Protocol for a cervical screening implementation trial comparing two approaches for delivering HPV self-collection in low-resource settings in India: a type 3 hybrid cluster randomised controlled trial (SHE-CAN)

Probably not a substantial claim: may not pass S3 (load-bearing).

The 12 Group 1 carcinogenic HPV types have been grouped according to their prevalence in cervical cancer into Groups 1a, 1b, 1c, and 1d.

“The 12 Group 1 carcinogenic HPV types have been recently grouped according to their prevalence in cervical cancer, which is a marker of their carcinogenicity, into Groups 1a (HPV 16: most carcinogenic), 1b (HPV types 18 and 45), 1c (HPV types 31,33,35,52,58) and 1d (39,51,56,59 - least carcinogenic).37 38”

• cites [37] sourceCould not verify

  The section “Classification of weakly carcinogenic human papillomavirus types” says HPV types differ in carcinogenic potential and identifies HPV 16 and 18 as powerful carcinogens, but it does not give the claimed 12-type classification into Groups 1a–1d. Searches for those group labels and for classification by prevalence in cervical cancer found no supporting passage in our truncated copy. (LLM, conf=0.72)

  Experimental — accuracy not yet measured
• cites [38] World Health Organization . Target product profiles for human papillomavirus screening tests to detect cervical pre-cancer and cancer, 2024. Available: https://www.who.int/publications/i/item/9789240100275 [Accessed 20 Jan 2025]. sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

canSCREEN has been successfully used in projects in other low- and middle-income countries including Papua New Guinea, Malaysia, Kenya and Vanuatu.

“canSCREEN has been successfully used in projects in other low- and middle-income countries including Papua New Guinea, Malaysia, Kenya and Vanuatu.33 35”

• cites [33] Australian Centre for the Prevention of Cervical Cancer . Digital health - canSCREEN, Available: https://acpcc.org.au/services/digital-health [Accessed 12 Feb 2025].Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [35] Woo, 2022, The Implementation of a Primary HPV Self-Testing Cervical Screening Program in Malaysia through Program ROSE-Lessons Learnt and Moving Forward, Curr Oncol sourcePartly supported

  Section 4.3 says canSCREEN powered Program ROSE’s digital registry in Malaysia and helped staff identify participants overdue for follow-up. Section 5 reports the program’s screening reach and linkage to care. The paper does not report canSCREEN projects in Papua New Guinea, Kenya or Vanuatu, so it supports the Malaysia example but not the full country list. (LLM, conf=0.87)

  Experimental — accuracy not yet measured

May combine two claims.

Vulnerable groups such as tribal populations have shown a higher prevalence of HPV infection and face significant challenges to screening and follow-up.

“Vulnerable groups such as tribal populations have shown a higher prevalence of HPV infection and also face significant challenges to screening and follow-up.16 19”

• cites [16] Oommen, 2024, Strategies for primary HPV test-based cervical cancer screening programme in resource-limited settings in India: Results from a quasi-experimental pragmatic implementation trial, PLoS One sourceSupported
• cites [19] Ghosh, 2019, Human papilloma and other DNA virus infections of the cervix: A population based comparative study among tribal and general population in India, PLoS One sourcePartly supported

  The Results (Prevalence of viral infections; page unavailable) report HPV prevalence of 40.6% among tribal women versus 14.3% in the general population. The paper describes screening camps and recommends future follow-up studies, but the passages found do not establish that tribal women face significant challenges accessing screening or clinical follow-up. (LLM, conf=0.88)

  Experimental — accuracy not yet measured

May combine two claims.

Self-collection is highly acceptable across settings internationally and helps overcome major barriers to cervical screening using cytology or VIA.

