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Browsing by Author "Vermund SH"

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    A randomized trial of the intrauterine contraceptive device vs hormonal contraception in women who are infected with the human immunodeficiency virus.
    (2007-Aug) Stringer EM; Kaseba C; Levy J; Sinkala M; Goldenberg RL; Chi BH; Matongo I; Vermund SH; Mwanahamuntu M; Stringer JS; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia. eli@uab.edu; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    OBJECTIVE: The purpose of this study was to determine whether the intrauterine contraceptive device (IUD) is effective and safe among women who are infected with the human immunodeficiency virus (HIV). STUDY DESIGN: We randomly assigned 599 postpartum, HIV-infected women in Zambia to receive either a copper IUD or hormonal contraception and followed them for at least 2 years. RESULTS: Women who were assigned randomly to hormonal contraception were more likely to become pregnant than those who were assigned randomly to receive an IUD (rate, 4.6/100 vs 2.0/100 woman-years; hazards ratio, 2.4; 95% CI, 1.3-4.7). One woman who was assigned to the IUD experienced pelvic inflammatory disease (crude rate, 0.16/100 woman-years; 95% CI, 0.004-868); there was no pelvic inflammatory disease among those women who were assigned to hormonal contraception. Clinical disease progression (death or CD4+ lymphocyte count dropping below 200 cells/microL) was more common in women who were allocated to hormonal contraception (13.2/100 woman-years) than in women who were allocated to the IUD (8.6/100 woman-years; hazard ratio, 1.5; 95% CI, 1.04-2.1). CONCLUSION: The IUD is effective and safe in HIV-infected women. The unexpected observation that hormonal contraception was associated with more rapid HIV disease progression requires urgent further study.
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    Advancing cervical cancer prevention initiatives in resource-constrained settings: insights from the Cervical Cancer Prevention Program in Zambia.
    (2011-May) Mwanahamuntu MH; Sahasrabuddhe VV; Kapambwe S; Pfaendler KS; Chibwesha C; Mkumba G; Mudenda V; Hicks ML; Vermund SH; Stringer JS; Parham GP; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    Groesbeck Parham and colleagues describe their Cervical Cancer Prevention Program in Zambia, which has provided services to over 58,000 women over the past five years, and share lessons learned from the program's implementation and integration with existing HIV/AIDS programs.
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    An empirical approach to defining loss to follow-up among patients enrolled in antiretroviral treatment programs.
    (2010-Apr-15) Chi BH; Cantrell RA; Mwango A; Westfall AO; Mutale W; Limbada M; Mulenga LB; Vermund SH; Stringer JS; Centre for Infectious Disease Research in Zambia, Box 34681, 1275 Lubuto Road, Lusaka, Zambia. bchi@cidrz.org; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    In many programs providing antiretroviral therapy (ART), clinicians report substantial patient attrition; however, there are no consensus criteria for defining patient loss to follow-up (LTFU). Data on a multisite human immunodeficiency virus (HIV) treatment cohort in Lusaka, Zambia, were used to determine an empirical "days-late" definition of LTFU among patients on ART. Cohort members were classified as either "in care" or LTFU as of December 31, 2007, according to a range of days-late intervals. The authors then looked forward in the database to determine which patients actually returned to care at any point over the following year. The interval that best minimized LTFU misclassification was described as "best-performing." Overall, 33,704 HIV-infected adults on ART were included. Nearly one-third (n = 10,196) were at least 1 day late for an appointment. The best-performing LTFU definition was 56 days after a missed visit, which had a sensitivity of 84.1% (95% confidence interval (CI): 83.2, 85.0), specificity of 97.5% (95% CI: 97.3, 97.7), and misclassification of 5.1% (95% CI: 4.8, 5.3). The 60-day threshold performed similarly well, with only a marginal difference (<0.1%) in misclassification. This analysis suggests that > or =60 days since the last appointment is a reasonable definition of LTFU. Standardization to empirically derived definitions of LTFU will permit more reliable comparisons within and across programs.
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    Antiretroviral therapy in sub-Saharan Africa: adherence lessons from tuberculosis and leprosy.
