Acceptance of and Adherence to a Four-Dose RTS,S/AS01 Schedule: Findings from a Longitudinal Qualitative Evaluation Study for the Malaria Vaccine Implementation Programme.

BACKGROUND: The WHO recommended the use of the RTS,S/AS01 malaria vaccine (RTS,S) based on a pilot evaluation in routine use in Ghana, Kenya, and Malawi. A longitudinal qualitative study was conducted to examine facilitators and barriers to uptake of a 4-dose RTS,S schedule. METHODS: A cohort of 198 caregivers of RTS,S-eligible children from communities where RTS,S was provided through the pilot were interviewed three times over a ≈22-month, 4-dose schedule. The interviews examined caregiver perceptions and behaviors. Children's vaccination history was obtained to determine dose uptake. RESULTS: 162 caregivers remained at round 3 (R3); vaccination history was available for 152/162 children. Despite early rumors/fears, the uptake of initial doses was high, driven by vaccine trust. Fears dissipated by R2, replaced with an enthusiasm for RTS,S as caregivers perceived its safety and less frequent and severe malaria. By R3, 98/152 children had received four doses; 34 three doses; 9 one or two doses; and 11 zero doses. The health system and information barriers were important across all under-dose cases. Fears about AEFIs/safety were important in zero-, one-, and two-dose cases. Competing life/livelihood demands and complacency were found in three-dose cases. Regardless of the doses received, caregivers had positive attitudes towards RTS,S by R3. CONCLUSIONS: Findings from our study will help countries newly introducing the vaccine to anticipate and preempt reasons for delayed acceptance and missed RTS,S doses.

Exploring Shigella vaccine priorities and preferences: Results from a mixed-methods study in low- and middle-income settings.

Background: Shigella is the leading bacterial cause of diarrheal mortality in children and can cause long-term effects on growth and development. No licensed Shigella vaccines currently exist but several promising candidates are in development and could be available in the next five years. Despite Shigella being a well-known public health target of the World Health Organization for decades, given current burden estimates and competing preventable disease priorities in low-income settings, whether the availability of an effective Shigella vaccine will lead to its prioritization and widespread introduction among countries at highest risk is unknown. Methods: We conducted a mixed-methods study of national stakeholders and healthcare providers in five countries in Asia and Africa and regional stakeholders in the Pan American Health Organization to identify preferences and priorities for forthcoming Shigella vaccines. Results: In our study of 89 individuals, diarrhea was the most frequently mentioned serious health concern for children under five years. Antimicrobial resistance (AMR) was more often considered very concerning than diarrhea or stunting. Shigella awareness was high but not considered a serious health concern by most stakeholders. Most participants were willing to consider adding a new vaccine to the routine immunization schedule but expressed reservations about a Shigella vaccine because of lower perceived burden relative to other preventable diseases and an already crowded schedule; interest was highest among national stakeholders in countries receiving more financial support for immunization. The priority of a Shigella vaccine rose when participants considered vaccine impacts on reducing stunting and AMR. Participants strongly preferred oral and combination vaccines compared to injectable and a single-antigen presentations, citing greater perceived community acceptability. Conclusions: This study provides a critical opportunity to hear directly from country and regional stakeholders about health priorities and preferences around new vaccines. These findings should inform ongoing Shigella vaccine development efforts and eventual vaccine introduction and implementation planning.

Healthcare provider perspectives on delivering next generation rotavirus vaccines in five low-to-middle-income countries.

BACKGROUND: Live oral rotavirus vaccines (LORVs) have significantly reduced rotavirus hospitalizations and deaths worldwide. However, LORVs are less effective in low- and middle-income countries (LMICs). Next-generation rotavirus vaccines (NGRVs) may be more effective but require administration by injection or a neonatal oral dose, adding operational complexity. Healthcare providers (HPs) were interviewed to assess rotavirus vaccine preferences and identify delivery issues as part of an NGRV value proposition. OBJECTIVE: Determine HP vaccine preferences about delivering LORVs compared to injectable (iNGRV) and neonatal oral (oNGRV) NGRVs. METHODS: 64 HPs from Ghana, Kenya, Malawi, Peru, and Senegal were interviewed following a mixed-method guide centered on three vaccine comparisons: LORV vs. iNGRV; LORV vs. oNGRV; oNGRV vs. iNGRV. HPs reviewed attributes for each vaccine in the comparisons, then indicated and explained their preference. Additional questions elicited views about co-administering iNGRV+LORV for greater public health impact, a possible iNGRV-DTP-containing combination vaccine, and delivering neonatal doses. RESULTS: Almost all HPs preferred oral vaccine options over iNGRV, with many emphasizing an aversion to additional injections. Despite this strong preference, HPs described challenges delivering oral doses. Preferences for LORV vs. oNGRV were split, marked by disparate views on rotavirus disease epidemiology and the safety, need, and feasibility of delivering neonatal vaccines. Although overwhelmingly enthusiastic about an iNGRV-DTP-containing combination option, several HPs had concerns. HP views were divided on the feasibility of co-administering iNGRV+LORV, citing challenges around logistics and caregiver sensitization. CONCLUSION: Our findings provide valuable insights on delivering NGRVs in routine immunization. Despite opposition to injectables, openness to co-administering LORV+iNGRV to improve efficacy suggests future HP support of iNGRV if adequately informed of its advantages. Rationales for LORV vs. oNGRV underscore needs for training on rotavirus epidemiology and stronger service integration. Expressed challenges delivering existing LORVs merit further examination and indicate need for improved delivery.

