Browsing by Author "Bolton-Moore, Carolyn"

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A controlled study to assess the effects of a Fast Track (FT) service delivery model among stable HIV patients in Lusaka Zambia.
(2022) Bolton-Moore, Carolyn; Pry, Jake M.; Mukumbwa-Mwenechanya, Mpande; Eshun-Wilson, Ingrid; Topp, Stephanie; Mwamba, Chanda; Roy, Monika; Sohn, Hojoon; Dowdy, David W.; Padian, Nancy; Holmes, Charles B.; Geng, Elvin H.; Sikazwe, Izukanji
Fast Track models-in which patients coming to facility to pick up medications minimize waiting times through foregoing clinical review and collecting pre-packaged medications-present a potential strategy to reduce the burden of treatment. We examine effects of a Fast Track model (FT) in a real-world clinical HIV treatment program on retention to care comparing two clinics initiating FT care to five similar (in size and health care level), standard of care clinics in Zambia. Within each clinic, we selected a systematic sample of patients meeting FT eligibility to follow prospectively for retention using both electronic medical records as well as targeted chart review. We used a variety of methods including Kaplan Meier (KM) stratified by FT, to compare time to first late pick up, exploring late thresholds at >7, >14 and >28 days, Cox proportional hazards to describe associations between FT and late pick up, and linear mixed effects regression to assess the association of FT with medication possession ratio. A total of 905 participants were enrolled with a median age of 40 years (interquartile range [IQR]: 34-46 years), 67.1% were female, median CD4 count was 499 cells/mm3 (IQR: 354-691), and median time on ART was 5 years (IQR: 3-7). During the one-year follow-up period FT participants had a significantly reduced cumulative incidence of being >7 days late for ART pick-up (0.36, 95% confidence interval [CI]: 0.31-0.41) compared to control participants (0.66; 95% CI: 0.57-0.65). This trend held for >28 days late for ART pick-up appointments, at 23% (95% CI: 18%-28%) among intervention participants and 54% (95% CI: 47%-61%) among control participants. FT models significantly improved timely ART pick up among study participants. The apparent synergistic relationship between refill time and other elements of the FT suggest that FT may enhance the effects of extending visit spacing/multi-month scripting alone. ClinicalTrials.gov Identifier: NCT02776254 https://clinicaltrials.gov/ct2/show/NCT02776254.
A Review of Differentiated Service Delivery for HIV Treatment: Effectiveness, Mechanisms, Targeting, and Scale.
(2019-Aug) Roy, Monika; Bolton-Moore, Carolyn; Sikazwe, Izukanji; Holmes, Charles B.
PURPOSE OF REVIEW: Differentiated service delivery (DSD) models were initially developed as a means to combat suboptimal long-term retention in HIV care, and to better titrate limited health systems resources to patient needs, primarily in low-income countries. The models themselves are designed to streamline care along the HIV care cascade and range from individual to group-based care and facility to community-based health delivery systems. However, much remains to be understood about how well and for whom DSD models work and whether these models can be scaled, are sustainable, and can reach vulnerable and high-risk populations. Implementation science is tasked with addressing some of these questions through systematic, scientific inquiry. We review the available published evidence on the implementation of DSD and suggest further health systems innovations needed to maximize the public health impact of DSD and future implementation science research directions in this expanding field. RECENT FINDINGS: While early observational data supported the effectiveness of various DSD models, more recently published trials as well as evaluations of national scale-up provide more rigorous evidence for effectiveness and performance at scale. Deeper understanding of the mechanism of effect of various DSD models and generalizability of studies to other countries or contexts remains somewhat limited. Relative implementability of DSD models may differ based on patient preference, logistical complexity of model adoption and maintenance, human resource and pharmacy supply chain needs, and comparative cost-effectiveness. However, few studies to date have evaluated comparative implementation or cost-effectiveness from a health systems perspective. While DSD represents an exciting and promising "next step" in HIV health care delivery, this innovation comes with its own set of implementation challenges. Evidence on the effectiveness of DSD generally supports the use of most DSD models, although it is still unclear which models are most relevant in diverse settings and populations and which are the most cost-effective. Challenges during scale-up highlight the need for accurate differentiation of patients, sustainable inclusion of a new cadre of health care worker (the community health care worker), and substantial strengthening of existing pharmacy supply chains. To maximize the public health impact of DSD, systems need to be patient-centered and adaptive, as well as employ robust quality improvement processes.
Accurate dried blood spots collection in the community using non-medically trained personnel could support scaling up routine viral load testing in resource limited settings.
