Patient-reported outcomes of adverse events after COVID-19 vaccination in Nigeria: A mixed methods study.

BACKGROUND: Adverse events following immunization (AEFIs), especially if serious, may impact vaccine recipients' quality of life and financial well-being and fuel vaccine hesitancy. Nigeria rolled out COVID-19 vaccination in 2021 with little known about the impact of AEFIs on an individual's quality of life. No study in Africa has explored the health and financial impact of AEFIs. We explored patient-reported outcomes (PROs) of adverse events after COVID-19 vaccination and documented the lived experiences of those with serious AEFIs to understand the effect on their health, financial well-being, and attitude to future vaccinations. METHODS: We conducted a convergent mixed-methods study using the RAND 36-item health survey and in-depth interviews to collect PROs on vaccine recipients in Nigeria. Eight health scale scores and two summary composite scores were used to measure the health-related quality of life outcomes from the survey and inductive analysis was used to identify themes from the interview scripts. The results of both studies were integrated in a joint display to highlight areas of concordance. RESULTS: In total, 785 survey responses were analyzed (53% females, 68% aged 18-30 years). Responders reporting an AEFI were 58%, of whom 62% received the first dose only. Younger age and first vaccine dose (p < .001 respectively) were associated with experiencing an AEFI. Not reporting an AEFI was associated with better quality of life, measured as higher scores on all eight SF-36 Health scales and the physical and mental component summary scores. All six interviewees with serious AEFIs experienced physical, mental, and financial distress. Some expressed a strong negative attitude toward future COVID-19 vaccinations but not toward vaccines for routine immunization. CONCLUSION: AEFIs negatively impact the health and financial well-being of affected individuals and their attitude to future vaccinations, especially if serious. Understanding the impact of AEFIs on people is important and should inform future policies and interventions. The results of our study can inform policy and planning for future mass vaccination campaigns in LMICs.

Exploring the Role of the Private Sector in Tuberculosis Detection and Management in Lima, Peru: A Mixed-Methods Patient Pathway Analysis.

In Latin America, little is known about the involvement of private health-care providers in tuberculosis (TB) detection and management. We sought to gain a better understanding of current and potential roles of the private sector in delivering TB services in Peru. We conducted a mixed-methods study in North Lima, Peru. The quantitative component comprised a patient pathway analysis assessing the alignment of TB services with patient care-seeking behavior. The qualitative component comprised in-depth interviews with 18 private health-care providers and 5 key informants. We estimated that 77% of patients sought care initially at a facility with TB diagnostic capacity and 59% at a facility with TB treatment capacity. Among private facilities, 43% offered smear microscopy, 13% offered radiography, and none provided TB treatment. Among public-sector facilities, 100% offered smear microscopy, 26% offered radiography, and 99% provided TB treatment. Private providers believed they offered shorter wait times and a faster diagnosis, but they struggled with a lack of referral systems and communication with the public sector. Nonrecognition of private-sector tests by the public sector led to duplicate testing of referred patients. Although expressing willingness to collaborate with public-sector programs for diagnosis and referral, private providers had limited interest in treating TB. This study highlights the role of private providers in Peru as an entry point for TB care. Public-private collaboration is necessary to harness the potential of the private sector as an ally for early diagnosis.

A biosocial analysis of perinatal and late neonatal mortality among Indigenous Maya Kaqchikel communities in Tecpán, Guatemala: a mixed-methods study.

INTRODUCTION: Neonatal mortality is a global public health challenge. Guatemala has the fifth highest neonatal mortality rate in Latin America, and Indigenous communities are particularly impacted. This study aims to understand factors driving neonatal mortality rates among Maya Kaqchikel communities. METHODS: We used sequential explanatory mixed methods. The quantitative phase was a secondary analysis of 2014-2016 data from the Global Maternal and Newborn Health Registry from Chimaltenango, Guatemala. Multivariate logistic regression models identified factors associated with perinatal and late neonatal mortality. A number of 33 in-depth interviews were conducted with mothers, traditional Maya midwives and local healthcare professionals to explain quantitative findings. RESULTS: Of 33 759 observations, 351 were lost to follow-up. There were 32 559 live births, 670 stillbirths (20/1000 births), 1265 (38/1000 births) perinatal deaths and 409 (12/1000 live births) late neonatal deaths. Factors identified to have statistically significant associations with a higher risk of perinatal or late neonatal mortality include lack of maternal education, maternal height <140 cm, maternal age under 20 or above 35, attending less than four antenatal visits, delivering without a skilled attendant, delivering at a health facility, preterm birth, congenital anomalies and presence of other obstetrical complications. Qualitative participants linked severe mental and emotional distress and inadequate maternal nutrition to heightened neonatal vulnerability. They also highlighted that mistrust in the healthcare system-fueled by language barriers and healthcare workers' use of coercive authority-delayed hospital presentations. They provided examples of cooperative relationships between traditional midwives and healthcare staff that resulted in positive outcomes. CONCLUSION: Structural social forces influence neonatal vulnerability in rural Guatemala. When coupled with healthcare system shortcomings, these forces increase mistrust and mortality. Collaborative relationships among healthcare staff, traditional midwives and families may disrupt this cycle.

