Browsing by Author "Sikazwe, Izukanji"

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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.
Breaking barriers, changing paradigms: Africa's radical agenda for HIV sustainability.
(2025) Chola, Mumbi; Robalo, Magda; Buse, Kent; Oduro-Bonsrah, Pokuaa ; Ozoemene, Jekwu; Dieng, Abdoul; Akulu, Ruth; Madzima, Bernard; Coll-Seck, Awa M.; Sheneberger, Robb; Nene, Sesupo M. ; Sikazwe, Izukanji ; Sidibe, Michel
Despite significant progress in the HIV response, the sustainability of this journey is threatened by over-reliance on external support and imported and often inappropriate models. The recent sudden shifts in the United States Government's foreign aid policy have heightened the urgency for independence. Africa is at a critical point, which presents an opportunity to move from dependency on external assistance to establishing itself as a self-sustaining center of innovation and sustainable growth. Africa must reshape its approach to the HIV response by addressing the continent's over-reliance on external funding and shift towards self-sustainability and inclusiveness. For Africa to sustain its HIV response, it is critical to have African voices and leadership in the HIV response, adopt African-centric approaches in moving from silos to the integration of programme governance, ensure renewed governance and accountability frameworks, Africanizing research and development and also ensure African medicines security and sovereignty. Africa must leverage Ubuntu approaches to empowering communities, women, youth, and key and vulnerable populations, and work with community networks for service delivery. There must also be sustained HIV Programmes in Fragile and Post-conflict Settings. It is also critical to secure domestic financing through a continental approach to financing health and well-being. For Africa to realize the vision of a sustainable, African-led, and owned HIV response and health agenda, collective action is imperative. African stakeholders must fully support this agenda and claim it as their own in the spirit of Ubuntu, within the context of continental plans for transformation and revitalization. Together, we can realize the vision of the "Africa we want."
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).
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.
Effect of a person-centered care intervention on return and sustained reengagement after treatment interruptions from HIV care in Zambia: A post-hoc analysis of a stepped-wedged cluster randomized trial.
(2026-Sep) Mody, Aaloke; Sikombe, Kombatende; Simbeza, Sandra ; Mukamba, Njekwa ; Beres, Laura K.; Pry, Jake M.; Sharma, Anjali; Mutale, Jacob; Dube, Alida Z.; Mulabe, Musunge; Mulenga, Lloyd ; Sivile, Suilanji; Ratliff, April; Goss, Charles W.; Holmes, Charles B.; Bolton-Moore, Carolyn ; Sikazwe, Izukanji; Geng, Elvin H.
BACKGROUND: Poor client-provider interactions lead to reinforcing cycles of treatment interruptions (TIs) from HIV care and fear of return, undermining sustained retention. We previously demonstrated a multi-component person-centered care intervention (PCC) targeting healthcare worker (HCW) behavior improved client experience and retention in HIV care. To understand mechanisms of improved retention, we evaluated the effect of the PCC intervention on return after TIs and sustained retention after return in a post-hoc analysis, hypothesizing that friendlier HCW attitudes enable successful reengagement into care. METHODS AND FINDINGS: We implemented the PCC intervention at 24 clinics in Zambia in a stepped-wedge, cluster randomized trial from Aug 2019 to Nov 2021. Clinics were allocated into 4 groups (8 clinics in Groups 1 and 4, and 4 each in Groups 2 and 3) and randomly assigned to crossover from control to intervention every 6 months. Under control, clinics provided routine HIV care without additional support. Afterwards, clinics received the PCC intervention targeting caring aspects of HCW behavior with 1) training and coaching on PCC practices, 2) measurement and feedback of client experience (via exit interviews), and 3) small facility-level incentives. We examined individuals living with HIV who became >30 days late to a scheduled visit (i.e., TI), categorizing intervention exposure based on the last visit prior to TI. We used electronic health records to assess the effect of the PCC intervention on 1) return to HIV care after a TI, and 2) repeat TIs among those who returned. We used multistate analytic methods to estimate crude incidence of return and repeat TIs and prevalence of being in care at 1-year. We used shared frailty Cox proportional hazards and mixed-effects Poisson models to obtain formal comparisons that accounted for the stepped-wedge design. Individuals were censored at intervention crossover or database closure. During the study period, 128,910 clients (n = 69,671 control, n = 59,239 intervention) became >30 days late (64.3% female, median