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Shapiro, Roger

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Shapiro, Roger

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2007 - 200912010 - 201920

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Author's Publications: search.filters.isAuthorOfPublication.02afd5dd-55ab-401a-9b92-b614987c51a4

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    Audit of Early Mortality among Patients Admitted to the General Medical Ward at a District Hospital in Botswana
    (Ubiquity Press, Ltd., 2019) Kershaw, Colleen; Williams, Margaret; Kilaru, Saikiran; Zash, Rebecca; Kalenga, Kitenge; Masole, Felly; Shapiro, Roger; Barak, Tomer
    Background: Mortality among adult general medical admissions has been reported to be high across sub-Saharan Africa, yet there is a paucity of literature on causes of general medical inpatient mortality and quality-related factors that may contribute to the high incidence of deaths. Based on a prior study at our hospital as well as our clinical experience, death early in the hospitalization is common among patients admitted to the adult medical wards. Objective: Identify factors contributing to early in-hospital mortality of medical patients in a resource-limited hospital setting in Botswana. Methods: Twenty-seven cases of patients who died within 48 hours of admission to the medical wards at Scottish Livingstone Hospital in Molepolole, Botswana from December 1, 2015-April 25, 2016 were reviewed through a modified root cause analysis. Findings: Early in-hospital mortality was most frequently attributed to septic shock, identified in 20 (74%) of 27 cases. The most common care management problems were delay in administration of antibiotics (15, 56%), inappropriate fluid management (15, 56%), and deficient coordination of care (15, 56%). The most common contributing factors were inadequate provider knowledge and skills in 25 cases (93%), high complexity of presenting condition in 20 (74%), and inadequate communication between team members in 18 (67%). Conclusions: Poor patient outcomes in low- and middle-income countries like Botswana are often attributed to resource limitations. Our findings suggest that while early in-hospital mortality in such settings is associated with severe presenting conditions like septic shock, primary contributors to lack of better outcomes may be healthcare-provider and system-factors rather than lack of diagnostic and therapeutic resources. Low-cost interventions to improve knowledge, skills and communication through a focus on provider education and process improvement may provide the key to reducing early in-hospital mortality and improving hospitalization outcomes in this setting.
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    Optimal breastfeeding durations for HIV‐exposed infants: the impact of maternal ART use, infant mortality and replacement feeding risk
    (John Wiley and Sons Inc., 2018) Mallampati, Divya; MacLean, Rachel L; Shapiro, Roger; Dabis, Francois; Engelsmann, Barbara; Freedberg, Kenneth; Leroy, Valeriane; Lockman, Shahin; Walensky, Rochelle; Rollins, Nigel; Ciaranello, Andrea
    Abstract Introduction: In 2010, the WHO recommended women living with HIV breastfeed for 12 months while taking antiretroviral therapy (ART) to balance breastfeeding benefits against HIV transmission risks. To inform the 2016 WHO guidelines, we updated prior research on the impact of breastfeeding duration on HIV‐free infant survival (HFS) by incorporating maternal ART duration, infant/child mortality and mother‐to‐child transmission data. Methods: Using the Cost‐Effectiveness of Preventing AIDS Complications (CEPAC)‐Infant model, we simulated the impact of breastfeeding duration on 24‐month HFS among HIV‐exposed, uninfected infants. We defined “optimal” breastfeeding durations as those maximizing 24‐month HFS. We varied maternal ART duration, mortality rates among breastfed infants/children, and relative risk of mortality associated with replacement feeding (“RRRF”), modelled as a multiplier on all‐cause mortality for replacement‐fed infants/children (range: 1 [no additional risk] to 6). The base‐case simulated RRRF = 3, median infant mortality, and 24‐month maternal ART duration. Results: In the base‐case, HFS ranged from 83.1% (no breastfeeding) to 90.2% (12‐months breastfeeding). Optimal breastfeeding durations increased with higher RRRF values and longer maternal ART durations, but did not change substantially with variation in infant mortality rates. Optimal breastfeeding durations often exceeded the previous WHO recommendation of 12 months. Conclusions: In settings with high RRRF and long maternal ART durations, HFS is maximized when mothers breastfeed longer than the previously‐recommended 12 months. In settings with low RRRF or short maternal ART durations, shorter breastfeeding durations optimize HFS. If mothers are supported to use ART for longer periods of time, it is possible to reduce transmission risks and gain the benefits of longer breastfeeding durations.
