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Permanent URI for this collectionhttps://pubs.cidrz.org/handle/123456789/10189

Welcome to the CIDRZ Published Research Collection. This collection serves as a central repository of peer-reviewed publications authored, co-authored, or supported by the Centre for Infectious Disease Research in Zambia (CIDRZ). It provides open access to scientific knowledge that contributes to public health, clinical research, and evidence-based policy in Zambia and beyond.

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Now showing 1 - 10 of 24
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    The Tuberculosis Sentinel Research Network (TB-SRN) of the International epidemiology Databases to Evaluate AIDS (IeDEA): protocol for a prospective cohort study in Africa, Southeast Asia and Latin America.
    (2024-Jan-09) Enane LA; Duda SN; Chanyachukul T; Bolton-Moore C; Navuluri N; Messou E; Mbonze N; McDade LR; Figueiredo MC; Ross J; Evans D; Diero L; Akpata R; Zotova N; Freeman A; Pierre MF; Rupasinghe D; Ballif M; Byakwaga H; de Castro N; Tabala M; Sterling TR; Sohn AH; Fenner L; Wools-Kaloustian K; Poda A; Yotebieng M; Huebner R; Marcy O; Vanderbilt Institute of Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.; Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.; Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.; Duke Global Health Institute, Duke University, Durham, North Carolina, USA.; Division of Infectious Diseases, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.; Indiana University Center for Global Health Equity, Indianapolis, Indiana, USA.; Mbarara University of Science and Technology Faculty of Medicine, Mbarara, Uganda.; Department of Infectious Diseases, Bern University Hospital and University of Bern, Bern, Switzerland.; Center for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.; The Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.; The Kirby Institute, UNSW, Sydney, New South Wales, Australia.; Health Economics and Epidemiology Research Office, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.; Centre Hospitalier Universitaire Sourô Sanou, Bobo Dioulasso, Burkina Faso.; TREAT Asia/amfAR - The Foundation for AIDS Research, Bangkok, Thailand.; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.; Kinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.; The Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA lenane@iu.edu.; Vanderbilt Tuberculosis Center, Division of Infectious Diseases, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.; Centre de Prise en Charge de Recherche et de Formation (Aconda-CePReF), Abidjan, Côte d'Ivoire.; Université de Bordeaux, Bordeaux, France.; Department of Medicine, Moi University College of Health Sciences, Eldoret, Kenya.
    INTRODUCTION: Tuberculosis (TB) is a leading infectious cause of death globally. It is the most common opportunistic infection in people living with HIV, and the most common cause of their morbidity and mortality. Following TB treatment, surviving individuals may be at risk for post-TB lung disease. The TB Sentinel Research Network (TB-SRN) provides a platform for coordinated observational TB research within the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium. METHODS AND ANALYSIS: This prospective, observational cohort study will assess treatment and post-treatment outcomes of pulmonary TB (microbiologically confirmed or clinically diagnosed) among 2600 people aged ≥15 years, with and without HIV coinfection, consecutively enrolled at 16 sites in 11 countries, across 6 of IeDEA's global regions. Data regarding clinical and sociodemographic factors, mental health, health-related quality of life, pulmonary function, and laboratory and radiographic findings will be collected using standardised questionnaires and data collection tools, beginning from the initiation of TB treatment and through 12 months after the end of treatment. Data will be aggregated for proposed analyses. ETHICS AND DISSEMINATION: Ethics approval was obtained at all implementing study sites, including the Vanderbilt University Medical Center Human Research Protections Programme. Participants will provide informed consent; for minors, this includes both adolescent assent and the consent of their parent or primary caregiver. Protections for vulnerable groups are included, in alignment with local standards and considerations at sites. Procedures for requesting use and analysis of TB-SRN data are publicly available. Findings from TB-SRN analyses will be shared with national TB programmes to inform TB programming and policy, and disseminated at regional and global conferences and other venues.
