[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"human-papillomavirus-hpv-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:human-papillomavirus-hpv-infection":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,72,109,144],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100609081","secondary-cervical-cancer-prevention-of-vulnerable-women-with-hpv-and-hiv-co-infection-in-india-100609081",false,"NCT07209917","Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India","Secondary Cervical Cancer Prevention of Vulnerable Women With Human Papillomavirus (HPV) and Human Immunodeficiency Virus (HIV) Co-infection in India","SAKHI","Inclusion Criteria:\n\n1. WLH, 25 - 50 years of age; based on HIV-based guidelines;\n2. Receiving ART for \\> 12 months to ensure medication stabilization, and ensure any impact on the cervical cancer outcomes will not be attributed solely to recent ART initiation, as validated by an ART card given to all ART patients;\n3. Screened as HPV positive by RT-PCR (Reverse Transcription Polymerase Chain Reaction) for oncogenic genes; and assessed to be VIA negative;\n4. Have not participated in Phase I Formative Study.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women due to hormonal and dietary guideline differences;\n2. Women older than age 50 These women will be immediately referred to a gynecology specialist.","FEMALE","25 Years","50 Years",{"count":21,"type":22},348,"ESTIMATED","INTERVENTIONAL",[25],"NA","Cervical cancer (CC) remains one of the most common malignancies among women in India, with nearly 100,000 women diagnosed annually and over 60,000 preventable deaths annually. With high-risk human papillomavirus (HR-HPV) as the causative agent for CC, one risk factor that places women at high risk for CC is human immunodeficiency virus (HIV), as impaired immune response against Human papillomavirus (HPV) may result in persistent HR-HPV infection, a critical risk factor for progression of HPV-related cervical oncogenesis. Progression of precancerous lesions among women living with HIV (WLH) is also associated with: 1) lack of HPV screening; 2) high levels of depressive symptoms and stigma; and 3) malnutrition, which negatively impacts the activation and proliferation of immune cells. Yet programs that offer WLH with comprehensive services focused on HPV screening and psychological and nutritional support are almost non-existent, and the gap is critical. Nutrition plays an integral role in relationship to HPV\u002FHIV co-infection, as demonstrated by an increased risk of HR-HPV associated with poor nutrition; nutritional deficiencies are likewise linked to cervical intra-epithelial neoplasia. The immunological effect of malnutrition may also be exacerbated among WLH due to elevated energy demands of chronic immune activation; worsened with HPV\u002FHIV co-infection. Further, depressive symptoms (aka depression for brevity) partially mediate the effect of food insecurity on HIV viral suppression. In our completed ASHA-Nutrition R01 study of antiretroviral (ART) adherence, the investigators trained lay community health peer counselors, named Accredited Social Health Activist (ASHA), to improve the health of 600 rural WLH by providing emotional support, skill-building, nutrition education, and\u002For protein-enriched food supplements. In that study, our intervention, co-delivered by our trained peer counselors, and guided by nurses, led to increased CD4+ T cell recovery and improved anthropometric and psychosocial outcomes. The investigators found that peer counselors support plus protein supplements and nutritional education were significantly associated with improved CD4 counts and increased lean mass at 18 months (P \\\u003C 0.001), as well as significant improvements in depression, ART adherence, social support and internalized stigma. In our sub study, CC screening of 598 of these WLH revealed that 13% were found to have abnormal cervical lesions and 4 (1%) had squamous CC. Preliminary evidence also revealed that nutritional supplements may be associated with a 40% reduction in the risk of abnormal cervical lesions (adjusted odds ratio \\[aOR\\] = 0.60), with an association between serum albumin and reduced risk of abnormal lesions (aOR= 0.39).