May 08, 2026

Implementation of HPV Self-Sampling in Cervical Screening: A Scoping Review of Barriers, Facilitators and Key Challenges (protocol) V.3

  • Daisy Urquhart-Dixon1,
  • Natalia Calanzani1,
  • Lisa Iversen1,
  • Sharon Hanley1
  • 1Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZD, UK
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Protocol CitationDaisy Urquhart-Dixon, Natalia Calanzani, Lisa Iversen, Sharon Hanley 2026. Implementation of HPV Self-Sampling in Cervical Screening: A Scoping Review of Barriers, Facilitators and Key Challenges (protocol). protocols.io https://dx.doi.org/10.17504/protocols.io.e6nvww7e9vmk/v3Version created by Daisy Urquhart-Dixon
License: This is an open access  protocol  distributed under the terms of the  Creative Commons Attribution License,  which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: May 07, 2026
Last Modified: May 08, 2026
Protocol  Integer ID: 316567
Keywords: Cervical screening, self-sampling, HPV, implementation strategies, process evaluation, COM-B, informing future cervical screening programme, cervical screening programme, future cervical screening programme, women in cervical screening programme, implementation studies of cervical screening, sampling in cervical screening, cervical screening, hpv self, implementation of hpv self, human papillomavirus, hpv, screening, independent screening, scoping review guidance, sampling intervention, based screening, rayyan for screening, scoping review, scoping review of barrier, text screening against eligibility criteria, review guidance from the joanna briggs institute, success of any intervention, text screening, implementation outcomes such as uptake, reported implementation outcome, screened women
Funders Acknowledgements:
Cancer Research UK
Grant ID: RG-17947-10
Abstract
Introduction: Human papillomavirus (HPV) self-sampling has emerged as a promising strategy to reach under-screened women in cervical screening programmes, particularly among populations hesitant to undergo clinician-based screening. Understanding how to best implement self-sampling and the contextual factors that influence the success of any intervention is essential for informing future cervical screening programmes.
Aim: This scoping review will map the state of the current evidence from process evaluations and implementation studies of cervical screening which incorporates HPV self-sampling, focusing on reported implementation outcomes such as uptake and acceptability, process measures and barriers and facilitators.
Methods: Informed by scoping review guidance from the Joanna Briggs Institute and the PRISMA extension for scoping reviews (PRISMA-ScR), systematic searches using keywords and subject headings will be carried out in MEDLINE, Embase, PsycINFO, Web of Science and Scopus. Grey literature will also be searched, including policy documents, theses and expert group reports. All citations will be imported into RAYYAN for screening, with screening of titles and abstracts for relevance, followed by independent full-text screening against eligibility criteria. We will include primary studies (including programme evaluations and grey literature) published since 2011 (any language, any country) that report on the implementation of self-sampling interventions (adopted strategies, measured outcomes, identified barriers and facilitators). Qualitative, quantitative and mixed-methods designs are eligible for inclusion. Editorials, abstracts from Conference Proceedings (without a full article), commentaries and reviews will be excluded. Data from included studies will be extracted using a purpose-built extraction tool in Microsoft Excel capturing study characteristics, implementation strategies and how they were operationalised, and key barriers and facilitators. Analyses will include descriptive summaries, classification of implementation strategies, thematic synthesis of determinants and mapping of implementation outcomes. Synthesis will be guided by a behaviour change model (COM-B) and implementation outcomes widely described in the literature. Findings will be presented narratively, with quantitative findings presented in tables.
Attachments
Abstract
Introduction: Human papillomavirus (HPV) self-sampling has emerged as a promising strategy to reach under-screened women in cervical screening programmes, particularly among populations hesitant to undergo clinician-based screening. Understanding how to best implement self-sampling and the contextual factors that influence the success of any intervention is essential for informing future cervical screening programmes.
Aim: This scoping review will map the state of the current evidence from process evaluations and implementation studies of cervical screening which incorporates HPV self-sampling, focusing on reported implementation outcomes such as uptake and acceptability, process measures, and barriers and facilitators.
Methods: Informed by scoping review guidance from the Joanna Briggs Institute and the PRISMA extension for scoping reviews (PRISMA-ScR), systematic searches using keywords and subject headings will be carried out in MEDLINE, Embase, PsycINFO, Web of Science and Scopus. Grey literature will also be searched, including policy documents, theses and expert group reports. All citations will be imported into RAYYAN for screening, with screening of titles and abstracts for relevance, followed by independent full-text screening against eligibility criteria. We will include primary studies (including programme evaluations and grey literature) published since 2011 (any language, any country) that report on the implementation of self-sampling interventions (adopted strategies, measured outcomes, identified barriers and facilitators). Qualitative, quantitative and mixed-methods designs are eligible for inclusion. Editorials, abstracts from Conference Proceedings (without a full article), commentaries and reviews will be excluded. Data from included studies will be extracted using a purpose-built extraction tool in Microsoft Excel capturing study characteristics, implementation strategies and how they were operationalised, and key barriers and facilitators. Analyses will include descriptive summaries, classification of implementation strategies, thematic synthesis of determinants and mapping of implementation outcomes. Synthesis will be guided by a behaviour change model (COM-B) and implementation outcomes widely described in the literature. Findings will be presented narratively, with findings presented in figures and tables.
Key Words
Cervical screening; self-sampling; HPV; implementation strategies; process evaluation; COM-B
Introduction/Rationale
Cervical cancer is caused by a persistent infection with one or more high-risk (hr) human papillomavirus (HPV). It is the fourth most common cancer in women globally[1]. In 2022, Globocan reported over 662,301 cases and 348,874 deaths worldwide [2]. Cervical cancer is a disease of inequity, both within and across countries – it remains the second most common cancer among women of reproductive age[3], with a disproportionate burden falling on low- and middle-income countries (LMICs) where nearly 94% of deaths occurred in 2022[1,4]. In Scotland, a high-income country, the number of cancer deaths is four times higher in those living in the most deprived areas compared to those in the least deprived [5]. Lower vaccination uptake (around 75% in comparison to 90% in affluent areas) and lower screening attendance means women in deprived communities are more likely to be diagnosed with cervical cancer at a later stage[5]. To address cervical cancer inequities, in 2020, the World Health Organisation (WHO) launched the Global Initiative for Accelerated Elimination of Cervical Cancer[4,6]. Elimination is defined as <4 cases per 100,000 women. In order to reach and maintain the elimination threshold by 2099, WHO announced three key pillars and corresponding 90-70-90 targets that need to be met by 2030 [4,6]:

  • Vaccination: 90% of girls fully vaccinated with HPV vaccine by age 15 years
  • Screening: 70% of women are screened with a high-performance test by 35 years of age and again by 45 years of age
  • Treatment: 90% of women with cervical disease receive treatment (90% of women with precancer, and 90% of women with invasive cancer managed)

While vaccination will drive elimination, improving screening coverage will accelerate time to elimination as there are still women who were not eligible for vaccination, who do not have access to vaccination, or are vaccine-hesitant due to misinformation [7–9]. Most vaccination guidelines around the world recommend routine HPV vaccination to girls between the ages of 9-14, and where feasible, boys and high-risk individuals, such as men who have sex with men and sex workers [10]. Many at-risk individuals who were born before the vaccination threshold or do not fall into high-risk categories are left unprotected[11], and therefore screening is their primary means of prevention[12].

There are many reasons for non-attendance at cervical screening, such as embarrassment, fear of pain or what the test may find, lack of awareness, history of trauma, practical barriers, or various religious or cultural influences[13]. Self-sampling using a vaginal swab for high-risk HPV offers privacy, convenience and the potential to reduce fear, stigma and discomfort associated with clinician-taken samples[14]. It can expand coverage in both established and resource-limited screening contexts[15,16], and is recommended by the WHO to improve uptake in under screened individuals and non-attenders[17]. Evidence suggests it is acceptable and cost-effective for under-screened populations[16].
The transition from cytology to HPV testing as the primary method of cervical cancer screening has enabled the introduction of self-sampling as an alternative for individuals facing barriers to clinic-based screening[18]. Cytology requires a cervical sample and involves the use of a speculum to visualise the cervix for this sample to be taken[19] – one of the main reasons many women avoid attending screening as this is often an uncomfortable procedure [20]. Primary HPV testing, however, tests if the virus that causes cervical cancer is present, and this can be detected in the vagina, meaning that there is no need for cervical visualisation with a speculum[21].