(2019) Sikombe, Kombatende; Hantuba, Cardinal; Musukuma, Kalo; Sharma, Anjali; Padian, Nancy; Holmes, Charles; Czaicki, Nancy; Simbeza, Sandra; Somwe, Paul; Bolton-Moore, Carolyn; Sikazwe, Izukanji; Geng, Elvin
Regular plasma HIV-RNA testing for persons living with HIV on antiretroviral therapy (ART) is now the global standard, but as many as 60% of persons in Africa today on ART do not have access to standard laboratory HIV-RNA assays. As a result, patients in Zambia often receive treatment without any means of determining true virologic failure, which poses a risk of premature switch of ART regimens and widespread HIV drug resistance. Dry blood spots (DBS) on the other hand require unskilled personnel and less complex storage supply chain so are ideal to capture viral-load results from HIV patients outside clinic settings. We assess collection of DBS in the community using non-medically trained personnel (NMP) and documented challenges. We trained 23 NMP to collect DBS from lost to follow-up (LTFU) patients in 4 rural and urban Zambian districts. We developed a phlebotomy box to transport DBS without contamination at ambient temperature and concomitant training and standard operating procedures. We evaluated this through field observations, bi-weekly meetings, reports, and staff meetings. The laboratory assessed DBS quality for testing validity. We attempted to collect DBS from 357 participants in the community. Though individual reasons for refusal from the remaining 37% were not collected, NMPs reported privacy concerns, awkward box-size which drew attention in the community and fears of undisclosed uses of samples related to witchcraft and circulating narratives about past research. Successful DBS collection was not associated with patient gender, age, time on ART, enrolment CD4, facility. DBS viral-load collection by NMP is feasible in Zambia. Our training approach and assessments of NMP not part of the health system can be extended to patients by giving them more responsibility to manage their own differentiated care groups. Concerted efforts that compare collection of DBS by NMP to those collected by skilled-medical personnel are needed.
Application of a Multistate Model to Evaluate Visit Burden and Patient Stability to Improve Sustainability of Human Immunodeficiency Virus Treatment in Zambia.
(2018-Sep-28) Roy, Monika; Holmes, Charles; Sikazwe, Izukanji; Savory, Thea; wa Mwanza, Mwanza; Bolton-Moore, Carolyn; Mulenga, Kafula; Czaicki, Nancy; Glidden, David V.; Padian, Nancy; Geng, Elvin
BACKGROUND: Differentiated service delivery (DSD) for human immunodeficiency virus (HIV)-infected persons who are clinically stable on antiretroviral therapy (ART) has been embraced as a solution to decrease access barriers and improve quality of care. However, successful DSD implementation is dependent on understanding the prevalence, incidence, and durability of clinical stability. METHODS: We evaluated visit data in a cohort of HIV-infected adults who made at least 1 visit between 1 March 2013 and 28 February 2015 at 56 clinics in Zambia. We described visit frequency and appointment intervals using conventional stability criteria and used a mixed-effects linear regression model to identify predictors of appointment interval. We developed a multistate model to characterize patient stability over time and calculated incidence rates for transition between states. RESULTS: Overall, 167819 patients made 3418018 post-ART initiation visits between 2004 and 2015. Fifty-four percent of visits were pharmacy refill-only visits, and 24% occurred among patients on ART for >6 months and whose current CD4 was >500 cells/mm3. Median appointment interval at clinician visits was 59 days, and time on ART and current CD4 were not strong predictors of appointment interval. Cumulative incidence of clinical stability was 66.2% at 2 years after enrollment, but transition to instability (31 events per 100 person-years) and lapses in care (41 events per100 person-years) were common. CONCLUSIONS: Current facility-based care was characterized by high visit burden due to pharmacy refills and among treatment-experienced patients. Differentiated service delivery models targeted toward stable patients need to be adaptive given that clinical stability was highly transient and lapses in care were common.
Association of Virologic Failure and Nonnucleoside Reverse Transcriptase Inhibitor Resistance Found in Antiretroviral-Naive Children Infected With Human Immunodeficiency Virus and Given Efavirenz-Based Treatment.
(2020-Apr-30) Higa, Nikki; Pelz, Amy; Birch, Donald; Beck, Ingrid A.; Sils, Tatiana; Samson, Pearl; Bwakura-Dangarembizi, Mutsawashe; Bolton-Moore, Carolyn; Capparelli, Edmund; Chadwick, Ellen; Frenkel, Lisa M.
Among 66 antiretroviral-naive children aged <3 years with human immunodeficiency virus (HIV) or coinfected with HIV and tuberculosis and initiating efavirenz-based antiretroviral therapy (ART), non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance was detected before ART in 5 (7.6%). Virologic failure occurred in 2 of these children; they were last tested at 16 and 24 weeks of ART. Pre-ART NNRTI resistance was not associated with virologic failure.
Barriers to HIV care and adherence for young people living with HIV in Zambia and mHealth.