\n\nWith a focus on secondary prevention of CC, the investigators hope to mitigate the link between HR-HPV persistence and risk of CC as well as improve the health of women co-infected with HPV\u002FHIV (W-Co-V). Our stellar team plans to build upon our prior ASHA-Nutrition intervention, using formative research to refine a nurse-led, peer counselors co-delivered, nutrition-enhanced SAKHI HPV intervention, adapted for W-Co-V. This will be followed by a randomized controlled trial (RCT), assessing the efficacy of our refined comprehensive, multifaceted SAKHI HPV intervention, as compared with an enhanced Standard of Care (SOC+) (usual care + 3 sessions \\[wellness, basic nutrition and HPV\u002FHIV health promotion\\]) among 348 high-risk co-infected women to prevent CC while remaining engaged in the HIV treatment cascade, and managing nutritional health. Recruited participants will be individually randomized in a 1:1 ratio to one of the two study arms. Our Primary outcome is HR-HPV persistence (2 positive tests for the same HR-HPV type, separated by 12-18 months). The two aims incorporating RCT interventions are as follows:\n\nAim 2. To evaluate the efficacy of SAKHI HPV intervention among 348 W-Co-V on the primary outcome (HR-HPV persistence) as compared to the Enhanced Standard of Care (SOC+) program. H2: Compared to the SOC+ participants, SAKHI participants will have lower rates of HR-HPV persistence.\n\nAim 3. Assess the impact of the SAKHI program secondarily on: 1) HIV indices (HIV viral load; CD4 count); 2) Nutritional index (serum albumin) at 6-, 12-, and 18-months.",[28,29,30],"Cervical Cancer","Human Papillomavirus (HPV) Infection","Human Immunodeficiency Virus (HIV) Infection",[32,33,34],"Cervical Cancer Prevention","HPV-HIV Co-Infection","ASHA-Nutrition","RECRUITING","2026-07-29",{"date":38,"type":39},"2026-07-31","ACTUAL",{"date":41,"type":39},"2026-02-01",{"date":43,"type":22},"2029-04-30",{"name":45,"class":46},"University of California, Irvine","OTHER",4,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100649342","hpv-detection-using-self-collected-menstrual-blood-100649342","NCT07733557","HPV Detection Using Self-Collected Menstrual Blood","Concordance of HPV Detection Using Self-Collected Menstrual Blood","Inclusion Criteria:\n\n* Are 21 to 49 years old.\n* Are female, have not yet gone through menopause, and expect to have a menstrual period during the study.\n* Have a cervix (have not had a hysterectomy that removed the cervix). Had a routine high-risk HPV (human papillomavirus) test within the past 90 days and received a valid result (positive or negative).\n* Receive medical care at the participating clinic and have been identified by the study team as a possible candidate for the study.\n* Can read, understand, and communicate in English.\n* Are willing and able to follow study procedures, including using a menstrual blood collection kit and returning the sample for testing.\n* Are willing to provide informed consent before any study procedures are performed.\n* May be of any race or ethnicity.\n\nExclusion Criteria:\n\n* Had an HPV test in the past 90 days, but the result was unclear, invalid, or could not be interpreted.\n* Are currently pregnant.\n* Have had a hysterectomy that removed the cervix.\n* Are not currently having menstrual periods or are unable to provide a menstrual blood sample during the study period.\n* Have a medical, mental health, cognitive, social, or other condition that, in the opinion of the study doctor, could make it difficult to safely participate or complete the study procedures.\n* Are unable to understand the study requirements, use the collection kit, or return the sample for testing.\n* Do not wish to participate, withdraw consent, or are unwilling to complete the required study procedures.\n* Are taking part in another research study or have another circumstance that, in the opinion of the study team, could affect study results or participant safety.