Despite growing interest, there are limited process evaluations of self-sampling implementation for cervical screening, particularly analyses grounded in behaviour change frameworks[22] and implementation theories/frameworks. Incorporating theory and frameworks when implementing an intervention helps researchers understand the underlying factors that explain how and why the intervention does – or does not – work[23,24]. Process evaluation is essential for understanding the how and why interventions work, or fail, in specific contexts[25,26]. Without it, there is a risk of scaling interventions that are ineffective or inequitable. For cervical screening, where cultural norms, health system structures and resource availability vary widely, process evaluations help identify factors that can influence real-world uptake and impact.

This scoping review aims to map the state of the current evidence from process evaluations and implementation studies of cervical cancer screening programmes incorporating HPV self-sampling. The aim will be met by addressing three questions:

  • Which implementation outcomes and process factors have been investigated?
  • What are the reported barriers and facilitators to implementation?
  • Which theoretical models, frameworks and implementation science approaches have been used?
Methods
Protocol and registration:
This scoping review will be conducted following the guidance of PRISMA extension for scoping reviews (PRISMA-ScR)[27], in accordance with the Joanna Briggs Institute methodology for scoping reviews[28]. This review title will be registered with Protocols.io (https://dx.doi.org/10.17504/protocols.io.e6nvww7e9vmk/v2)
Eligibility Criteria:
The PCC acronym (Population, Concept, Context) was utilised to establish the inclusion criteria.

This review will include studies involving women eligible for cervical cancer screening, primary care providers, programme implementers, policymakers and other stakeholders involved in self-sampling cervical screening.

The core concept of interest is cervical screening through implementation of HPV self-sampling. An inclusive approach will be adopted for implementation outcomes, process measures and barriers and facilitators to allow for the inclusion of studies adopting different methodologies, informed by different theories and frameworks. Expected outcomes/measures include feasibility, acceptability, uptake, dosage, reach, fidelity, appropriateness, adoption, penetration, sustainability, contextual factors, and mechanisms of impact.

All geographic settings, health system contexts and service delivery models will be considered. Studies from countries of all income level will be eligible. No restrictions will be placed on setting (e.g., community-based, primary care, laboratory-based, screening programme settings) or language.

Given the objective of a scoping review is to map existing evidence, a wide range of study designs will be included, consistent with PRISMA‑ScR guidance[27], to encompass all relevant evidence types that can inform understanding of implementation phenomena in the context of HPV self-sampling. Qualitative, quantitative and mixed-methods designs are eligible for inclusion. We will include primary studies (including programme evaluations and grey literature) published since 2011. This year was chosen as this was when evidence on the COM-B model (Capability, Opportunity, Motivation and Behaviour) was first published[22]. Editorials, abstracts from Conference Proceedings (without a full article), commentaries and reviews will be excluded. Reference lists of relevant reviews identified in searches will be checked.
Information Sources and Search Strategy:
An initial limited search of MEDLINE (Ovid) was undertaken to identify articles on the topic. The text words contained in the titles and abstracts of relevant articles, and the index terms used to describe the articles were used to develop a full search strategy for MEDLINE, Embase, PsycINFO (all Ovid), Web of Science, and Scopus (see Appendix I). A search strategy was developed with the assistance of an expert librarian for Medline using keywords and their synonyms (including “cervical cancer screening”, “self‑sampling”, “implementation”, “process evaluation” and “COM‑B”) and subject headings. The Medline search strategy was adapted for each included database and/or information source. The reference lists of included sources will be screened for additional eligible primary studies.