“Self-collection is highly acceptable across settings internationally and helps overcome some of the major barriers to cervical screening using cytology or VIA, including stigma, shame, embarrassment, past trauma, fear and shortage of time, space, and healthcare workers to undertake speculum-based screening.913”

• cites [9] Creagh NS , Boyd LAP , Bavor C , et al . Self-Collection Cervical Screening in the Asia-Pacific Region: A Scoping Review of Implementation Evidence. JCO Global Oncology 2023;e2200297. doi:10.1200/GO.22.00297 sourcePartly supported

  The Discussion (page unavailable) describes self-collection as highly acceptable across diverse Asia-Pacific settings and says this concurs with global reviews. The Introduction and Results say it can reduce barriers associated with clinician-collected, speculum-based screening, including embarrassment and the need for trained providers. Our copy does not establish that it overcomes barriers specific to VIA, or substantiate every listed barrier, such as past trauma and shortages of space. (LLM, conf=0.86)

  Experimental — accuracy not yet measured
• cites [13] Mishra, 2025, Acceptability and validity of HPV self-sampling for cervical cancer screening among women living in different ecological settings in India, Int J Cancer sourcePartly supported

  The Introduction says studies in several countries found HPV self-sampling well accepted and explains that avoiding a speculum examination can reduce discomfort and allow testing at home. The Discussion reports high acceptance across the study’s urban and rural Indian settings and identifies stigma and embarrassment as screening barriers. Our copy does not establish that self-collection overcomes past trauma or shortages of screening space and healthcare workers, as the full citing sentence claims. (LLM, conf=0.85)

  Experimental — accuracy not yet measured

May combine two claims.

In India, coverage of VIA cervical screening is low (1.9% ever screened) due to multiple provider- and recipient-related barriers.

“While India’s current policy solution of Visual Inspection of the cervix with Acetic acid (VIA)2 is primarily based on affordability, the coverage achieved is low (1.9% ever screened)3 due to multiple provider and recipient-related barriers.4”

• cites [2] Ministry of health and family welfare, Government of India . National programme for prevention and control of non communicable diseases (np-ncd) guidelines. Available: https://mohfw.gov.in/?q=Major-Programmes/non-communicable-diseases-injury-trauma/Non-Communicable-Disease-II/National-Programme-for-Prevention-and-Control-of-Cancer-Diabetes-Cardiovascular-diseases-and-Stroke-NPCDCS [Accessed Feb 2025].Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [3] Gopika, 2022, Status of cancer screening in India: An alarm signal from the National Family Health Survey (NFHS-5), J Family Med Prim Care sourcePartly supported

  The Results (‘Cancer screening participation in India’) report that 1.9% of women in India had ever undergone cervical cancer screening, supporting the low-coverage figure. The figure is for cervical screening overall, not VIA specifically. The provider- and recipient-related barriers carry a separate citation in the citing sentence and are not assessed against this source. (LLM, conf=0.86)

  Experimental — accuracy not yet measured
• cites [4] Nyblade, 2017, A qualitative exploration of cervical and breast cancer stigma in Karnataka, India, BMC Womens Health sourcePartly supported

  The Background identifies healthcare-system and psychosocial barriers to screening, and the Results (Consequences of stigma; Manifestations of stigma) describe fear of stigma and distrust of provider confidentiality as reasons women may avoid cervical screening. But this qualitative study in Karnataka does not establish that those barriers caused India’s low VIA screening coverage. The 1.9% figure is attached to a different citation in the citing sentence. (LLM, conf=0.82)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

Scheduled Tribe populations rate lower on social and health indicators compared with the rest of the population.

“These populations rate lower on social and health indicators compared with the rest of the population24 and form around 8.6% of the country’s population.25”

• cites [24] Saha, 2020, Water quality, sanitation, and hygiene among the tribal community residing in Jawadhi hills, Tamilnadu: An observational study from Southern India, J Family Med Prim Care sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Tamil Nadu and Mizoram have higher rates of cervical cancer incidence and mortality compared with most other Indian states.