(2019) St Clair-Sullivan, Natalie; Mwamba, Chanda; Whetham, Jennifer; Bolton-Moore, Carolyn; Darking, Mary; Vera, Jaime
BACKGROUND: The control of HIV/AIDS has been a contemporary public health success story however, whilst infection rates are falling and people are living longer due to antiretroviral therapy, adolescents and young people remain disproportionally affected. Infection rates and AIDS-related deaths continue to increase in these age groups in some areas globally. This has been primarily attributed to structural barriers including HIV-services not being youth friendly with opening hours conflicting with school time, fears around unintended disclosure and confidentiality, and the attitudes of healthcare professionals-but research targeting these specific age groups remains limited. Early mHealth (i.e., the use of mobile and wireless devices to assist in achieving health objectives) projects have been shown to improve health outcomes in other disease areas and health settings however, amongst people living with HIV, current research is limited. The aim of this study was to explore barriers to HIV care and the acceptability and feasibility of using mHealth to improve retention into care and ART adherence for young people living with HIV (16-24 years old) in Lusaka, Zambia. METHODS: Qualitative in-depth interviews and focus group discussions were carried out in four CIDRZ-supported health facilities in Lusaka, Zambia. Six interviews were carried out with nurses and peer-support workers working with young people living with HIV and three focus groups with a total of 24 young people. Recruitment was via purposive sampling. Interviews and focus groups were recorded, translated and transcribed and entered into NVivo for thematic analysis. RESULTS: Twenty-four of the young persons interviewed had access to mobile phones and reported using them for social networking, information gathering and regular communication. Barriers to HIV care and adherence were largely underpinned by stigma. Participants described healthcare facilities as not being conducive for confidentiality and therefore were reluctant to be seen attending or collecting medication from the pharmacy due to possible unintended disclosure and consequential HIV-related stigma. Clinic opening and waiting times and experiences with healthcare professionals also served as barriers. It was felt unanimously by participants that mHealth would be beneficial in improving retention into care and ART adherence in young people living with HIV. CONCLUSIONS: HIV-related stigma remains a barrier to care. With growing access to mobile phones and internet, and a growing population of adolescents who are already using their phones to support each other and seek information, mHealth appears to be both a feasible and acceptable tool to support retention, provide young people with information, and potentially reduce time spent at health facilities via appointment reminders and electronic drug refill requests.
Causes of morbidity among HIV-infected children on antiretroviral therapy in primary care facilities in Lusaka, Zambia.
(2009-Oct) Mubiana-Mbewe, Mwangelwa; Bolton-Moore, Carolyn; Banda, Yolan; Chintu, Namwinga; Nalubamba-Phiri, Mutinta; Giganti, Mark; Guffey, Brad M.; Sambo, Pauline; Stringer, Elizabeth M.; Stringer, Jeffrey S.; Chi, Benjamin H.
OBJECTIVES: To describe the pattern of incident illness in children after initiation of antiretroviral therapy (ART) in a large public health sector programme in Lusaka, Zambia. METHODS: Systematic chart review to retrospectively extract data from medical records of children (i.e. <15 years) initiating ART in the Lusaka, Zambia public sector. Incident conditions were listed separately and then grouped according to broad categories. Predictors for incident diagnoses were determined using univariate and multivariable analysis. RESULTS: Between May 2004 and June 2006, 1705 HIV-infected children initiated ART. Of these, 1235 (72%) had their medical records reviewed. Median age at ART initiation was 77 months and 554 (45%) were females. Eight hundred and forty-one (68%) children had an incident condition during this period, with a median time of occurrence of 64 days from ART initiation. Twenty-eight incident conditions were documented. When categorized, the most common were mucocutaneous conditions [incidence rate (IR): 70.6 per 100 child-years, 95% CI: 64.5-77.2] and upper respiratory tract infection (IR: 70.1 per 100 child-years; 95% CI: 64.0-76.7). Children with severe immunosuppression (i.e. CD4 < 10%) were more likely to develop lower respiratory tract infection (16.3%vs. 10.2%; P = 0.003) and mucocutaneous conditions (43.9% vs. 35.3%; P = 0.005) than those with CD4 > or = 10%. CONCLUSION: There is a high incidence of new illness after ART initiation, emphasizing the importance of close monitoring during this period. Early initiation of ART and use of antimicrobial prophylaxis may also help to reduce the occurrence of such co-morbidities.
Causes of stillbirth, neonatal death and early childhood death in rural Zambia by verbal autopsy assessments.
(2011-Jul) Turnbull, Eleanor; Lembalemba, Mwila K.; Guffey, Brad M.; Bolton-Moore, Carolyn; Mubiana-Mbewe, Mwangelwa; Chintu, Namwinga; Giganti, Mark J.; Nalubamba-Phiri, Mutinta; Stringer, Elizabeth M.; Stringer, Jeffrey S.; Chi, Benjamin H.
OBJECTIVES: To describe specific causes of the high rates of stillbirth, neonatal death and early child childhood death in Zambia. METHODS: We conducted a household-based survey in rural Zambia. Socio-demographic and delivery characteristics were recorded, alongside a maternal HIV test. Verbal autopsy questionnaires were administered to elicit mortality-related information and independently reviewed by three experienced paediatricians who assigned a cause and contributing factor to death. For this secondary analysis, deaths were categorized into: stillbirths (foetal death ≥28 weeks of gestation), neonatal deaths (≤28 days) and early childhood deaths (>28 days to <2 years). RESULTS: Among 1679 households, information was collected on 148 deaths: 34% stillbirths, 26% neonatal and 40% early childhood deaths. Leading identifiable causes of stillbirth were intrauterine infection (26%) and birth asphyxia (18%). Of 32 neonatal deaths, 38 (84%) occurred within the first week of life, primarily because of infections (37%) and prematurity (34%). The majority of early childhood deaths were caused by suspected bacterial infections (82%). HIV prevalence was significantly higher in mothers who reported an early childhood death (44%) than mothers who did not (17%; P < 0.01). Factors significantly associated with mortality were lower socio-economic status (P < 0.01), inadequate water or sanitation facilities (P < 0.01), home delivery (P = 0.04) and absence of a trained delivery attendant (P < 0.01). CONCLUSION: We provide community-level data about the causes of death among children under 2 years of age. Infectious etiologies for mortality ranked highest. At a public health level, such information may have an important role in guiding prevention and treatment strategies to address perinatal and early childhood mortality.