    (2004-Nov) Reid SE; Reid CA; Vermund SH; Centre for Infectious Disease Research in Zambia, PO Box 34681, Plot 5977 Benakale Road, Northmead, Lusaka, Zambia. stewart@cidrz.org; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    Declining drug costs and increases in international donor interest are leading to greater availability of antiretroviral treatment programmes for persons living with the human immunodeficiency virus in parts of sub-Saharan Africa. Ensuring adequate adherence to antiretroviral drug therapy is one of the principal challenges facing successful implementation in Africa, where 70% of the world's infected persons live. Tuberculosis and leprosy are two diseases of global importance whose control programmes can provide important lessons for developing antiretroviral drug adherence strategies. This paper examines various approaches used in tuberculosis and leprosy control which could help enhance adherence to antiretroviral therapy in resource-limited settings.
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    Clinical performance of digital cervicography and cytology for cervical cancer screening in HIV-infected women in Lusaka, Zambia.
    (2014-Oct-01) Bateman AC; Parham GP; Sahasrabuddhe VV; Mwanahamuntu MH; Kapambwe S; Katundu K; Nkole T; Mulundika J; Pfaendler KS; Hicks ML; Shibemba A; Vermund SH; Stringer JS; Chibwesha CJ; *Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; †University of North Carolina at Chapel Hill, Chapel Hill, NC; ‡University Teaching Hospital, Lusaka, Zambia; §Vanderbilt University, Nashville, TN; ‖University of Cincinnati, Cincinnati, OH; and ¶Michigan Cancer Institute, Pontiac, MI.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    Although there is a growing literature on the clinical performance of visual inspection with acetic acid in HIV-infected women, to the best of our knowledge, none have studied visual inspection with acetic acid enhanced by digital cervicography. We estimated clinical performance of cervicography and cytology to detect cervical intraepithelial neoplasia grade 2 or worse. Sensitivity and specificity of cervicography were 84% [95% confidence interval (CI): 72 to 91) and 58% (95% CI: 52 to 64). At the high-grade squamous intraepithelial lesion or worse cutoff for cytology, sensitivity and specificity were 61% (95% CI: 48 to 72) and 58% (95% CI: 52 to 64). In our study, cervicography seems to be as good as cytology in HIV-infected women.
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    Do targeted HIV programs improve overall care for pregnant women?: Antenatal syphilis management in Zambia before and after implementation of prevention of mother-to-child HIV transmission programs.
    (2008-Jan-01) Potter D; Goldenberg RL; Chao A; Sinkala M; Degroot A; Stringer JS; Bulterys M; Vermund SH; Schools of Public Health and Medicine, University of Alabama at Birmingham, Birmingham, AL, USA. dara.potter@cidrz.org; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: The implementation of disease-specific research or service programs may have an ancillary beneficial or harmful impact on routine clinical services. METHODS: We reviewed the records of 5801 first visits to 22 antenatal clinics from 1997 to 2004 in Lusaka, Zambia and examined documented syphilis rapid plasma reagin (RPR) screening and syphilis treatment before and after implementation of research and/or service programs in prevention of mother-to-child (PMTCT) HIV transmission. FINDINGS: Compared with before PMTCT program implementation, the prevalence odds ratios (PORs) and 95% confidence intervals (CIs) for documented RPR screening were 0.9 (0.7 to 1.1) after implementation of research, 0.7 (0.6 to 0.8) after service, and 2.5 (2.1 to 3.0) after research and service programs. CONCLUSIONS: Documented RPR screening was improved after implementation of PMTCT research and service were operating simultaneously and not with research or service alone. Health policy makers and researchers should plan explicitly for how the targeted HIV programs, service, and/or research can have a broader primary care impact.
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    Early clinical and immune response to NNRTI-based antiretroviral therapy among women with prior exposure to single-dose nevirapine.