age 38y [IQR 31,45], median years in care 2.5y [IQR 0.6,6.7]). The PCC intervention increased incidence of return after TI at 12-months (72.3% intervention versus 67.7% control, crude risk difference [RD] +4.6% [CI 4.1,5.2], adjusted hazard ratio [aHR] 1.16 [CI 1.12,1.20]; p < 0.001). Among returners, the intervention decreased incidence of repeat TIs (44.3% versus 55.6%, RD -11.4% [CI -12.2,-10.6], aHR 0.50 [CI 0.45,0.55]; p < 0.001) and increased the proportion in care (with or without repeat TIs) (82.7% versus 73.4%, RD +9.3% [CI 8.6,10.0], adjusted risk ratio [aRR] 1.14 [CI 1.05,1.25]; p = 0.002) at 12-months after return. Overall, the PCC intervention increased the proportion in care 12-months after a TI from 51.5% to 60.1% (RD +8.7% [CI 8.0,9.3], aRR 1.19 [CI 1.05,1.35]; p = 0.008). Effect sizes were similar in direction and magnitude in multiple sensitivity analyses with varying precision. Limitations included post-hoc analysis and those associated with stepped-wedge design. CONCLUSIONS: The PCC intervention likely improved rates of return to care after TIs, sustained reengagement after return, and overall retention among individuals with TIs. Strategies targeting caring aspects of HCW behavior and client experience may help lower barriers to and address persistent challenges with reengagement in care.
Estimated mortality on HIV treatment among active patients and patients lost to follow-up in 4 provinces of Zambia: Findings from a multistage sampling-based survey.
(2018-Jan) Holmes, Charles B.; Sikazwe, Izukanji; Sikombe, Kombatende; Eshun-Wilson, Ingrid; Czaicki, Nancy; Beres, Laura K.; Mukamba, Njekwa; Simbeza, Sandra; Bolton-Moore, Carolyn; Hantuba, Cardinal; Mwaba, Peter; Phiri, Caroline; Padian, Nancy; Glidden, David V.; Geng, Elvin
BACKGROUND: Survival represents the single most important indicator of successful HIV treatment. Routine monitoring fails to capture most deaths. As a result, both regional assessments of the impact of HIV services and identification of hotspots for improvement efforts are limited. We sought to assess true mortality on treatment, characterize the extent under-reporting of mortality in routine health information systems in Zambia, and identify drivers of mortality across sites and over time using a multistage, regionally representative sampling approach. METHODS AND FINDINGS: We enumerated all HIV infected adults on antiretroviral therapy (ART) who visited any one of 64 facilities across 4 provinces in Zambia during the 24-month period from 1 August 2013 to 31 July 2015. We identified a probability sample of patients who were lost to follow-up through selecting facilities probability proportional to size and then a simple random sample of lost patients. Outcomes among patients lost to follow-up were incorporated into survival analysis and multivariate regression through probability weights. Of 165,464 individuals (64% female, median age 39 years (IQR 33-46), median CD4 201 cells/mm3 (IQR 111-312), the 2-year cumulative incidence of mortality increased from 1.9% (95% CI 1.7%-2.0%) to a corrected rate of 7.0% (95% CI 5.7%-8.4%) (all ART users) and from 2.1% (95% CI 1.8%-2.4%) to 8.3% (95% CI 6.1%-10.7%) (new ART users). Revised provincial mortality rates ranged from 3-9 times higher than naïve rates for new ART users and were lowest in Lusaka Province (4.6 per 100 person-years) and highest in Western Province (8.7 per 100 person-years) after correction. Corrected mortality rates varied markedly by clinic, with an IQR of 3.5 to 7.5 deaths per 100 person-years and a high of 13.4 deaths per 100 person-years among new ART users, even after adjustment for clinical (e.g., pretherapy CD4) and contextual (e.g., province and clinic size) factors. Mortality rates (all ART users) were highest year 1 after treatment at 4.6/100 person-years (95% CI 3.9-5.5), 2.9/100 person-years (95% CI 2.1-3.9) in year 2, and approximately 1.6% per year through 8 years on treatment. In multivariate analysis, patient-level factors including male sex and pretherapy CD4 levels and WHO stage were associated with higher mortality among new ART users, while male sex and HIV disclosure were associated with mortality among all ART users. In both cases, being late (>14 days late for appointment) or lost (>90 days late for an appointment) was associated with deaths. We were unable to ascertain the vital status of about one-quarter of those lost and selected for tracing and did not adjudicate causes of death. CONCLUSIONS: HIV treatment in Zambia is not optimally effective. The high and sustained mortality rates and marked under-reporting of mortality at the provincial-level and unexplained heterogeneity between regions and sites suggest opportunities for the use of corrected mortality rates for quality improvement. A regionally representative sampling-based approach can bring gaps and opportunities for programs into clear epidemiological focus for local and global decision makers.
