Browsing by Author "Savory, Theodora"

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An exploration of multi-level factors affecting routine linkage to HIV care in Zambia's PEPFAR-supported treatment program in the treat all era.
(2024) Chipungu, Jenala; Smith, Helene; Mwamba, Chanda; Haambokoma, Mwiza; Sharma, Anjali; Savory, Theodora; Musheke, Maurice; Pry, Jake; Bolton, Carolyn; Sikazwe, Izukanji; Herce, Michael E.
Multiple steps from HIV diagnosis to treatment initiation and confirmed engagement with the health system are required for people living with HIV to establish full linkage to care in the modern treat all era. We undertook a qualitative study to gain an in-depth understanding of the impeding and enabling factors at each step of this linkage pathway. In-depth interviews were conducted with fifty-eight people living with HIV recruited from ten routine HIV care settings supported by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) in Lusaka, Zambia. Using a semi-structured interview guide informed by an established conceptual framework for linkage to care, questions explored the reasons behind late, missed, and early linkage into HIV treatment, as well as factors influencing the decision to silently transfer to a different clinic after an HIV diagnosis. We identified previously established and intersecting barriers of internal and external HIV-related stigma, concerns about ART side effects, substance use, uncertainties for the future, and a perceived lack of partner and social support that impeded linkage to care at every step of the linkage pathway. However, we also uncovered newer themes specific to the current test and treat era related to the rapidity of ART initiation and insufficient patient-centered post-test counseling that appeared to exacerbate these well-known barriers, including callous health workers and limited time to process a new HIV diagnosis before treatment. Long travel distance to the clinic where they were diagnosed was the most common reason for silently transferring to another clinic for treatment. On the other hand, individual resilience, quality counseling, patient-centered health workers, and a supportive and empathetic social network mitigated these barriers. These findings highlight potential areas for strengthening linkage to care and addressing early treatment interruption and silent transfer in the test and treat era in Zambia.
Estimating the real-world effects of expanding antiretroviral treatment eligibility: Evidence from a regression discontinuity analysis in Zambia.
(2018-Jun) Mody, Aaloke; Sikazwe, Izukanji; Czaicki, Nancy L.; Wa Mwanza, Mwanza; Savory, Theodora; Sikombe, Kombatende; Beres, Laura K.; Somwe, Paul; Roy, Monika; Pry, Jake M.; Padian, Nancy; Bolton-Moore, Carolyn; Holmes, Charles B.; Geng, Elvin H.
BACKGROUND: Although randomized trials have established the clinical efficacy of treating all persons living with HIV (PLWHs), expanding treatment eligibility in the real world may have additional behavioral effects (e.g., changes in retention) or lead to unintended consequences (e.g., crowding out sicker patients owing to increased patient volume). Using a regression discontinuity design, we sought to assess the effects of a previous change to Zambia's HIV treatment guidelines increasing the threshold for treatment eligibility from 350 to 500 cells/μL to anticipate effects of current global efforts to treat all PLWHs. METHODS AND FINDINGS: We analyzed antiretroviral therapy (ART)-naïve adults who newly enrolled in HIV care in a network of 64 clinics operated by the Zambian Ministry of Health and supported by the Centre for Infectious Disease Research in Zambia (CIDRZ). Patients were restricted to those enrolling in a narrow window around the April 1, 2014 change to Zambian HIV treatment guidelines that raised the CD4 threshold for treatment from 350 to 500 cells/μL (i.e., August 1, 2013, to November 1, 2014). Clinical and sociodemographic data were obtained from an electronic medical record system used in routine care. We used a regression discontinuity design to estimate the effects of this change in treatment eligibility on ART initiation within 3 months of enrollment, retention in care at 6 months (defined as clinic attendance between 3 and 9 months after enrollment), and a composite of both ART initiation by 3 months and retention in care at 6 months in all new enrollees. We also performed an instrumental variable (IV) analysis to quantify the effect of actually initiating ART because of this guideline change on retention. Overall, 34,857 ART-naïve patients (39.1% male, median age 34 years [IQR 28-41], median CD4 268 cells/μL [IQR 134-430]) newly enrolled in HIV care during this period; 23,036 were analyzed after excluding patients around the threshold to allow for clinic-to-clinic variations in actual guideline uptake. In all newly enrolling patients, expanding the CD4 threshold for treatment from 350 to 500 cells/μL was associated with a 13.6% absolute increase in ART initiation within 3 months of enrollment (95% CI, 11.1%-16.2%), a 4.1% absolute increase in retention at 6 months (95% CI, 1.6%-6.7%), and a 10.8% absolute increase in the percentage of patients who initiated ART by 3 months and were retained at six months (95% CI, 8.1%-13.5%). These effects were greatest in patients who would have become newly eligible for ART with the change in guidelines: a 43.7% increase in ART initiation by 3 months (95% CI, 37.5%-49.9%), 13.6% increase in retention at six months (95% CI, 7.3%-20.0%), and a 35.5% increase in the percentage of patients on ART at 3 months and still in care at 6 months [95% CI, 29.2%-41.9%). We did not observe decreases in ART initiation or retention in patients not directly targeted by the guideline change. An IV analysis found that initiating ART in response to the guideline change led to a 37.9% (95% CI, 28.8%-46.9%) absolute increase in retention in care. Limitations of this study include uncertain generalizability under newer models of care, lack of laboratory data (e.g., viral load), inability to account for earlier stages in the HIV care cascade (e.g., HIV testing and linkage), and potential for misclassification of eligibility status or outcome. CONCLUSIONS: In this study, guidelines raising the CD4 threshold for treatment from 350 to 500 cells/μL were associated with a rapid rise in ART initiation as well as enhanced retention among newly treatment-eligible patients, without negatively impacting patients with lower CD4 levels. These data suggest that health systems in Zambia and other high-prevalence settings could substantially enhance engagement even among those with high CD4 levels (i.e., above 500 cells/μL) by expanding treatment without undermining existing care standards.