Cervical cancer screening outcomes in Zambia, 2010-19: a cohort study.
(2021-Jun) Pry, Jake M.; Manasyan, Albert; Kapambwe, Sharon; Taghavi, Katayoun; Duran-Frigola, Miquel; Mwanahamuntu, Mulindi ; Sikazwe, Izukanji; Matambo, Jane; Mubita, Jack; Lishimpi, Kennedy; Malama, Kennedy; Bolton-Moore, Carolyn
BACKGROUND: Globally, cervical cancer is the fourth leading cause of cancer-related death among women. Poor uptake of screening services contributes to the high mortality. We aimed to examine screening frequency, predictors of screening results, and patterns of sensitisation strategies by age group in a large, programmatic cohort. METHODS: We did a cohort study including 11 government health facilities in Lusaka, Zambia, in which we reviewed routine programmatic data collected through the Cervical Cancer Prevention Program in Zambia (CCPPZ). Participants who underwent cervical cancer screening in one of the participating study sites were considered for study inclusion if they had a screening result. Follow-up was accomplished per national guidelines. We did descriptive analyses and mixed-effects logistic regression for cervical cancer screening results allowing random effects at the individual and clinic level. FINDINGS: Between Jan 1, 2010, and July 31, 2019, we included 183 165 women with 204 225 results for visual inspection with acetic acid and digital cervicography (VIAC) in the analysis. Of all those screened, 21 326 (10·4%) were VIAC-positive, of whom 16 244 (76·2%) received treatment. Of 204 225 screenings, 92 838 (45·5%) were in women who were HIV-negative, 76 607 (37·5%) were in women who were HIV-positive, and 34 780 (17·0%) had an unknown HIV status. Screening frequency increased 65·7% between 2010 and 2019 with most appointments being first-time screenings (n=158 940 [77·8%]). Women with HIV were more likely to test VIAC-positive than women who were HIV-negative (adjusted odds ratio 3·60, 95% CI 2·14-6·08). Younger women (≤29 years) with HIV had the highest predictive probability (18·6%, 95% CI 14·2-22·9) of screening positive. INTERPRETATION: CCPPZ has effectively increased women's engagement in screening since its inception in 2006. Customised sensitisation strategies relevant to different age groups could increase uptake and adherence to screening. The high proportion of screen positivity in women younger than 20 years with HIV requires further consideration. Our data are not able to discern if women with HIV have earlier disease onset or whether this difference reflects misclassification of disease in an age group with a higher sexually transmitted infection prevalence. These data inform scale-up efforts required to achieve WHO elimination targets. FUNDING: US President's Emergency Plan for AIDS Relief.
Characteristics and outcomes of adolescents living with perinatally acquired HIV within Southern Africa.
(2020-Dec-01) Tsondai, Priscilla R.; Braithwaite, Kate; Fatti, Geoffrey; Bolton-Moore, Carolyn; Chimbetete, Cleophas ; Rabie, Helena; Phiri, Sam; Sawry, Shobna ; Eley, Brian; Hobbins, Michael A.; Boulle, Andrew; Taghavi, Katayoun; Sohn, Annette H.; Davies, Mary-Ann
BACKGROUND: Using data from 15 International epidemiology Databases to Evaluate AIDS in Southern Africa sites, we compared the characteristics and outcomes of adolescents living with perinatally acquired HIV (ALPH). METHODS: We included ALPH entering care aged less than 13 years with at least one HIV care visit during adolescence (10-19 years). We compared the characteristics and cross-sectional outcomes: transfer out, loss to follow-up (no visit in the 12 months prior to database closure), mortality, and retention between those who entered care aged less than 10 vs. aged 10-13 years; and explored predictors of mortality after age 13 years using Cox Proportional Hazards models. RESULTS: Overall, 16 229 (50% female) ALPH who entered HIV care aged less than 10 years and 8897 (54% female) aged 10-13 years were included and followed for 152 574 person-years. During follow-up, 94.1% initiated antiretroviral therapy, with those who entered care aged less than 10 more likely to have initiated antiretroviral therapy [97.9%, 95% confidence interval (CI) 97.6; 98.1%] than those who presented aged 10-13 years (87.3%, 95% CI 86.6; 88.0%). At the end of follow-up, 3% had died (entered care aged <10 vs. 10-13 years; 1.4 vs. 5.1%), 22% were loss to follow-up (16.2 vs. 33.4%), and 59% (66.4 vs. 45.4%) were retained. There was no difference in the risk of dying after the age of 13 years between adolescents entering care aged less than 10 vs. 10-13 years (adjusted hazard ratio 0.72; 95% CI 0.36; 1.42). CONCLUSION: Retention outcomes for ALPH progressively worsened with increasing age, with these outcomes substantially worse among adolescents entering HIV care aged 10-13 vs. less than 10 years.
Clinical outcomes and CD4 cell response in children receiving antiretroviral therapy at primary health care facilities in Zambia.
