Implementing quality management strategies improves clinical quality as a voluntary medical male circumcision program in Namibia matures: a process analysis.

BACKGROUND: Surgical voluntary medical male circumcision (VMMC) is a safe procedure; however, maintaining quality standards at scale, particularly during scale-up, is a challenge making ongoing quality management (QM) efforts essential. This study describes program quality measured by rates of adverse events (AEs) over four years of VMMC implementation in Namibia, compares AE rates over time, and discusses QM processes that contextualize AE trends and illustrate improvements in quality as the program matured. The International Training and Education Center for Health (I-TECH) assisted the Namibian Ministry of Health and Social Services (MoHSS) in expanding VMMC in three regions among boys and men over 10 years of age between January 2015 and September 2019. METHODS: A comprehensive package of QM strategies was implemented by multi-disciplinary onsite teams with support from national and international technical advisors. Retrospective routine MoHSS data from the VMMC register, client forms, and monthly AE reports were collected during implementation in the three regions to assess the impact of QM interventions on AEs and to calculate the proportion of clients who experienced AEs over time. The proportion of clients who experienced an AE over time was compared using a Cochran-Armitage test for trend. RESULTS: Between January 2015 and September 2019, 40,336 clients underwent VMMC and 593 (1.5%) clients experienced a post-operative AE in the three supported regions. The AE rate was highest in the first quarter of clinical service delivery in each region (January-March 2015 in Oshana and Zambezi, October-December 2017 in //Kharas) but declined over the implementation period as the program matured. This observed trend between program maturity and declining AE rates over time was significant (p < 0.001) when compared using a Cochran-Armitage test for trend. CONCLUSIONS: As the I-TECH-supported VMMC program matured, QM measures were introduced and routinized, and clinical quality improved over time with the rate of AEs decreasing significantly over the implementation period. Applying systematic and continuous QM processes and approaches across the continuum of VMMC services and considering local context can contribute to increased clinical safety. QM measures that are established in more mature program sites can be quickly adopted to respond to quality issues in program expansion sites.

Taking care to the patients: a qualitative evaluation of a community-based ART care program in northern Namibia.

BACKGROUND: Namibia is a large sparsely populated country with a high prevalence of HIV. People living with HIV who reside in remote areas often travel long distances through tough desert terrain to access HIV care and treatment. To address this barrier, community-based antiretroviral therapy (C-BART) sites were established in Okongo (2007-2008) and Eenhana districts (2016) of northern Namibia with the goal of bringing HIV and other health services closer patients' homes. We conducted a qualitative evaluation of the acceptability and challenges of C-BART to guide program improvement. METHODS: For this qualitative descriptive study, research assistants collected data (August-December 2017) through in-depth interviews with 40 patients, seven health extension workers, and 11 policy/program managers, and through four focus group discussions with healthcare workers. Interviews were audio-recorded, translated, and coded using MAXQDA v.12. Data were analyzed using thematic analysis. RESULTS: The evaluation identified five themes: community ownership, acceptance of the C-BART sites, benefits of the C-BART program for the PLHIV community and their social networks, benefits of the C-BART program to the main health facility, and challenges with the C-BART program. The C-BART program was reported as life-changing by many patients who had previously struggled to afford four-wheel drive vehicles to access care. Patients and healthcare workers perceived that the community as a whole benefited from the C-BART sites not only due to the financial pressure lifted from friends and family members previously asked to help cover expensive transportation, but also due to the perception of diminished stigmatization of people living with HIV and improved health. The C-BART sites became a source of community and social support for those accessing the sites. Healthcare workers reported greater job satisfaction and decongestion of health facilities. The challenges that they reported included delays in authorization of vehicles for transportation to C-BART sites and lack of incentives to provide services in the community. CONCLUSION: The C-BART program can serve as a model of care to expand access to HIV care and treatment and other health services to populations in remote settings, including rural and difficult-to-reach regions. The needs of healthcare workers should also be considered for the optimal delivery of such a model.

Implementation and evaluation of a Project ECHO telementoring program for the Namibian HIV workforce.