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    Similar HIV protection from four weeks of zidovudine versus nevirapine prophylaxis among formula-fed infants in Botswana
    (AOSIS, 2018) Powis, Kathleen; Lockman, Shahin; Ajibola, Gbolahan; Hughes, Michael D.; Bennett, Kara; Leidner, Jean; Batlang, Oganne; Botebele, Kerapetse; Moyo, Sikhulile; van Widenfelt, Erik; Makhema, Joseph; Petlo, Chipo; Jibril, Haruna B.; McIntosh, Kenneth; Essex, Max; Shapiro, Roger
    Background: The World Health Organization HIV guidelines recommend either infant zidovudine (ZDV) or nevirapine (NVP) prophylaxis for the prevention of intrapartum mother-to-child HIV transmission (MTCT) among formula-fed infants. No study has evaluated the comparative efficacy of infant prophylaxis with twice daily ZDV versus once daily NVP in exclusively formula-fed HIV-exposed infants. Methods: Using data from the Mpepu Study, a Botswana-based clinical trial investigating whether prophylactic co-trimoxazole could improve infant survival, retrospective analyses of MTCT events and Division of AIDS (DAIDS) Grade 3 or Grade 4 occurrences of anaemia or neutropenia were performed among infants born full-term (≥ 37 weeks gestation), with a birth weight ≥ 2500 g and who were formula-fed from birth. ZDV infant prophylaxis was used from Mpepu Study inception. A protocol modification mid-way through the study led to the subsequent use of NVP infant prophylaxis. Results: Among infants qualifying for this secondary retrospective analysis, a total of 695 (52%) infants received ZDV, while 646 (48%) received NVP from birth for at least 25 days but no more than 35 days. Confirmed intrapartum HIV infection occurred in two (0.29%) ZDV recipients and three (0.46%) NVP recipients (p = 0.68). Anaemia occurred in 19 (2.7%) ZDV versus 12 (1.9%) NVP (p = 0.36) recipients. Neutropenia occurred in 28 (4.0%) ZDV versus 21 (3.3%) NVP recipients (p = 0.47). Conclusions: Both ZDV and NVP resulted in low intrapartum transmission rates and no significant differences in severe infant haematologic toxicity (DAIDS Grade 3 or Grade 4) among formula-fed full-term infants with a birthweight ≥ 2500 g.
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    Contribution of Maternal Antiretroviral Therapy and Breastfeeding to 24-Month Survival in Human Immunodeficiency Virus-Exposed Uninfected Children: An Individual Pooled Analysis of African and Asian Studies
    (Oxford University Press, 2017) Arikawa, Shino; Rollins, Nigel; Jourdain, Gonzague; Humphrey, Jean; Kourtis, Athena P; Hoffman, Irving; Essex, Max; Farley, Tim; Coovadia, Hoosen M; Gray, Glenda; Kuhn, Louise; Shapiro, Roger; Leroy, Valériane; Bollinger, Robert C; Onyango-Makumbi, Carolyne; Lockman, Shahin; Marquez, Carina; Doherty, Tanya; Dabis, François; Mandelbrot, Laurent; Le Coeur, Sophie; Rolland, Matthieu; Joly, Pierre; Newell, Marie-Louise; Becquet, Renaud
    Abstract Background: Human immunodeficiency virus (HIV)–infected pregnant women increasingly receive antiretroviral therapy (ART) to prevent mother-to-child transmission (PMTCT). Studies suggest HIV-exposed uninfected (HEU) children face higher mortality than HIV-unexposed children, but most evidence relates to the pre-ART era, breastfeeding of limited duration, and considerable maternal mortality. Maternal ART and prolonged breastfeeding while on ART may improve survival, although this has not been reliably quantified. Methods: Individual data on 19 219 HEU children from 21 PMTCT trials/cohorts undertaken from 1995 to 2015 in Africa and Asia were pooled to estimate the association between 24-month mortality and maternal/infant factors, using random-effects Cox proportional hazards models. Adjusted attributable fractions of risks computed using the predict function in the R package “frailtypack” were used to estimate the relative contribution of risk factors to overall mortality. Results: Cumulative incidence of death was 5.5% (95% confidence interval, 5.1–5.9) by age 24 months. Low birth weight (LBW <2500 g, adjusted hazard ratio (aHR, 2.9), no breastfeeding (aHR, 2.5), and maternal death (aHR, 11.1) were significantly associated with increased mortality. Maternal ART (aHR, 0.5) was significantly associated with lower mortality. At the population level, LBW accounted for 16.2% of 24-month mortality, never breastfeeding for 10.8%, mother not receiving ART for 45.6%, and maternal death for 4.3%; combined, these factors explained 63.6% of deaths by age 24 months. Conclusions: Survival of HEU children could be substantially improved if public health practices provided all HIV-infected mothers with ART and supported optimal infant feeding and care for LBW neonates.