Experiences of Justice-Involved People Transitioning to HIV Care in the Community After Prison Release in Lusaka, Zambia: A Qualitative Study.
(2023-Apr-28) Smith, Helene J.; Herce, Michael E.; Mwila, Chilambwe; Chisenga, Peter; Yenga, Chisenga; Chibwe, Besa; Mai, Vivien; Kashela, Lillian; Nanyagwe, Mirriam; Hatwiinda, Sisa; Moonga, Clement N.; Musheke, Maurice; Lungu, Yotam; Sikazwe, Izukanji; Topp, Stephanie M.
INTRODUCTION: In sub-Saharan Africa (SSA), incarcerated people experience a higher HIV burden than the general population. While access to HIV care and treatment for incarcerated people living with HIV (PLHIV) in SSA has improved in some cases, little is known about their transition to and post-release experience with care in the community. To address this gap, we conducted a qualitative study to describe factors that may influence post-release HIV care continuity in Zambia. METHODS: In March-December 2018, we recruited study participants from a larger prospective cohort study following incarcerated and newly released PLHIV at 5 correctional facilities in 2 provinces in Zambia. We interviewed 50 participants immediately before release; 27 (54%) participated in a second interview approximately 6 months post-release. Demographic and psychosocial data were collected through a structured survey. RESULTS: The pre-release setting was strongly influenced by the highly structured prison environment and assumptions about life post-release. Participants reported accessible HIV services, a destigmatizing environment, and strong informal social supports built through comradery among people facing the same trying detention conditions. Contrary to their pre-release expectations, during the immediate post-release period, participants struggled to negotiate the health system while dealing with unexpected stressors. Long-term engagement in HIV care was possible for participants with strong family support and a high level of self-efficacy. CONCLUSION: Our study highlights that recently released PLHIV in Zambia face acute challenges in meeting their basic subsistence needs, as well as social isolation, which can derail linkage to and retention in community HIV care. Releasees are unprepared to face these challenges due to a lack of community support services. To improve HIV care continuity in this population, new transitional care models are needed that develop client self-efficacy, facilitate health system navigation, and pragmatically address structural and psychosocial barriers like poverty, gender inequality, and substance use.
HIV care experiences and health priorities during the first wave of COVID-19: clients' perspectives - a qualitative study in Lusaka, Zambia.
(2022-Nov-30) Mukamba, Njekwa; Sharma, Anjali; Mwamba, Chanda; Nyirenda, Herbert; Foloko, Marksman; Lumbo, Kasapo; Christopoulos, Katerina; Simbeza, Sandra; Sikombe, Kombatende; Holmes, Charles B.; Geng, Elvin H.; Sikazwe, Izukanji; Bolton-Moore, Carolyn; Beres, Laura K.