“These states have higher rates of cervical cancer incidence and mortality compared with most other Indian states, with greatly differing health systems and cultures.23”

• cites [23] Singh, 2022, Secular trends in incidence and mortality of cervical cancer in India and its states, 1990-2019: data from the Global Burden of Disease 2019 Study, BMC Cancer sourceSupported

May combine two claims.

HPV-based cervical screening every 5 years is more accurate and cost-effective than 3 yearly VIA screening and decreases both incidence and mortality due to cervical cancer.

“HPV-based cervical screening every 5 years is more accurate and cost-effective than 3 yearly VIA screening and decreases both incidence and mortality due to cervical cancer.6 7”

• cites [6] Simms, 2023, Benefits, harms and cost-effectiveness of cervical screening, triage and treatment strategies for women in the general population, Nat Med sourceSupported
• cites [7] sourcePartly supported

  The sections on HPV DNA testing compared with VIA and on screening effectiveness report better detection of precancerous lesions and greater reductions in cervical cancer and associated mortality with HPV testing. The copy does not establish the specific comparison of HPV screening every five years with VIA every three years, or show that the former is more cost-effective. It describes VIA as low-cost but does not provide that economic comparison. (LLM, conf=0.88)

  Experimental — accuracy not yet measured

May combine two claims.

Home or community-based screening has been evaluated in many countries and is now part of screening policy and routine practice in many countries, and this has led to improved screening rates among unscreened women.

“This has led to improved screening rates among unscreened women.8 9 16 18 48”

• cites [8] Arbyn, 2018, Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses, BMJ sourceSupported
• cites [9] Creagh NS , Boyd LAP , Bavor C , et al . Self-Collection Cervical Screening in the Asia-Pacific Region: A Scoping Review of Implementation Evidence. JCO Global Oncology 2023;e2200297. doi:10.1200/GO.22.00297 sourcePartly supported

  The Discussion (page unavailable) reports that reviews found mail-out and door-to-door self-collection effective in increasing screening participation. The Results (Implementation Outcome Measures; page unavailable) report uptake in an underscreened group, but do not establish that screening rates improved specifically among previously unscreened women. (LLM, conf=0.82)

  Experimental — accuracy not yet measured
• cites [16] Oommen, 2024, Strategies for primary HPV test-based cervical cancer screening programme in resource-limited settings in India: Results from a quasi-experimental pragmatic implementation trial, PLoS One sourcePartly supported

  The Discussion reports about 30% screening uptake in eight months with the self-sampling programme, compared with 6–8% annually under the existing visual-inspection programme at the rural site. Results show that most participants had not been screened in the previous three years, but the paper does not establish an improvement specifically among never-screened women or isolate the effect of home- or community-based screening from the programme’s other components. (LLM, conf=0.82)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

One study offered home-based self-collection following an initial round of facility-based screening, showing a greater response for home-based screening (58% vs 46%).

“One study offered home-based self-collection following an initial round of facility-based screening, showing a greater response for home-based screening (58% vs 46%),10”

• cites [10] sourceSupported

May combine two claims.

Challenges to cancer screening in the Indian setting include a historical lack of a culture of prevention, inequality in healthcare access (especially for women), stigma and myths regarding cancer, all of which result in low uptake and follow-up, even when screening and treatment services are available.

“Challenges to cancer screening in the Indian setting include a historical lack of a ‘culture of prevention’, inequality in healthcare access (especially for women), stigma and myths regarding cancer, all of which result in low uptake and follow-up, even when screening and treatment services are available.4”

• cites [4] Nyblade, 2017, A qualitative exploration of cervical and breast cancer stigma in Karnataka, India, BMC Womens Health sourcePartly supported

  Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  Experimental — accuracy not yet measured

Classified as probably not a substantial claim.

HPV-based screening is more effective than VIA screening.