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    Targeted HIV testing at birth supported by low and predictable mother‐to‐child transmission risk in Botswana
    (John Wiley and Sons Inc., 2018) Ibrahim, Maryanne; Maswabi, Kenneth; Ajibola, Gbolahan; Moyo, Sikhulile; Hughes, Michael; Batlang, Oganne; Sakoi, Maureen; Auletta‐Young, Chloe; Vaughan, Laura; Lockman, Shahin; Jean‐Philippe, Patrick; Yu, Xu; Lichterfeld, Matthias; Kuritzkes, Daniel R; Makhema, Joseph; Shapiro, Roger
    Abstract Introduction: Most African countries perform infant HIV testing at 6 weeks or later. The addition of targeted testing at birth may improve retention in care, treatment outcomes and survival for HIV‐infected infants. Methods: HIV‐exposed infants were screened as part of the Early Infant Treatment (EIT) study in Botswana. Screened infants were ≥35 weeks gestational age and ≥2000 g at birth. Risk factors for mother‐to‐child transmission (MTCT) were assessed by maternal obstetric card or verbally. Risk factors included <8 weeks ART in pregnancy, last known CD4 <250 cells/mm3, last known HIV RNA >400 copies/mL, poor maternal ART adherence, lack of maternal zidovudine (ZDV) in labour, or lack of infant post‐exposure prophylaxis. Infants underwent dried blood spot testing by Roche Cobas Ampliprep/Cobas Taqman HIV‐1 qualitative PCR. Results: From April 2015 to April 2016, 2303 HIV‐exposed infants were tested for HIV in the EIT study. Of these, 369 (16%) were identified as high risk for HIV infection by information available at birth, and 12 (0.5% overall, 3.25% of high risk) were identified as HIV positive at birth. All 12 positive infants were identified as high risk at the time of screening, and only 2 risk factors were required to identify all positive infants: either <8 weeks of maternal ART in pregnancy (75%) or lack of maternal HIV suppression at last test (25%). Conclusions: In utero MTCT occurred only among infants identified as high risk at delivery, using information available from the mother or obstetric record. Birth testing that targets high‐risk infants based on maternal ART receipt is likely to identify the majority of in utero HIV transmissions, and allows early ART initiation for these infants.
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    Cotrimoxazole prophylaxis was associated with enteric commensal bacterial resistance among HIV‐exposed infants in a randomized controlled trial, Botswana
    (John Wiley and Sons Inc., 2017) Powis, Kathleen; Souda, Sajini; Lockman, Shahin; Ajibola, Gbolahan; Bennett, Kara; Leidner, Jean; Hughes, Michael; Moyo, Sikhulile; van Widenfelt, Erik; Jibril, Haruna B; Makhema, Joseph; Essex, Max; Shapiro, Roger
    Abstract Introduction: Despite declining risk of vertical HIV transmission, prophylactic cotrimoxazole (CTX) remains widely used to reduce morbidity and mortality in the event of HIV infection among exposed infants, with an inherent risk of conferring commensal antimicrobial resistance. Using data from a randomized, placebo‐controlled trial of infant CTX prophylaxis, we sought to quantify emergence of antibiotic resistance. Methods: HIV‐exposed uninfected infants enrolled in the Botswana Mpepu study were randomized to prophylactic CTX or placebo between 14 and 34 days of life and continued through 15 months. Stool samples were collected from a subset of participating infants at randomization, three, and six months, and stored at −70°C prior to culture. Specimens that grew Escherichia coli (E. coli) or Klebsiella species (Klebsiella spp.) underwent antibiotic susceptibility testing by Kirby Bauer method using CTX (CTX 1.25/23.75 μg) and Amoxicillin (10 μg) in Mueller Hinton agar. Fisher's exact testing was used to compare prevalence of resistance by randomization arm (CTX/placebo). Results and Discussion A total of 381 stool samples from 220 infants were cultured: 118 at randomization, 151 at three months, and 112 at six‐months. E. coli was isolated from 206 specimens and Klebsiella spp. from 138 specimens. Resistance to CTX was common in both E. coli and Klebsiella spp. at the randomization visit (52.2% and 37.7% respectively) and did not differ by study arm. E. Coli isolates from CTX recipients at three and six months had 94.9% and 84.2% CTX resistance, as compared with 51.4% and 57.5% CTX resistance in isolates from placebo recipients (p=0.01). Klebsiella spp. isolates from CTX recipients had 79.0% and 68.8% CTX resistance at three and six months, as compared with 19.1% and 14.3% in isolates from placebo recipients (p<0.01). Conclusions: HIV‐exposed infants randomized to CTX prophylaxis had increased CTX‐resistant commensal gastrointestinal bacteria compared with placebo recipients. Additional research is needed to determine the longer‐term clinical, microbiologic, and public health consequences of antimicrobial resistance selected by infant CTX prophylaxis.