BACKGROUND: The novel COVID-19 pandemic threatened to disrupt access to human immunodeficiency (HIV) treatment for persons living with HIV (PLHIV), two-thirds of whom live in sub-Saharan Africa. To inform a health system response supportive of continuity of care, we sought to understand clients' HIV care experiences and health priorities during the first wave of COVID-19 outbreak in Lusaka, Zambia. METHODS: Leveraging a study cohort of those who completed periodic SMS surveys on HIV care, we purposefully sampled 25 PLHIV after first confirmed COVID-19 case was reported in Zambia on 18 RESULTS: All participants were aware of COVID-19, and HIV care experiences and health priorities of clients were affected by associated changes at health system, household, and individual level. The health system instituted early clinic visits to provide 6-months of antiretroviral therapy (ART) for stable patients and 3-months for unstable patients to reduce clinic visits and wait times. Most patients welcomed this long-desired extended appointment spacing. Some reported feeling respected and engaged when health care workers telephoned requesting their early clinic visit. However, others felt discouraged by an absence of physical distancing during their clinic visit due to 'severe acute respiratory syndrome coronavirus 2' (SARS-CoV-2) infection concerns. Several expressed a lack of clarity regarding next viral load monitoring date and means for receiving results. Patients suggested regular patient-facility communication by telephone and SMS. Patients emphasized that COVID-19 restrictions led to loss of employment and household income, exacerbating poverty and difficulties in taking ART. At individual level, most participants felt motivated to stay healthy during COVID-19 by ART adherence and regular laboratory monitoring. CONCLUSIONS: Clients' HIV care and health priorities during the first wave of COVID-19 in Lusaka province were varied with a combination of positive and negative experiences that occurred especially at health system and individual levels, while at household level, the experiences were all negative. More research is needed to understand how patients practice resiliency in the widespread context of socio-economic instability. Governments and patients must work together to find local, health systems solutions to support ART adherence and monitoring. Additionally, the health system should consider how to build on changes for long-term HIV management and service delivery.
How might improved estimates of HIV programme outcomes influence practice? A formative study of evidence, dissemination and response.
(2020-Oct-16) Mukamba, Njekwa; Beres, Laura K.; Mwamba, Chanda; Law, Jeanna W.; Topp, Stephanie M.; Simbeza, Sandra; Sikombe, Kombatende; Padian, Nancy; Holmes, Charles B.; Geng, Elvin H.; Sikazwe, Izukanji
BACKGROUND: While HIV programmes have started millions of persons on life-saving antiretroviral therapy in Africa, longitudinal health information systems are frail and, therefore, data about long-term survival is often inaccurate or unknown to HIV programmes. The 'Better Information for Health in Zambia' (BetterInfo) Study - a regional sampling-based survey to assess retention and mortality in HIV programmes in Zambia - found both retention and mortality to be higher than prevailing estimates from national surveillance systems. We sought to understand how Zambian health decision-makers at different health system levels would respond to these new data, with a view to informing research translation. METHODS: We interviewed 25 purposefully sampled health decision-makers from community, facility, district, provincial and national levels. During the interviews, we shared retention and mortality estimates from both routine programme surveillance and those generated by the study. Transcripts were analysed for inductive and deductive themes, the latter drawing on Weiss's framework that policy-makers interpret and apply evidence as 'warning', 'guidance', 'reconceptualisation' or 'mobilisation of support'. FINDINGS: All decision-makers found study findings relevant and important. Decision-makers viewed the underestimates of mortality to be a warning about the veracity and informativeness of routine data systems. Decision-makers felt guided by the findings to improve data monitoring and, acknowledging limitations of routine data, utilised episodic patient tracing to support improved data accuracy. Findings catalysed renewed motivation and mobilisation by national level decision-makers for differentiated models of HIV care to improve patient outcomes and also improved data management systems to better capture patient outcomes. Inductive analysis highlighted a programmatic application data interpretation, in which study findings can influence facility and patient-level decision-making, quality of care and routine data management. CONCLUSIONS: New epidemiological data on patient outcomes were widely seen as informative and relevant and can potentially catalyse health system action such as using evaluations to supplement electronic medical record data to improve HIV programmes. Formative evidence suggests that targeting research dissemination at different levels of the health system will elicit different responses. Researchers supporting the translation of evidence to action should leverage all relevant levels of the health system to facilitate both policy and programmatic action.
Identifying care gaps along the HIV treatment failure cascade: A multistate analysis of viral load monitoring, re-suppression, and regimen switches in Zambia.
