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Pediatric Participant Retention Rates in a Longitudinal Malaria Immunology Study
Anushay Mistry1, Boaz Odwar2, Fredrick Olewe2
1University of Massachusetts Chan Medical School, Worcester, Massachusetts.
Insights
Participant retention in malaria vaccine studies is crucial. Addressing parental concerns about blood draws, especially venous samples, is key to improving pediatric cohort study completion rates.
Area of Science:
- Malariology
- Vaccinology
- Epidemiology
- Public Health
Background:
- Drug-resistant Plasmodium falciparum necessitates new malaria vaccines.
- Immuno-epidemiologic studies of naturally acquired immunity (NAI) identify vaccine targets.
- Pediatric participant retention is vital for longitudinal malaria studies.
Purpose of the Study:
- To assess factors influencing participant retention in a 3-year pediatric malaria vaccine cohort study.
- To identify parental concerns impacting study adherence.
- To inform strategies for improving retention in future clinical trials.
Main Methods:
- Qualitative surveys (focus groups, key informant interviews) with parents/guardians and community health volunteers.
- Two phases of data collection conducted 3 and 15 months post-enrollment.
- Analysis of participant satisfaction and reported concerns regarding study procedures.
Main Results:
- Initial high satisfaction with study participation and healthcare access.
- Concerns arose regarding blood sample handling and venous blood draw volume.
- Missed visits increased when venous blood collection was scheduled, indicating a retention challenge.
Conclusions:
- Parental concerns, particularly about venous blood draws, significantly impact retention in pediatric malaria studies.
- Community engagement and education are potential strategies to mitigate these concerns.
- Addressing participant feedback is essential for successful longitudinal research and vaccine development.
Abstract:
The resurgence of drug-resistant Plasmodium falciparum parasites continues to motivate the development of a safe and efficacious malaria vaccine. Immuno-epidemiologic studies of naturally acquired immunity (NAI) have been a useful strategy to identify new malaria vaccine targets. However, retention of pediatric participants throughout longitudinal studies is essential for gathering comprehensive exposure and outcome data. Within the context of a 3-year cohort (N = 400) study involving monthly finger prick and bi-annual venous blood sample collections, we conducted qualitative surveys to assess factors impacting participant retention. Phase 1 was conducted 3 months after enrollment in July 2018 and phase 2, 12 months later. In phase 1, 236 parents/guardians participated in focus groups and three withdrawn participants and 10 community health volunteers (CHVs) in key informant interviews. Qualitative analysis indicated overall satisfaction with the study, with 61.8% (136/220 respondents) reporting no concerns. Focus group discussants associated attendance with benefits such as improved access to comprehensive healthcare services. Community health volunteers reported concerns over village rumors of inappropriate use of blood samples and dangers associated with venous blood draws. Phase 2 involved 205 parents/guardians and revealed continued satisfaction, with 46.3% (95/205) identifying no concerns, but expressed increasing worries regarding the amount of venous blood sample. This concern was reflected in an uptick of missed visits when venous blood samples were scheduled. Future studies will address parental concerns to determine whether community engagement and education measures increase study retention until completion.
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