    (2007-May-11) Chi BH; Sinkala M; Stringer EM; Cantrell RA; Mtonga V; Bulterys M; Zulu I; Kankasa C; Wilfert C; Weidle PJ; Vermund SH; Stringer JS; Centre for Infectious Disease Research in Zambia, Zambia. bchi@cidrz.org; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    OBJECTIVE: To determine whether prior exposure to single-dose nevirapine (NVP) for prevention of mother-to-child HIV transmission (PMTCT) is associated with attenuated CD4 cell response, death, or clinical treatment failure in women starting antiretroviral therapy (ART) containing non-nucleoside reverse transcriptase inhibitors (NNRTI). METHODS: Open cohort evaluation of outcomes for women in program sites across Zambia. HIV treatment was provided according to Zambian/World Health Organization guidelines. RESULTS: Peripartum NVP exposure status was known for 6740 women initiating NNRTI-containing ART, of whom 751 (11%) reported prior use of NVP for PMTCT. There was no significant difference in mean CD4 cell change between those exposed or unexposed to NVP at 6 (+202 versus +182 cells/microl; P = 0.20) or 12 (+201 versus +211 cells/microl; P = 0.60) months. Multivariable analyses showed no significant differences in mortality [adjusted hazard ratio (HR), 1.2; 95% confidence interval (CI), 0.8-1.8] or clinical treatment failure (adjusted HR, 1.1; 95% CI, 0.8-1.5). Comparison of recent NVP exposure with remote exposure suggested a less favorable CD4 cell response at 6 (+150 versus +219 cells/microl; P = 0.06) and 12 (+149 versus +215 cells/microl; P = 0.39) months. Women with recent NVP exposure also had a trend towards elevated risk for clinical treatment failure (adjusted HR, 1.6; 95% CI, 0.9-2.7). CONCLUSION: Exposure to maternal single-dose NVP was not associated with substantially different short-term treatment outcomes. However, evidence was suggestive that exposure within 6 months of ART initiation may be a risk factor for poor treatment outcomes, highlighting the importance of ART screening and initiation early in pregnancy.
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    Effectiveness of a city-wide program to prevent mother-to-child HIV transmission in Lusaka, Zambia.
    (2005-Aug-12) Stringer JS; Sinkala M; Maclean CC; Levy J; Kankasa C; Degroot A; Stringer EM; Acosta EP; Goldenberg RL; Vermund SH; Schools of Medicine and Public Health, University of Alabama at Birmingham, USA. stringer@cidrz.org; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    OBJECTIVE: To determine the population effectiveness of a city-wide perinatal HIV prevention program. DESIGN: An anonymous surveillance of newborn cord blood for HIV serology and nevirapine (NVP). METHODS: All 10 public-sector delivery centers in Lusaka, Zambia participated. All mother-infant pairs delivering during the 12-week surveillance period at the participating centers and who received antenatal care at a public-sector facility in Lusaka were included in the study. The main outcome measure was population NVP coverage, defined as the proportion of HIV-infected women and HIV-exposed infants in the population that ingested NVP. RESULTS: Of 8787 women in the surveillance population, 7204 (82%) had been offered antenatal HIV testing, of which 5149 (71%) had accepted, and of which 5129 (99%) had received a result. Overall, 2257 of 8787 (26%) were cord seropositive. Of the 1246 (55%) cord blood seropositive women who received an antenatal HIV test result, 1112 (89%) received a positive result; the other 134 comprise seroconverters and clerical errors. Only 751 of 1112 (68%) women who received a positive antenatal test result and a NVP tablet for ingestion at labor onset had NVP detected in the cord blood (i.e., maternal non-adherence rate was 32%). A total of 675 infants born to 751 adherent mothers (90%) received NVP before discharge. Thus, only 675 of 2257 (30%) seropositive mother-infant pairs in the surveillance population received both a maternal and infant dose of NVP. CONCLUSIONS: Successful perinatal HIV prevention requires each mother-infant pair to negotiate a cascade of events that begins with offering HIV testing and continues through adherence to the prescribed regimen. This novel surveillance demonstrates that failures occur at each step, resulting in reduced coverage and diminished program effectiveness.
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    HIV incidence rates and risk factors for urban women in Zambia: preparing for a microbicide clinical trial.