(2025-Sep) Sikombe, Kombatende; Le Tourneau, Noelle; Rice, Brian; Pry, Jake M.; Simbeza, Sandra; Beres, Laura K.; Sharma, Anjali; Mukamba, Njekwa; Wringe, Alison; Hargreaves, James R.; Mutale, Jacob; Bolton-Moore, Carolyn ; Sikazwe, Izukanji; Geng, Elvin; Mody, Aaloke
BACKGROUND: Timely response to treatment failure is critical for improved outcomes and viral re-suppression among people living with HIV, but care gaps along the treatment failure cascade can occur due to delays by both clients (e.g., retention and adherence) and health systems (e.g., fidelity to viral load [VL] monitoring guidelines). We used multistate analysis to identify drivers of implementation gaps in the treatment failure cascade, including time to HIV VL monitoring, re-suppression, and regimen switches, in Zambia. METHODS AND FINDINGS: We used national electronic HIV health records to identify adults on antiretroviral therapy (ART) for more than 6 months who experienced treatment failure (VL ≥ 1,000 copies/ml) at 24 clinics in Lusaka, Zambia, between August 2019 and November 2021. Using multistate analyses, we examined how care evolved after treatment failure, accounting for transitions across the treatment failure cascade over time, such as return visits, repeat VL testing, treatment interruptions (>60 days late for visit), and viral re-suppression. Analyses were stratified by ART regimen at cohort entry: tenofovir disoproxil fumarate/lamivudine or emtricitabine/dolutegravir TDF/XTC/DTG (TLD) and tenofovir disoproxil fumarate/lamivudine or emtricitabine/efavirenz TDF/XTC/EFV (TLE). We repeated analyses to assess switch to second-line therapy among those with consecutively unsuppressed VL test results who were due for regimen switch. Among 179,855 individuals on ART (143,857 with documented VL), 7,916 (4.4%) had a documented elevated VL and drug regimen at the time of treatment failure (52.3% female, median age was 36.7 years (IQR 29.9-43.6), median time on ART 3.3 years (IQR 1.7-6.6), 54.6% on TLD and 45.4% on TLE). Among those with treatment failure, 72.2% (CI 71.3, 73.0%) had returned to clinic 6 months after initial elevated VL was drawn. After one year, 70.1% (CI 69.3, 70.9%) had a repeat VL, 16.6% (CI 15.9, 17.2%) experienced treatment interruption, and 11.4% (CI 10.3, 12.4%) returned to care without repeat VL testing. Among those with a repeat VL, 85.0% (CI 83.9, 86.1%) on TLD and 58.2% (CI 56.8, 59.8%) on TLE had resuppressed. Among those due for second-line switch, 27.9% (CI 24.1, 31.5%) on TLD and 66.6% (CI 64.5, 68.9%) on TLE had changed regimens after one year while 52.4% on TLD had a third VL repeated prior to switch (CI 47.2, 57.4%) (68.0% CI 61.6, 75.2% suppressed of those with repeated VL) compared to 32.1% (CI 29.9, 34.1%) (40.7% CI 36.1, 45.4% suppressed) on TLE. This study was limited by the inability to capture all aspects of care delivery related to treatment failure, such as outreach, enhanced adherence counseling confirmation, and provider rationale for delayed VL rechecking. CONCLUSION: After treatment failure, we identified substantial delays in returning for adherence counseling, treatment interruptions, and missed opportunities in rechecking VL status or switching to second-line therapy in routine care in Zambia. Among those who did have VL tests rechecked, re-suppression rates were significantly higher among individuals on TLD compared to TLE. To optimize response and outcomes after treatment failure, strategies must prioritize and target both client and health systems behaviors to meet the care needs in the modern era of TLD.
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.
Mitigating the effects of COVID-19 on HIV treatment and care in Lusaka, Zambia: a before-after cohort study using mixed effects regression.
(2022-Jan) Pry, Jake M.; Sikombe, Kombatende; Mody, Aaloke; Iyer, Shilpa; Mutale, Jacob; Vlahakis, Natalie; Savory, Theodora; Wa Mwanza, Mwanza; Mweebo, Keith; Mwila, Annie; Mwale, Consity; Mukumbwa-Mwenechanya, Mpande; Kerkhoff, Andrew D.; Sikazwe, Izukanji; Bolton-Moore, Carolyn; Mwamba, Daniel; Geng, Elvin H.; Herce, Michael E.
