{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T12:18:29Z","timestamp":1788005909875,"version":"build-2784847793"},"update-to":[{"DOI":"10.12688\/wellcomeopenres.26218.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T00:00:00Z","timestamp":1787961600000}},{"DOI":"10.12688\/wellcomeopenres.26218.2","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T00:00:00Z","timestamp":1787961600000}}],"reference-count":37,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T00:00:00Z","timestamp":1787961600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Wellcome under CREATE PhD Scheme","award":["223492_Z_21_Z"],"award-info":[{"award-number":["223492_Z_21_Z"]}]}],"content-domain":{"domain":["wellcomeopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Wellcome Open Res"],"abstract":"<ns3:p>Background Acquired epidermodysplasia verruciformis (aEV) is a skin condition caused by increased vulnerability to cutaneous human papillomaviruses. aEV disproportionately affects people who acquire HIV perinatally. There are no accepted diagnostic criteria for aEV. The lack of routine diagnosis has limited research into this condition. There are no community prevalence estimates, no evidence-based treatments and no cohort studies to understand the risk of skin malignancy. Most people with perinatally-acquired HIV, live in low-resource settings without access to specialist skin doctors or skin biopsies. There is therefore a need to develop diagnostic criteria that can be used by non-specialists and are applicable in low-resource settings. Aim This Delphi study aims reach consensus on screening and diagnostic criteria for HIV-associated aEV which are applicable in both high and low resource settings. Methods Modified Delphi methodology will be used to achieve expert consensus. A panel of 20\u201330 experts with at least 5\u00a0years\u2019 experience in HIV or dermatology and experience with aEV will be asked to complete a series of surveys. Firstly, they will contribute all possible features of aEV. They will then rate these features in terms of importance. This will be used to guide the creation of draft diagnostic criteria. Panellists will rate their agreement with each criterion and adoption of the criteria as a whole. This will continue until consensus is reached. Consensus is defined a priori as when more than &gt;60% of the panel either agree or strongly agree with each criterion and\u00a0\u2265\u00a080% of the panel with the adoption of criteria as a whole. Expected Outcomes A screening tool to identify people with possible aEV who warrant further examination. A set of diagnostic criteria that can be applied in real world settings to diagnose aEV. Ethical Approval This study has been approved by the LSHTM Research Ethics Committee (Reference: 33189.)<\/ns3:p>","DOI":"10.12688\/wellcomeopenres.26218.3","type":"journal-article","created":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T11:44:07Z","timestamp":1788003847000},"page":"276","update-policy":"https:\/\/doi.org\/10.12688\/wellcomeopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["HIVE MIND - Establishing diagnostic criteria for HIV associated acquired epidermodysplasia verruciformis: an international Delphi study."],"prefix":"10.12688","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3865-6534","authenticated-orcid":false,"given":"Sophie H","family":"Kelly","sequence":"first","affiliation":[{"name":"London England London School of Hygiene & Tropical Medicine"},{"name":"Harare Harare Province Biomedical Research and Training Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen L","family":"Walker","sequence":"additional","affiliation":[{"name":"London England London School of Hygiene & Tropical Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0452-0196","authenticated-orcid":false,"given":"Nicola","family":"Willis","sequence":"additional","affiliation":[{"name":"Harare Zvandiri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7660-9176","authenticated-orcid":false,"given":"Rashida A","family":"Ferrand","sequence":"additional","affiliation":[{"name":"London England London School of Hygiene & Tropical Medicine"},{"name":"Harare Harare Province Biomedical Research and Training Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L Claire","family":"Fuller","sequence":"additional","affiliation":[{"name":"London England Chelsea and Westminster Hospital NHS Foundation Trust"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eneyi","family":"Kpokiri","sequence":"additional","affiliation":[{"name":"London England London School of Hygiene & Tropical Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vimbainashe","family":"Karimatsenga","sequence":"additional","affiliation":[{"name":"Harare Harare Province University of Zimbabwe"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sin\u00e9ad M","family":"Langan","sequence":"additional","affiliation":[{"name":"London England London School of Hygiene & Tropical Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2560","published-online":{"date-parts":[[2026,8,29]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"315-320","DOI":"10.1016\/j.jaad.2008.08.035","article-title":"Acquired epidermodysplasia verruciformis.","volume":"60","author":"H Rogers","year":"2009","journal-title":"J Am Acad Dermatol."