    (2009-Mar) Kapina M; Reid C; Roman K; Cyrus-Cameron E; Kwiecien A; Weiss S; Vermund SH; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    OBJECTIVES: A preparedness study was conducted to evaluate the suitability of sites and populations following the same study procedures intended for a larger scale microbicide efficacy trial. In the process the study evaluated human immunodeficiency virus (HIV) incidence, prevalence, and risk profiles for HIV-acquisition among young women in urban Zambia. METHODS: Women aged 16 to 49 years were screened for participation in the study that involved HIV/sexually transmitted infection testing and the assessment of sexual behavioral characteristics. Two hundred thirty-nine eligible women were enrolled and followed up for 12 months. RESULTS: Baseline HIV prevalence at screening was 38.7% (95% CI: 34.2%-43.3%). The highest age-specific prevalence of HIV was 54.1% (95% CI: 46.3%-61.8%) seen in women aged 26 to 34 years. HIV incidence was 2.6% per 100 woman years. Pregnancy rates were high at 17.4 per 100 woman years (95% CI: 12.2-24.1). CONCLUSION: It was concluded that our general population sample, characterized by high HIV prevalence and ongoing incidence rates despite receiving regular risk reduction counseling and free condoms qualifies for future microbicide studies.A microbicide preparedness study conducted in Lusaka, Zambia found high HIV prevalence and appreciable HIV incidence in a population of women in an urban setting.
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    How we implemented an analytical support clinic to strengthen student research capacity in Zambia.
    (2015-Jul) Andrews B; Musonda P; Simuyemba M; Wilson CM; Nzala S; Vermund SH; Michelo C; b University of Zambia , Zambia.; d East Anglia University , UK.; c Centre for Infectious Disease Research in Zambia (CIDRZ) , Zambia.; a Vanderbilt University , USA.; e University of Alabama at Birmingham , USA.
    BACKGROUND: Research outputs in sub-Saharan Africa may be limited by a scarcity of clinical research expertise. In Zambia, clinical and biomedical postgraduate students are often delayed in graduation due to challenges in completing their research dissertations. We sought to strengthen institutional research capacity by supporting student and faculty researchers through weekly epidemiology and biostatistics clinics. METHODS: We instituted a weekly Analytical Support Clinic at the University of Zambia, School of Medicine. A combination of biostatisticians, clinical researchers and epidemiologists meet weekly with clients to address questions of proposal development, data management and analysis. Clinic sign-in sheets were reviewed. RESULTS: 109 students and faculty members accounted for 197 visits to the Clinic. Nearly all clients (107/109, 98.2%) were undergraduate or postgraduate students. Reasons for attending the Clinic were primarily for proposal development (46.7%) and data management/analysis (42.1%). The most common specific reasons for seeking help were data analysis and interpretation (36.5%), development of study design and research questions (26.9%) and sample size calculation (21.8%). CONCLUSIONS: The Analytical Support Clinic is an important vehicle for strengthening postgraduate research through one-on-one and small group demand-driven interactions. The clinic approach supplements mentorship from departmental supervisors, providing specific expertise and contextual teaching.
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    Implementation and Operational Research: Age Distribution and Determinants of Invasive Cervical Cancer in a "Screen-and-Treat" Program Integrated With HIV/AIDS Care in Zambia.
    (2015-Sep-01) Kapambwe S; Sahasrabuddhe VV; Blevins M; Mwanahamuntu MH; Mudenda V; Shepherd BE; Chibwesha CJ; Pfaendler KS; Hicks ML; Vermund SH; Stringer JS; Parham GP; *Center for Infectious Disease Research in Zambia, Lusaka, Zambia; †University of Zambia, Lusaka, Zambia; ‡Vanderbilt University, Nashville, TN; §University of North Carolina at Chapel Hill, Chapel Hill, NC; ‖University of Cincinnati, Cincinnati, OH; ¶Michigan Cancer Institute, Pontiac, MI.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: Cervical cancer screening efforts linked to HIV/AIDS care programs are being expanded across sub-Saharan Africa. Evidence on the age distribution and determinants of invasive cervical cancer (ICC) cases detected in such programs is limited. METHODS: We analyzed program operations data from the Cervical Cancer Prevention Program in Zambia, the largest public sector programs of its kind in sub-Saharan Africa. We examined age distribution patterns by HIV serostatus of histologically confirmed ICC cases and used multivariable logistic regression to evaluate independent risk factors for ICC among younger (≤35 years) and older (>35 years) women. RESULTS: Between January 2006 and April 2010, of 48,626 women undergoing screening, 571 (1.2%) were diagnosed with ICC, including 262 (46%) HIV seropositive (median age: 35 years), 131 (23%) HIV seronegative (median age: 40 years), and 178 (31%) of unknown HIV serostatus (median age: 38 years). Among younger (≤35 years) women, being HIV seropositive was associated with a 4-fold higher risk of ICC [adjusted odds ratio = 4.1 (95% confidence interval: 2.8, 5.9)] than being HIV seronegative. The risk of ICC increased with increasing age among HIV-seronegative women and women with unknown HIV serostatus, but among HIV-seropositive women, the risk peaked around age 35 and nonsignificantly declined with increasing ages. Other factors related to ICC included being married (vs. being unmarried/widowed) in both younger and older women, and with having 2+ (vs. ≤1) lifetime sexual partners among younger women. CONCLUSIONS: HIV infection seems to have increased the risk of cervical cancer among younger women in Zambia, pointing to the urgent need for expanding targeted screening interventions.