BACKGROUND: The Namibian Ministry of Health and Social Services (MoHSS) piloted the first HIV Project ECHO (Extension for Community Health Outcomes) in Africa at 10 clinical sites between 2015 and 2016. Goals of Project ECHO implementation included strengthening clinical capacity, improving professional satisfaction, and reducing isolation while addressing HIV service challenges during decentralization of antiretroviral therapy. METHODS: MoHSS conducted a mixed-methods evaluation to assess the pilot. Methods included pre/post program assessments of healthcare worker knowledge, self-efficacy, and professional satisfaction; assessment of continuing professional development (CPD) credit acquisition; and focus group discussions and in-depth interviews. Analysis compared the differences between pre/post scores descriptively. Qualitative transcripts were analyzed to extract themes and representative quotes. RESULTS: Knowledge of clinical HIV improved 17.8% overall (95% confidence interval 12.2-23.5%) and 22.3% (95% confidence interval 13.2-31.5%) for nurses. Professional satisfaction increased 30 percentage points. Most participants experienced reduced professional isolation (66%) and improved CPD credit access (57%). Qualitative findings reinforced quantitative results. Following the pilot, the Namibia MoHSS Project ECHO expanded to over 40 clinical sites by May 2019 serving more than 140 000 people living with HIV. CONCLUSIONS: Similar to other Project ECHO evaluation results in the United States of America, Namibia's Project ECHO led to the development of ongoing virtual communities of practice. The evaluation demonstrated the ability of the Namibia HIV Project ECHO to improve healthcare worker knowledge and satisfaction and decrease professional isolation.

Sentinel site active surveillance of safety of first-line antiretroviral medicines in Namibia.

PURPOSE: Active surveillance pharmacovigilance systems better estimate the burden of adverse events (AEs) and can generate useful information on risk factors of AEs for more effective medicine use, especially in conjunction with introduction of new medicines and/or changes in treatment guidelines. This project aimed to implement an active surveillance pilot program for first-line antiretroviral therapy (ART) at sentinel sites in Namibia. METHODS: Sentinel sites were outpatient ART clinics at the Windhoek Central Hospital and Katutura Intermediate Hospital. An active surveillance data collection form was developed and placed into patient charts. HIV+ adults naïve to ART were enrolled. Physicians recorded ART and health information during each follow-up visit, including presence or absence of AEs. RESULTS: A total of 413 patients were included from August 2012 to April 2013. Average age was 37 years; 51% of patients were at WHO clinical stage 1; and mean baseline CD4 count was 216. The most common ART regimen was tenofovir/lamivudine/nevirapine. Presence or absence of AEs was recorded in active surveillance forms for 94% of first follow-up visits. In total, 66 patients experienced 119 AEs of any severity. Incidence of experiencing at least one AE was 33/100 person-years. Most common AEs were rash and abdominal pain. On active surveillance forms, demographic variables were missing in 14% of patients, and follow-up visits were recorded for 82% of patients. CONCLUSIONS: Completeness of AE recording on active surveillance forms was high. With improved logistical considerations, such as incorporation of active surveillance forms into medical records, long-term active surveillance programs could be successful. Copyright © 2016 John Wiley & Sons, Ltd.

Records linkage of electronic databases for the assessment of adverse effects of antiretroviral therapy in sub-Saharan Africa.

PURPOSE: In 2009, the Ministry of Health and Social Services in Namibia decided to conduct a confirmatory assessment of the risk of anemia associated with zidovudine (AZT)-based highly active antiretroviral therapy (HAART) using records contained in three electronic databases. These records did not share a unique identifying number. The first step was to apply probabilistic record linkage methods to link records in the three databases. METHODS: Records of persons, aged 19-65 years, newly initiated on HAART between January 2007 and June 2008, were selected from a pharmacy electronic dispensing tool (EDT) and linked to an electronic medical records database (ePMS) and a laboratory database (MEDITECH). Using the paper-based clinical record as the gold standard, we measured the sensitivity of the starting HAART regimen, that is, proportion of AZT users in the clinical record correctly identified in electronic record, and specificity of severe anemia, that is, proportion of non-cases of severe anemia in the clinical records correctly identified in the electronic record. Kappa and intraclass correlation coefficients were used to determine reliability. RESULTS: A total of 12 358 records were selected from EDT. Seventy-six percent and 58% of EDT records were linked to ePMS and MEDITECH, respectively. The sensitivity of the starting HAART regimen was 98%, whereas specificity of severe anemia was 100%. The reliability scores for variables including weight, hemoglobin, and CD4 counts were moderate to perfect and ranged from 0.59 to 0.99. CONCLUSION: Probabilistic record linkage methods were effective for records linkage in this sub-Saharan African setting.

Adverse event profile and associated factors following surgical voluntary medical male circumcision in two regions of Namibia, 2015-2018.