Non-communicable disease care in Sierra Leone: a mixed-methods study of the drivers and barriers to retention in care for hypertension.

OBJECTIVE: To retrospectively analyse routinely collected data on the drivers and barriers to retention in chronic care for patients with hypertension in the Kono District of Sierra Leone. DESIGN: Convergent mixed-methods study. SETTING: Koidu Government Hospital, a secondary-level hospital in Kono District. PARTICIPANTS: We conducted a descriptive analysis of key variables for 1628 patients with hypertension attending the non-communicable disease (NCD) clinic between February 2018 and August 2019 and qualitative interviews with 21 patients and 7 staff to assess factors shaping patients' retention in care at the clinic. OUTCOMES: Three mutually exclusive outcomes were defined for the study period: adherence to the treatment protocol (attending >80% of scheduled visits); loss-to-follow-up (LTFU) (consecutive 6 months of missed appointments) and engaged in (but not fully adherent) with treatment (<80% attendance). RESULTS: 57% of patients were adherent, 20% were engaged in treatment and 22% were LTFU. At enrolment, in the unadjusted variables, patients with higher systolic and diastolic blood pressures had better adherence than those with lower blood pressures (OR 1.005, 95% CI 1.002 to 1.009, p=0.004 and OR 1.008, 95% CI 1.004 to 1.012, p<0.001, respectively). After adjustment, there were 14% lower odds of adherence to appointments associated with a 1 month increase in duration in care (OR 0.862, 95% CI 0.801 to 0.927, p<0.001). Qualitative findings highlighted the following drivers for retention in care: high-quality education sessions, free medications and good interpersonal interactions. Challenges to seeking care included long wait times, transport costs and misunderstanding of the long-term requirement for hypertension care. CONCLUSION: Free medications, high-quality services and health education may be effective ways of helping NCD patients stay engaged in care. Facility and socioeconomic factors can pose challenges to retention in care.

Exploring the role of the private sector in tuberculosis detection and management in Lima, Peru: a mixed-methods patient pathway analysis.

In Latin America, little is known about the involvement of private healthcare providers in TB detection and management. We sought to gain a better understanding of current and potential roles of the private sector in delivering TB services in Peru. We conducted a mixed-methods study in Lima, Peru. The quantitative component comprised a patient pathway analysis assessing the alignment of TB services with patient care-seeking behavior. The qualitative component comprised in-depth interviews with 18 private healthcare providers and 5 key informants. We estimated that 77% of patients initially sought care at a facility with TB diagnostic capacity and 59% at a facility with TB treatment capacity. The lack of TB services at initial care-seeking location was driven by the 41% of patients estimated to seek care first at a private facility. Among private facilities, 43% offered smear microscopy, 13% offered radiography, and none provided TB treatment. Among public sector facilities, 100% offered smear microscopy, 26% offered radiography, and 99% provided TB treatment. Interviews revealed that private providers believed that they offered shorter wait times and a quicker diagnosis, but they struggled with a lack of follow-up systems and communication barriers with the public sector. While expressing willingness to collaborate with public sector programs for diagnosis and referral, private providers had limited interest in treating TB. This study highlights the role of private providers in Peru as an entry point for TB care. Public-private collaboration is necessary to harness the potential of the private sector as an ally for early diagnosis.

Understanding barriers to tuberculosis diagnosis and treatment completion in a low-resource setting: A mixed-methods study in the Kingdom of Lesotho.