Global Trends in CD4 Count Measurement and Distribution at First Antiretroviral Treatment Initiation.
(2025-Jul-18) de Waal, Renee; Wools-Kaloustian, Kara; Brazier, Ellen; Althoff, Keri N.; Jaquet, Antoine; Duda, Stephany N.; Kumarasamy, Nagalingeswaran; Savory, Theodora; Byakwaga, Helen; Murenzi, Gad; Justice, Amy; Ekouevi, Didier K.; Cesar, Carina; Pasayan, Mark K. U.; Thawani, Agness; Kasozi, Charles; Babakazo, Pelagie; Karris, Maile; Messou, Eugene; Cortes, Claudia P.; Kunzekwenyika, Cordelia; Choi, Jun Y.; Owarwo, Noela C.; Niyongabo, Annabelle; Marconi, Vincent C.; Ezechi, Oliver; Castilho, Jessica L.; Petoumenos, Kathy; Johnson, Leigh F.; Ford, Nathan; Kassanjee, Reshma
BACKGROUND: While people with human immunodeficiency virus (PWH) start antiretroviral treatment (ART) regardless of CD4 count, CD4 measurement remains crucial for detecting advanced human immunodeficiency virus (HIV) disease and evaluating ART programs. We explored CD4 measurement (proportion of PWH with a CD4 result available) and prevalence of CD4 <200 cells/µL (hereafter "CD4 <200") at ART initiation within the International epidemiology Databases to Evaluate AIDS (IeDEA) global collaboration. METHODS: We included PWH at participating ART programs who first initiated ART at age 15-80 years during 2005-2019. We described proportions of PWH with a CD4 result (measured within 6 months before to 2 weeks after ART initiation) and, among those with a CD4 result, with CD4 <200, by year of ART initiation and region. RESULTS: We included 1 355 104 PWH from 42 countries in 7 regions; 63% were female. The median (interquartile range) age at ART initiation was 37 (3144) years in males and 32 (26-39) years in females. CD4 measurement initially increased, or remained stable over time until around 2013, but then declined to low levels in some regions (Southern Africa, except South Africa: from 54% to 13%; East Africa: 85% to 31%; Central Africa: 72% to 20%; West Africa: 91% to 53%; and Latin America: 87% to 56%). Prevalence of CD4 <200 declined over time in all regions, but plateaued after 2015 at ≥30%. CONCLUSIONS: CD4 measurement has declined sharply in recent years, especially in sub-Saharan Africa. Among those with a CD4 measurement, the prevalence of CD4 <200 remains concerningly high. Scaling up CD4 testing and securing adequate funding are urgent priorities.
Implementing SARS-CoV-2 routine surveillance in antenatal care in Zambia, 2021-2022: best practices and lessons learned.
(2025-Feb-28) Tembo, Tannia ; Heilmann, Elizabeth; Kabamba, Bupe M.; Fwoloshi, Sombo; Kalenga, Kalubi; Chilambe, Felix; Siwinga, Mpanji; Rutagwera, Marie-Reine ; Musunse, Maximillian; Kangale, Chabu; Yingst, Samuel; Yadav, Ruchi; Savory, Theodora; Gutman, Julie R.; Sikazwe, Izukanji ; Mulenga, Lloyd B.; Bolton-Moore, Carolyn; Hines, Jonas Z.