“This trial is an implementation research trial that accepts a priori, on the basis of existing local and international evidence, that HPV-based screening is more effective than VIA screening6”

• cites [6] Simms, 2023, Benefits, harms and cost-effectiveness of cervical screening, triage and treatment strategies for women in the general population, Nat Med sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Another study reported that during the pandemic period home-based self-collection enabled maintaining the same numbers of women reached for screening as in the pre-pandemic period when facility-based provider collection had been used.

“whereas another study reported that during the pandemic period home-based self-collection enabled maintaining the same numbers of women reached for screening as in the pre-pandemic period when facility-based provider collection had been used.55”

• cites [55] Bose, 2023, A Study of the Impact and Restitutive Efforts of Cervical Cancer Screening during the COVID-19 Pandemic in a Regional Cancer Centre in Eastern India, Asian Pac J Cancer Prev sourceSupported

May combine two claims.

Previous studies from India have demonstrated that home-based approaches are feasible and effective.

“Previous studies from India have demonstrated that home-based approaches are feasible and effective, as shown in studies from Andhra Pradesh, Tamil Nadu and West Bengal.10 46 47”

• cites [10] sourceSupported
• cites [46] Peedicayil, 2016, Community Prevalence of Human Papillomavirus by Self-Collected Samples in South India, Indian J Gynecol Oncolog sourceNot checked — no full text of the source
• cites [47] Basu, 2019, A pilot study to evaluate home-based screening for the common non-communicable diseases by a dedicated cadre of community health workers in a rural setting in India, BMC Public Health sourcePartly supported

  The Conclusions report that home-based NCD prevention and screening by community health workers was feasible and well accepted in the study population. They also say that its effectiveness needs further evaluation, so this paper does not support the claim that effectiveness was demonstrated. (LLM, conf=0.90)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

The trial will be reported using the Consolidated Standards of Reporting Trials checklist and its extension for cluster RCTs.

“The trial will be reported using the Consolidated Standards of Reporting Trials checklist and its extension for cluster RCTs.43”

• cites [43] sourceSupported

Classified as probably not a substantial claim.

The study will document the nature of any modifications, rationale, timing and the decision-making process.

“We will document the nature of any modifications, rationale, timing and the decision-making process.44”

• cites [44] Miller, 2021, The FRAME-IS: a framework for documenting modifications to implementation strategies in healthcare, Implement Sci sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Another study in Kenya compared community campaign-based self-collection to facility-based self-collection, based on the standard screening approach in the country.

“Another study in Kenya also compared community campaign-based self-collection to facility-based self-collection, which was also based on the standard screening approach in the country.49”

• cites [49] Huchko, 2017, Study protocol for a cluster-randomized trial to compare human papillomavirus based cervical cancer screening in community-health campaigns versus health facilities in western Kenya, BMC Cancer sourceSupported

May combine two claims.

Extended genotyping to determine whom to treat based on risk has been shown to improve sensitivity for the detection of CIN 3+ and facilitate safe deferring of colposcopy if the HPV types are of lower carcinogenic potential (Group d).

“Extended genotyping (inclusion of the next most carcinogenic types - Group 1c) to determine whom to treat based on risk has also been shown to improve sensitivity for the detection of CIN 3+ and facilitate safe deferring of colposcopy if the HPV types are of lower carcinogenic potential (Group d).51 52”

• cites [51] Bukowski, 2022, Extended Human Papillomavirus Genotyping to Predict Progression to High-Grade Cervical Precancer: A Prospective Cohort Study in the Southeastern United States, Cancer Epidemiol Biomarkers Prev sourcePartly supported

  The Discussion (page unavailable) supports the potential use of extended genotyping to distinguish progression risks and guide more conservative management. But this study assessed CIN2+ risk in patients already referred for colposcopy, not improved sensitivity for detecting CIN3+ or the safety of deferring colposcopy. Its Results also report that the lowest-risk genotype group had a five-year CIN2+ risk similar to the intermediate groups. (LLM, conf=0.90)