BACKGROUND: Lesotho is one of the 30 countries with the highest tuberculosis incidence rates in the world, estimated at 650 per 100,000 population. Tuberculosis case detection is extremely low, particularly with the rapid spread of COVID-19, dropping from an estimated 51% in 2020 to 33% in 2021. The aim of this study is to understand the barriers to tuberculosis diagnosis and treatment completion. METHODS: We used a convergent mixed methods study design. We collected data on the number of clients reporting symptoms upon tuberculosis screening, their sputum test results, the number of clients diagnosed, and the number of clients who started treatment from one district hospital and one health center in Berea district, Lesotho. We conducted in-depth interviews and focus group discussions with 53 health workers and patients. We used a content analysis approach to analyze qualitative data and integrated quantitative and qualitative findings in a joint display. FINDINGS: During March-August, 2019, 218 clients at the hospital and 292 clients at the health center reported tuberculosis symptoms. The full diagnostic testing process was completed for 66% of clients at the hospital and 68% at the health center. Among clients who initiated tuberculosis treatment, 68% (61/90) at the hospital and 74% (32/43) at the health center completed treatment. The main barriers to testing and treatment completion were challenges at sample collection, lack of decentralized diagnostic services, and socioeconomic factors such as food insecurity and high patient movement to search for jobs. CONCLUSIONS: Tuberculosis diagnosis could be improved through the effective decentralization of laboratory services at the health facility level, and treatment completion could be improved by providing food and other forms of social support to patients.

Adverse Events to SARS-CoV-2 (COVID-19) Vaccines and Policy Considerations that Inform the Funding of Safety Surveillance in Low- and Middle-Income Countries: A Mixed Methods Study.

INTRODUCTION/OBJECTIVE: Rapid global approval of coronavirus disease 2019 (COVID-19) vaccines and concurrent introduction in high-income countries and low- and middle-income countries (LMIC) highlights the importance of equitable safety surveillance of adverse events following immunization (AEFIs). We profiled AEFIs to COVID-19 vaccines, explored reporting differences between Africa and the rest of the world (RoW), and analyzed policy considerations that inform strengthening of safety surveillance in LMICs. METHODS: Using a convergent mixed-methods design we compared the rate and profile of COVID-19 vaccines' AEFIs reported to VigiBase by Africa versus the RoW, and interviewed policymakers to elicit considerations that inform the funding of safety surveillance in LMICs. RESULTS: With 87,351 out of 14,671,586 AEFIs, Africa had the second-lowest crude number and a reporting rate of 180 adverse events (AEs) per million administered doses. Serious AEs (SAEs) were 27.0%. Death accounted for about 10.0% of SAEs. Significant differences were found in reporting by gender, age group, and SAEs between Africa and the RoW. AstraZeneca and Pfizer BioNTech vaccines were associated with a high absolute number of AEFIs for Africa and RoW; Sputnik V contributed a considerably high rate of AEs per 1 million administered doses. Funding decisions for safety surveillance in LMICs were not based on explicit policies but on country priorities, perceived utility of data, and practical implementation issues. CONCLUSION: African countries reported fewer AEFIs relative to the RoW. To enhance Africa's contribution to the global knowledge on COVID-19 vaccine safety, governments must explicitly consider safety monitoring as a priority, and funding organizations need to systematically and continuously support these programs.

Understanding reasons for suboptimal tuberculosis screening in a low-resource setting: A mixed-methods study in the Kingdom of Lesotho.

Lesotho has one of the highest tuberculosis (TB) incidence rates in the world, estimated at 654/100,000 population. However, TB detection remains low, with only 51% of people with TB being diagnosed and treated. The aim of this study was to evaluate implementation of TB screening and identify drivers of suboptimal TB screening in Lesotho. We used a convergent mixed methods study design. We collected data on the number of health facility visits and the number of clients screened for TB during March-August, 2019 from one district hospital and one health center. We conducted interviews and focus group discussions with patients and health workers to elucidate the mechanisms associated with suboptimal screening. Out of an estimated 70,393 visitors to the two health facilities, only 22% of hospital visitors and 48% of health center visitors were asked about TB symptoms. Only 2% of those screened at each facility said that they had TB symptoms, comprising a total of 510 people. Lack of training on tuberculosis screening, overall staff shortages, barriers faced by patients in accessing care, and health care worker mistrust of tuberculosis screening procedures were identified as drivers of suboptimal TB screening. TB screening could be improved by ensuring the availability of well-trained, incentivized, and dedicated screeners at health facilities, and by providing TB screening services in community settings.