(2007-Oct-24) Bolton-Moore, Carolyn; Mubiana-Mbewe, Mwangelwa; Cantrell, Ronald A.; Chintu, Namwinga; Stringer, Elizabeth M.; Chi, Benjamin H.; Sinkala, Moses; Kankasa, Chipepo; Wilson, Craig M.; Wilfert, Catherine M.; Mwango, Albert; Levy, Jens; Abrams, Elaine J.; Bulterys, Marc; Stringer, Jeffrey S.
CONTEXT: The Zambian Ministry of Health provides pediatric antiretroviral therapy (ART) at primary care clinics in Lusaka, where, despite scale-up of perinatal prevention efforts, many children are already infected with the human immunodeficiency virus (HIV). OBJECTIVE: To report early clinical and immunologic outcomes of children enrolled in the pediatric treatment program. DESIGN, SETTING, AND PATIENTS: Open cohort assessment using routinely collected clinical and outcome data from an electronic medical record system in use at 18 government primary health facilities in Lusaka, Zambia. Care was provided primarily by nurses and clinical officers ("physician extenders" akin to physician assistants in the United States). Patients were children (<16 years of age) presenting for HIV care between May 1, 2004, and June 29, 2007. INTERVENTION: Three-drug ART (zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz) for children who met national treatment criteria. MAIN OUTCOME MEASURES: Survival, weight gain, CD4 cell count, and hemoglobin response. RESULTS: After enrollment of 4975 children into HIV care, 2938 (59.1%) started ART. Of those initiating ART, the median age was 81 months (interquartile range, 36-125), 1531 (52.1%) were female, and 2087 (72.4%) with World Health Organization stage information were in stage III or IV. At the time of analysis, 158 children (5.4%) had withdrawn from care and 382 (13.0%) were at least 30 days late for follow-up. Of the remaining 2398 children receiving ART, 198 (8.3%) died over 3018 child-years of follow-up (mortality rate, 6.6 deaths per 100 child-years; 95% confidence interval [CI], 5.7-7.5); of these deaths, 112 (56.6%) occurred within 90 days of therapy initiation (early mortality rate, 17.4/100 child-years; post-90-day mortality rate, 2.9/100 child-years). Mortality was associated with CD4 cell depletion, lower weight-for-age, younger age, and anemia in multivariate analysis. The mean CD4 cell percentage at ART initiation among the 1561 children who had at least 1 repeat measurement was 12.9% (95% CI, 12.5%-13.3%) and increased to 23.7% (95% CI, 23.1%-24.3%) at 6 months, 27.0% (95% CI, 26.3%-27.6%) at 12 months, 28.0% (95% CI, 27.2%-28.8%) at 18 months, and 28.4% (95% CI, 27.4%-29.4%) at 24 months. CONCLUSIONS: Care provided by clinicians such as nurses and clinical officers can result in good outcomes for HIV-infected children in primary health care settings in sub-Saharan Africa. Mortality during the first 90 days of therapy is high, pointing to a need for earlier intervention.
Cohort profile: Noncommunicable diseases and ideal cardiovascular health among people living with and without HIV in Zambia and Zimbabwe (NCDzz cohort).
(2025-Feb-07) Chihota, Belinda V.; Mandiriri, Ardele; Muula, Guy; Banda, Esau; Shamu, Tinei; Bolton-Moore, Carolyn; Chimbetete, Cleophas; Bosomprah, Samuel; Wandeler, Gilles
PURPOSE: The NCDzz study is a prospective cohort of people living with and without HIV attending primary care clinics in Zambia and Zimbabwe and was established in 2019 to understand the intersection between noncommunicable diseases (NCDs) and HIV in Southern Africa. Here, we describe the study design and population and evaluate their ideal cardiovascular health (ICVH) using the Life's Simple 7 (LS7) score according to the American Heart Association. PARTICIPANTS: Antiretroviral therapy-naïve people living with HIV (PLWH) and people living without HIV (PLWOH) 30 years or older were recruited from three primary care clinics in Lusaka and Harare, and underwent comprehensive clinical, laboratory and behavioural assessments. All study measurements are repeated during yearly follow-up visits. PLWOH were recruited from the same neighbourhoods and had similar socioeconomic conditions as PLWH. FINDINGS TO DATE: Between August 2019 and March 2023, we included 1100 adults, of whom 618 (56%) were females and 539 (49%) were PLWH. The median age at enrolment was 39 years (IQR 34-46 years). Among 1013 participants (92%) with complete data, the median LS7 score was 11/14 (IQR 10-12). Overall, 60% of participants met the criteria of ICVH metrics (5-7 ideal components) and among individual components of the LS7, more females had poor body mass index (BMI) than males, regardless of HIV status (27% vs 3%, p<0.001). Our data show no apparent difference in cardiovascular health determinants between men and women, but high BMI in women and overall high hypertension prevalence need detailed investigation. Untreated HIV (OR: 1.36 (IQR 1.05-1.78)) and being a Zambian participant (OR: 1.81 (IQR 1.31-2.51)) were associated with having ICVH metrics, whereas age older than 50 years (OR: 0.46 (IQR 0.32-0.65)) was associated with not having ICVH metrics. FUTURE PLANS: Our study will be regularly updated with upcoming analyses using prospective data including a focus on arterial hypertension and vascular function. We plan to enrich the work through conducting in-depth assessments on the determinants of cardiovascular, liver and kidney end-organ disease outcomes yearly. Additionally, we seek to pilot NCD interventions using novel methodologies like the trials within cohorts. Beyond the initial funding support, we aim to collect at minimum yearly data for an additional 5-year period.