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    Cotrimoxazole Prophylaxis and Risk of Severe Anemia or Severe Neutropenia in HAART-Exposed, HIV-Uninfected Infants
    (Public Library of Science, 2013) Dryden-Peterson, Scott; Jayeoba, Oluwemimo; Hughes, Michael; Jibril, Haruna; McIntosh, Kenneth; Modise, Taolo A.; Asmelash, Aida; Powis, Kathleen; Essex, Max; Shapiro, Roger; Lockman, Shahin
    Background: Prophylactic cotrimoxazole is recommended for infants born to HIV-infected mothers. However, cotrimoxazole may increase the risk of severe anemia or neutropenia. Methods: We compared the proportion of HIV-exposed uninfected (HIV-EU) infants experiencing incident severe anemia (and separately, severe neutropenia) between a prospective cohort receiving prophylactic cotrimoxazole from 1 to 6 months vs. infants from two prior trials who did not receive cotrimoxazole. Infants were from rural and urban communities in southern Botswana. Results: A total of 1705 HIV-EU infants were included. Among these 645 (37.8%) were fed with iron-supplemented formula from birth. Severe anemia developed in 87 (5.1%) infants, and severe neutropenia in 164 (9.6%) infants. In an analysis stratified by infant feeding method, there were no significant differences in the risk of severe anemia by prophylactic cotrimoxazole exposure–risk difference, −0.69% (95% confidence interval [CI] −2.1 to 0.76%). Findings were similar in multivariable analysis, adjusted odds ratio (aOR) 0.35 (95% CI 0.07 to 1.65). There were also no significant differences observed for severe neutropenia by cotrimoxazole exposure, risk difference 2.0% (95% CI −1.3 to 5.2%) and aOR 0.80 (95% CI 0.33 to 1.93). Conclusions: Severe anemia and severe neutropenia were infrequent among HIV-exposed uninfected infants receiving cotrimoxazole from 1–6 months of age. Concerns regarding hematologic toxicity should not limit the use of prophylactic cotrimoxazole in HIV-exposed uninfected infants. ClinicalTrials.gov Registration Numbers NCT01086878 (http://clinicaltrials.gov/show/NCT01086878), NCT00197587 (http://clinicaltrials.gov/show/NCT00197587), and NCT00270296 (http://clinicaltrials.gov/show/NCT00270296).
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    Nef-Specific CD8+ T Cell Responses Contribute to HIV-1 Immune Control
    (Public Library of Science, 2013) Adland, Emily; Carlson, Jonathan M.; Paioni, Paolo; Kløverpris, Henrik; Shapiro, Roger; Ogwu, Anthony; Riddell, Lynn; Luzzi, Graz; Chen, Fabian; Balachandran, Thambiah; Heckerman, David; Stryhn, Anette; Edwards, Anne; Ndung’u, Thumbi; Walker, Bruce; Buus, Søren; Goulder, Philip; Matthews, Philippa C.
    Recent studies in the SIV-macaque model of HIV infection suggest that Nef-specific CD8+ T-cell responses may mediate highly effective immune control of viraemia. In HIV infection Nef recognition dominates in acute infection, but in large cohort studies of chronically infected subjects, breadth of T cell responses to Nef has not been correlated with significant viraemic control. Improved disease outcomes have instead been associated with targeting Gag and, in some cases, Pol. However analyses of the breadth of Nef-specific T cell responses have been confounded by the extreme immunogenicity and multiple epitope overlap within the central regions of Nef, making discrimination of distinct responses impossible via IFN-gamma ELISPOT assays. Thus an alternative approach to assess Nef as an immune target is needed. Here, we show in a cohort of >700 individuals with chronic C-clade infection that >50% of HLA-B-selected polymorphisms within Nef are associated with a predicted fitness cost to the virus, and that HLA-B alleles that successfully drive selection within Nef are those linked with lower viral loads. Furthermore, the specific CD8+ T cell epitopes that are restricted by protective HLA Class I alleles correspond substantially to effective SIV-specific epitopes in Nef. Distinguishing such individual HIV-specific responses within Nef requires specific peptide-MHC I tetramers. Overall, these data suggest that CD8+ T cell targeting of certain specific Nef epitopes contributes to HIV suppression. These data suggest that a re-evaluation of the potential use of Nef in HIV T-cell vaccine candidates would be justified.