How community ART delivery may improve HIV treatment outcomes: Qualitative inquiry into mechanisms of effect in a randomized trial of community-based ART initiation, monitoring and re-supply (DO ART) in South Africa and Uganda.

INTRODUCTION: UNAIDS fast track targets for ending the AIDS epidemic by 2030 call for viral suppression in 95% of people using antiretroviral therapy (ART) to treat HIV infection. Difficulties in linking to care following a positive HIV test have impeded progress towards meeting treatment targets. Community-based HIV services may reduce linkage barriers and have been associated with high retention and favourable clinical outcomes. We use qualitative data from The Delivery Optimization of Antiretroviral Therapy (DO ART) Study, a three-arm randomized trial of community ART initiation, monitoring and re-supply conducted in western Uganda and KwaZulu-Natal South Africa, to identify mechanisms through which community ART delivery may improve treatment outcomes, defined as viral suppression in people living with HIV (PLHIV). METHODS: We conducted open-ended interviews with a purposeful sample of 150 DO ART participants across study arms and study sites, from October 2016 to November 2019. Interviews covered experiences of: (1) HIV testing; (2) initiating and refilling ART; and (3) participating in the DO ART Study. A combined inductive content analytic and thematic approach was used to characterize mechanisms through which community delivery of ART may have contributed to viral suppression in the DO ART trial. RESULTS: The analysis yielded four potential mechanisms drawn from qualitative data representing the perspectives and priorities of DO ART participants. Empowering participants to schedule, re-schedule and select the locations of community-based visits via easy phone contact with clinical staff is characterized as flexibility. Integration refers to combining the components of clinic-based visits into single interaction with a healthcare provider. Providers" willingness to talk at length with participants during visits, addressing non-HIV as well as HIV-related concerns, is termed "a slower pace". Finally, increased efficiency denotes the time savings and increased income-generating opportunities for participants brought about by delivering services in the community. CONCLUSIONS: Understanding the mechanisms through which HIV service delivery innovations produce an effect is key to transferability and potential scale-up. The perspectives and priorities of PLHIV can indicate actionable changes for HIV care programs that may increase engagement in care and improve treatment outcomes.

Literacy is power: structural drivers of child malnutrition in rural Liberia.

BACKGROUND: In Liberia, an estimated 32% of children under 5 are stunted. Malnutrition and hunger worsened during the country's civil war and were further exacerbated by the 2014-2016 outbreak of Ebola virus disease. Studies examining adherence to recommended infant and young child feeding practices frequently do so with an emphasis on the knowledge, attitudes and beliefs of mothers and caregivers. Often overlooked are the structural factors that enable or constrain their agency to practise evidence-based recommendations. METHODS: Between July and December 2017, we surveyed 100 Liberian mothers to assess the sociodemographic factors associated with the risk of severe acute malnutrition in children in Maryland County, Liberia. We also conducted 50 in-depth interviews at two government health facilities to qualitatively explore mothers' experiences, as well as health workers' understandings of the determinants of malnutrition in the region. We applied logistic regression to analyse quantitative data and inductive content analysis to thematically interpret qualitative data. RESULTS: Mothers were less likely to have a child with severe acute malnutrition if they had an income greater than US$50 per month (adjusted OR (aOR)=0.14, p<0.001), were literate (aOR=0.21, p=0.009) or exclusively breast fed during the first 6 months of life (aOR=0.18, p=0.049); they were more likely to have a child with severe acute malnutrition if they were married or in domestic partnerships (aOR=8.41, p<0.001). In-depth interviews elucidated several social, economic and programmatic factors that shaped suboptimal feeding practices, as well as decisions for and against seeking formal care for malnutrition. DISCUSSION: The lived experiences of Liberian mothers and health workers illustrate that child malnutrition is a direct consequence of abject poverty, food insecurity, illiteracy, the precarious nature of formal and informal work, and the lack of robust social protection. Behaviour change and health education interventions that do not seek to alleviate structural barriers to compliance are unlikely to be effective.

PrEP Discontinuation and Prevention-Effective Adherence: Experiences of PrEP Users in Ugandan HIV Serodiscordant Couples.