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    Trends in SARS-CoV-2 seroprevalence among pregnant women attending first antenatal care visits in Zambia: A repeated cross-sectional survey, 2021-2022.
    (2024) Heilmann E; Tembo T; Fwoloshi S; Kabamba B; Chilambe F; Kalenga K; Siwingwa M; Mulube C; Seffren V; Bolton-Moore C; Simwanza J; Yingst S; Yadav R; Rogier E; Auld AF; Agolory S; Kapina M; Gutman JR; Savory T; Kangale C; Mulenga LB; Sikazwe I; Hines JZ; Division of Parasitic Diseases and Malaria, U.S. Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.; Public Health Institute, Oakland, California, United States of America.; Division of Global HIV and Tuberculosis, U.S. Centers for Disease Control and Prevention, Lusaka, Zambia.; PATH, Lusaka, Zambia.; Adult Centre of Excellence, University Teaching Hospital, Lusaka, Zambia.; Surveillance and Disease Intelligence, Zambia National Public Health Institute, Lusaka, Zambia.; Division of Infectious Diseases, Ministry of Health, Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    SARS-CoV-2 serosurveys help estimate the extent of transmission and guide the allocation of COVID-19 vaccines. We measured SARS-CoV-2 seroprevalence among women attending ANC clinics to assess exposure trends over time in Zambia. We conducted repeated cross-sectional SARS-CoV-2 seroprevalence surveys among pregnant women aged 15-49 years attending their first ANC visits in four districts of Zambia (two urban and two rural) during September 2021-September 2022. Serologic testing was done using a multiplex bead assay which detects IgG antibodies to the nucleocapsid protein and the spike protein receptor-binding domain (RBD). We calculated monthly SARS-CoV-2 seroprevalence by district. We also categorized seropositive results as infection alone, infection and vaccination, or vaccination alone based on anti-RBD and anti-nucleocapsid test results and self-reported COVID-19 vaccination status (vaccinated was having received ≥1 dose). Among 8,304 participants, 5,296 (63.8%) were cumulatively seropositive for SARS-CoV-2 antibodies from September 2021 through September 2022. SARS-CoV-2 seroprevalence primarily increased from September 2021 to September 2022 in three districts (Lusaka: 61.8-100.0%, Chongwe: 39.6-94.7%, Chipata: 56.5-95.0%), but in Chadiza, seroprevalence increased from 27.8% in September 2021 to 77.2% in April 2022 before gradually dropping to 56.6% in July 2022. Among 5,906 participants with a valid COVID-19 vaccination status, infection alone accounted for antibody responses in 77.7% (4,590) of participants. Most women attending ANC had evidence of prior SARS-CoV-2 infection and most SARS-CoV-2 seropositivity was infection-induced. Capturing COVID-19 vaccination status and using a multiplex bead assay with anti-nucleocapsid and anti-RBD targets facilitated distinguishing infection-induced versus vaccine-induced antibody responses during a period of increasing COVID-19 vaccine coverage in Zambia. Declining seroprevalence in Chadiza may indicate waning antibodies and a need for booster vaccines. ANC clinics have a potential role in ongoing SARS-CoV-2 serosurveillance and can continue to provide insights into SARS-CoV-2 antibody dynamics to inform near real-time public health responses.
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    Early clinical and programmatic outcomes with tenofovir-based antiretroviral therapy in Zambia.