},{"key":"ref2","doi-asserted-by":"publisher","first-page":"394-398","DOI":"10.1046\/j.1468-3083.2003.00703.x","article-title":"Clinical aspects of epidermodysplasia verruciformis.","volume":"17","author":"W Oliveira","year":"2003","journal-title":"J Eur Acad Dermatol Venereol."},{"key":"ref3","doi-asserted-by":"publisher","first-page":"579-581","DOI":"10.1038\/ng1044","article-title":"Mutations in two adjacent novel genes are associated with epidermodysplasia verruciformis.","volume":"32","author":"N Ramoz","year":"2002","journal-title":"Nat Genet."},{"key":"ref4","doi-asserted-by":"publisher","first-page":"128-130","DOI":"10.1001\/archdermatol.2011.268","article-title":"Acquired epidermodysplasia verruciformis syndrome in HIV-infected pediatric patients: Prospective treatment trial with topical glycolic acid and human papillomavirus genotype characterization.","volume":"148","author":"R Moore","year":"2012","journal-title":"Arch Dermatol."},{"key":"ref5","doi-asserted-by":"publisher","first-page":"e119-e123","DOI":"10.1093\/cid\/cis118","article-title":"Acquired epidermodysplasia verruciformis due to multiple and unusual HPV infection among vertically-infected, HIV-positive adolescents in Zimbabwe.","volume":"54","author":"S Lowe","year":"2012","journal-title":"Clin Infect Dis."},{"key":"ref6","doi-asserted-by":"publisher","first-page":"346-351","DOI":"10.1097\/INF.0b013e3181c15da4","article-title":"Skin disease among human immunodeficiency virus-infected adolescents in Zimbabwe: A strong indicator of underlying HIV infection.","volume":"29","author":"S Lowe","year":"2010","journal-title":"Pediatr Infect Dis J."},{"key":"ref7","doi-asserted-by":"publisher","first-page":"1023-1025","DOI":"10.1177\/0956462415613933","article-title":"Acquired epidermodysplasia verruciformis in an HIV-positive patient.","volume":"27","author":"C Lau","year":"2016","journal-title":"Int. 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Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/11-276\/v3\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/11-276\/v3\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/11-276\/v3\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T11:44:09Z","timestamp":1788003849000},"score":1,"resource":{"primary":{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/11-276\/v3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,29]]},"references-count":37,"URL":"https:\/\/doi.org\/10.12688\/wellcomeopenres.26218.3","relation":{"has-version":[{"id-type":"doi","id":"10.12688\/wellcomeopenres.26218.2","asserted-by":"subject"},{"id-type":"doi","id":"10.12688\/wellcomeopenres.26218.1","asserted-by":"subject"}]},"ISSN":["2398-502X"],"issn-type":[{"value":"2398-502X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,29]]},"assertion":[{"value":"Indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/11-276\/v3#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/wellcomeopenres.29831.r159617, Tarun Narang, Post Graduate Institute of Medical Education and Research, Chandigarh, Punjab, 17 Jul 2026, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/11-276\/v2#referee-response-159617","order":0,"name":"referee-response-159617","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.29831.r159618, I Made Dwi Mertha Adnyana, Universitas Jambi, Jambi, 13 Jul 2026, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/11-276\/v2#referee-response-159618","order":1,"name":"referee-response-159618","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Sophie Kelly<\/b>; \n<i>Posted: 05 Aug 2026<\/i>; Dear Reviewer, We\n<i>&nbsp;would like to thank you for your ongoing review. We have made significant improvements based on the comments provided and believe that the concerns raised have been adequately addressed.&nbsp;<\/i> &nbsp;  \n<b>Comment 1 <\/b> This event is to be attended by at least 15 participants from Africa, as well as at least one participant from each of the other four regions. It is clear that one participant per region is a very low threshold for claiming meaningful regional clinical representation. The authors must tone down the claim of &quot;globally relevant&quot; in the title to a more precise phrase, such as &quot;criteria informed by a globally representative but Africa-weighted panel.&quot; &nbsp;  \n<i>We have moderated this claim in both the title and subsequent text. &nbsp;The title now reads<\/i>\n<i>: HIVE MIND - Establishing diagnostic criteria for HIV associated acquired epidermodysplasia verruciformis: an international Delphi study. <\/i> &nbsp;  \n<b>Comment 2<\/b> The additional sentences merely cite two systematic reviews without synthesising their main findings (lesion types, geographic distribution of cases, and reported diagnostic limitations). Add two to three sentences summarising the findings of Cuestas et al. (2024) and Moore et al. (2022) to strengthen the empirical basis of the introduction. &nbsp;  \n<i>We have made some changes to the structure of the introduction to improve flow and added the following text: <\/i> &nbsp; \u201cClinical and scientific knowledge of HIV-associated aEV is predominantly based on descriptions of patients in case report and case series, small cohort studies and two systematic reviews.