BACKGROUND: In Zambia, the true extent of SARS-CoV-2 infections is unknown because initial surveillance focused on patients with symptoms or severe disease. Antenatal sentinel surveillance had not been used to assess infection trends. The ANC COVID-19 surveillance study sought to determine SARS-CoV-2 seroprevalence and COVID-19 vaccine uptake among pregnant women. We provide insight into the study implementation, challenges encountered, best practices, and lessons learned. METHODS: A repeated cross-sectional seroprevalence survey was implemented at 39 health facilities in four districts from September 2021 to September 2022. Pregnant women aged 15-49 years were enrolled at their first antenatal care visits. An electronic questionnaire gathered demographics and other COVID-19 related information from consenting participants. A dried blood sample was collected to detect IgG antibodies using a multiplex bead assay. Seropositive results were categorized as infection, infection and vaccination or infection based on anti-RBD and anti-nucleocapsid test results. Problems and their root causes were identified as they occurred. Practical problem-solving strategies were devised, implemented, and monitored to ensure that goals were accomplished. RESULTS: In the primary analysis, 7% of the 9,221 samples collected from participants were not tested because they were missing. COVID-19 vaccine uptake of 9,111 pregnant women was assessed. Approximately 64% of participants were cumulatively seropositive for SARS-CoV-2 antibodies. Seroprevalence increased from 27.8% in September 2021 to 56.6% in July 2022. We observed an increase in vaccine coverage (0.5-27%) over time. Women aged 40-49 years old, without education and with prior COVID-19 infection were associated with higher vaccine uptake. The Delta variant of COVID-19 and the reallocation of health facilities between two partners delayed surveillance activities and increased the cost of implementation (e.g., the purchase of additional calibration and validation kits and DBS cards). Protocol deviations were attributed to the lack of experience in conducting research but, the district RAs repeatedly trained health facility staff to enhance their research knowledge. CONCLUSIONS: Incorporating SARS-CoV-2 surveillance into routine antenatal care is feasible and potentially sustainable when existing health system infrastructure, human resources, and surveillance systems are leveraged. Yet, careful planning is needed to anticipate implementation challenges and ensure high-quality data collection.
Patient-reported reasons for declining same-day antiretroviral therapy initiation in routine HIV care settings in Lusaka, Zambia: results from a mixed-effects regression analysis.
(2020-Jul) Pry, Jake; Chipungu, Jenala; Smith, Helene J.; Bolton-Moore, Carolyn; Mutale, Jacob; Duran-Frigola, Miquel; Savory, Theodora; Herce, Michael E.
INTRODUCTION: In the current "test and treat" era, HIV programmes are increasingly focusing resources on linkage to care and same-day antiretroviral therapy (ART) initiation to meet UNAIDS 95-95-95 targets. After observing sub-optimal treatment indicators in health facilities supported by the Centre for Infectious Disease Research in Zambia (CIDRZ), we piloted a "linkage assessment" tool in facility-based HIV testing settings to uncover barriers to same-day linkage to care and ART initiation among newly identified people living with HIV (PLHIV) and to guide HIV programme quality improvement efforts. METHODS: The one-page, structured linkage assessment tool was developed to capture patient-reported barriers to same-day linkage and ART initiation using three empirically supported categories of barriers: social, personal and structural. The tool was implemented in three health facilities, two urban and one rural, in Lusaka, Zambia from 1 November 2017 to 31 January 2018, and administered to all newly identified PLHIV declining same-day linkage and ART. Individuals selected as many reasons as relevant. We used mixed-effects logistic regression modelling to evaluate predictors of citing specific barriers to same-day linkage and ART, and Fisher's Exact tests to assess differences in barrier citation by socio-demographics and HIV testing entry point. RESULTS: A total of 1278 people tested HIV positive, of whom 126 (9.9%) declined same-day linkage and ART, reporting a median of three barriers per respondent. Of these 126, 71.4% were female. Females declining same-day ART were younger, on average, (median 28.5 years, interquartile range (IQR): 21 to 37 years) than males (median 34.5 years, IQR: 26 to 44 years). The most commonly reported barrier category was structural, "clinics were too crowded" (n = 33), followed by a social reason, "friends and family will condemn me" (n = 30). The frequency of citing personal barriers differed significantly across HIV testing point (χ CONCLUSIONS: Given differences observed in barriers to same-day ART initiation reported across sex, age, testing point, and facility type, new, tailored counselling and linkage to care approaches are needed, which should be rigorously evaluated in routine programme settings.
Patterns of engagement in care during clients' first 12 months after HIV treatment initiation in Zambia: a retrospective cohort analysis using routinely collected data.