INTRODUCTION: Monitoring clinical safety of voluntary medical male circumcision (VMMC) is critical to minimize risk as VMMC programs for HIV prevention are scaled. This cross-sectional analysis describes the adverse event (AE) profile of a large-scale, routine VMMC program and identifies factors associated with the development, severity, and timing of AEs to provide recommendations for program quality improvement. MATERIALS AND METHODS: From 2015-2018 there were 28,990 circumcisions performed in International Training and Education Center for Health (I-TECH) supported regions of Namibia in collaboration with the Ministry of Health and Social Services. Two routine follow-up visits after VMMC were scheduled to identify clients with AEs. Summary statistics were used to describe characteristics of all VMMC clients and the subset who experienced an AE. We used chi-square tests to evaluate associations between AE timing, patient age, and other patient and AE characteristics. We used a logistic regression model to explore associations between patient characteristics and AE severity. RESULTS: Of the 498 clients with AEs (AE rate of 1.7%), 40 (8%) occurred ≤2 days, 262 (53%) occurred 3-7 days, 161 (32%) between day 8 and 14, and 35 (7%) were ≥15 days post-VMMC. Early AEs (on or before day 2) tended to be severe and categorized as bleeding, while infections were the most common AEs occurring later (p<0.001). Younger clients (aged 10-14 years) experienced more infections, whereas older clients experienced more bleeding (p<0.001). CONCLUSIONS: Almost 40% of AEs occurred after the second follow-up visit, of which 179 (91%) were infections. Improvements in pre-surgical and post-surgical counselling and post-operative educational materials encouraging clients to seek care at any time, adoption of alternative follow-up methods, and the addition of a third follow-up visit may improve outcomes for patients. Enhancing post-surgical counselling and emphasizing wound care for younger VMMC clients and their caregivers could help mitigate elevated risk of infection.

HIV-1 Recent Infection Testing Algorithm With Antiretroviral Drug Detection to Improve Accuracy of Incidence Estimates.

BACKGROUND: HIV-1 incidence calculation currently includes recency classification by HIV-1 incidence assay and unsuppressed viral load (VL ≥ 1000 copies/mL) in a recent infection testing algorithm (RITA). However, persons with recent classification not virally suppressed and taking antiretroviral (ARV) medication may be misclassified. SETTING: We used data from 13 African household surveys to describe the impact of an ARV-adjusted RITA on HIV-1 incidence estimates. METHODS: HIV-seropositive samples were tested for recency using the HIV-1 Limiting Antigen (LAg)-Avidity enzyme immunoassay, HIV-1 viral load, ARVs used in each country, and ARV drug resistance. LAg-recent result was defined as normalized optical density values ≤1.5. We compared HIV-1 incidence estimates using 2 RITA: RITA1: LAg-recent + VL ≥ 1000 copies/mL and RITA2: RITA1 + undetectable ARV. We explored RITA2 with self-reported ARV use and with clinical history. RESULTS: Overall, 357 adult HIV-positive participants were classified as having recent infection with RITA1. RITA2 reclassified 55 (15.4%) persons with detectable ARV as having long-term infection. Those with detectable ARV were significantly more likely to be aware of their HIV-positive status (84% vs. 10%) and had higher levels of drug resistance (74% vs. 26%) than those without detectable ARV. RITA2 incidence was lower than RITA1 incidence (range, 0%-30% decrease), resulting in decreased estimated new infections from 390,000 to 341,000 across the 13 countries. Incidence estimates were similar using detectable or self-reported ARV (R2 > 0.995). CONCLUSIONS: Including ARV in RITA2 improved the accuracy of HIV-1 incidence estimates by removing participants with likely long-term HIV infection.

Low Case Finding Among Men and Poor Viral Load Suppression Among Adolescents Are Impeding Namibia's Ability to Achieve UNAIDS 90-90-90 Targets.

BACKGROUND: In 2015, Namibia implemented an Acceleration Plan to address the high burden of HIV (13.0% adult prevalence and 216 311 people living with HIV [PLHIV]) and achieve the UNAIDS 90-90-90 targets by 2020. We provide an update on Namibia's overall progress toward achieving these targets and estimate the percent reduction in HIV incidence since 2010. METHODS: Data sources include the 2013 Namibia Demographic and Health Survey (2013 NDHS), the national electronic patient monitoring system, and laboratory data from the Namibian Institute of Pathology. These sources were used to estimate (1) the percentage of PLHIV who know their HIV status, (2) the percentage of PLHIV on antiretroviral therapy (ART), (3) the percentage of patients on ART with suppressed viral loads, and (4) the percent reduction in HIV incidence. RESULTS: In the 2013 NDHS, knowledge of HIV status was higher among HIV-positive women 91.8% (95% confidence interval [CI], 89.4%-93.7%) than HIV-positive men 82.5% (95% CI, 78.1%-86.1%). At the end of 2016, an estimated 88.3% (95% CI, 86.3%-90.1%) of PLHIV knew their status, and 165 939 (76.7%) PLHIV were active on ART. The viral load suppression rate among those on ART was 87%, and it was highest among ≥20-year-olds (90%) and lowest among 15-19-year-olds (68%). HIV incidence has declined by 21% since 2010. CONCLUSIONS: With 76.7% of PLHIV on ART and 87% of those on ART virally suppressed, Namibia is on track to achieve UNAIDS 90-90-90 targets by 2020. Innovative strategies are needed to improve HIV case identification among men and adherence to ART among youth.

