{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T18:50:08Z","timestamp":1791831008996,"version":"4.3.4"},"reference-count":43,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100006808","name":"University of North Carolina","doi-asserted-by":"publisher","award":["5-K12-HD103085-04"],"award-info":[{"award-number":["5-K12-HD103085-04"]}],"id":[{"id":"10.13039\/100006808","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["1R34CA284983-0"],"award-info":[{"award-number":["1R34CA284983-0"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100011072","name":"Center for AIDS Research, University of North Carolina at Chapel Hill","doi-asserted-by":"publisher","award":["5-P30-AI050410"],"award-info":[{"award-number":["5-P30-AI050410"]}],"id":[{"id":"10.13039\/100011072","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cancer Control"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), who account for 90% of deaths from the disease. Human papillomavirus (HPV) is responsible for 99% of cervical cancer cases. Women living with HIV (WLWH) have a higher risk of persistent HPV infection and a greater likelihood of developing cervical cancer. Prevention of cervical cancer requires effective screening and precancer treatment programs. In LMICs, the common treatment method for cervical precancer is thermal ablation. However, for WLWH, thermal ablation is associated with high rates of persistent HPV infection following treatment, a key risk factor for precancer recurrence. Adjuvant topical treatments with cytotoxic or antiviral properties may reduce HPV persistence following ablation. Preclinical and early-phase clinical trials indicate that topical artesunate is active against HPV-associated anogenital lesions, including cervical precancer, and can induce HPV clearance. Consequently, intravaginal artesunate may improve HPV clearance following thermal ablation, although no clinical trials have investigated this.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We are conducting a phase II, double-blind, randomized, placebo-controlled trial among 120 HIV seropositive women in Kenya to investigate the feasibility of self-administered intravaginal artesunate pessaries as adjuvant therapy following thermal ablation treatment for cervical precancer. The primary outcome is type-specific HPV clearance 6 months after randomization. Secondary outcomes are safety, adherence, acceptability, uptake, and retention. Participants will be enrolled at least 4 weeks after ablation and will self-administer pessaries on weeks 1, 3, and 5, with alternating drug-free weeks. Study follow-up will extend to 24 weeks after randomization.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>High rates of persistent HPV infection in WLWH is a key limitation of thermal ablation, the most accessible cervical precancer treatment in LMICs. This trial will investigate the feasibility of repurposing topical artesunate as an adjuvant therapy to improve HPV clearance following thermal ablation in WLWH.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      identifier: NCT06519994\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10732748251374418","type":"journal-article","created":{"date-parts":[[2025,9,4]],"date-time":"2025-09-04T20:47:56Z","timestamp":1757018876000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["Feasibility of Intravaginal Artesunate as an Adjuvant HPV &amp; Cervical Precancer Treatment Among Women Living With HIV in Kenya: Study Protocol for a Phase II Clinical Trial"],"prefix":"10.1177","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4496-0030","authenticated-orcid":false,"given":"Annum","family":"Sadana","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology, University of North Carolina Chapel Hill, Chapel Hill, NC, USA"},{"name":"New York University Grossman School of Medicine, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jackton","family":"Omoto","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Maseno University School of Medicine, Kisumu, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine","family":"Sorgi","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, University of North Carolina Chapel Hill, Chapel Hill, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Rahangdale","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, University of North Carolina Chapel Hill, Chapel Hill, NC, USA"},{"name":"Center for AIDS Research, University of North Carolina Chapel Hill, Chapel Hill, NC, USA"},{"name":"Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, Chapel Hill, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer S.","family":"Smith","sequence":"additional","affiliation":[{"name":"Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, Chapel Hill, NC, USA"},{"name":"Department of Epidemiology, University of North Carolina Chapel Hill, Chapel Hill, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mihaela","family":"Plesa","sequence":"additional","affiliation":[{"name":"Frantz Medical Development, Ltd, Mentor, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3655-4721","authenticated-orcid":false,"given":"Chemtai","family":"Mungo","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, University of North Carolina Chapel Hill, Chapel Hill, NC, USA"},{"name":"Center for AIDS Research, University of North Carolina Chapel Hill, Chapel Hill, NC, USA"},{"name":"Department of Epidemiology, University of North Carolina Chapel Hill, Chapel Hill, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,9,4]]},"reference":[{"key":"e_1_3_6_2_2","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21834"},{"key":"e_1_3_6_3_2","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21660"},{"key":"e_1_3_6_4_2","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21696"},{"key":"e_1_3_6_5_2","volume-title":"Global Strategy to Accelerate the Elimination of Cervical Cancer as a Public Health Problem","year":"2020","unstructured":"Global Strategy to Accelerate the Elimination of Cervical Cancer as a Public Health Problem. 1st ed. World Health Organization; 2020.","edition":"1"},{"key":"e_1_3_6_6_2","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2016.86"},{"key":"e_1_3_6_7_2","unstructured":"World Health Organization and Special Programme of Research Development. Research training in human reproduction (world health organization) - 2021 - WHO guideline for screening and treatment of cervi.pdf. https:\/\/iris.who.int\/bitstream\/handle\/10665\/342365\/9789240030824-eng.pdf?sequence=1&isAllowed=y. Accessed 31 January 2025."