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    Implementation of 'see-and-treat' cervical cancer prevention services linked to HIV care in Zambia.
    (2009-Mar-27) Mwanahamuntu MH; Sahasrabuddhe VV; Pfaendler KS; Mudenda V; Hicks ML; Vermund SH; Stringer JS; Parham GP; University Teaching Hospital, Ministry of Health, Lusaka, Zambia. mulindi.mwanahamuntu@cidrz.org; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
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    Implementation of cervical cancer prevention services for HIV-infected women in Zambia: measuring program effectiveness.
    (2010) Parham GP; Mwanahamuntu MH; Sahasrabuddhe VV; Westfall AO; King KE; Chibwesha C; Pfaendler KS; Mkumba G; Mudenda V; Kapambwe S; Vermund SH; Hicks ML; Stringer JS; Chi BH; University of Cincinnati, OH, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia ; University Teaching Hospital, Lusaka, Zambia.; University of Alabama at Birmingham, AL, USA ; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia ; University Teaching Hospital, Lusaka, Zambia.; Vanderbilt University, TN, USA.; Michigan Cancer Institute, MI, USA.; University of Michigan, MI, USA.; University Teaching Hospital, Lusaka, Zambia.; University of Alabama at Birmingham, AL, USA ; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Vanderbilt University, TN, USA ; National Cancer Institute, MD, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: Cervical cancer kills more women in low-income nations than any other malignancy. A variety of research and demonstration efforts have proven the efficacy and effectiveness of low-cost cervical cancer prevention methods but none in routine program implementation settings of the developing world, particularly in HIV-infected women. METHODS: In our public sector cervical cancer prevention program in Zambia, nurses conduct screening using visual inspection with acetic acid aided by digital cervicography. Women with visible lesions are offered same-visit cryotherapy or referred for histologic evaluation and clinical management. We analyzed clinical outcomes and modeled program effectiveness among HIV-infected women by estimating the total number of cervical cancer deaths prevented through screening and treatment. RESULTS: Between 2006 and 2008, 6572 HIV-infected women were screened, 53.6% (3523) had visible lesions, 58.5% (2062) were eligible for cryotherapy and 41.5% (1461) were referred for histologic evaluation. A total of 75% (1095 out of 1462) of patients who were referred for evaluation complied. Pathology results from 65% (715 out of 1095) of women revealed benign abnormalities in 21% (151), cervical intraepithelial neoplasia (CIN) I in 30% (214), CIN 2/3 in 33% (235) and invasive cervical cancer in 16.1% (115, of which 69% were early stage). Using a conditional probability model, we estimated that our program prevented 142 cervical cancer deaths (high/low range: 238-96) among the 6572 HIV-infected women screened, or one cervical cancer death prevented per 46 (corresponding range: 28-68) HIV-infected women screened. CONCLUSION: Our prevention efforts using setting-appropriate human resources and technology have reduced morbidity and mortality from cervical cancer among HIV-infected women in Zambia. Financial support for implementing cervical cancer prevention programs integrated within HIV/AIDS care programs is warranted. Our prevention model can serve as the implementation platform for future low-cost HPV-based screening methods, and our results may provide the basis for comparison of programmatic effectiveness of future prevention efforts.