  Experimental — accuracy not yet measured
• cites [52] Benevolo, 2024, Comparison of HPV-positive triage strategies combining extended genotyping with cytology or p16/ki67 dual staining in the Italian NTCC2 study, EBioMedicine sourcePartly supported

  Table 3 (Results, page unavailable) shows that one extended-genotyping strategy detected a greater proportion of CIN3 immediately than a partial-genotyping strategy. The Discussion (Main findings, page unavailable) supports deferring colposcopy for a low-risk group, but only when genotype is combined with negative cytology or dual staining; the study evaluates triage and retesting, not whom to treat directly. (LLM, conf=0.85)

  Experimental — accuracy not yet measured

May combine two claims.

Tribal areas in both states have common challenges such as poor roads, high cost and distance of transport to secondary care facilities, representing areas that are least included in most studies.

“Tribal areas in both states have common challenges such as poor roads, high cost and distance of transport to secondary care facilities, representing areas that are least included in most studies.56”

• cites [56] Kumar, 2020, Tribal population in India: A public health challenge and road to future, J Family Med Prim Care sourcePartly supported

  The Present Scenario: Disease Burden section describes geographically isolated tribal habitats, and Status of healthcare delivery system reports shortages of facilities and specialists in tribal areas. The paper does not establish poor roads, transport costs or distance to secondary care as common challenges in the two states, nor does it say these areas are least included in most studies. No page numbers were available in our copy. (LLM, conf=0.82)

  Experimental — accuracy not yet measured

Classified as probably not a substantial claim.

Stakeholders in all settings rejected same day screen and treat using a point-of-care HPV test.

“Stakeholders in all settings rejected the idea of same day screen and treat (using a point-of-care HPV test to give same day results) as this could be too overwhelming for women, pose difficulties in maintaining confidentiality of results and require a large number of women to wait for their test results on the same day in outreach clinics.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Stakeholders emphasised the critical role of in-community group education and including males in community sessions to facilitate community-level acceptance and understanding.

“Stakeholders emphasised the critical role of in-community group education and including males in community sessions, to facilitate community level acceptance and understanding.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Tamil Nadu, there was a need to develop new culturally appropriate educational content.

“However, for Tamil Nadu, there was a need to develop new culturally appropriate content.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The play developed by tribal female volunteers was piloted among health providers and in two tribal villages and received positive feedback and suggestions for improvement.

“This play was piloted among both health providers (doctors, nurses, social workers) as well as in two tribal villages and received positive feedback and suggestions for improvement.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Stakeholders preferred a triage step for HPV positive women to reduce the potential for overtreatment.

“They also preferred a triage step for HPV positive women to reduce the potential for overtreatment.”

Classified as probably not a substantial claim.

Stakeholders preferred a camp-based approach that offers group education and is sufficiently close to homes, such that women can collect samples at the campsite in a private room/toilet or at homes if nearby.

“Hence, the stakeholders preferred a camp-based approach that offers the possibility for group education and is sufficiently close to homes, such that women can either collect samples at the campsite in a private room/toilet or at homes (if nearby).”

May combine two claims.

The co-design phase revealed that in these low-resource settings, peers often influence decisions, and discussion and informed decisions may be better made collectively.

“Our co-design phase revealed that in these low-resource settings where the trial is to be conducted, peers often influence decisions, and discussion and informed decisions may be better made collectively.”

Classified as probably not a substantial claim.

All consenting HPV positive women requiring treatment will undergo biopsy before treatment to confirm disease burden, positive predictive value of the tests and identify occult cancers.

“All consenting HPV positive women requiring treatment will undergo biopsy before treatment, to confirm disease burden, positive predictive value of the tests and identify occult cancers.”

Classified as probably not a substantial claim. May combine two claims.

No biopsies will be taken from screen negative women because determining sensitivity of the screening test is not an objective of this study.

“No biopsies will be taken from screen negative women, as determining sensitivity of the screening test is not an objective of this study, with these parameters well studied in multiple trials.”

