT - University for Health Sciences, Medical Decision Making and Health Technology Assessment, Hall in Tirol, Austria.; Inserm U1027, Université Paul Sabatier Toulouse 3, Toulouse, France.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)INTRODUCTION: Stunting is a key issue for adolescents with perinatally acquired HIV (APH) that needs to be better understood. As part of the IeDEA multiregional consortium, we described growth evolution during adolescence for APH on antiretroviral therapy (ART). METHODS: We included data from sub-Saharan Africa, the Asia-Pacific, and the Caribbean, Central and South America regions collected between 2003 and 2016. Adolescents on ART, reporting perinatally acquired infection or entering HIV care before 10 years of age, with at least one height measurement between 10 and 16 years of age, and followed in care until at least 14 years of age were included. Characteristics at ART initiation and at 10 years of age were compared by sex. Correlates of growth defined by height-for-age z-scores (HAZ) between ages 10 and 19 years were studied separately for males and females, using linear mixed models. RESULTS: Overall, 8737 APH were included, with 46% from Southern Africa. Median age at ART initiation was 8.1 years (interquartile range (IQR) 6.1 to 9.6), 50% were females, and 41% were stunted (HAZ<-2 SD) at ART initiation. Males and females did not differ by age and stunting at ART initiation, CD4 count over time or retention in care. At 10 years of age, 34% of males were stunted versus 39% of females (p < 0.001). Females had better subsequent growth, resulting in a higher prevalence of stunting for males compared to females by age 15 (48% vs. 25%) and 18 years (31% vs. 15%). In linear mixed models, older age at ART initiation and low CD4 count were associated with poor growth over time (p < 0.001). Those stunted at 10 years of age or at ART initiation had the greatest growth improvement during adolescence. CONCLUSIONS: Prevalence of stunting is high among APH worldwide. Substantial sex-based differences in growth evolution during adolescence were observed in this global cohort, which were not explained by differences in age of access to HIV care, degree of immunosuppression or region. Other factors influencing growth differences in APH, such as differences in pubertal development, should be better documented, to guide further research and inform interventions to optimize growth and health outcomes among APH.