(2025-Aug-11) Benade, Mariet; Maskew, Mhairi; Chilembo, Phillip; Mwansa, Mwansa W.; Savory, Theodora; Nichols, Brooke; Bolton, Carolyn; Mulenga, Lloyd B ; Sivile, Suilanji; Zyambo, Khozya D. ; Rosen, Sydney
BACKGROUND: The first year after HIV treatment initiation or re-initiation is the period of highest risk of a treatment interruption or disengagement, yet little is known about the timing, patterns and effects of interruptions in the early treatment period. METHODS: Using routinely collected electronic medical record data from 543 Zambian facilities from 2018 to 2023, we described patterns of engagement during the first year of HIV treatment. We defined engagement patterns for months 0-6 and months 7-12 after initiation or reinitiation as (1) continuous (attended all scheduled clinic and medication pickup visits as planned; (2) cyclical (attended ≥1 visits late >28 days but returned to and remained in care) or (3) disengaged (missed a scheduled visit by >28 days and had no evidence of return). RESULTS: Our sample population comprised 159 429 adult participants (61% female, median age 33). Of the 513 322 interactions observed ≤12 months after initiation, 53% occurred as planned, 22% were late ≤28 days late, 9% were >28 days late, and 17% were scheduled but never attended. In 0-6 months after initiation, 51% clients were continuously engaged, 12% cyclically engaged and 33% disengaged. Two-thirds of disengagers (21% of cohort) did not return after the initiation visit. During months 7-12, most clients who had been continuously engaged in months 0-6 (54%) remained continuous, while 18% moved to cyclical engagement. Among cyclical engagers in months 0-6, nearly half (47%) moved to being continuously engaged by month 12. Only 34% of the study population remained engaged continuously by the end of the 12-month period. CONCLUSIONS: Fewer than 60% of clients initiating antiretroviral therapy care between 2018 and 2022 at Zambian facilities remained continuously engaged at month 6 and 34% at month 12. Cyclical engagement and frequent interruptions should be accepted as the norm and models of service delivery designed to accommodate them.
Programme science in action: lessons from an observational study of HIV prevention programming for key populations in Lusaka, Zambia.
(2024-Jul) Sikazwe, Izukanji; Musheke, Maurice; Chiyenu, Kanema ; Ngosa, Benard; Pry, Jake M.; Mulubwa, Chama; Zimba, Martin; Sakala, Martin; Sakala, Mphatso; Somwe, Paul; Nyirenda, Goodwin; Savory, Theodora; Bolton, Carolyn; Herce, Michael E.
INTRODUCTION: Optimizing uptake of pre-exposure prophylaxis (PrEP) for individuals at risk of HIV acquisition has been challenging despite clear scientific evidence and normative guidelines, particularly for key populations (KPs) such as men who have sex with men (MSM), female sex workers (FSWs), transgender (TG) people and persons who inject drugs (PWID). Applying an iterative Programme Science cycle, building on the effective programme coverage framework, we describe the approach used by the Centre for Infectious Disease Research in Zambia (CIDRZ) to scale up PrEP delivery and address inequities in PrEP access for KP in Lusaka, Zambia. METHODS: In 2019, CIDRZ partnered with 10 local KP civil society organizations (CSOs) and the Ministry of Health (MOH) to offer HIV services within KP-designated community safe spaces. KP CSO partners led KP mobilization, managed safe spaces and delivered peer support; MOH organized clinicians and clinical commodities; and CIDRZ provided technical oversight. In December 2021, we introduced a community-based intervention focused on PrEP delivery in venues where KP socialize. We collected routine programme data from September 2019 to June 2023 using programme-specific tools and the national electronic health record. We estimated the before-after effects of our intervention on PrEP uptake, continuation and equity for KP using descriptive statistics and interrupted time series regression, and used mixed-effects regression to estimate marginal probabilities of PrEP continuity. RESULTS: Most (25,658) of the 38,307 (67.0%) Key Population Investment Fund beneficiaries were reached with HIV prevention services at community-based venues. In total, 23,527 (61.4%) received HIV testing services, with 15,508 (65.9%) testing HIV negative and found PrEP eligible, and 15,241 (98.3%) initiating PrEP. Across all programme quarters and KP types, PrEP uptake was >90%. After introducing venue-based PrEP delivery, PrEP uptake (98.7% after vs. 96.5% before, p < 0.001) and the number of initiations (p = 0.014) increased significantly. The proportion of KP with ≥1 PrEP continuation visit within 6 months of initiation was unchanged post-intervention (46.7%, 95% confidence interval [CI]: 45.7%, 47.6%) versus pre-intervention (47.2%, 95% CI: 45.4%, 49.1%). CONCLUSIONS: Applying Programme Science principles, we demonstrate how decentralizing HIV prevention services to KP venues and safe spaces in partnership with KP CSOs enabled successful community-based PrEP delivery beyond the reach of traditional facility-based services.