\n<sup>4,5<\/sup> Sixty percent (n=48) of the 80 reported cases in the systematic review by Cuestas et al., were in people from Africa.\n<sup>4<\/sup> The remainder of the cases were from the Americas (n = 17), Europe (n=14) and Asia (n=1).\n<sup>4<\/sup> The described clinical presentation was predominantly of widespread flat warts, hypopigmented macules and pityriasis versicolour-like lesions across the face upper limbs and upper trunk.\n<sup>4,5<\/sup> There was no standard method of diagnosis, with biopsy carried out in 37.5% of cases and HPV typing carried out in 73.5%; the most detected genotypes were 5, 20 and 8.\n<sup>4<\/sup>\u201d &nbsp;  \n<b>Comment 3<\/b> The author's response in the reply letter was scientifically honest regarding the risk of malignancy associated with aEV versus classic EV, but that statement does not appear to have been directly included in the &quot;Discussion&quot; or &quot;Limitations&quot; sections of the manuscript. An explicit sentence must be added to the &quot;Limitations&quot; section stating that the risk of malignancy associated with aEV cannot yet be assumed to be equivalent to that of congenital EV. &nbsp;  \n<i>Many thanks for this comment. We have added the following sentences to the introduction and discussion to make this clear. <\/i> &nbsp;  \n<b>Introduction <\/b> \u201cThis is not routine practice for patients with HIV-associated aEV in the global south and, although some cases have been reported, the rate of progression to malignancy is not known.\n<sup>4,15\u201318\u201d<\/sup> &nbsp;  \n<b>Discussion<\/b> \u201cAt present, the risk of progression to malignancy in patients with aEV is not known and cannot be assumed to be the same as that of those with congenital EV. An agreed definition of aEV is the first step in designing epidemiological studies to assess this.\u201d  \n<b>Comment 4<\/b> The argument for avoiding priming bias is consistent with the principles of the classical Delphi method (J&uuml;nger et al., CREDES 2017). The protocol does not yet explain the mechanism for the completeness check. Specifically, it does not say whether the steering committee will compare the list of items from Round 1 against the findings of the literature review. This would be used to identify aEV phenotypes that may have been overlooked by the panel, prior to drafting Round 3. It is imperative that this step is added to verify the completeness of the literature case data. &nbsp;  \n<i>Many thanks. We have added the following paragraph to make this clearer. &nbsp;<\/i> &nbsp; \u201cThe steering committee will also review a collated summary of the published literature following round 2.  The features present in the literature review will be compared to those rated as important by the panel. If discrepancies are present, these will be discussed and features added for rating by the expert panellists in round 3 if necessary.\u201d &nbsp;  \n<i>We have also added a preliminary validation step: <\/i> \u201cPreliminary Validation Exercise Once consensus on the diagnostic criteria has been reached, two members of the steering committee will independently go through each biopsy confirmed case identified in the literature review and apply the agreed criteria based on reported clinical findings and\/or photographs. The proportion meeting the consensus criteria will be reported and any cases not meeting the criteria discussed and reported in detail.\u201d &nbsp; &nbsp;  \n<b>Comment 5 <\/b> The CAB's role has been explained, but the resolution mechanism for cases where the CAB's input differs from the expert panel's rating has not yet been outlined in procedural terms. We recommend adding a specific escalation process. The steering committee must retain the final decision, and written justification must be provided if it deviates from the CAB's input.  &nbsp; \n<i>We have added this step to the methods - many thanks. <\/i> &nbsp; \u201cCAB input will be sought at key points throughout the study.&nbsp; The CAB will be asked for their feedback on the draft diagnostic criteria following round 3.&nbsp; If there is significant disagreement between the CAB members responses and the responses of the panellists, this will be discussed by the steering committee. The steering committee will retain the final decision. If there is significant deviation, then this will be recorded with written justification and fed back to the CAB who will be given opportunity to respond.\u201d &nbsp; &nbsp;  Many thanks again for your input.