Table 4 Level 2 (full text review) draft data abstraction tool (variables and definitions)

Study characteristics

Study unique reference identification number

Author last name, initials

Year of publication

Full title of manuscript

Original language of publication

Geographic location (country) of study

Data collection period (start to end of recruitment)

Data collection method(s)

Reported funding source(s) for study

Indigenous population, community or ethnicity, as defined by study authors and eligibility criteria as reported by authors

Target population (health care providers, vaccine recipients, parents, policy makers etc.)

Source(s) of reported barriers and/or supports

Number of participants in study

Age of included participants [mean (SD), median (IQR), or categorical age, as reported]

Study participants (or cohort of study participants) were < 18 years (Yes = 1, No = 0, Not Reported NR =99)

% female

Female, male, female and male

Describe context of implementation (may include a description of the social, economic, policy, healthcare, organizational or other contextual facets that may influence scale implementation)

Describe study setting, as defined by study authors (may include characteristics of the locations, personnel, resources for implementation and/or criteria for eligibility as an implementation site that are used in the study

Describe ‘other setting’, as defined by study authors

Study aims and objectives

Study design

0 = RCT (Randomized controlled trial)

1 = NRCT (non-randomized controlled trial)

2 = cohort

3 = case control

4 = controlled before-after

5 = interrupted time series

6 = qualitative

7 = cross-sectional survey

8 = scoping, systematic or other synthesis

9 = mixed methods

10 = other

Describe ‘other study design’

Describe sampling strategy

Study inclusion criteria, as reported by study authors

Study exclusion criteria, as reported by study authors

Agency, authority, or group(s) administering vaccine

The environment (clinic, school or other) where the vaccine was delivered

Type and/or batch of vaccine administered

Describe how the vaccine administered (one dose, 3 doses etc.)

Reported vaccination status of study participants (Yes = 1, No = 0)

If yes, describe whether full series, or only partial vaccination etc.

Authors describe explicitly, a health model, framework or theory utilized to frame their study (Yes = 1, No = 0, Not clear = 99)

Did the researchers use or test the model/framework or theory? (Yes = 1, No = 0, Not reported = 99)

Describe model, framework or theory

Reported study limitations

Location of participants (on reserve, off reserve)

Describe location of participants if participants are located off reserve

Relative geographic location as reported by study authors

Reported socioeconomic status of participants

Reported level of education of participants

Reported participant knowledge about vaccination

Reported participant attitudes about vaccination

Reported participant beliefs about vaccination

Reported participant behaviors regarding vaccination

Reported participant knowledge about HPV vaccination

Reported participant attitudes about HPV vaccination

Reported participant beliefs about HPV vaccination

Reported participant behaviors regarding HPV vaccination

Awareness of HPV vaccine

Participants reporting sexually active

Participants reporting prior abnormal pap smear test

Participants reporting previous STI

Participants reporting prior HPV infection

Barriers and Supports

Describe which vaccine type the reported barriers discuss

Describe which vaccine type the reported supports discuss

Describe which vaccine type the recommendations pertain to

Vaccine Intervention Outcomes

Describe primary and other outcomes of the implementation strategy, and how they were measured

Describe primary and other outcomes of the intervention, and how they were measured

Describe the process evaluation objectives and outcomes related to the mechanism by which the strategy is expected to work

Describe the implementation strategy

Describe the HPV-specific implementation strategy

Describe any subgroups or nested studies undertaken in the study

Risk ratios reported

Reported p-values for RR

Odds ratios reported

Reported p-values for OR

Methods for resource use, costs, economic outcomes and analysis for the intervention

Methods for resource use, costs, economic outcomes and analysis for the implementation strategy

Describe the sample sizes, calculations

Describe analytic methods with rationale for methodological choice

Describe subanalyses, representativeness and outcomes of subgroups including those recruited to specific research tasks

Fidelity of the implementation strategy as planned and adaptation to suit context and preferences

Fidelity of delivering the core components of the intervention

Describe contextual changes that may affect outcomes

Describe all important harms or unintended effects for each group

Reported factors influencing vaccine acceptance (study participant attitudes and beliefs)

A rate or quantification of the number or proportion of the study population who received vaccine intervention

A rate or quantification of the number or proportion of the population who refused vaccine intervention

Describe reported factors relating to under-immunization, delay or questioning of vaccines, selecting only certain vaccines, desire to access a trustworthy healthcare provider [Specific description of hesitancy as a barrier (all types of vaccine)]

Describe reported factors relating to under-immunization, delay or questioning of vaccines, selecting only certain vaccines, desire to access a trustworthy healthcare provider [Specific description of hesitancy as a barrier (HPV vaccination)]

CGDA Intervention Category [142] – Informational, Behavioral, Environmental

CDGA Intervention Intensity Level [142] – active engagement to individual, active engagement to population, passive engagement with significant effort, passive engagement with minimal effort

Describe policy, practice or research implications for the intervention, including sustainability

Describe policy, practice or research implications for the implementation strategy, specifically related to scalability

Ethics approval, trial/study registration (and protocol if available), governance of data use, presence of conflicts of interest etc.