Browsing by Author "Ballif M"

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Correcting mortality estimates among children and youth on antiretroviral therapy in southern Africa: A comparative analysis between a multi-country tracing study and linkage to a health information exchange.
(2024-Aug) Nyakato P; Schomaker M; Boulle A; Euvrard J; Wood R; Eley B; Prozesky H; Christ B; Anderegg N; Ayakaka I; Rafael I; Kunzekwenyika C; Moore CB; van Lettow M; Chimbetete C; Mbewe S; Ballif M; Egger M; Yiannoutsos CT; Cornell M; Davies MA
OBJECTIVES: The objective of this study is to assess the outcomes of children, adolescents and young adults with HIV reported as lost to follow-up, correct mortality estimates for children, adolescents and young adults with HIV for unascertained outcomes in those loss to follow-up (LTFU) based on tracing and linkage data separately using data from the International epidemiology Databases to Evaluate AIDS in Southern Africa. METHODS: We included data from two different populations of children, adolescents and young adults with HIV; (1) clinical data from children, adolescents and young adults with HIV aged ≤24 years from Lesotho, Malawi, Mozambique, Zambia and Zimbabwe; (2) clinical data from children, adolescents and young adults with HIV aged ≤14 years from the Western Cape (WC) in South Africa. Outcomes of patients lost to follow-up were available from (1) a tracing study and (2) linkage to a health information exchange. For both populations, we compared six methods for correcting mortality estimates for all children, adolescents and young adults with HIV. RESULTS: We found substantial variations of mortality estimates among children, adolescents and young adults with HIV reported as lost to follow-up versus those retained in care. Ascertained mortality was higher among lost and traceable children, adolescents and young adults with HIV and lower among lost and linkable than those retained in care (mortality: 13.4% [traced] vs. 12.6% [retained-other Southern Africa countries]; 3.4% [linked] vs. 9.4% [retained-WC]). A high proportion of lost to follow-up children, adolescents and young adults with HIV had self-transferred (21.0% and 47.0%) in the traced and linked samples, respectively. The uncorrected method of non-informative censoring yielded the lowest mortality estimates among all methods for both tracing (6.0%) and linkage (4.0%) approaches at 2 years from ART start. Among corrected methods using ascertained data, multiple imputation, incorporating ascertained data (MI(asc.)) and inverse probability weighting with logistic weights were most robust for the tracing approach. In contrast, for the linkage approach, MI(asc.) was the most robust. CONCLUSIONS: Our findings emphasise that lost to follow-up is non-ignorable and both tracing and linkage improved outcome ascertainment: tracing identified substantial mortality in those reported as lost to follow-up, whereas linkage did not identify out-of-facility deaths, but showed that a large proportion of those reported as lost to follow-up were self-transfers.
Detection and management of drug-resistant tuberculosis in HIV-infected patients in lower-income countries.
(2014-Nov) Ballif M; Nhandu V; Wood R; Dusingize JC; Carter EJ; Cortes CP; McGowan CC; Diero L; Graber C; Renner L; Hawerlander D; Kiertiburanakul S; Du QT; Sterling TR; Egger M; Fenner L
SETTING: Drug resistance threatens tuberculosis (TB) control, particularly among human immunodeficiency virus (HIV) infected persons. OBJECTIVE: To describe practices in the prevention and management of drug-resistant TB under antiretroviral therapy (ART) programs in lower-income countries. DESIGN: We used online questionnaires to collect program-level data on 47 ART programs in Southern Africa (n = 14), East Africa (n = 8), West Africa (n = 7), Central Africa (n = 5), Latin America (n = 7) and the Asia-Pacific (n = 6 programs) in 2012. Patient-level data were collected on 1002 adult TB patients seen at 40 of the participating ART programs. RESULTS: Phenotypic drug susceptibility testing (DST) was available in 36 (77%) ART programs, but was only used for 22% of all TB patients. Molecular DST was available in 33 (70%) programs and was used in 23% of all TB patients. Twenty ART programs (43%) provided directly observed therapy (DOT) during the entire course of treatment, 16 (34%) during the intensive phase only, and 11 (23%) did not follow DOT. Fourteen (30%) ART programs reported no access to second-line anti-tuberculosis regimens; 18 (38%) reported TB drug shortages. CONCLUSIONS: Capacity to diagnose and treat drug-resistant TB was limited across ART programs in lower-income countries. DOT was not always implemented and drug supplies were regularly interrupted, which may contribute to the global emergence of drug resistance.