INTRODUCTION: The Zambian Ministry of Health (MoH) issued COVID-19 mitigation guidance for HIV care immediately after the first COVID-19 case was confirmed in Zambia on 18 March 2020. The Centre for Infectious Disease Research in Zambia implemented MoH guidance by: 1) extending antiretroviral therapy (ART) refill duration to 6 multi-month dispensation (6MMD) and 2) task-shifting communication and mobilisation of those in HIV care to collect their next ART refill early. We assessed the impact of COVID-19 mitigation guidance on HIV care 3 months before and after guidance implementation. METHODS: We reviewed all ART pharmacy visit data in the national HIV medical record for PLHIV in care having ≥1 visit between 1 January-30 June 2020 at 59 HIV care facilities in Lusaka Province, Zambia. We undertook a before-after evaluation using mixed-effects Poisson regression to examine predictors and marginal probability of early clinic return (pharmacy visit >7 days before next appointment), proportion of late visit (>7 days late for next appointment) and probability of receiving a 6MMD ART refill. RESULTS: A total of 101 371 individuals (64% female, median age 39) with 130 486 pharmacy visits were included in the analysis. We observed a significant increase in the adjusted prevalence ratio (4.63; 95% CI 4.45 to 4.82) of early return before compared with after guidance implementation. Receipt of 6MMD increased from a weekly mean of 47.9% (95% CI 46.6% to 49.2%) before to 73.4% (95% CI 72.0% to 74.9%) after guidance implementation. The proportion of late visits (8-89 days late) was significantly higher before (18.8%, 95% CI17.2%to20.2%) compared with after (15.1%, 95% CI13.8%to16.4%) guidance implementation . CONCLUSIONS: Timely issuance and implementation of COVID-19 mitigation guidance involving task-shifted patient communication and mobilisation alongside 6MMD significantly increased early return to ART clinic, potentially reducing interruptions in HIV care during a global public health emergency.
Mortality & recurrent seizure risk after new-onset seizure in HIV-positive Zambian adults.
(2018-Dec-07) Elafros, Melissa A.; Johnson, Brent A.; Siddiqi, Omar K.; Okulicz, Jason F.; Sikazwe, Izukanji; Bositis, Christopher M.; Potchen, Michael J.; Koralnik, Igor J.; Theodore, William H.; Kalungwana, Lisa; Birbeck, Gretchen L.
BACKGROUND: Recurrent seizure risks in HIV-positive people with new-onset seizure are largely unknown, making it challenging to offer optimal recommendations regarding antiepileptic drug (AED) initiation. Existing outcomes data is limited, and risk factor identification requires a diagnostic assessment, which is often unavailable in regions heavily effected by HIV, like sub-Saharan Africa. METHODS: HIV-positive Zambian adults with new-onset seizure were enrolled in a prospective cohort study to determine seizure recurrence and risk factors for recurrence. Seizure etiology was evaluated, and recurrent seizures and medication usage were assessed during clinic visits. Due to unexpectedly high mortality rates, predictors of death were evaluated using proportional hazards with Gray's test to compare cumulative incidence functions for recurrent seizure across groups adjusting for the competing outcome of death. RESULTS: 95 patients were enrolled (mean age 37 years, 43% female, 83% with Karnofsky > 50) and followed for a mean of 293 days (median 241 (IQR: 29-532)). At presentation, 50 (53%) were in status epilepticus. The majority (91, 85%) had advanced HIV disease and 65 (68%) were not on combined antiretroviral therapy (cART). After extensive workup, seizure etiology remained unknown in 16 (17%). Average time to cART initiation after enrollment was 61 days. During follow up, 37 (39%) died and 23 (24%) had recurrent seizure. Most deaths (25/37, 68%) occurred in the first 60 days post-index seizure. Individuals with advanced HIV were more likely to die (HR: 19.1 [95% CI: 1.1-333.4]) as were those whose seizure etiology remained unknown (HR: 2.2 [95% CI: 1.1-4.4]). Among participants that survived from enrolment to the end of data collection on 10 May 2013 (n = 58), 20 (34%) experienced recurrent seizures. CONCLUSIONS: New-onset seizure among HIV-positive Zambian adults is associated with high mortality despite good functional status prior to presentation. Advanced HIV infection and failure to identify an underlying seizure etiology are associated with greater mortality. Recurrent seizures occur in over a third of survivors within only 2 years of follow-up. This provides evidence to support AED initiation after first seizure in HIV-positive individuals with advanced HIV disease at the time of presentation though the risks of AED-cART interactions remain a concern and warrant further study.