    (2010-May-01) Chi BH; Mwango A; Giganti M; Mulenga LB; Tambatamba-Chapula B; Reid SE; Bolton-Moore C; Chintu N; Mulenga PL; Stringer EM; Sheneberger R; Mwaba P; Stringer JS; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia. bchi@uab.edu; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: In July 2007, amid some controversy over cost, Zambia was the first African country to introduce tenofovir (TDF) as a component of first-line antiretroviral therapy (ART) on a wide scale. METHODS: We compared drug substitutions, mortality, and "programmatic failure" among adults starting TDF-, zidovudine (ZDV)-, and stavudine (d4T)-containing ART. Programmatic failure was defined as death, withdrawal, or loss to follow-up. RESULTS: Between July 2007 and January 2009, 10,485 adults initiated ART (66% on TDF, 23% on ZDV, 11% on d4T), with a median follow-up time of 239 (interquartile range 98, 385) days. Those starting TDF were more likely to be male and more likely to have indicators of severe disease at baseline. In adjusted Cox proportional hazards models, ZDV- (adjusted hazard ratio [AHR] = 2.74, 95% confidence interval [CI] = 2.30-3.28) and d4T-based regimens (AHR = 1.92, 95% CI = 1.55-2.38) were associated with higher risk for drug substitution when compared with TDF-based regimens. Similar hazards were noted for overall mortality (ZDV: AHR = 0 .81, 95% CI = 0.62-1.06; d4T: AHR = 1.03, 95% CI = 0.74-1.43) and programmatic failure (ZDV: AHR = 0.99, 95% CI = 0.88-1.11; d4T: AHR = 1.11, 95% CI = 0.96-1.28) when compared with TDF. CONCLUSIONS: TDF is associated with similar clinical and programmatic outcomes as ZDV and d4T but appears to be better tolerated. Although further evaluation is needed, these results are encouraging and support Zambia's policy decision.
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    Comparative outcomes of tenofovir-based and zidovudine-based antiretroviral therapy regimens in Lusaka, Zambia.
    (2011-Dec-15) Chi BH; Mwango A; Giganti MJ; Sikazwe I; Moyo C; Schuttner L; Mulenga LB; Bolton-Moore C; Chintu NT; Sheneberger R; Stringer EM; Stringer JS; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia. bchi@uab.edu; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: Although tenofovir (TDF) is a common component of antiretroviral therapy (ART), recent evidence suggests inferior outcomes when it is combined with nevirapine (NVP). METHODS: We compared outcomes among patients initiating TDF + emtricitabine or lamivudine (XTC) + NVP, TDF + XTC + efavirenz (EFV), zidovudine (ZDV) + lamuvidine (3TC) + NVP, and ZDV + 3TC + EFV. We categorized drug exposure by initial ART dispensation by a time-varying analysis that accounted for drug substitutions and by predominant exposure (>75% of drug dispensations) during an initial window period. Risks for death and program failure were estimated using Cox proportional hazard models. All regimens were compared with ZDV + 3TC + NVP. RESULTS: Between July 2007 and November 2010, 18,866 treatment-naive adults initiated ART: 18.2% on ZDV + 3TC + NVP, 1.8% on ZDV + 3TC + EFV, 36.2% on TDF + XTC + NVP, and 43.8% on TDF + XTC + EFV. When exposure was categorized by initial prescription, patients on TDF + XTC + NVP [adjusted hazard ratio (AHR): 1.45; 95% confidence interval (CI): 1.03 to 2.06] had a higher post-90-day mortality. TDF + XTC + NVP was also associated with an elevated risk for mortality when exposure was categorized as time-varying (AHR: 1.51; 95% CI: 1.18 to 1.95) or by predominant exposure over the first 90 days (AHR: 1.91, 95% CI: 1.09 to 3.34). However, these findings were not consistently observed across sensitivity analyses or when program failure was used as a secondary outcome. CONCLUSION: TDF + XTC + NVP was associated with higher mortality when compared with ZDV + 3TC + NVP but not consistently across sensitivity analyses. These findings may be explained in part by inherent limitations to our retrospective approach, including residual confounding. Further research is urgently needed to compare the effectiveness of ART regimens in use in resource-constrained settings.
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    Six-month hemoglobin concentration and its association with subsequent mortality among adults on antiretroviral therapy in Lusaka, Zambia.