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    Monitoring the performance of "screen-and-treat" cervical cancer prevention programs.
    (2014-Jul) Mwanahamuntu MH; Sahasrabuddhe VV; Blevins M; Kapambwe S; Shepherd BE; Chibwesha C; Pfaendler KS; Mkumba G; Vwalika B; Hicks ML; Vermund SH; Stringer JSA; Parham GP; Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, USA.; Center for Infectious Disease Research in Zambia, Lusaka, Zambia.; Michigan Cancer Institute, Pontiac, USA.; Department of Obstetrics and Gynecology, University Teaching Hospital, Lusaka, Zambia.; Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, USA.; Department of Medicine, Vanderbilt University School of Medicine, Nashville, USA.; Department of Obstetrics and Gynecology, University of Cincinnati, Cincinnati, USA.; Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
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    Population-level scale-up of cervical cancer prevention services in a low-resource setting: development, implementation, and evaluation of the cervical cancer prevention program in Zambia.
    (2015) Parham GP; Mwanahamuntu MH; Kapambwe S; Muwonge R; Bateman AC; Blevins M; Chibwesha CJ; Pfaendler KS; Mudenda V; Shibemba AL; Chisele S; Mkumba G; Vwalika B; Hicks ML; Vermund SH; Chi BH; Stringer JS; Sankaranarayanan R; Sahasrabuddhe VV; Center for Infectious Disease Research in Zambia, Lusaka, Zambia; University of California, Irvine, Irvine, California, United States of America.; Center for Infectious Disease Research in Zambia, Lusaka, Zambia; University of Zambia, Lusaka, Zambia.; International Agency for Research on Cancer, Lyon, France.; Vanderbilt University, Nashville, Tennessee, United States of America; National Cancer Institute, Bethesda, Maryland, United States of America.; Center for Infectious Disease Research in Zambia, Lusaka, Zambia; University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.; Michigan Cancer Institute, Pontiac, Michigan, United States of America.; University of Zambia, Lusaka, Zambia.; Vanderbilt University, Nashville, Tennessee, United States of America.; Center for Infectious Disease Research in Zambia, Lusaka, Zambia; University of Zambia, Lusaka, Zambia; University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America; International Agency for Research on Cancer, Lyon, France.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: Very few efforts have been undertaken to scale-up low-cost approaches to cervical cancer prevention in low-resource countries. METHODS: In a public sector cervical cancer prevention program in Zambia, nurses provided visual-inspection with acetic acid (VIA) and cryotherapy in clinics co-housed with HIV/AIDS programs, and referred women with complex lesions for histopathologic evaluation. Low-cost technological adaptations were deployed for improving VIA detection, facilitating expert physician opinion, and ensuring quality assurance. Key process and outcome indicators were derived by analyzing electronic medical records to evaluate program expansion efforts. FINDINGS: Between 2006-2013, screening services were expanded from 2 to 12 clinics in Lusaka, the most-populous province in Zambia, through which 102,942 women were screened. The majority (71.7%) were in the target age-range of 25-49 years; 28% were HIV-positive. Out of 101,867 with evaluable data, 20,419 (20%) were VIA positive, of whom 11,508 (56.4%) were treated with cryotherapy, and 8,911 (43.6%) were referred for histopathologic evaluation. Most women (87%, 86,301 of 98,961 evaluable) received same-day services (including 5% undergoing same-visit cryotherapy and 82% screening VIA-negative). The proportion of women with cervical intraepithelial neoplasia grade 2 and worse (CIN2+) among those referred for histopathologic evaluation was 44.1% (1,735/3,938 with histopathology results). Detection rates for CIN2+ and invasive cervical cancer were 17 and 7 per 1,000 women screened, respectively. Women with HIV were more likely to screen positive, to be referred for histopathologic evaluation, and to have cervical precancer and cancer than HIV-negative women. INTERPRETATION: We creatively disrupted the 'no screening' status quo prevailing in Zambia and addressed the heavy burden of cervical disease among previously unscreened women by establishing and scaling-up public-sector screening and treatment services at a population level. Key determinants for successful expansion included leveraging HIV/AIDS program investments, and context-specific information technology applications for quality assurance and filling human resource gaps.