Sources of unpublished studies and grey literature include policy documents, expert group reports, organisational publications (WHO, IARC, national screening bodies), theses and dissertations (ProQuest).
Selection of Sources of Evidence:
All identified citations will be collated and uploaded into the RAYYAN software[29] and duplicates will be removed. Titles and abstracts will be screened for relevance, and potentially relevant full-text sources will then be independently screened against eligibility criteria by DUD, with second screening performed between NC, LI and SH. Full text not freely available online will be requested via the University of Aberdeen’s Library services. The results of the search and the study inclusion process will be reported in and presented in a PRISMA flow diagram[30]
Data Extraction and Data Items:
Data will be extracted from included papers using a purpose-built data extraction tool. The data extracted will include specific details about the study (name, year), design, setting, implementation strategy, how this strategy was operationalised, outcomes measured, theories and frameworks that informed each study, key findings for the implementation outcomes, and barriers and facilitators to implementation. The form will first be piloted on two included papers and results compared to ensure consistency between reviewers. The draft data extraction tool will then be modified and revised as necessary before data extraction for the remaining included studies – a draft extraction tool is attached in the appendices (Appendix II). Any modifications will be detailed in the scoping review manuscript. Data extraction will be carried out by DUD, and checked by NC, LI or SH, with an additional 30% of studies being extracted independently by at least two reviewers. If required, authors of papers will be contacted to request missing or additional data.
Data Analysis:
Data analysis will focus on providing a descriptive overview of the implementation strategies used to support HPV self-sampling for cervical cancer screening, alongside the contextual factors that influence delivery, adherence, and reported outcomes. Extracted data will be summarised using basic descriptive techniques (study characteristics, populations, settings and implementation approaches).

In keeping with the scoping review methodology, no synthesis of outcomes or meta-analysis will be undertaken. Qualitative data will be analysed descriptively, using simple coding to categorise information relevant to implementation determinants, reported barriers and facilitators. To support conceptual clarity, these findings will then be mapped using the COM-B model and the TDF (Theoretical Domains Framework) as an organising framework to categorise determinants relating to capability, opportunity and motivation, and further classify barriers, facilitators and intervention functions.
Using COM-B and TDF provides a transparent and contemporary structure for describing behavioural determinants within implementation research. Limiting the search to studies published after the development of COM-B ensures that the included research is informed by, or compatible with, current behaviour change theory. All analytic decisions will be explicitly reported to ensure clarity, transparency and justification of the chosen approach.
Acknowledgements
Melanie Bickerton (Librarian at University of Aberdeen) for assistance with search strategy
Funding
Research conducted alongside the AYEScreen study, funded by Cancer Research UK. DUD is supported by a Cancer Research UK PhD studentship (RG-17947-10). The evidence presented here does not represent the views of CRUK.
Potential Conflicts of Interest
SH has received conference support from COPAN.
References
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Appendices
Appendix I:
Search Strategies