High Unreported Mortality in Children and Youth (<25 Years) Living With HIV Who Were Lost to Care From Antiretroviral Therapy Programs in Southern Africa: Results From a Multicountry Tracing Study.
(2022-Dec-15) Nyakato P; Christ B; Anderegg N; Muhairwe J; Jefferys L; van Dijk J; Vinikoor MJ; van Lettow M; Chimbetete C; Phiri SJ; Egger M; Ballif M; Yiannoutsos CT; Schomaker M; Kassanjee R; Davies MA; Cornell M
BACKGROUND: Antiretroviral therapy program mortality maybe underestimated if deceased patients are misclassified as lost. METHODS: We used two-stage inverse probability weighting to account for probability of being: sampled for tracing and found by the tracer. RESULTS: Among 680 children and youth aged <25 years on antiretroviral therapy who were lost and traced in Southern Africa between October 2017 and November 2019, estimated mortality was high at 9.1% (62/680). After adjusting for measured covariates and within-site clustering, mortality remained lower for young adults aged 20-24 years compared with infants aged <2 years [adjusted hazard ratio: 0.40 (95% confidence interval: 0.31 to 0.51)]. CONCLUSIONS: Our study confirms high unreported mortality in children and youth who are lost and the need for tracing to assess vital status among those who are lost to accurately report on program mortality.
Mental, physical, and respiratory health in people with tuberculosis in Southern Africa: a multi-country cohort analysis.
(2025-Aug-20) Banholzer N; Muula G; Mureithi F; Evans D; Huwa J; Rafael I; Kunzekwenyika C; Jinga N; Fernando A; Thawani A; Schmutz R; Bolton C; Günther G; Egger M; Haas AD; Sweetland AC; Ballif M; Fenner L
BACKGROUND: Tuberculosis (TB) affects people's quality of life (QoL). We prospectively monitored physical and mental health-related QoL over time in people with TB in the Southern African region with a high HIV and TB burden. METHODS: Adults aged ≥ 15 years with pulmonary TB were enrolled in five cohorts in Malawi, Mozambique, South Africa, Zambia, and Zimbabwe from October 2022 to September 2024. We assessed six QoL outcomes using validated instruments at the start (baseline), end of treatment, and 6 months post-treatment: symptoms of depression (PHQ-9), mental and physical health (SF-12 mental, SF12-MC, SF-12 physical component, SF12-PC), physical fitness (6-Minute Walk Test, 6MWT; 1-min Sit-To-Stand Test, STST), and respiratory health (Saint-George-Respiratory-Questionnaire, SGRQ). Missing QoL scores were imputed with multivariate imputation by chained equations. We compared the proportion of participants with impaired QoL, defining impairment based on outcome-specific cut-off values. We also estimated changes in QoL scores and examined their associations with baseline characteristics using Bayesian multivariable regression models. RESULTS: We included 1438 participants with a median follow-up of 344 days (interquartile range [IQR] 183-373). The median age was 39 years (IQR 30-50); 67% were male, and 39% living with HIV. At baseline, 49% had symptoms of depression, 73% had impaired mental health and 92% impaired physical health-related QoL, 68-74% had reduced physical fitness (68%: 6MWT, 74%: STST), and 78% impaired respiratory health. All QoL outcomes improved by the end of treatment, notably depressive symptoms (48% to 5%), mental health-related QoL (73% to 28%), and respiratory health (78% to 11%). Most QoL impairments continued to decrease post-treatment, especially physical and respiratory health; depressive symptoms remained below 5%. Across QoL domains and study visits, better outcomes were associated with age < 30 (83% probability), and worse outcomes with female gender (86%) and a prior TB history (89%). Living with HIV and alcohol drinking were associated with worse QoL only at baseline (88% and 87%). CONCLUSIONS: TB negatively impacts QoL across physical, mental, and social domains, including post-treatment. The study highlights the need for integrated mental and physical healthcare and rehabilitation during TB treatment and beyond, especially for high-risk populations, to address the long-term impact of TB on QoL.
Scale of differentiated service delivery implementation in HIV care facilities in low- and middle-income countries: a global facility survey.