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    Selected hematologic and biochemical measurements in African HIV-infected and uninfected pregnant women and their infants: the HIV Prevention Trials Network 024 protocol.
    (2009-Aug-07) Mwinga K; Vermund SH; Chen YQ; Mwatha A; Read JS; Urassa W; Carpenetti N; Valentine M; Goldenberg RL; Department of Paediatrics of the University Teaching Hospital and the University of Zambia School of Medicine, and the Centre for Infectious Disease Research in Zambia, Lusaka, Zambia. mwingak@zm.afro.who.int; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: Reference values for hematological and biochemical assays in pregnant women and in newborn infants are based primarily on Caucasian populations. Normative data are limited for populations in sub-Saharan Africa, especially comparing women with and without HIV infection, and comparing infants with and without HIV infection or HIV exposure. METHODS: We determined HIV status and selected hematological and biochemical measurements in women at 20-24 weeks and at 36 weeks gestation, and in infants at birth and 4-6 weeks of age. All were recruited within a randomized clinical trial of antibiotics to prevent chorioamnionitis-associated mother-to-child transmission of HIV (HPTN024). We report nearly complete laboratory data on 2,292 HIV-infected and 367 HIV-uninfected pregnant African women who were representative of the public clinics from which the women were recruited. Nearly all the HIV-infected mothers received nevirapine prophylaxis at the time of labor, as did their infants after birth (always within 72 hours of birth, but typically within just a few hours at the four study sites in Malawi (2 sites), Tanzania, and Zambia. RESULTS: HIV-infected pregnant women had lower red blood cell counts, hemoglobin, hematocrit, and white blood cell counts than HIV-uninfected women. Platelet and monocyte counts were higher among HIV-infected women at both time points. At the 4-6-week visit, HIV-infected infants had lower hemoglobin, hematocrit and white blood cell counts than uninfected infants. Platelet counts were lower in HIV-infected infants than HIV-uninfected infants, both at birth and at 4-6 weeks of age. At 4-6 weeks, HIV-infected infants had higher alanine aminotransferase measures than uninfected infants. CONCLUSION: Normative data in pregnant African women and their newborn infants are needed to guide the large-scale HIV care and treatment programs being scaled up throughout the continent. These laboratory measures will help interpret clinical data and assist in patient monitoring in a sub-Saharan Africa context.
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    Simple adherence assessments to predict virologic failure among HIV-infected adults with discordant immunologic and clinical responses to antiretroviral therapy.
    (2008-Aug) Goldman JD; Cantrell RA; Mulenga LB; Tambatamba BC; Reid SE; Levy JW; Limbada M; Taylor A; Saag MS; Vermund SH; Stringer JS; Chi BH; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    We evaluated the association between two antiretroviral therapy (ART) adherence measurements--the medication possession ratio (MPR) and patient self-report--and detectable HIV viremia in the setting of rapid service scale-up in Lusaka, Zambia. Drug adherence and outcomes were assessed in a subset of patients suspected of treatment failure based on discordant clinical and immunologic responses to ART. A total of 913 patients were included in this analysis, with a median time of 744 days (Q1, Q3: 511, 919 days) from ART initiation to viral load (VL) measurement. On aggregate over the period of follow-up, 531 (58%) had optimal adherence (MPR > or =95%), 306 (34%) had suboptimal adherence (MPR 80-94%), and 76 (8%) had poor adherence (MPR <80%). Of the 913 patients, 238 (26%) had VL > or =400 copies/ml when tested. When compared to individuals with optimal adherence, there was increasing risk for virologic failure in those with suboptimal adherence [adjusted relative risk (ARR): 1.3; 95% confidence interval (CI): 1.0, 1.6] and those with poor adherence (ARR: 1.7; 95% CI: 1.3, 2.4) based on MPR. During the antiretroviral treatment course, 676 patients (74%) reported no missed doses. The proportion of patients with virologic failure did not differ significantly among those reporting any missed dose from those reporting perfect adherence (26% vs. 26%, p = 0.97). Among patients with suspected treatment failure, a lower MPR was associated with higher rates of detectable viremia. However, the suboptimal sensitivity and specificity of MPR limit its utility as a sole predictor of virologic failure.