&nbsp;  Yours sincerely, Sophie Kelly on behalf of the co-authors","URL":"https:\/\/wellcomeopenresearch.org\/articles\/11-276\/v3#referee-comment-6688","order":2,"name":"referee-comment-6688","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.29831.r160213, Luis Alberto Ribeiro Fr\u00f3es J\u00fanior, Universidade de Sao Paulo, S\u00e3o Paulo, State of S\u00e3o Paulo, 22 Jul 2026, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/11-276\/v2#referee-response-160213","order":3,"name":"referee-response-160213","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Sophie Kelly<\/b>; \n<i>Posted: 05 Aug 2026<\/i>; \n<i>We would like to thank the reviewer for taking the time to thoroughly review our protocol. We hope that we have adequately addressed the concerns raised with the changes set out below.<\/i> This is a relevant and well-motivated protocol addressing an important diagnostic gap. The modified Delphi design is appropriate, but two methodological issues require clarification.  &nbsp; \n<b>Comment 1 <\/b> First, individual diagnostic criteria may be retained with only 60% agreement. This threshold permits substantial disagreement within the panel. The authors should provide a stronger justification or require strong consensus for core diagnostic criteria, with moderate-consensus items classified separately as supportive features.  \n<i>We have clarified this. The \u201cEssential\u201d criteria require over 80% agreement, suggesting that they are nearly always present in cases of AEV; \u201cSupportive\u201d criteria will require over 60% agreement allowing features to be included that are supportive but not present in all cases. <\/i> &nbsp; \u201cFeatures with a median value higher than 60\/100 will be considered for inclusion in the draft diagnostic criteria by the steering committee. Those with scores between 60 and 79 will be included in the draft \u201csupportive\u201d criteria; to reflect that they are present in some but not all cases of aEV. In line with similar studies, all features with a median of \u226580\/100 will be included in the draft diagnostic criteria.\n<sup>24&nbsp; <\/sup>The steering committee will discuss each feature for inclusion in either the \u201cessential\u201d or \u201csupportive\u201d criteria. The final decision will rest with the steering committee to reflect that some features may be consistent but still may not be essential to diagnosis.\u201d  &nbsp; \n<b>Comment 2<\/b> Second, the steering committee retains considerable discretion in coding and consolidating Round 1 responses, integrating the literature review, and deciding whether to include items scoring 60\u201379. These procedures should be predefined and reported transparently. The protocol should also include a formal comparison between panel-generated items and the literature review to identify potentially omitted features. &nbsp; &nbsp; \u201cThe steering committee will also review a collated summary of the published literature following round 2. The features present in the literature review will be compared to those rated as important by the panel. If discrepancies are present, these will be discussed and features added for rating by the expert panellists in round 3 if necessary. A record of these discussions will be maintained for transparency.\u201d  \n<i>We have added a step at the end of the process where the case report literature is reviewed to see the proportion biopsy confirmed cases would meet the criteria based on their reported findings and photographs included.&nbsp; &nbsp;<\/i> &nbsp; \u201cPreliminary Validation Exercise Once consensus on the diagnostic criteria has been reached, two members of the steering committee will independently go through each biopsy confirmed case identified in the literature review and apply the agreed criteria based on reported clinical findings and\/or photographs. The proportion meeting the consensus criteria will be reported and any cases not meeting the criteria discussed in detail.\u201d  \n<b>Comment 3<\/b> The claim of global relevance should be moderated because representation outside the African region may consist of only one participant per WHO region. External validation will remain necessary before the criteria can be considered broadly generalizable.  &nbsp; \n<i>We have moderated this claim in the title and throughout the text. We have added a preliminary validation step based on the published literature but have plans for external validation following this process in a separate study.<\/i> &nbsp; \n<i>The title now reads:<\/i>\n<i> HIVE MIND - Establishing diagnostic criteria for HIV associated acquired epidermodysplasia verruciformis: an international Delphi study.<\/i> &nbsp; &nbsp;  Many thanks for your input.  &nbsp; Yours sincerely, Sophie Kelly on behalf of all co-authors","URL":"https:\/\/wellcomeopenresearch.org\/articles\/11-276\/v3#referee-comment-6689","order":4,"name":"referee-comment-6689","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This work is funded by Wellcome CREATE Grant reference:  223492_Z_21_Z, as part of SHK\u2019s doctoral fellowship. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":5,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}