(2025-Jul) Fernández Villalobos NV; Helfenstein F; Khol V; Twizere C; Secco M; Castelnuovo B; Huwa J; Tiendredbeogo T; Wester CW; Fong SM; Murenzi G; Caro-Vega Y; Lyamuya RE; Rafael I; Zannou DM; Petoumenos K; Nsonde DM; Pinto J; Wools-Kaloustian K; Moore CB; Takassi OE; Kiertiburanakul S; Awoh RA; Ali SM; Fatti G; Malateste K; Zaniewski E; Ballif M
INTRODUCTION: In 2016, the World Health Organization recommended differentiated service delivery (DSD) as a client-centred approach to simplify HIV care in frequency and intensity, thus reducing the clinic visit burden on individuals and HIV programmes. We describe the scale of DSD implementation among HIV facilities in low- and middle-income countries (LMICs) in Latin America, Africa and the Asia-Pacific before the COVID-19 pandemic. METHODS: We analysed facility-level survey data from HIV care facilities participating in the International epidemiology Databases to Evaluate AIDS consortium in 2019. We used descriptive statistics to summarise the availability of DSD, multi-month dispensing (MMD) and DSD for HIV treatment models. We explored factors associated with DSD implementation using multivariable models. RESULTS: We included 175 facilities in the Asia-Pacific (n = 30), Latin America (n = 8), Central Africa (n = 21), East Africa (n = 74), Southern Africa (n = 28) and West Africa (n = 14). Overall, 133 facilities (76%) reported implementing DSD. Of these, 91% offered DSD for HIV treatment, 61% for HIV testing and 59% for antiretroviral therapy (ART) initiation. The most common duration of ART refills for clinically stable clients was 3MMD, (70%), followed by monthly (14%) and 6MMD (10%). Facility-based individual models were the most frequently available DSD for the HIV treatment model (82%), followed by client-managed group models (60%). Out-of-facility individual models were available at 48% of facilities. Facility-based individual models were particularly common among facilities in East (92%) and Southern Africa (96%). Facilities in medium and high HIV prevalence countries, and those with 3MMD, were more likely to implement DSD. CONCLUSIONS: In 2019, DSD was available in most HIV care facilities globally but was not evenly implemented across regions and HIV services. Most offered facility-based DSD for HIV treatment models and 3MMD for clinically stable clients. Efforts to expand DSD for HIV testing and ART initiation and to offer longer MMD can improve long-term retention in care of people living with HIV in LMICs, while further alleviating the operational burden on healthcare services. These findings from the pre-COVID-19 era underline the need for strengthening DSD in HIV care, which remains at the centre of current efforts towards client-centred care.
Seasonal variations in tuberculosis diagnosis among HIV-positive individuals in Southern Africa: analysis of cohort studies at antiretroviral treatment programmes.
(2018-Jan-11) Ballif M; Zürcher K; Reid SE; Boulle A; Fox MP; Prozesky HW; Chimbetete C; Zwahlen M; Egger M; Fenner L
OBJECTIVES: Seasonal variations in tuberculosis diagnoses have been attributed to seasonal climatic changes and indoor crowding during colder winter months. We investigated trends in pulmonary tuberculosis (PTB) diagnosis at antiretroviral therapy (ART) programmes in Southern Africa. SETTING: Five ART programmes participating in the International Epidemiology Database to Evaluate AIDS in South Africa, Zambia and Zimbabwe. PARTICIPANTS: We analysed data of 331 634 HIV-positive adults (>15 years), who initiated ART between January 2004 and December 2014. PRIMARY OUTCOME MEASURE: We calculated aggregated averages in monthly counts of PTB diagnoses and ART initiations. To account for time trends, we compared deviations of monthly event counts to yearly averages, and calculated correlation coefficients. We used multivariable regressions to assess associations between deviations of monthly ART initiation and PTB diagnosis counts from yearly averages, adjusted for monthly air temperatures and geographical latitude. As controls, we used Kaposi sarcoma and extrapulmonary tuberculosis (EPTB) diagnoses. RESULTS: All programmes showed monthly variations in PTB diagnoses that paralleled fluctuations in ART initiations, with recurrent patterns across 2004-2014. The strongest drops in PTB diagnoses occurred in December, followed by April-May in Zimbabwe and South Africa. This corresponded to holiday seasons, when clinical activities are reduced. We observed little monthly variation in ART initiations and PTB diagnoses in Zambia. Correlation coefficients supported parallel trends in ART initiations and PTB diagnoses (correlation coefficient: 0.28, 95% CI 0.21 to 0.35, P<0.001). Monthly temperatures and latitude did not substantially change regression coefficients between ART initiations and PTB diagnoses. Trends in Kaposi sarcoma and EPTB diagnoses similarly followed changes in ART initiations throughout the year. CONCLUSIONS: Monthly variations in PTB diagnosis at ART programmes in Southern Africa likely occurred regardless of seasonal variations in temperatures or latitude and reflected fluctuations in clinical activities and changes in health-seeking behaviour throughout the year, rather than climatic factors.