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    Use of traditional medicine among pregnant women in Lusaka, Zambia.
    (2007) Banda Y; Chapman V; Goldenberg RL; Stringer JS; Culhane JF; Sinkala M; Vermund SH; Chi BH; University of Zambia School of Medicine, Lusaka, Zambia. yolan.banda@cidrz.org; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    OBJECTIVE: We studied the prevalence of and predictors for traditional medicine use among pregnant women seeking care in the Lusaka, Zambia public health system. SUBJECTS: We surveyed 1128 pregnant women enrolled in a clinical trial of perinatal human immunodeficiency virus (HIV) prevention strategies at two district delivery centers. OUTCOME MEASURES: Postpartum questionnaires were administered to determine demographic characteristics, behavioral characteristics, HIV knowledge, and prior use of traditional medicines. RESULTS: Of the 1128 women enrolled, 335 (30%) reported visiting a traditional healer in the past; 237 (21%) reported using a traditional healer during the current pregnancy. Overall, 54% believed that admitting to a visit to a traditional healer would result in worse medical care. When women who had used traditional medicines were compared to those who had not, no demographic differences were noted. However, women who reported use of traditional medicine were more likely to drink alcohol during pregnancy, have >or=2 sex partners, engage in "dry sex," initiate sex with their partner, report a previously treated sexually transmitted disease, and use contraception (all p < 0.01). HIV-infected women who reported using traditional healers were also less likely to adhere to a proven medical regimen to reduce HIV transmission to their infant (25% versus 50%, p = 0.048). CONCLUSIONS: Use of traditional medicine during pregnancy is common, stigmatized, and may be associated with nonadherence to antiretroviral regimens. Health care providers must open lines of communication with traditional healers and with pregnant women themselves to maximize program success.
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    Utilization of cervical cancer screening services and trends in screening positivity rates in a 'screen-and-treat' program integrated with HIV/AIDS care in Zambia.
    (2013) Mwanahamuntu MH; Sahasrabuddhe VV; Blevins M; Kapambwe S; Shepherd BE; Chibwesha C; Pfaendler KS; Mkumba G; Vwalika B; Hicks ML; Vermund SH; Stringer JS; Parham GP; Center for Infectious Disease Research in Zambia, Lusaka, Zambia ; University Teaching Hospital, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: In the absence of stand-alone infrastructures for delivering cervical cancer screening services, efforts are underway in sub-Saharan Africa to dovetail screening with ongoing vertical health initiatives like HIV/AIDS care programs. Yet, evidence demonstrating the utilization of cervical cancer prevention services in such integrated programs by women of the general population is lacking. METHODS: We analyzed program operations data from the Cervical Cancer Prevention Program in Zambia (CCPPZ), the largest public sector programs of its kind in sub-Saharan Africa. We evaluated patterns of utilization of screening services by HIV serostatus, examined contemporaneous trends in screening outcomes, and used multivariable modeling to identify factors associated with screening test positivity. RESULTS: Between January 2006 and April 2011, CCPPZ services were utilized by 56,247 women who underwent cervical cancer screening with visual inspection with acetic acid (VIA), aided by digital cervicography. The proportion of women accessing these services who were HIV-seropositive declined from 54% to 23% between 2006-2010, which coincided with increasing proportions of HIV-seronegative women (from 22% to 38%) and women whose HIV serostatus was unknown (from 24% to 39%) (all p-for trend<0.001). The rates of VIA screening positivity declined from 47% to 17% during the same period (p-for trend <0.001), and this decline was consistent across all HIV serostatus categories. After adjusting for demographic and sexual/reproductive factors, HIV-seropositive women were more than twice as likely (Odds ratio 2.62, 95% CI 2.49, 2.76) to screen VIA-positive than HIV-seronegative women. CONCLUSIONS: This is the first 'real world' demonstration in a public sector implementation program in a sub-Saharan African setting that with successful program scale-up efforts, nurse-led cervical cancer screening programs targeting women with HIV can expand and serve all women, regardless of HIV serostatus. Screening program performance can improve with adequate emphasis on training, quality control, and telemedicine-support for nurse-providers in clinical decision making.

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