\n* Are currently incarcerated.","21 Years","49 Years",{"count":58,"type":22},50,[25],"This study is evaluating whether human papillomavirus (HPV) can be accurately detected from self-collected menstrual blood samples. Participants who have had routine clinical HPV testing within the previous 90 days will collect a menstrual blood sample at home using a study-provided collection kit. The HPV test result from the menstrual blood sample will be compared with the participant's prior clinical HPV test result to assess agreement between the two methods. The goal is to determine whether menstrual blood collection may provide a feasible, noninvasive approach for HPV testing.",[29],"NOT_YET_RECRUITING","2026-07-24",{"date":36,"type":39},{"date":66,"type":22},"2026-07",{"date":68,"type":22},"2029-07",{"name":70,"class":46},"Samantha Batman",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100644166","comparing-digital-and-collaborative-gamified-reinforcement-strategies-for-hpv-literacy-and-retention-among-nursing-students-100644166","NCT07667127","Comparing Digital and Collaborative Gamified Reinforcement Strategies for HPV Literacy and Retention Among Nursing Students","Comparing Digital and Collaborative Gamified Reinforcement Strategies for HPV Literacy and Retention Among Nursing Students: A Randomized Comparative Study","Inclusion Criteria:\n\n* Being a nursing student\n* Voluntary participation\n* Aged 18 years or older\n* Participation in all measurement points\n* Ownership of a smartphone\n* Internet access\n* Having headphones\n\nExclusion Criteria:\n\n* Incomplete data forms\n* Not participating in intervention sessions\n* Absence in posttest or follow-up",true,"ALL","18 Years","45 Years",{"count":84,"type":22},64,[25],"This randomized comparative study aims to evaluate the effectiveness of two gamified reinforcement strategies, Gimkit and Escape Room, on human papillomavirus (HPV) literacy, short-term retention, and gameful learning experiences among undergraduate nursing students. Following standardized theoretical instruction on HPV infection, participants will be randomly assigned to either a digital quiz-based gamification intervention (Gimkit) or a collaborative Escape Room activity. Outcomes will be assessed using the Human Papillomavirus Literacy Scale (HPV-LS) and the Gameful Experience Scale (GAMEX) at multiple time points, including baseline, post-theoretical instruction, post-intervention, and one-month follow-up.",[88,29,89],"Health Literacy","Nursing Education",[91,92,93,94,95,96,97,98,99],"HPV literacy","nursing education","educational intervention","gimkit","escape room","Human Papillomavirus","game-based learning","gamification","knowledge retention","2026-06-30",{"date":102,"type":39},"2026-07-02",{"date":104,"type":22},"2026-09-21",{"date":106,"type":22},"2026-10-26",{"name":108,"class":46},"Aydin Adnan Menderes University",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":79,"sex":17,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":124,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":71},"100614110","human-papillomavirus-self-sampling-for-enhancing-cervical-screening-during-the-war-in-ukraine-100614110","NCT07275333","Human Papillomavirus Self-sampling for Enhancing Cervical Screening During the War in Ukraine","Inclusion Criteria:\n\n* Female aged 30-60 years\n* Intact uterus (no prior hysterectomy)\n* Eligible for cervical cancer screening according to local guidelines\n* Able to provide informed consent\n* Able to perform self-sampling at home or at a clinic\n\nExclusion Criteria:\n\n* History of total hysterectomy\n* Pregnancy at the time of enrollment\n* Known diagnosis of cervical cancer\n* Inability or unwillingness to provide informed consent\n* Unable to perform self-sampling or comply with study procedures","30 Years","60 Years",{"count":118,"type":22},1000,[25],"In 2020, a cervical screening center was established in Zaporizhzhia (Ukraine), initiating a pilot project to evaluate the prevalence of HPV among women in Eastern Ukraine. The findings were intended to lay the groundwork for the Ukrainian Ministry of Health in establishing a structured national screening program. However, all efforts were halted due to the nearby armed conflict, situated just 40 kilometers from the border.\n\nThe World Health Organization's goal to eliminate cervical cancer globally has a gap when it comes to managing cancer control during crises like armed conflicts. We propose a demonstration project to assess whether a simpler, yet modern, cervical cancer control strategy (based on using self-sampling for HPV detection) could also be effective for cervical cancer screening in Zaporizhzhia.\n\nWomen aged 30-60 years who have not had a recent negative HPV test will be invited to participate. Participants receive a self-sampling kit from their primary care provider and can return the sample free of charge to the clinic or community volunteers. All samples are analyzed in accredited laboratories in Zaporizhzhia.