Clinical trial · Interventional
Prevention and Control of Neoplasms Associated With HPV in High-risk Groups in Mexico City: The Condesa Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objective: To evaluate the effectiveness of a combined strategy of human papillomavirus virus (HPV) vaccination and high-risk HPV screening to reduce the occurrence of neoplasms in the anogenital region and oral cavity among men who have sex with men, people with HIV, homeless people, transgender women, female sex workers and rape victims. Methods: This mixed methods study evaluates the effectiveness of a combined vaccination-screening strategy to reduce HPV prevalence/incidence and occurrence of cervical intraepithelial neoplasms grade 2+ and/or anal intraepithelial neoplasms grade 2+, using Kaplan-Meier. The time-to-event method will evaluate time from positive results for specific anogenital HPV to incidence of anogenital lesions containing that HPV type. Conclusions: This study will generate scientific evidence on effectiveness of a combined vaccination-screening strategy to reduce the burden of HPV-associated neoplasms within vulnerable populations in Mexico.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Cervix | Malignant Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2 dose vaccination over 6 month | Biological | — | UNRESOLVED |
| Control group | Other | — | UNRESOLVED |
| Gardasil® [Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant vaccine] | Biological | — | UNRESOLVED |
| Two dose | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- OTHER
- label
- Group 1: MSM
- description
- Arm 1: HPV vaccination in an alternative schedule for MSM of 1 dose (M0). Arm 2: HPV vaccination in an alternative schedule for MSM of 2 doses over a 6-month period (M0,6) Arm 3: a control group will be screened for high-risk HPV and vaccinated at 12 months
- interventionNames
- Biological: Gardasil® [Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant vaccine]
- Biological: Two dose
- Other: Control group
- type
- OTHER
- label
- Group 2: TRANSGENDER WOMEN
- description
- Arm 1: Transgender women
- interventionNames
- Biological: 2 dose vaccination over 6 month
- type
- OTHER
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Between 14 and 45 years of age * Men who identify themselves as having sex with other men * Transgender women * Women or men living on the street/homeless * Women or men who have suffered rape * People with or without HIV infection Exclusion Criteria: * Under 14 years or over 45 years of age * History of any serious adverse reaction prior to any component of the influenza vaccine, such as life-threating, hospitalization, partial or total disability, or incurable damage * Chronic HIV infection in stages A3, B3 and C3, and/or CD4 cell count less than 200 cells per cubic millimeter * Presence in the HIV-positive participant of an active opportunistic infection such as: Toxoplasma Gondii encephalitis, Cryptococcosis, Tuberculous meningitis, Pulmonary tuberculosis, Community acquired pneumonia, Pneumocystis jiroveci, Isosporidiasis, Cryptosporidiasis, Salmonellosis, Candida esophagitis and esophagitis, Esophagitis Vascular neoplasia * Pregnancy confirmed by laboratory test * Previous vaccination against HPV * Previous treatment of intraanal lesions
References
Publications (1)
- DERIVEDBergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2. PMID 41276263