BACKGROUND: Optimal adherence to oral pre-exposure prophylaxis (PrEP) for HIV prevention involves aligning consistent PrEP use with periods of risk to achieve prevention-effective adherence. Prevention-effective adherence is predicated on individuals discontinuing PrEP during periods without expected risk. For stable, serodiscordant couples, antiretroviral therapy (ART) adherence by the HIV-positive partner markedly decreases HIV transmission risk, potentially obviating the need for continued PrEP use; yet little is known about actual lived experiences of discontinuing PrEP. METHODS: In-depth qualitative interviews were conducted with HIV-uninfected PrEP users in serodiscordant couples taking part in the Partners Demonstration Project at IDI-Kasangati, Kampala, Uganda. Open-ended interviews elicited information on the partnered relationship; understandings of PrEP; prevention strategies; and experiences of PrEP discontinuation. An inductive, thematic, content-analytic approach was used to analyze study data. RESULTS: Uninfected partners experienced PrEP as a valued resource for preventing HIV acquisition. Despite ongoing ART use by HIV-positive partners for a period of time consistent with viral suppression, discontinuation of PrEP was experienced as a loss of protection and a corresponding increase in risk of HIV acquisition. Uninfected partners responded with strategies aimed at offsetting this subjective sense of increased risk, specifically: (1) changing sexual practices; (2) prioritizing fidelity in the relationship; (3) increasing reliance on condoms; and (4) seeking evidence of partners' ART adherence. CONCLUSIONS: These experiences highlight the challenges PrEP users in serodiscordant couples face in discontinuing PrEP for prevention-effective adherence. Flexible interventions that support individuals during this transition may increase comfort with discontinuing PrEP when alternative prevention strategies provide protection, such as a partner's consistent adherence to ART.

Messaging Circumstances and Economic Pressures as Influences on Linkage to Medical Male Circumcision following Community-Based HIV Testing for Men in Rural Southwest Uganda: A Qualitative Study.

Voluntary medical male circumcision (MMC) reduces risk of HIV infection, but uptake remains suboptimal among certain age groups and locations in sub-Saharan Africa. We analysed qualitative data as part of the Linkages Study, a randomized controlled trial to evaluate community-based HIV testing and follow-up as interventions promoting linkage to HIV treatment and prevention in Uganda and South Africa. Fifty-two HIV-negative uncircumcised men participated in the qualitative study. They participated in semistructured individual interviews exploring (a) home HTC experience; (b) responses to test results; (c) efforts to access circumcision services; (d) outcomes of efforts; (e) experiences of follow-up support; and (f) local HIV education and support. Interviews were audio-recorded, translated, transcribed, and summarized into "linkage summaries." Summaries were analysed inductively to identify the following three thematic experiences shaping men's circumcision choices: (1) intense relief upon receipt of an unanticipated seronegative diagnosis, (2) the role of peer support in overcoming fear, and (3) anticipation of missed economic productivity. Increased attention to the timing of demand creation activities, to who delivers information about the HIV prevention benefits of MMC, and to the importance of missed income during recovery as a barrier to uptake promises to strengthen and sharpen future MMC demand creation strategies.

Patient Experiences of Decentralized HIV Treatment and Care in Plateau State, North Central Nigeria: A Qualitative Study.

Background. Decentralization of care and treatment for HIV infection in Africa makes services available in local health facilities. Decentralization has been associated with improved retention and comparable or superior treatment outcomes, but patient experiences are not well understood. Methods. We conducted a qualitative study of patient experiences in decentralized HIV care in Plateau State, north central Nigeria. Five decentralized care sites in the Plateau State Decentralization Initiative were purposefully selected. Ninety-three patients and 16 providers at these sites participated in individual interviews and focus groups. Data collection activities were audio-recorded and transcribed. Transcripts were inductively content analyzed to derive descriptive categories representing patient experiences of decentralized care. Results. Patient participants in this study experienced the transition to decentralized care as a series of "trade-offs." Advantages cited included saving time and money on travel to clinic visits, avoiding dangers on the road, and the "family-like atmosphere" found in some decentralized clinics. Disadvantages were loss of access to ancillary services, reduced opportunities for interaction with providers, and increased risk of disclosure. Participants preferred decentralized services overall. Conclusion. Difficulty and cost of travel remain a fundamental barrier to accessing HIV care outside urban centers, suggesting increased availability of community-based services will be enthusiastically received.