MEDLINE 1  Uterine Cervical Neoplasms/   2  cervical cancer*.tw.   3  cervical carcinoma*.tw.   4  uterine cervical dysplasia.tw.   5  (cervix adj4 (cancer* or neoplasm* or carcinoma*)).tw.   6  Papillomavirus Infections/   7  (human papilloma virus* or human papiloma virus* or human papillomavirus* or human papilomavirus* or papillomaviridae or HPV or high-risk HPV or high risk HPV or hrHPV).tw.   8  1 or 2 or 3 or 4 or 5 or 6 or 7   9  (self-sampl* or self sampl* or selfsampl* or self-collect* or self collect* or selfcollect* or self-test* or self test* or selftest* or self-screen* or self screen* or selfscreen* or home-based test* or home based test* or home test* or home-test* or hometest* or pharmacy-based test* or pharmacy based test* or self-administer* or self administer* or selfadminister*).tw.   10  (acceptance or acceptab* or uptake or adopt* or implement* or feasibil* or fidelity or barrier* or facilitat* or challeng* or cost* or penetrat* or sustainab* or evaluat* or utiliz* or utilis*).tw.   11  (process evaluation or nested or program theory or programme theory or RE-AIM or CFIR or CICI or Implementation Outcome* or Behaviour Change Wheel or BCW or Normali?ation Process Theory or NPT or COM-B or TDF or Theoretical Domains Framework or MRC Framework or Medical Research Council Framework or theory of change or logic model).tw.   12  10 or 11   13  8 and 9 and 12   14  limit 13 to yr="2011 -Current"   Embase 1              exp uterine cervix cancer/ or exp uterine cervix neoplasm/         2              cervical cancer?.tw.             3              cervical carcinoma?.tw.      4              (uterine cervical dysplasia or cervical intraepithelial neoplasia or CIN).tw.                5              (cervix adj4 (cancer? or neoplasm? or carcinoma?)).tw.              6              (human papilloma virus* or human papiloma virus* or human papillomavirus* or human papilomavirus* or papillomaviridae or HPV or high-risk HPV or high risk HPV or hrHPV).tw.              7              1 or 2 or 3 or 4 or 5 or 6      8              (self-sampl* or self sampl* or selfsampl* or self-collect* or self collect* or selfcollect* or self-test* or self test* or selftest* or self-screen* or self screen* or selfscreen* or home-based test* or home based test* or home test* or home-test* or hometest* or pharmacy-based test* or pharmacy based test* or self-administer* or self administer* or selfadminister*).tw.  9              7 and 8   10           (acceptance or acceptab* or uptake or adopt* or implement* or feasibil* or fidelity or barrier* or facilitat* or challeng* or cost* or penetrat* or sustainab* or evaluat* or utiliz* or utilis*).tw.        11            (process evaluation or nested or program theory or programme theory or RE-AIM or CFIR or CICI or Implementation Outcome* or Behaviour Change Wheel or BCW or Normali?ation Process Theory or NPT or COM-B or TDF or Theoretical Domains Framework or MRC Framework or Medical Research Council Framework or theory of change or logic model).tw.          12           10 or 11 13           7 and 9 and 12     14           limit 13 to yr="2011 -Current"             PsycINFO 1              (((cervical cancer* or cervical carcinoma* or cervix) adj4 (cancer* or neoplasm* or carcinoma*)) or uterine cervical dysplasia or cervical intraepithelial neoplasia or CIN).tw.               2              (human papilloma virus* or human papiloma virus* or human papillomavirus* or human papilomavirus* or papillomaviridae or HPV or high-risk HPV or high risk HPV or hrHPV).tw.              3              1 or 2      4              (self-sampl* or self sampl* or selfsampl* or self-collect* or self collect* or selfcollect* or self-test* or self test* or selftest* or self-screen* or self screen* or selfscreen* or home-based test* or home based test* or home test* or home-test* or hometest* or pharmacy-based test* or pharmacy based test* or self-administer* or self administer* or selfadminister*).tw.  5              3 and 4   6              (acceptance or acceptab* or uptake or adopt* or implement* or feasibil* or fidelity or barrier* or facilitat* or challeng* or cost* or penetrat* or sustainab* or evaluat* or utiliz* or utilis*).tw.        7              (process evaluation or nested or program theory or programme theory or RE-AIM or CFIR or CICI or Implementation Outcome* or Behaviour Change Wheel or BCW or Normali?ation Process Theory or NPT or COM-B or TDF or Theoretical Domains Framework or MRC Framework or Medical Research Council Framework or theory of change or logic model).tw.          8              6 or 7      9              5 and 8   10           limit 9 to yr="2011 -Current"               Scopus TITLE-ABS-KEY ( ( "cervical cancer*" OR "cervical carcinoma*" OR "uterine cervical dysplasia" OR ( cervix W/4 ( cancer* OR neoplasm* OR carcinoma* ) ) OR "Papillomavirus Infections" OR "human papilloma virus*" OR "human papiloma virus*" OR "human papillomavirus*" OR "human papilomavirus*" OR "papillomaviridae" OR "HPV" OR "high-risk HPV" OR "high risk HPV" OR "hrHPV" ) AND ( "self-sampl*" OR "self sampl*" OR "selfsampl*" OR "self-collect*" OR "self collect*" OR "selfcollect*" OR "self-test*" OR "self test*" OR "selftest*" OR "self-screen*" OR "self screen*" OR "selfscreen*" OR "home-based test*" OR "home based test*" OR "home-test*" OR "home test*" OR "hometest*" OR "pharmacy-based test*" OR "pharmacy based test*" OR "self-administer*" OR "self administer*" OR "selfadminister*" ) AND ( "acceptance" OR "acceptab*" OR "uptake" OR "adopt*" OR "implement*" OR "feasibil*" OR "fidelity" OR "barrier*" OR "facilitat*" OR "challeng*" OR "cost*" OR "penetrat*" OR "sustainab*" OR "evaluat*" OR "utiliz*" OR "utilis*" OR "process evaluation" OR "nested" OR "program theory" OR "programme theory" OR "RE-AIM" OR "CFIR" OR "CICI" OR "Implementation Outcome*" OR "Behaviour Change Wheel" OR "BCW" OR "Normali?ation Process Theory" OR "NPT" OR "COM-B" OR "TDF" OR "Theoretical Domains Framework" OR "MRC Framework" OR "Medical Research Council Framework" OR "theory of change" OR "logic model" ) ) AND PUBYEAR > 2011 Web of Science TS=(("Uterine Cervical Neoplasms" OR "cervical cancer*" OR "cervical carcinoma*" OR "uterine cervical dysplasia" OR ("cervix" NEAR/4 ("cancer*" OR "neoplasm*" OR "carcinoma*")) OR "Papillomavirus Infections" OR "human papilloma virus*" OR "human papiloma virus*" OR "human papillomavirus*" OR "human papilomavirus*" OR “papillomaviridae” OR “HPV” OR "high-risk HPV" OR "high risk HPV" OR "hrHPV") AND ("self-sampl*" OR "self sampl*" OR “selfsampl*” OR "self-collect*" OR "self collect*" OR “selfcollect*” OR "self-test*" OR "self test*" OR “selftest*” OR "self-screen*" OR "self screen*" OR “selfscreen*” OR "home-based test*" OR "home based test*" OR "home-test*" OR "home test*" OR “hometest*” OR "pharmacy-based test*" OR "pharmacy based test*" OR "self-administer*" OR "self administer*" OR “selfadminister*”) AND (“acceptance” OR “acceptab*” OR “uptake” OR “adopt*” OR “implement*” OR “feasibil*” OR “fidelity” OR “barrier*” OR “facilitat*” OR “challeng*” OR “cost*” OR “penetrat*” OR “sustainab*” OR “evaluat*” OR “utiliz*” OR “utilis*” OR "process evaluation" OR “nested” OR "program theory" OR "programme theory" OR "RE-AIM" OR "CFIR" OR "CICI" OR "Implementation Outcome*" OR "Behaviour Change Wheel" OR “BCW” OR "Normali?ation Process Theory" OR “NPT” OR "COM-B" OR "TDF" OR "Theoretical Domains Framework" OR "MRC Framework" OR "Medical Research Council Framework" OR "theory of change" OR "logic model"))
ProQuest TI,AB,SU( ( "cervical cancer*" OR "cervical carcinoma*" OR "uterine cervical dysplasia" Or (cervix NEAR/4 (cancer* OR neoplasm* OR carcinoma*)) OR "papillomavirus infections" OR "human papilloma virus*" OR "human papiloma virus*" OR "human papillomavirus*" OR "human papilomavirus*" OR "papillomaviridae" OR "HPV" OR "high-risk HPV" OR "high risk HPV" OR "hrHPV") AND ( "self-sampl*" OR "self sampl*" OR selfsampl* OR "self-collect*" OR "self collect*" OR selfcollect* OR "self-test*" OR "self test*" OR selftest* OR "self-screen*" OR "self screen*" OR “selfscreen*” OR "home-based test*" OR "home based test*" OR "home-test*" OR "home test*" OR hometest* OR "pharmacy-based test*" OR "pharmacy based test*" OR "self-administer*" OR "self administer*" OR “selfadminister*”) AND (“acceptance” OR “acceptab*” OR “uptake” OR “adopt*” OR “implement*” OR “feasibil*” OR “fidelity” OR “barrier*” OR “facilitat*” OR “challeng*” OR “cost*” OR “penetrat*” OR “sustainab*” OR “evaluat*” OR “utiliz*” OR “utilis*” OR "process evaluation" OR “nested” OR "program theory" OR "programme theory" OR "RE-AIM" OR "CFIR" OR "CICI" OR "Implementation Outcome*" OR "Behaviour Change Wheel" OR “BCW” OR "Normali?ation Process Theory" OR “NPT” OR "COM-B" OR "TDF" OR "Theoretical Domains Framework" OR "MRC Framework" OR "Medical Research Council Framework" OR "theory of change" OR "logic model”) AND PD (>2011) )

Appendix II:
Data Extraction Tool


ABCDEFGHIJK
Citation Study aim Study characteristics Theoretical Foundations Intervention/implementation strategy Screening approach Resources Outcomes Barriers Facilitators Evidence gaps/future needs
Author (year) Primary research question or objective Design, Methods and Population/Setting Theory/framework used and rationale/how it informed the study Strategy components, delivery, fidelity and quality assurance Delivery method and additional mechanisms (opt in/out, reminders, incentives) Cost/requirements Outcomes measured/implementation outcomes (adoption, reach, acceptability, feasibility, fidelity, sustainability…) List of barriers identified List of facilitators identified Identified gaps/needs

Protocol references
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