Assessment of the nevirapine safety signal using data from the national antiretroviral dispensing database: a retrospective study.

BACKGROUND: Clinical trials showed a higher risk of skin- and liver- related adverse reactions when NVP-based antiretroviral therapy (ART) was initiated in female and male patients with baseline CD4 cell counts ≥250 and ≥400, respectively. Some studies reported no difference in risk between the high and low CD4 count groups. Consequently, the use of NVP-based ART in all patients with a CD4 cell count <350, was recommended. In 2011, the Pharmacovigilance Centre detected an increase in reports of grade III and IV reactions. The center was required to determine if there was an increase in NVP-related reactions. METHODS: Automated dispensing records from January 2008 to November 2011 were accessed from the National Antiretroviral Dispensing Database (NDB). Records of patients who were initiated on NVP-based ART were selected, and records showing a replacement of NVP with protease inhibitor (PI) were identified. The proportions of grade III and IV reactions were calculated per quarter, and Odds Ratios (OR) were calculated, with the confidence interval set at 95 % and a p-value of <0.05. RESULTS: From 2008 to 2011 a total of 84,741 patients were started on ART. Of these 67,794 were initiated on NVP-containing ART. Of these, 211 females and 79 males were substituted from NVP to a PI. The OR for females was 2.4 (95 % confidence interval [CI] 1.8 - 3.1). For males the OR was 2.4 (OR 2.4; 95 % CI 1.4 - 3.8) which occurred nine months after the change observed in the females. The odds of a NVP-to-PI substitution in females compared to males before the launch of Namibia's 2010 ART guidelines was the same as the odds after the publication of the guidelines (before, OR 1.6; 95 % CI 1.1 - 2.5; after, OR 1.6; 95 % CI 1.2 - 2.2). CONCLUSIONS: There was an increase in substitutions of NVP with a PI following the increase in the CD4 threshold for initiating NVP-based HAART, meaning that there was an increase in grade III and IV reactions associated with NVP. Therefore the NVP-safety signal was confirmed to be a true signal, which contributed to the Ministry's decision to review the use of NVP.

Active Surveillance versus Spontaneous Reporting for First-Line Antiretroviral Medicines in Namibia: A Cost-Utility Analysis.

INTRODUCTION: Active surveillance pharmacovigilance is a systematic approach to medicine safety assessment and health systems strengthening, but has not been widely implemented in low- and middle-income countries. This study aimed to assess the cost effectiveness of a national active surveillance pharmacovigilance system for highly active antiretroviral therapy (HAART) compared with the existing spontaneous reporting system in Namibia. METHODS: A cost-utility analysis from a governmental perspective compared active surveillance pharmacovigilance to spontaneous reporting. Data from a sentinel site active surveillance program in Namibia from August 2012 to April 2013 was projected to all HIV-infected adults initiating HAART in Namibia. Costs (pharmacovigilance program, HAART, adverse event [AE] treatment), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs, dollars/QALY) were evaluated. Analysis was completed for (i) cohort analysis: a single cohort beginning HAART in 1 year in Namibia followed over their remaining lifetime, and (ii) population analysis: patients continued to enter and leave care and treatment over 10 years. RESULTS: For the cohort analysis, totals were US$21,267,902 (2015 US dollars) and 116,224 QALYs for care and treatment under active surveillance pharmacovigilance versus US$15,257,381 and 116,122 QALYs for care and treatment under spontaneous reporting pharmacovigilance, resulting in an ICER of US$58,867/QALY for active surveillance compared with spontaneous reporting pharmacovigilance. The population analysis ICER was US$4989/QALY. Results were sensitive to quality of life associated with AEs. CONCLUSION: Active surveillance pharmacovigilance was projected to be highly cost effective to improve treatment for HIV in Namibia. Active surveillance pharmacovigilance may be valuable to improve lives of HIV patients and more efficiently allocate health resources in Namibia.

Tenofovir substitution in Namibia based on an analysis of the antiretroviral dispensing database.