Classified as probably not a substantial claim.

Ethics approval has been obtained from the listed committees.

“Ethics approval has been obtained from the Institutional Review Board (IRB) and Ethics Committee of the Christian Medical College Vellore, Tamil Nadu, India (IRB Min. No 14314; INTERVEN)”

Probably not a substantial claim: may not pass S3 (load-bearing).

Written informed consent will be obtained from participants.

“Written informed consent will be obtained from participants.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The trial has been registered with the Clinical Trials Registry - India: CTRI/2022/04/042327.

“The trial has been registered with the Clinical Trials Registry - India: CTRI/2022/04/042327.”

May combine two claims.

The age group 30-49 years is targeted for HPV-based screening in line with WHO guidelines because the possibility of detecting precancers is highest in this age group.

“The age group targeted for HPV-based screening will be 30–49 years, in line with the WHO guidelines,30 as the possibility of detecting precancers is highest in this age group.”

• cites [30] World Health Organization . WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, second edition: use of mrna tests for human papillomavirus (hpv. Geneva; 2021. Available: https://apps.who.int/iris/handle/10665/350652 [Accessed 12 Feb 2025].Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Generalisability is limited to similar settings and populations in India.

“- Generalisability is limited to similar settings and populations in India.”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

We used appropriate statistical methods to calculate the sample size required to detect meaningful differences.

“We used appropriate statistical methods (described later) to calculate the sample size required to detect meaningful differences.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The study is approved by the State Scientific Advisory Committee, Directorate of Public Health and Preventive Medicine, Chennai, Tamil Nadu.

“The study is also approved by the State Scientific Advisory Committee, Directorate of Public Health and Preventive Medicine, Chennai, Tamil Nadu (R. No. 011575/HEB/A2/2023).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Quality control in each laboratory will be undertaken by running known samples periodically to confirm accuracy.

“Quality control in each laboratory will be undertaken by running known samples periodically to confirm accuracy.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The Alfred Hospital Approval is recognised and registered with the University of Melbourne Human Research Ethics Committee.

“The Alfred Hospital Approval, as an authorised Australian ethics committee for national mutual recognition, is recognised and registered with the University of Melbourne Human Research Ethics Committee (2024-25255-57650-1).”

Probably not a substantial claim: may not pass S3 (load-bearing).

The trial protocol was prepared based on SPIRIT guidelines.

“The protocol has been prepared based on the Standard Protocol Items: Recommendations for Interventional Trials guidelines (online supplemental additional file 1).29”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

The SHE-CAN study settings represent similar physically and culturally hard-to-access populations present across India that are rarely included in cervical screening trials.

“The SHE-CAN study settings represent similar physically and culturally hard-to-access populations present across the country that are rarely included in cervical screening trials.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

A total of 426 clusters were assessed for eligibility, of which 343 were excluded, and 28 clusters were selected.

“A total of 426 clusters were assessed for eligibility, of which 343 were excluded, either because implementing the study would not be logistically feasible in those clusters or screening studies had already been implemented in those areas (figure 1).”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

This trial is the first cluster randomised controlled trial from India comparing two implementation approaches for offering self-collection.

“- First cluster randomised controlled trial from India comparing two implementation approaches for offering self-collection.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

As a study funded by a foreign agency, clearance has been obtained from the Health Ministry Screening Committee (HMSC), under the Indian Council for Medical Research.

“As a study funded by a foreign agency, we have obtained clearance from the Health Ministry Screening Committee (HMSC), under the Indian Council for Medical Research.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The informed consent process at screening will include information about the research, its objectives and methods, the need for screening, the method used (self-collection), and options for treatment for those with a positive screening test, followed by written consent obtained by the CHW/research staff.

“The informed consent process at the time of screening will include information about the research, its objectives and methods, information about the need for screening, the method used (self-collection), and options for treatment for those with a positive screening test, followed by written consent obtained by the CHW/research staff (form in online supplemental additional file 3).”