Operational characteristics of antiretroviral therapy clinics in Zambia: a time and motion analysis.
(2019-Apr-24) Tampi, Radhika P.; Tembo, Taniya; Mukumba-Mwenechanya, Mpande; Sharma, Anjali; Dowdy, David W.; Holmes, Charles B.; Bolton-Moore, Carolyn; Sikazwe, Izukanji; Tucker, Austin; Sohn, Hojoon
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.
Patients' Satisfaction with HIV Care Providers in Public Health Facilities in Lusaka: A Study of Patients who were Lost-to-Follow-Up from HIV Care and Treatment.
(2020-Apr) Mukamba, Njekwa; Chilyabanyama, Obvious N.; Beres, Laura K.; Simbeza, Sandra; Sikombe, Kombatende; Padian, Nancy; Holmes, Charles; Sikazwe, Izukanji; Geng, Elvin; Schwartz, Sheree R.
Prognosis among those who are HIV infected has improved but long-term retention is challenging. Health systems may benefit from routinely measuring patient satisfaction which is a potential driver of engagement in HIV care, but it is not often measured in Africa, and Zambia in particular. This study aims to internally validate a patient satisfaction tool, assess satisfaction among patients previously lost-to-follow up (LTFU) from HIV care in Lusaka province and to measure association between patient satisfaction with their original clinic and re-engagement in HIV care. A cross-sectional assessment of satisfaction was conducted by tracing sampled patients drawn from public health facilities. Our findings suggest that satisfaction tool, previously validated in USA, exhibits high internal consistency for measuring patient satisfaction in the Zambian health system. Patient satisfaction with healthcare providers is associated with re-engagement in HIV care. Future interventions on patient-centred care are likely to optimize and support retention in care.
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.
Retention and viral suppression in a cohort of HIV patients on antiretroviral therapy in Zambia: Regionally representative estimates using a multistage-sampling-based approach.
(2019-May) Sikazwe, Izukanji; Eshun-Wilson, Ingrid; Sikombe, Kombatende; Czaicki, Nancy; Somwe, Paul; Mody, Aaloke; Simbeza, Sandra; Glidden, David V.; Chizema, Elizabeth; Mulenga, Lloyd B.; Padian, Nancy; Duncombe, Chris J.; Bolton-Moore, Carolyn; Beres, Laura K.; Holmes, Charles B.; Geng, Elvin
BACKGROUND: Although the success of HIV treatment programs depends on retention and viral suppression, routine program monitoring of these outcomes may be incomplete. We used data from the national electronic medical record (EMR) system in Zambia to enumerate a large and regionally representative cohort of patients on treatment. We traced a random sample with unknown outcomes (lost to follow-up) to document true care status and HIV RNA levels. METHODS AND FINDINGS: On 31 July 2015, we selected facilities from 4 provinces in 12 joint strata defined by facility type and province with probability proportional to size. In each facility, we enumerated adults with at least 1 clinical encounter after treatment initiation in the previous 24 months. From this cohort, we identified lost-to-follow-up patients (defined as 90 or more days late for their last appointment), selected a random sample, and intensively reviewed their records and traced them via phone calls and in-person visits in the community. In 1 of 4 provinces, we also collected dried blood spots (DBSs) for plasma HIV RNA testing. We used inverse probability weights to incorporate sampling outcomes into Aalen-Johansen and Cox proportional hazards regression to estimate retention and viremia. We used a bias analysis approach to correct for the known inaccuracy of plasma HIV RNA levels obtained from DBSs. From a total of 64 facilities with 165,464 adults on ART, we selected 32 facilities with 104,966 patients, of whom 17,602 (17%) were lost to follow-up: Those lost to follow-up had median age 36 years, 60% were female (N = 11,241), they had median enrollment CD4 count of 220 cells/μl, and 38% had WHO stage 1 clinical disease (N = 10,690). We