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    Prevalence and Characteristics of Hepatitis B Virus (HBV) Coinfection among HIV-Positive Women in South Africa and Botswana
    (Public Library of Science, 2015) Matthews, Philippa C.; Beloukas, Apostolos; Malik, Amna; Carlson, Jonathan M.; Jooste, Pieter; Ogwu, Anthony; Shapiro, Roger; Riddell, Lynn; Chen, Fabian; Luzzi, Graz; Jaggernath, Manjeetha; Jesuthasan, Gerald; Jeffery, Katie; Ndung’u, Thumbi; Goulder, Philip J. R.; Geretti, Anna Maria; Klenerman, Paul
    There is progressive concern about the evolving burden of morbidity and mortality caused by coinfection with HIV-1 and hepatitis B virus (HBV) in sub-Saharan Africa, but the epidemiology and impact of this problem are not well defined. We therefore set out to assimilate more information about the nature of HBV/HIV coinfection in this region by undertaking a retrospective observational study of southern African adult women. We used samples from previously recruited HIV-1 positive women attending antenatal clinics in three settings in South Africa and Botswana (n = 950) and added a small cohort of HIV-negative antenatal South African women for comparison (n = 72). We tested for HBsAg and followed up HBsAg-positive samples by testing for HBeAg, HBV DNA, HBV genotype, presence of drug-resistance associated mutations (RAMs) and HDV. We identified HBsAg in 72 individuals (7% of the whole cohort), of whom 27% were HBeAg-positive, and the majority HBV genotypes A1 and A2. We did not detect any HDV coinfection. HBV prevalence was significantly different between geographically distinct cohorts, but did not differ according to HIV status. Among adults from South Africa, HBV/HIV coinfected patients had lower CD4+ T cell counts compared to those with HIV-monoinfection (p = 0.02), but this finding was not replicated in the cohort from Botswana. Overall, these data provide a snapshot of the coinfection problem at the heart of the HIV/HBV co-epidemic, and are important to inform public health policy, resource allocation, education, surveillance and clinical care.
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    An Augmented SMS Intervention to Improve Access to Antenatal CD4 Testing and ART Initiation in HIV-Infected Pregnant Women: A Cluster Randomized Trial
    (Public Library of Science, 2015) Dryden-Peterson, Scott; Bennett, Kara; Hughes, Michael; Veres, Adrian; John, Oaitse; Pradhananga, Rosina; Boyer, Matthew; Brown, Carolyn; Sakyi, Bright; van Widenfelt, Erik; Keapoletswe, Koona; Mine, Madisa; Moyo, Sikhulile; Asmelash, Aida; Siedner, Mark; Mmalane, Mompati; Shapiro, Roger; Lockman, Shahin
    Background: Less than one-third of HIV-infected pregnant women eligible for combination antiretroviral therapy (ART) globally initiate treatment prior to delivery, with lack of access to timely CD4 results being a principal barrier. We evaluated the effectiveness of an SMS-based intervention to improve access to timely antenatal ART. Methods: We conducted a stepped-wedge cluster randomized trial of a low-cost programmatic intervention in 20 antenatal clinics in Gaborone, Botswana. From July 2011-April 2012, 2 clinics were randomly selected every 4 weeks to receive an ongoing clinic-based educational intervention to improve CD4 collection and to receive CD4 results via an automated SMS platform with active patient tracing. CD4 testing before 26 weeks gestation and ART initiation before 30 weeks gestation were assessed. Results: Three-hundred-sixty-six ART-naïve women were included, 189 registering for antenatal care under Intervention and 177 under Usual Care periods. Of CD4-eligible women, 100 (59.2%) women under Intervention and 79 (50.6%) women under Usual Care completed CD4 phlebotomy before 26 weeks gestation, adjusted odds ratio (aOR, adjusted for time that a clinic initiated Intervention) 0.87 (95% confidence interval [CI]0.47–1.63, P = 0.67). The SMS-based platform reduced time to clinic receipt of CD4 test result from median of 16 to 6 days (P<0.001), was appreciated by clinic staff, and was associated with reduced operational cost. However, rates of ART initiation remained low, with 56 (36.4%) women registering under Intervention versus 37 (24.2%) women under Usual Care initiating ART prior to 30 weeks gestation, aOR 1.06 (95%CI 0.53–2.13, P = 0.87). Conclusions: The augmented SMS-based intervention delivered CD4 results more rapidly and efficiently, and this type of SMS-based results delivery platform may be useful for a variety of tests and settings. However, the intervention did not appear to improve access to timely antenatal CD4 testing or ART initiation, as obstacles other than CD4 impeded ART initiation during pregnancy.