Probably not a substantial claim: may not pass S3 (load-bearing).

All aspects of the study will be conducted according to the amended Declaration of Helsinki.

“All aspects of the study will be conducted according to the amended Declaration of Helsinki.”

Probably not a substantial claim: may not pass S3 (load-bearing).

A Steering Committee will actively monitor participation, HPV positivity rates, disease detection rates and any adverse events and troubleshoot and refine implementation in an ongoing way.

“A Steering Committee will actively monitor participation, HPV positivity rates, disease detection rates and any adverse events and troubleshoot and refine implementation in an ongoing way.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The study is also approved by the State Scientific Advisory Committee, Directorate of Public Health and Preventive Medicine, Chennai, Tamil Nadu.

“The study is also approved by the State Scientific Advisory Committee, Directorate of Public Health and Preventive Medicine, Chennai, Tamil Nadu (R. No. 011575/HEB/A2/2023).”

Classified as probably not a substantial claim.

Analysis of clusters will be by intention to treat.

“Analysis of clusters will be by intention to treat.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Separate consent will be obtained for treatment at the time of follow-up visit at the referral clinics, by the treating physician.

“Separate consent will be obtained for treatment at the time of follow-up visit at the referral clinics, by the treating physician.”

Probably not a substantial claim: may not pass S3 (load-bearing).

A recent analysis highlighted the need to identify the eight most carcinogenic types in HPV-based screening.

“A recent analysis highlighted the need to identify the eight most carcinogenic types in HPV-based screening.39 53”

• cites [39] Wei, 2024, Causal attribution of human papillomavirus genotypes to invasive cervical cancer worldwide: a systematic analysis of the global literature, The Lancet sourceNot checked — no full text of the source
• cites [53] Schiffman, 2024, The rational design of cervical cancer prevention strategies, The Lancet sourceNot checked — no full text of the source

May combine two claims.

Because both arms use validated, standard clinical practices for screening and treatment, which are the same in both arms with only the location of screening differing, there is no standalone Safety and Data Monitoring Committee.

“As both arms use validated, standard clinical practices for screening and treatment, which are the same in both arms with only the location of screening differing, there is no standalone Safety and Data Monitoring Committee.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Although the trial will be unblinded, randomisation and revealing of the allocation sequence will occur only at the time of starting the trial.

“Although the trial will be an unblinded study, randomisation and revealing of the allocation sequence will occur only at the time of starting the trial.”

Probably not a substantial claim: may not pass S4 (based). May combine two claims.

A door-to-door community-based approach implies individual counselling and a personal decision of the woman to screen.

“However, a door-to-door community-based approach implies individual counselling and a personal decision of the woman to screen.”

May combine two claims.

Both trial arms are designed to be implementable in vulnerable populations and follow the same diagnostic/treatment approaches for women who return a positive screening test, although there are differences between sites based on differences in the health systems between each setting.

“Both trial arms are designed to be implementable in vulnerable populations and follow the same diagnostic/treatment approaches for women who return a positive screening test, although there are differences between sites based on differences in the health systems between each setting.”

Classified as probably not a substantial claim.

Adjustment for clustering will be included in both the univariate and multivariate regression models.

“Adjustment for clustering will be included in both the univariate and multivariate regression models.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Current options for triage tests include cytology, p16/Ki-67 dual-staining cytology, partial genotyping, VIA and colposcopy±biopsy.