Comparative effectiveness of in-person vs. remote delivery of the Common Elements Treatment Approach for addressing mental and behavioral health problems among adolescents and young adults in Zambia: protocol of a three-arm randomized controlled trial.
(2022-May-19) Figge, Caleb J.; Kane, Jeremy C.; Skavenski, Stephanie; Haroz, Emily; Mwenge, Mwamba; Mulemba, Saphira; Aldridge, Luke R.; Vinikoor, Michael J.; Sharma, Anjali; Inoue, Sachi; Paul, Ravi; Simenda, Francis; Metz, Kristina; Bolton-Moore, Carolyn; Kemp, Christopher; Bosomprah, Samuel; Sikazwe, Izukanji; Murray, Laura K.
BACKGROUND: In low- and middle-income countries (LMIC), there is a substantial gap in the treatment of mental and behavioral health problems, which is particularly detrimental to adolescents and young adults (AYA). The Common Elements Treatment Approach (CETA) is an evidence-based, flexible, transdiagnostic intervention delivered by lay counselors to address comorbid mental and behavioral health conditions, though its effectiveness has not yet been tested among AYA. This paper describes the protocol for a randomized controlled trial that will test the effectiveness of traditional in-person delivered CETA and a telehealth-adapted version of CETA (T-CETA) in reducing mental and behavioral health problems among AYA in Zambia. Non-inferiority of T-CETA will also be assessed. METHODS: This study is a hybrid type 1 three-arm randomized trial to be conducted in Lusaka, Zambia. Following an apprenticeship model, experienced non-professional counselors in Zambia will be trained as CETA trainers using a remote, technology-delivered training method. The new CETA trainers will subsequently facilitate technology-delivered trainings for a new cohort of counselors recruited from community-based partner organizations throughout Lusaka. AYA with mental and behavioral health problems seeking services at these same organizations will then be identified and randomized to (1) in-person CETA delivery, (2) telehealth-delivered CETA (T-CETA), or (3) treatment as usual (TAU). In the superiority design, CETA and T-CETA will be compared to TAU, and using a non-inferiority design, T-CETA will be compared to CETA, which is already evidence-based in other populations. At baseline, post-treatment (approximately 3-4 months post-baseline), and 6 months post-treatment (approximately 9 months post-baseline), we will assess the primary outcomes such as client trauma symptoms, internalizing symptoms, and externalizing behaviors and secondary outcomes such as client substance use, aggression, violence, and health utility. CETA trainer and counselor competency and cost-effectiveness will also be measured as secondary outcomes. Mixed methods interviews will be conducted with trainers, counselors, and AYA participants to explore the feasibility, acceptability, and sustainability of technology-delivered training and T-CETA provision in the Zambian context. DISCUSSION: Adolescents and young adults in LMIC are a priority population for the treatment of mental and behavioral health problems. Technology-delivered approaches to training and intervention delivery can expand the reach of evidence-based interventions. If found effective, CETA and T-CETA would help address a major barrier to the scale-up and sustainability of mental and behavioral treatments among AYA in LMIC. TRIAL REGISTRATION: ClinicalTrials.gov NCT03458039 . Prospectively registered on May 10, 2021.
Comparative outcomes of tenofovir-based and zidovudine-based antiretroviral therapy regimens in Lusaka, Zambia.
(2011-Dec-15) Chi, Benjamin H.; Mwango, Albert; Giganti, Mark J.; Sikazwe, Izukanji ; Moyo, Crispin; Schuttner, Linnaea; Mulenga, Lloyd B.; Bolton-Moore, Carolyn; Chintu, Namwinga T.; Sheneberger, Robert; Stringer, Elizabeth M.; Stringer, Jeffrey S.
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.
Comparison of patient exit interviews with unannounced standardised patients for assessing HIV service delivery in Zambia: a study nested within a cluster randomised trial.
(2023-Jul-05) Sikombe, Kombatende ; Pry, Jake M.; Mody, Aaloke; Rice, Brian; Bukankala, Chama; Eshun-Wilson, Ingrid; Mutale, Jacob; Simbeza, Sandra; Beres, Laura K.; Mukamba, Njekwa; Mukumbwa-Mwenechanya, Mpande ; Mwamba, Daniel; Sharma, Anjali; Wringe, Alison ; Hargreaves, James; Bolton-Moore, Carolyn; Holmes, Charles; Sikazwe, Izukanji; Geng, Elvin
OBJECTIVES: To compare unannounced standardised patient approach (eg, mystery clients) with typical exit interviews for assessing patient experiences in HIV care (eg, unfriendly providers, long waiting times). We hypothesise standardised patients would report more negative experiences than typical exit interviews affected by social desirability bias. SETTING: Cross-sectional surveys in 16 government-operated HIV primary care clinics in Lusaka, Zambia providing antiretroviral therapy (ART). PARTICIPANTS: 3526 participants aged ≥18 years receiving ART participated in the exit surveys between August 2019 and November 2021. INTERVENTION: Systematic sample (every n OUTCOME MEASURES: We compared patient experience among patients who received brief training prior to their care visit (explaining each patient experience construct in the exit survey, being anonymous, without manipulating behaviour) with those who did not undergo training on the survey prior to their visit. RESULTS: Among 3526 participants who participated in exit surveys, 2415 were untrained (56% female, median age 40 (IQR: 32-47)) and 1111 were trained (50% female, median age 37 (IQR: 31-45)). Compared with untrained, trained patients were more likely to report a negative care experience overall (adjusted prevalence ratio (aPR) for aggregate sum score: 1.64 (95% CI: 1.39 to 1.94)), with a greater proportion reporting feeling unwelcome by providers (aPR: 1.71 (95% CI: 1.20 to 2.44)) and witnessing providers behaving rude (aPR: 2.28 (95% CI: 1.63 to 3.19)). CONCLUSION: Trained patients were more likely to identify suboptimal care. They may have understood the items solicited better or felt empowered to be more critical. We trained existing patients, unlike studies that use 'standardised patients' drawn from outside the patient population. This low-cost strategy could improve patient-centred service delivery elsewhere. TRIAL REGISTRATION NUMBER: Assessment was nested within a parent study; www.pactr.org registered the parent study (PACTR202101847907585).