National stakeholder preferences for next-generation rotavirus vaccines: Results from a six-country study.

BACKGROUND: Currently available live, oral rotavirus vaccines (LORVs) have significantly reduced severe rotavirus hospitalizations and deaths worldwide. However, LORVs are not as effective in low- and middle-income countries (LMIC) where rotavirus disease burden is highest. Next-generation rotavirus vaccine (NGRV) candidates in development may have a greater public health impact where they are needed most. The feasibility and acceptability of possible new rotavirus vaccines were explored as part of a larger public health value proposition for injectable NGRVs in LMICs. OBJECTIVE: To assess national stakeholder preferences for currently available LORVs and hypothetical NGRVs and understand rationales and drivers for stated preferences. METHODS: Interviews were conducted with 71 national stakeholders who influence vaccine policy and national programming. Stakeholders from Ghana, Kenya, Malawi, Peru, Senegal, and Sri Lanka were interviewed using a mixed-method guide. Vaccine preferences were elicited on seven vaccine comparisons involving LORVs and hypothetical NGRVs based on information presented comparing the vaccines' attributes. Reasons for vaccine preference were elicited in open-ended questions, and the qualitative data were analyzed on key preference drivers. RESULTS: Nearly half of the national stakeholders interviewed preferred a highly effective standalone, injectable NGRV over current LORVs. When presented as having similar efficacy to the LORV, however, very few stakeholders preferred the injectable NGRV, even at substantially lower cost. Similarly, a highly effective standalone injectable NGRV was generally not favored over an equally effective oral NGRV following a neonatal-infant schedule, despite higher cost of the neonatal option. An NGRV-DTP-containing combination vaccine was strongly preferred over all other options, whether delivered alone with efficacy similar to current LORVs or co-administered alongside an LORV (LORV + NGRV-DTP) to increase efficacy. CONCLUSION: Results from these national stakeholder interviews provide valuable insights to inform ongoing and future NGRV research and development.

Lessons Learned From Implementing Prospective, Multicountry Mixed-Methods Evaluations for Gavi and the Global Fund.

INTRODUCTION: As global health programs have become increasingly complex, corresponding evaluations must be designed to assess the full complexity of these programs. Gavi and the Global Fund have commissioned 2 such evaluations to assess the full spectrum of their investments using a prospective mixed-methods approach. We aim to describe lessons learned from implementing these evaluations. METHODS: This article presents a synthesis of lessons learned based on the Gavi and Global Fund prospective mixed-methods evaluations, with each evaluation considered a case study. The lessons are based on the evaluation team's experience from over 7 years (2013-2020) implementing these evaluations. The Centers for Disease Control and Prevention Framework for Evaluation in Public Health was used to ground the identification of lessons learned. RESULTS: We identified 5 lessons learned that build on existing evaluation best practices and include a mix of practical and conceptual considerations. The lessons cover the importance of (1) including an inception phase to engage stakeholders and inform a relevant, useful evaluation design; (2) aligning on the degree to which the evaluation is embedded in the program implementation; (3) monitoring programmatic, organizational, or contextual changes and adapting the evaluation accordingly; (4) hiring evaluators with mixed-methods expertise and using tools and approaches that facilitate mixing methods; and (5) contextualizing recommendations and clearly communicating their underlying strength of evidence. CONCLUSION: Global health initiatives, particularly those leveraging complex interventions, should consider embedding evaluations to understand how and why the programs are working. These initiatives can learn from the lessons presented here to inform the design and implementation of such evaluations.