    (2012-Sep-01) Giganti MJ; Limbada M; Mwango A; Moyo C; Mulenga LB; Guffey MB; Mulenga PL; Bolton-Moore C; Stringer JS; Chi BH; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia. giganticidrz@gmail.com; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    Little is known about changes in hemoglobin concentration early in the course of antiretroviral therapy and its subsequent relation to survival. We analyzed data for 40,410 HIV-infected adults on antiretroviral therapy in Lusaka, Zambia. Our main exposure of interest was 6-month hemoglobin, but we stratified our analysis by baseline hemoglobin to allow for potential effect modification. Patients with a 6-month hemoglobin <8.5 g/dL, regardless of baseline, had the highest hazard for death after 6 months (hazard ratio: 4.5; 95% confidence interval: 3.3 to 6.3). Future work should look to identify causes of anemia in settings such as ours and evaluate strategies for more timely diagnosis and treatment.
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    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.
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    Prevention of mother-to-child HIV transmission within the continuum of maternal, newborn, and child health services.
    (2013-Sep) Chi BH; Bolton-Moore C; Holmes CB; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia. bchi@cidrz.org
    PURPOSE OF REVIEW: To reach virtual elimination of pediatric HIV, programs for the prevention of mother-to-child HIV transmission (PMTCT) must expand coverage and achieve long-term retention of mothers and infants. Although PMTCT have been traditionally aligned with maternal, newborn, and child health (MNCH) services, novel approaches are needed to address the increasing demands of evolving global PMTCT policies. RECENT FINDINGS: PMTCT-MNCH integration has improved the uptake and timely initiation of antiretroviral therapy (ART) among treatment-eligible pregnant women in public health settings. Postpartum engagement of HIV-infected mothers and HIV-exposed infants has been insufficient, although alignment of visits to the childhood immunization schedule and establishment of integrated mother-infant clinics may increase retention. Evidence also suggests that the integration of maternal HIV testing into childhood immunization clinics can significantly increase the identification of at-risk HIV-exposed infants previously missed by traditional PMTCT models. SUMMARY: Targeted service integration models can improve PMTCT uptake. However, as global PMTCT policy shifts to universal provision of maternal ART during pregnancy (i.e., Option B/B+), these findings must be reexamined in the context of increased service demand and systems burden. Intensive evaluation is needed to ensure quality clinical care is maintained both for PMTCT and for underpinning MNCH services.
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    Prognosis of children with HIV-1 infection starting antiretroviral therapy in Southern Africa: a collaborative analysis of treatment programs.
    (2014-Jun) Davies MA; May M; Bolton-Moore C; Chimbetete C; Eley B; Garone D; Giddy J; Moultrie H; Ndirangu J; Phiri S; Rabie H; Technau KG; Wood R; Boulle A; Egger M; Keiser O; From the *School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa; †School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom; ‡Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; §University of North Carolina, Chapel Hill, NC; ¶Newlands clinic, Harare, Zimbabwe; ‖Red Cross Children's Hospital and School of Child and Adolescent Health, University of Cape Town; **Médecins Sans Frontières (MSF) South Africa and Khayelitsha ART Programme, Cape Town; ††Sinikithemba Clinic, McCord Hospital, Durban; ‡‡Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg; §§Harriet Shezi Children's Clinic, Chris Hani Baragwanath Hospital, Soweto; ¶¶Africa Centre for Health and Population Studies, University of Kwazulu-Natal, Somkhele, South Africa; ‖‖Lighthouse Trust Clinic, Kamuzu Central Hospital, Lilongwe, Malawi and Liverpool School of Tropical Medicine, Liverpool, United Kingdom; ***Tygerberg Academic Hospital, University of Stellenbosch, Stellenbosch; †††Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, and University of the Witwatersrand, Johannesburg; ‡‡‡Gugulethu ART Programme and Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa; and §§§Institute of Social and Preventive Medicine (ISPM), University of Bern, Switzerland.