Contraceptive use among HIV-infected women and men receiving antiretroviral therapy in Lusaka, Zambia: a cross-sectional survey.
(2016-May-12) Hancock, Nancy L.; Chibwesha, Carla J.; Bosomprah, Samuel; Newman, Jonathan; Mubiana-Mbewe, Mwangelwa ; Sitali, Elizabeth S.; Bolton-Moore, Carolyn; Mbwili-Muleya, Clara; Chi, Benjamin H.
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.
Cross-sectional study to assess depression among healthcare workers in Lusaka, Zambia during the COVID-19 pandemic.
(2023-Apr-05) Simbeza, Sandra; Mutale, Jacob; Mulabe, Musunge; Jere, Lazarus; Bukankala, Chama; Sikombe, Kombatende; Sikazwe, Izukanji; Bolton-Moore, Carolyn; Mody, Aaloke; Geng, Elvin H.; Sharma, Anjali; Beres, Laura K.; Pry, Jake M.
OBJECTIVES: We sought to assess depression among healthcare workers (HCWs) in the context of COVID-19 in Lusaka Province, Zambia. DESIGN: This cross-sectional study is nested within a larger study, the Person-Centred Public Health for HIV Treatment in Zambia (PCPH), a cluster-randomised trial to assess HIV care and outcomes. SETTING: The research was conducted in 24 government-run health facilities from 11 August to 15 October 2020 during the first wave of the COVID-19 pandemic in Lusaka, Zambia. PARTICIPANTS: We used convenience sampling to recruit HCW participants who were previously enrolled in the PCPH study, had more than 6 months' experience working at the facility and were voluntarily willing to participate. PRIMARY OUTCOME MEASURES: We implemented the well-validated 9-question Patient Health Questionnaire (PHQ-9) to assess HCW depression. We used mixed-effects, adjusted Poisson regression to estimate the marginal probability of HCWs experiencing depression that may warrant intervention (PHQ-9 score ≥5) by healthcare facility. RESULTS: We collected PHQ-9 survey responses from 713 professional and lay HCWs. Overall, 334 (46.8%, 95% CI 43.1%, 50.6%) HCWs recorded a PHQ-9 score ≥5, indicating the need for further assessment and potential intervention for depression. We identified significant heterogeneity across facilities and observed a greater proportion of HCWs with symptoms of depression in facilities providing COVID-19 testing and treatment services. CONCLUSIONS: Depression may be a concern for a large proportion of HCWs in Zambia. Further work to understand the magnitude and aetiologies of depression among HCWs in the public sector is needed to design effective prevention and treatment interventions to meet the needs for mental health support and to minimise poor health outcomes.
Differentiated Care Preferences of Stable Patients on Antiretroviral Therapy in Zambia: A Discrete Choice Experiment.
(2019-Aug-15) Eshun-Wilson, Ingrid; Mukumbwa-Mwenechanya, Mpande; Kim, Hae-Young; Zannolini, Arianna; Mwamba, Chanda P.; Dowdy, David; Kalunkumya, Estella; Lumpa, Mwansa; Beres, Laura K.; Roy, Monika; Sharma, Anjali; Topp, Stephanie M.; Glidden, Dave V.; Padian, Nancy; Ehrenkranz, Peter; Sikazwe, Izukanji; Holmes, Charles B.; Bolton-Moore, Carolyn; Geng, Elvin H.