traced 2,892 (16%) and found updated outcomes for 2,163 (75%): 412 (19%) had died, 836 (39%) were alive and in care at their original clinic, 457 (21%) had transferred to a new clinic, 255 (12%) were alive and out of care, and 203 (9%) were alive but we were unable to determine care status. Estimates using data from the EMR only suggested that 42.7% (95% CI 38.0%-47.1%) of new ART starters and 72.3% (95% CI 71.8%-73.0%) of all ART users were retained at 2 years. After incorporating updated data through tracing, we found that 77.3% (95% CI 70.5%-84.0%) of new initiates and 91.2% (95% CI 90.5%-91.8%) of all ART users were retained (at original clinic or transferred), indicating that routine program data underestimated retention in care markedly. In Lusaka Province, HIV RNA levels greater than or equal to 1,000 copies/ml were present in 18.1% (95% CI 14.0%-22.3%) of patients in care, 71.3% (95% CI 58.2%-84.4%) of lost patients, and 24.7% (95% CI 21.0%-29.3%). The main study limitations were imperfect response rates and the use of self-reported care status. CONCLUSIONS: In this region of Zambia, routine program data underestimated retention, and the point prevalence of unsuppressed HIV RNA was high when lost patients were accounted for. Viremia was prevalent among patients who unofficially transferred: Sustained engagement remains a challenge among HIV patients in Zambia, and targeted sampling is an effective strategy to identify such gaps in the care cascade and monitor programmatic progress.
The revolving door of HIV care: Revising the service delivery cascade to achieve the UNAIDS 95-95-95 goals.
(2021-May) Ehrenkranz, Peter; Rosen, Sydney; Boulle, Andrew; Eaton, Jeffrey W.; Ford, Nathan; Fox, Matthew P.; Grimsrud, Anna; Rice, Brian D.; Sikazwe, Izukanji; Holmes, Charles B.
Peter Ehrenkranz and co-authors present a cyclical cascade of care for people with HIV infection, aiming to facilitate assessment of outcomes.
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, Elizabeth; Tembo, Tannia; Fwoloshi, Sombo; Kabamba, Bupe ; Chilambe, Felix; Kalenga, Kalubi; Siwingwa, Mpanji; Mulube, Conceptor; Seffren, Victoria; Bolton-Moore, Carolyn; Simwanza, John; Yingst, Samuel; Yadav, Ruchi ; Rogier, Eric; Auld, Andrew F.; Agolory, Simon; Kapina, Muzala; Gutman, Julie R.; Savory, Theodora; Kangale, Chabu; Mulenga, Lloyd B.; Sikazwe, Izukanji ; Hines, Jonas Z.
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.
Understanding Engagement in HIV Programmes: How Health Services Can Adapt to Ensure No One Is Left Behind.
(2020-Oct) Grimsrud, Anna; Wilkinson, Lynne; Eshun-Wilson, Ingrid; Holmes, Charles; Sikazwe, Izukanji; Katz, Ingrid T.
PURPOSE OF REVIEW: Despite the significant progress in the HIV response, gaps remain in ensuring engagement in care to support life-long medication adherence and viral suppression. This review sought to describe the different points in the HIV care cascade where people living with HIV were not engaging and highlight promising interventions. RECENT FINDINGS: There are opportunities to improve engagement both between testing and treatment and to support re-engagement in care for those in a treatment interruption. The gap between testing and treatment includes people who know their HIV status and people who do not know their status. People in a treatment interruption include those who interrupt immediately following initiation, early on in their treatment (first 6 months) and late (after 6 months or more on ART). For each of these groups, specific interventions are required to support improved engagement. There are diverse needs and specific populations of people living with HIV who are not engaged in care, and differentiated service delivery interventions are required to meet their needs and expectations. For the HIV response to realise the 2030 targets, engagement will need to be supported by quality care and patient choice combined with empowered patients who are treatment literate and have been supported to improve self-management.