The long-term impact of the COVID-19 pandemic on tuberculosis care and infection control measures in anti-retroviral therapy (ART) clinics in low- and middle-income countries: a multiregional site survey in Asia and Africa.
(2025-Mar-24) Ballif M; Banholzer N; Perrig L; Avihingsanon A; Nsonde DM; Obatsa S; Muula G; Komena E; Uemura H; Lelo P; Otaalo B; Huwa J; Gouéssé P; Kumarasamy N; Brazier E; Michael D; Rafael I; Ramdé R; Somia IKA; Yotebieng M; Diero L; Euvrard J; Ezechi O; Fenner L
BACKGROUND: The COVID-19 pandemic challenged healthcare systems, particularly in settings with high infectious disease burden. We examined the postpandemic long-term impacts of COVID-19 on tuberculosis (TB) services at anti-retroviral therapy (ART) clinics in lower-income countries. METHODS: Using standardised online questionnaires, we conducted a cross-sectional site survey among ART clinics providing TB services in Africa and Asia from July to September 2023 (site-level information and number of TB diagnoses and tests). RESULTS: Of 45 participating ART clinics, 32 (71%) were in Africa and 13 (29%) in Asia. During the COVID-19 pandemic (2020-2022), 43 (96%) clinics reported implementing social distancing or separation measures, 39 (87%) personal protections for staff members and 32 (71%) protections for patients. Infection control measures were in place in 45% of the clinics before the pandemic (until 2019), 23% introduced measures during the pandemic and 15% maintained them after the pandemic (after 2022). Service provision was affected during the pandemic in 33 (73%) clinics, including TB services in 22 (49%) clinics. TB service restrictions were addressed by introducing changes in directly observed therapy provision in 8 (18%) clinics, multimonth TB drug dispensing in 23 (51%), telehealth services in 25 (56%) and differentiated service delivery in 19 (42%). These changes were sustained after the pandemic at 4 (9%), 11 (24%), 17 (38%) and 12 (27%) clinics, respectively. Compared with 2018-2019, the number of TB diagnoses decreased sharply in 2020-2021 and improved after the pandemic. CONCLUSIONS: COVID-19 affected TB care services in ART clinics in Africa and Asia. This was paralleled by a reduction in TB diagnoses, which partly resumed after the pandemic. Infection control measures and alternative modes of service delivery were adopted during the pandemic and only partially maintained. Efforts should be made to sustain the lessons learnt during the COVID-19 pandemic, particularly approaches that reduce the risk of transmission of infectious diseases, including TB, in ART clinics.
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
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.
Tracing People Living With Human Immunodeficiency Virus Who Are Lost to Follow-up at Antiretroviral Therapy Programs in Southern Africa: A Sampling-Based Cohort Study in 6 Countries.
(2022-Jan-29) Ballif M; Christ B; Anderegg N; Chammartin F; Muhairwe J; Jefferys L; Hector J; van Dijk J; Vinikoor MJ; van Lettow M; Chimbetete C; Phiri SJ; Onoya D; Fox MP; Egger M
BACKGROUND: Attrition threatens the success of antiretroviral therapy (ART). In this cohort study, we examined outcomes of people living with human immunodeficiency virus (PLHIV) who were lost to follow-up (LTFU) during 2014-2017 at ART programs in Southern Africa. METHODS: We confirmed LTFU (missed appointment for ≥60 or ≥90 days, according to local guidelines) by checking medical records and used a standardized protocol to trace a weighted random sample of PLHIV who were LTFU in 8 ART programs in Lesotho, Malawi, Mozambique, South Africa, Zambia, and Zimbabwe, 2017-2019. We ascertained vital status and identified predictors of mortality using logistic regression, adjusted for sex, age, time on ART, time since LTFU, travel time, and urban or rural setting. RESULTS: Among 3256 PLHIV, 385 (12%) were wrongly categorized as LTFU and 577 (17%) had missing contact details. We traced 2294 PLHIV (71%) by phone calls, home visits, or both: 768 (34% of 2294) were alive and in care, including 385 (17%) silent transfers to another clinic; 528 (23%) were alive without care or unknown care; 252 (11%) had died. Overall, the status of 1323 (41% of 3256) PLHIV remained unknown. Mortality was higher in men than women, higher in children than in young people or adults, and higher in PLHIV who had been on ART <1 year or LTFU ≥1 year and those living farther from the clinic or in rural areas. Results were heterogeneous across sites. CONCLUSIONS: Our study highlights the urgent need for better medical record systems at HIV clinics and rapid tracing of PLHIV who are LTFU.