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: Prognostic models for children starting antiretroviral therapy (ART) in Africa are lacking. We developed models to estimate the probability of death during the first year receiving ART in Southern Africa. METHODS: We analyzed data from children ≤10 years of age who started ART in Malawi, South Africa, Zambia or Zimbabwe from 2004 to 2010. Children lost to follow up or transferred were excluded. The primary outcome was all-cause mortality in the first year of ART. We used Weibull survival models to construct 2 prognostic models: 1 with CD4%, age, World Health Organization clinical stage, weight-for-age z-score (WAZ) and anemia and the other without CD4%, because it is not routinely measured in many programs. We used multiple imputation to account for missing data. RESULTS: Among 12,655 children, 877 (6.9%) died in the first year of ART. We excluded 1780 children who were lost to follow up/transferred from main analyses; 10,875 children were therefore included. With the CD4% model probability of death at 1 year ranged from 1.8% [95% confidence interval (CI): 1.5-2.3] in children 5-10 years with CD4% ≥10%, World Health Organization stage I/II, WAZ ≥ -2 and without severe anemia to 46.3% (95% CI: 38.2-55.2) in children <1 year with CD4% < 5%, stage III/IV, WAZ< -3 and severe anemia. The corresponding range for the model without CD4% was 2.2% (95% CI: 1.8-2.7) to 33.4% (95% CI: 28.2-39.3). Agreement between predicted and observed mortality was good (C-statistics = 0.753 and 0.745 for models with and without CD4%, respectively). CONCLUSIONS: These models may be useful to counsel children/caregivers, for program planning and to assess program outcomes after allowing for differences in patient disease severity characteristics.
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    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.
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    Operational characteristics of antiretroviral therapy clinics in Zambia: a time and motion analysis.
    (2019-Apr-24) Tampi RP; Tembo T; Mukumba-Mwenechanya M; Sharma A; Dowdy DW; Holmes CB; Bolton-Moore C; Sikazwe I; Tucker A; Sohn H; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA. hsohn6@jhu.edu.; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA.; Centers for Infectious Disease Research (CIDRZ), Lusaka, Zambia.
    BACKGROUND: The mass scale-up of antiretroviral therapy (ART) in Zambia has taken place in the context of limited infrastructure and human resources resulting in many operational side-effects. In this study, we aimed to empirically measure current workload of ART clinic staff and patient wait times and service utilization. METHODS: We conducted time and motion (TAM) studies from both the healthcare worker (HCW) and patient perspectives at 10 ART clinics throughout Zambia. Trained personnel recorded times for consecutive discrete activities based on direct observation of clinical and non-clinical activities performed by counselors, clinical officers, nurses, and pharmacy technicians. For patient TAM, we recruited consenting patients and recorded times of arrival and departure and major ART services utilized. Data from 10 clinics were pooled to evaluate median time per patient spent for each activity and patient duration of stay in the clinic. RESULTS: The percentage of observed clinical time for direct patient interaction (median time per patient encounter) was 43.1% for ART counselors (4 min, interquartile range [IQR] 2-7), 46.1% for nurses (3 min, IQR 2-4), 57.2% for pharmacy technicians (2 min, IQR 1-2), and 78.5% for clinical officers (3 min, IQR 2-5). Patient workloads for HCWs were heaviest between 8 AM and 12 PM with few clinical activities observed after 2 PM. The length of patient visits was inversely associated with arrival time - patients arriving prior to 8 AM spent 61% longer at the clinic than those arriving after 8 AM (277 vs. 171 min). Overall, patients spent 219 min on average for non-clinical visits, and 244 min for clinical visits, but this difference was not significant in rural clinics. In comparison, total time patients spent directly with clinic staff were 9 and 12 min on average for non-clinical and clinical visits. CONCLUSION: Current Zambian ART clinic operations include substantial inefficiencies for both patients and HCWs, with workloads heavily concentrated in the first few hours of clinic opening, limiting HCW and patient interaction time. Use of a differentiated care model may help to redistribute workloads during operational hours and prevent backlogs of patients waiting for hours before clinic opening, which may substantially improve ART delivery in the Zambian context.

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