\n\nHPV-positive women will receive follow-up care according to national guidelines, including referral to gynecologists for additional tests and treatment if needed. HPV-negative women will be reassured and advised on future screening intervals.\n\nThe study also evaluates how well the screening program can be implemented during conflict conditions. This includes measuring women's acceptance of self-sampling, the willingness of providers to adopt the procedures, and whether the screening process is feasible, practical, and sustainable. Additional process evaluation will explore how the program adapts to challenges such as migration, disrupted health services, and safety concerns.\n\nThis project is conducted through collaboration between Zaporizhzhia State Medical and Pharmaceutical University, the Charitable Foundation \"World Against Cancer,\" and Karolinska Institutet in Sweden, which provides quality assurance support for laboratory procedures. The goal is to establish a safe, effective, and sustainable cervical cancer screening model that can be used in conflict-affected regions and similar settings.\n\nThis work is supported by a grant from the Union for International Cancer Control (UICC), as part of the Reimagining Cancer Research in Europe Initiative.",[28,122,29,123],"Cervical Cancer Screening","Cervical Intraepithelial Neoplasia",[125,126,127,128,129,130,131,132,133,134],"hpv self-sampling","hpv testing","cervical cancer prevention","cervical screening","implementation science","war-affected regions","ukraine","High-risk HPV","self-collection","Screening uptake","2025-12-11",{"date":137,"type":39},"2025-12-18",{"date":139,"type":39},"2025-04-01",{"date":141,"type":22},"2026-08-31",{"name":143,"class":46},"Karolinska Institutet",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":156,"conditions":157,"keywords":158,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":4},"100570290","phase-2-cnidium-monnieri-detoxification-formula-for-persistent-high-risk-human-papillomavirus-infection-of-cervix-100570290","NCT06705322","Cnidium Monnieri Detoxification Formula for Persistent High-risk Human Papillomavirus Infection of Cervix.","A Phase II, Multicenter Study on the Clinical Effectiveness of Cnidium Monnieri Detoxification Formula for Persistent High-risk Human Papillomavirus Infection of Cervix.","Inclusion Criteria:\n\n* Age ≥ 25 years to ≤ 75 years，with sexual life history\n* Meet the diagnostic criteria for high-risk human papillomavirus (HR-HPV) persistent infection\n* After surgery or physical therapy for high-grade squamous intraepithelial lesions (HSIL) of the cervix or high-grade squamous intraepithelial lesions (VaINIII) of the vagina, or radical surgery for cervical\u002Fvaginal cancer or radical chemoradiotherapy, the examination remained positive for HR-HPV ≥6 months after the end of treatment, with the same type or multiple types as before treatment, and no progression or recurrence of the disease.\n* No local or systemic therapy has been administered to patients in the last 3 months\n* Patients were informed of the study protocol, agreed to cooperate with the treatment, and signed informed consent.\n\nExclusion Criteria:\n\n* Only low-risk HPV infection\n* Colposcopy for high-grade intraepithelial lesions or cancer of the cervix, vagina, vulva, who have not received or are receiving treatment\n* Immunocompromised or immunosuppressant\n* Pregnant and lactating women\n* Patients with other malignant tumors not controlled, serious heart, lung, liver, renal insufficiency and coagulation dysfunction\n* People with communication or cognitive impairment\n* Patients have contraindications to oral administration of traditional Chinese medicine preparations\n* In the same period, other anti-HPV measures were used to treat, which affected the efficacy judgment","75 Years",{"count":153,"type":22},79,[155],"PHASE2","The purpose of this study is to evaluate the clinical efficacy and safety of Cnidium Monnieri Detoxification Formula in clearing HPV infection, improving clinical symptoms and quality of life in female patients with persistent cervical high-risk HPV infection.",[29,28],[159,160],"Human papillomavirus infection","Cervical cancer","2024-11-23",{"date":163,"type":39},"2024-11-26",{"date":165,"type":22},"2024-12-01",{"date":167,"type":22},"2027-03-27",{"name":169,"class":46},"Fudan University"]