BACKGROUND: Although differentiated service delivery (DSD) models for stable patients on antiretroviral therapy (ART) offer a range of health systems innovations, their comparative desirability to patients remains unknown. We conducted a discrete choice experiment to quantify service attributes most desired by patients to inform model prioritization. METHODS: Between July and December 2016, a sample of HIV-positive adults on ART at 12 clinics in Zambia were asked to choose between 2 hypothetical facilities that differed across 6 DSD attributes. We used mixed logit models to explore preferences, heterogeneity, and trade-offs. RESULTS: Of 486 respondents, 59% were female and 85% resided in urban locations. Patients strongly preferred infrequent clinic visits [3- vs. 1-month visits: β (ie, relative utility) = 2.84; P < 0.001]. Milder preferences were observed for waiting time for ART pick-up (1 vs. 6 hours.; β = -0.67; P < 0.001) or provider (1 vs. 3 hours.; β = -0.41; P = 0.002); "buddy" ART collection (β = 0.84; P < 0.001); and ART pick-up location (clinic vs. community: β = 0.35; P = 0.028). Urban patients demonstrated a preference for collecting ART at a clinic (β = 1.32, P < 0.001), and although most rural patients preferred community ART pick-up (β = -0.74, P = 0.049), 40% of rural patients still preferred facility ART collection. CONCLUSIONS: Stable patients on ART primarily want to attend clinic infrequently, supporting a focus in Zambia on optimizing multimonth prescribing over other DSD features-particularly in urban areas. Substantial preference heterogeneity highlights the need for DSD models to be flexible, and accommodate both setting features and patient choice in their design.
Does provider-initiated counselling and testing (PITC) strengthen early diagnosis and treatment initiation? Results from an analysis of an urban cohort of HIV-positive patients in Lusaka, Zambia.
(2012-Sep-24) Topp, Stephanie M.; Li, Michelle S.; Chipukuma, Julien M.; Chiko, Matimba M.; Matongo, Evelyn; Bolton-Moore, Carolyn; Reid, Stewart E.
INTRODUCTION: Building on earlier works demonstrating the effectiveness and acceptability of provider-initiated counselling and testing (PITC) services in integrated outpatient departments of urban primary healthcare clinics (PHCs), this study seeks to understand the relative utility of PITC services for identifying clients with early-stage HIV-related disease compared to traditional voluntary testing and counselling (VCT) services. We additionally seek to determine whether there are any significant differences in the clinical and demographic profile of PITC and VCT clients. METHODS: Routinely collected, de-identified data were collated from two cohorts of HIV-positive patients referred for HIV treatment, either from PITC or VCT in seven urban-integrated PHCs. Univariate and multivariate analyses were conducted to compare the two cohorts across demographic and clinical characteristics at enrolment. RESULTS: Forty-five per cent of clients diagnosed via PITC had CD4 < 200, and more than 70% (i.e. two thirds) had CD4 < 350 at enrollment, with significantly lower CD4 counts than that of VCT clients (p < 0.001). PITC clients were more likely to be male (p = 0.0005) and less likely to have secondary or tertiary education (p < 0.0001). Among those who were initiated on antiretroviral therapy (ART), PITC clients had lower odds of initiating treatment within four weeks of enrollment into HIV care (adjusted odds ratio, or AOR: 0.86; 95% confidence interval, or CI: 0.75-0.99; p = 0.035) and significantly lower odds of retention in care at six months (AOR: 0.84; CI: 0.77-0.99; p = 0.004). CONCLUSIONS: In Lusaka, Zambia, large numbers of individuals with late-stage HIV are being incidentally diagnosed in outpatient settings. Our findings suggest that PITC in this setting does not facilitate more timely diagnosis and referral to care but rather act as a "safety net" for individuals who are unwilling or unable to seek testing independently. Further work is needed to document the way provision of clinic-based services can be strengthened and linked to community-based interventions and to address socio-cultural norms and socio-economic status that underpin healthcare-seeking behaviour.
Drivers of uptake of HIV testing services, a snapshot of barriers and facilitators among adolescent boys and young men in Lusaka: a qualitative study.
(2023-Sep-11) Nyirenda, Herbert C.; Foloko, Marksman; Bolton-Moore, Carolyn; Vera, Jaime; Sharma, Anjali
BACKGROUND: Striking gender and rural-urban disparities highlight the need to redesign HIV services to improve HIV testing and linkage by adolescent boys and young men (ABYM) in sub-Saharan African cities. PURPOSE: We sought to understand drivers of HIV testing among ABYM living in urban Lusaka in order to design a targeted intervention that may increase their entry into the HIV prevention and treatment cascade. METHODS: In May and June 2019, two male moderators conducted three focus group discussions lasting 1.25 hours with seven to nine ABYM per group and six in-depth interviews with healthcare providers (HCPs) working with adolescents. ABYM were conveniently selected from first aid training, sports and youth-friendly sites in three settlement areas. We purposefully selected HCP from community, facility and district levels. Thematic analyses using inductive reasoning were applied. RESULTS: The 24 ABYM were 18-24 years old (median 21 years), single, from 11 different neighbourhoods and 79% had 9-12 years of education. Facilitators of HIV testing uptake included the importance ABYM placed on good health and planning their future in order to fulfil their masculine identity and societal roles. Barriers included peer norms, life-long treatment along with anticipated changes to sexual life and alcohol use, fear of results and judgement and disappointment among HCP. HCPs agreed that masculine roles ('many things to do') and arduous clinical processes deterred ABYM from accessing testing services. They suggested that ABYM were prone to depression which both caused and resulted from behavioural issues such as alcohol use and risk-taking, which prevented uptake of HIV testing services. Both parties agreed that ABYM needed services specifically designed for them and that offered convenient, private, swift and non-judgemental services. CONCLUSIONS: ABYM disillusioned by standard counselling procedures, systemic barriers and stigma, avoid HIV test and treat services. Innovative ways and youth-specific spaces are needed to increase access to non-judgemental services that facilitate entry into the HIV prevention and treatment cascade in this population.