“Current options for triage tests include cytology, p16/Ki-67 dual-staining cytology, partial genotyping (prioritising the most carcinogenic Group 1a-b HPV types 16 and 18 for further assessment or treatment), VIA and colposcopy±biopsy.30”

• cites [30] World Health Organization . WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, second edition: use of mrna tests for human papillomavirus (hpv. Geneva; 2021. Available: https://apps.who.int/iris/handle/10665/350652 [Accessed 12 Feb 2025].Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Ethics approval has been obtained from the Institutional Review Board (IRB) and Ethics Committee of the Christian Medical College Vellore, Tamil Nadu, India; the Alfred Hospital Ethics Committee, Melbourne, Australia; the IARC Ethics Committee, Lyon, France; the Salem Polyclinic Institutional Ethics Committee, Tamil Nadu, India; and the Institutional Ethics Committee, Civil Hospital, Aizawl, Mizor

“Ethics approval has been obtained from the Institutional Review Board (IRB) and Ethics Committee of the Christian Medical College Vellore, Tamil Nadu, India (IRB Min. No 14314; INTERVEN), the Alfred Hospital Ethics Committee (HREC Ref 80134, Local Reference: project 601/21), Melbourne, Australia, the IARC Ethics Committee (IEC 21-32), Lyon, France”

Probably not a substantial claim: may not pass S3 (load-bearing).

A community advisory group of around 4-8 members at each study site has and will continue to contribute to all study phases from co-design through to assessment of sustainability.

“A community advisory group of around 4–8 members at each study site has and will continue to contribute to all study phases from co-design through to assessment of sustainability.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

All study processes involve obtaining individual informed consent from participants as well as community consent from key community leaders.

“All study processes involve obtaining individual informed consent from participants as well as community consent from key community leaders.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Compliance with the trial protocol will be monitored, documented and managed by site specific study managers with oversight from Indian based CIs.

“Compliance with the trial protocol will be monitored, documented and managed by site specific study managers with oversight from Indian based CIs.”

May combine two claims.

The only RCT on cervical cancer screening from India compared provider collected HPV-based screening to cytology and VIA-based screening, demonstrating the greater effectiveness of a single round of HPV screening in reducing mortality.

“The only RCT on cervical cancer screening from India compared provider collected HPV-based screening to cytology and VIA-based screening, demonstrating the greater effectiveness of a single round of HPV screening in reducing mortality.54”

• cites [54] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

The Alfred Hospital Approval, as an authorised Australian ethics committee for national mutual recognition, is recognised and registered with the University of Melbourne Human Research Ethics Committee.

“The Alfred Hospital Approval, as an authorised Australian ethics committee for national mutual recognition, is recognised and registered with the University of Melbourne Human Research Ethics Committee (2024-25255-57650-1).”

Classified as probably not a substantial claim.

The implementation trial approach allows for deviations and adaptation to maximise the likelihood of successful implementation of the intervention approach in the real-world setting.

“The implementation trial approach allows for deviations and adaption to maximise the likelihood of successful implementation of the intervention approach in the real-world setting.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Approval has been obtained from the district health authorities in both states.

“Approval has been obtained from the district health authorities in both states.”

May combine two claims.

Home-based screening offers the advantage of screening in the privacy of homes and reduces the costs and time involved in travelling to a health centre, especially for asymptomatic women who have low motivation for such screening.

“Home-based screening offers the advantage of screening in the privacy of homes and reduces the costs and time involved in travelling to a health centre, especially for asymptomatic women who have low motivation for such screening.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Block randomisation will be done to randomise clusters into Arm one and Arm two, using computer generated random numbers, by an offsite statistician, using Stata V.17.0, with allocation ratio 1:1 in each arm.

“Block randomisation will be done to randomise clusters into Arm one and Arm two, using computer generated random numbers, by an offsite statistician, using Stata V.17.0, with allocation ratio as 1:1 in each arm.”

Probably not a substantial claim: may not pass S2 (checkable), S4 (based).

With careful documentation of fidelity to the intended implementation, implementation trials are able to generate key learnings about reasons for implementation success or failure and how and why any adaptations were necessary.

“With careful documentation of fidelity to the intended implementation, implementation trials are able to generate key learnings about reasons for implementation success or failure and how and why any adaptations were necessary.”