OBJECTIVES: In the management of HIV infection, tenofovir is preferred to its predecessors - zidovudine and stavudine - in the antiretroviral therapy (ART) nucleoside backbone. Tenofovir's (TDF) preference is based on its safety profile. Nevertheless, TDF causes adverse reactions, some of which warrant its substitution for patients. The rate of TDF-substitution is suggestive of the rate of occurrence of TDF-related adverse reactions. However, the rate of substitution of TDF with another nucleoside reverse transcriptase inhibitor (NRTI) in Namibia was unknown. The objective of this review was to measure the rate of TDF's substitution for the period of January 1, 2008 to November 30, 2011, and to compare the gender difference in the rates of TDF's substitution. METHODS: We accessed antiretroviral medicine dispensing records from the national antiretroviral dispensing database (NDB). We selected patients who were started on a TDF-containing conventional ART regimen - 2NRTI+1NNRT. We used the initial and current ART regimens to identify records of TDF's substitution with another NRTI. RESULTS: A total of 84,741 patients were initiated on ART (Jan-1-2008 to Nov-30-2011). A total of 52,612 patient-records were excluded from the analysis because they did not meet the criteria for inclusion. Of the 32,129 included records, 59.4% (n=19 096) and 40.6% (n=13 033) were for female and male patients, respectively. Of these, 1.2% (n=380) of the patients had their TDF substituted with another NRTI. Of the females and males, respectively, 1.1% (95% CI: 0.9-1.3; n=210) and 1.3% (95% CI: 1.1-1.5; n=170) had TDF substituted with another NRTI. No gender difference was observed (p-value = 0.11). CONCLUSION: The percentage of patients for whom TDF was substituted with another NRTI, possibly due to TDF-related adverse reactions, was within the current published limits. However, 1.2% is likely not a true representation of the percentage of patients who experience adverse events because some patients could have been maintained on TDF even in the presence of adverse events. Further investigation is required to determine the clinical reasons for TDF's withdrawal.

Antimicrobial sensitivity patterns of cerebrospinal fluid (CSF) isolates in Namibia: implications for empirical antibiotic treatment of meningitis.

OBJECTIVE: Bacterial meningitis is a medical emergency associated with high mortality rates. Cerebrospinal fluid (CSF) culture is the "gold standard" for diagnosis of meningitis and it is important to establish the susceptibility of the causative microorganism to rationalize treatment. The Namibia Standard Treatment Guidelines (STGs) recommends initiation of empirical antibiotic treatment in patients with signs and symptoms of meningitis after taking a CSF sample for culture and sensitivity. The objective of this study was to assess the antimicrobial sensitivity patterns of microorganisms isolated from CSF to antibiotics commonly used in the empirical treatment of suspected bacterial meningitis in Namibia. METHODS: This was a cross-sectional descriptive study of routinely collected antibiotic susceptibility data from the Namibia Institute of Pathology (NIP) database. Results of CSF culture and sensitivity from January 1, 2009 to May 31, 2012, from 33 state hospitals throughout Namibia were analysed. RESULTS: The most common pathogens isolated were Streptococcus species, Neisseria meningitidis, Haemophilus influenzae, Staphylococcus, and Escherichia coli. The common isolates from CSF showed high resistance (34.3% -73.5%) to penicillin. Over one third (34.3%) of Streptococcus were resistance to penicillin which was higher than 24.8% resistance in the United States. Meningococci were susceptible to several antimicrobial agents including penicillin. The sensitivity to cephalosporins remained high for Streptococcus, Neisseria, E. coli and Haemophilus. The highest percentage of resistance to cephalosporins was seen among ESBL K. pneumoniae (n = 7, 71%-100%), other Klebsiella species (n = 7, 28%-80%), and Staphylococcus (n = 36, 25%-40%). CONCLUSIONS: The common organisms isolated from CSF were Streptococcus Pneumoniae, Neisseria meningitidis, Haemophilus influenzae, Staphylococcus, and E. coli. All common organisms isolated from CSF showed high sensitivity to cephalosporins used in the empirical treatment of meningitis. The resistance of the common isolates to penicillin is high. Most ESBL K. pneumoniae were isolated from CSF samples drawn from neonates and were found to be resistant to the antibiotics recommended in the Namibia STGs. Based on the above findings, it is recommended to use a combination of aminoglycoside and third-generation cephalosporin to treat non-ESBL Klebsiella isolates. Carbapenems (e.g., meropenem) and piperacillin/tazobactam should be considered for treating severely ill patients with suspected ESBL Klebsiella infection. Namibia should have a national antimicrobial resistance surveillance system for early detection of antibiotics that may no longer be effective in treating meningitis and other life-threatening infections due to resistance.