},{"key":"e_1_3_6_8_2","doi-asserted-by":"publisher","DOI":"10.1002\/ijgo.12191"},{"key":"e_1_3_6_9_2","unstructured":"Kenya Ministry of Health. National cancer screening and early diagnosis guidelines. 2024. Published online."},{"key":"e_1_3_6_10_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-024-03080-w"},{"key":"e_1_3_6_11_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2021.2683"},{"key":"e_1_3_6_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ypmed.2018.10.006"},{"key":"e_1_3_6_13_2","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.34737"},{"key":"e_1_3_6_14_2","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.34221"},{"key":"e_1_3_6_15_2","doi-asserted-by":"publisher","DOI":"10.1097\/LGT.0000000000000525"},{"key":"e_1_3_6_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2015.10.008"},{"key":"e_1_3_6_17_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0298520"},{"key":"e_1_3_6_18_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1004115"},{"key":"e_1_3_6_19_2","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-20-1177"},{"key":"e_1_3_6_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(19)30635-7"},{"key":"e_1_3_6_21_2","doi-asserted-by":"publisher","DOI":"10.1089\/gyn.1988.4.23"},{"key":"e_1_3_6_22_2","doi-asserted-by":"publisher","DOI":"10.1097\/LGT.0000000000000355"},{"key":"e_1_3_6_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.labinv.2025.104166"},{"key":"e_1_3_6_24_2","doi-asserted-by":"publisher","DOI":"10.1055\/a-1202-2157"},{"key":"e_1_3_6_25_2","volume-title":"Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living with HIV","author":"UNC Lineberger Comprehensive Cancer Center","year":"2024","unstructured":"UNC Lineberger Comprehensive Cancer Center. Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living with HIV. clinicaltrials.gov; 2024. https:\/\/clinicaltrials.gov\/study\/NCT05413811. Accessed 27 March 2025."},{"key":"e_1_3_6_26_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13027-021-00370-7"},{"key":"e_1_3_6_27_2","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2021.828856"},{"key":"e_1_3_6_28_2","doi-asserted-by":"publisher","DOI":"10.1186\/1748-717X-9-84"},{"key":"e_1_3_6_29_2","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-05-1216"},{"key":"e_1_3_6_30_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygyno.2019.12.035"},{"key":"e_1_3_6_31_2","unstructured":"SPIRIT 2013 statement: defining standard protocol items for clinical trials | Ann Intern Med. Accessed July 24 2025."},{"key":"e_1_3_6_32_2","volume-title":"Kenya Population and Housing Census","author":"Kenya National Bureau of Statistics","year":"2019","unstructured":"Kenya National Bureau of Statistics. In: Kenya Population and Housing Census. Kenya National Bureau of Statistics; 2019."},{"key":"e_1_3_6_33_2","unstructured":"National Syndemic Diseases Control Council. HIV 10 year progress report. 2024."},{"key":"e_1_3_6_34_2","unstructured":"National Syndemic Diseases Control Council. Kenya HIV estimates portal. 2025. Published online."},{"key":"e_1_3_6_35_2","article-title":"Human papillomavirus and related cancers, fact sheet 2023","author":"Kenya","year":"2023","unstructured":"Kenya. Human papillomavirus and related cancers, fact sheet 2023. Fact Sheet. 2023. Published online.","journal-title":"Fact Sheet"},{"key":"e_1_3_6_36_2","doi-asserted-by":"publisher","DOI":"10.1002\/ijgo.12415"},{"key":"e_1_3_6_37_2","unstructured":"KMHFR | facilities. https:\/\/kmhfr.health.go.ke\/public\/facilities?page=6. Accessed April 11 2025."},{"key":"e_1_3_6_38_2","unstructured":"Health facilities layered under sub-county. Homabay Health. https:\/\/homabayhealth.org\/partners\/health-facilities-layered-under-sub-county\/. Accessed April 11 2025."},{"key":"e_1_3_6_39_2","unstructured":"NIAID NIH. Female genital grading table for use in microbicide studies version 1.0. Published online November 2007."},{"key":"e_1_3_6_40_2","unstructured":"Common terminology criteria for adverse events (CTCAE). 2017. Published online."},{"key":"e_1_3_6_41_2","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiac428"},{"key":"e_1_3_6_42_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13027-022-00442-2"},{"key":"e_1_3_6_43_2","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0b013e3181ca03df"},{"key":"e_1_3_6_44_2","doi-asserted-by":"publisher","unstructured":"Mungo C Sorgi K Ogollah C et al. Phase I study on the pharmacokinetics of intravaginal self-administered artesunate vaginal pessaries among women in Kenya. medRxiv. doi:10.1101\/2024.07.08.24309596. Published online August 12 2024:2024.07.08.24309596.","DOI":"10.1101\/2024.07.08.24309596"}],"container-title":["Cancer Control"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10732748251374418","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10732748251374418","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10732748251374418","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:23:59Z","timestamp":1777386239000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10732748251374418"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8]]},"references-count":43,"alternative-id":["10.1177\/10732748251374418"],"URL":"https:\/\/doi.org\/10.1177\/10732748251374418","relation":{"has-review":[{"id-type":"doi","id":"10.1177\/10732748251374418\/v2\/response1","asserted-by":"object"},{"id-type":"doi","id":"10.1177\/10732748251374418\/v2\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1177\/10732748251374418\/v2\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1177\/10732748251374418\/v1\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1177\/10732748251374418\/v1\/review2","asserted-by":"object"},{"id-type":"doi","id":"10.1177\/10732748251374418\/v1\/decision1","asserted-by":"object"}],"has-preprint":[{"id-type":"doi","id":"10.1101\/2025.06.02.25327779","asserted-by":"object"}]},"ISSN":["1073-2748","1526-2359"],"issn-type":[{"value":"1073-2748","type":"print"},{"value":"1526-2359","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8]]},"article-number":"10732748251374418"}}