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Prevention and Control of Neoplasms Associated With HPV in High-risk Groups in Mexico City: The Condesa Study

NCT05149248CompletedPHASE2, PHASE3INTERVENTIONAL

Summary

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.

Key Facts

Lead Sponsor

Instituto Nacional de Salud Publica, Mexico

Enrollment

6000

Start Date

2018-05-30

Completion Date

2019-10-30

Study Type

INTERVENTIONAL

Official Title

Prevention and Control of Neoplasms Associated With HPV in High-risk Groups in Mexico City: The Condesa Study

Interventions

Gardasil® [Quadrivalent Human Papillomavirus (Types 6111618) Recombinant vaccine]Two doseControl group2 dose vaccination over 6 month

Conditions

Cancer of Cervix

Eligibility

Age Range

14 Years – 45 Years

Sex

ALL

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

Outcome Measures

Primary Outcomes

HPV DNA in anal, vaginal, and oral cavity.

Change in prevalence of any and specific HPV DNA in anal, vaginal and oral cavity from baseline and at 12 months after vaccination.

Time frame: 18 months to achieve 12-month follow-up in group 1 MSM

Secondary Outcomes

Prevalence of any and specific HPV DNA in anal, vaginal and oral cavity at 12 months after vaccination between groups

Change in prevalence of any and specific HPV DNA in anal, vaginal and oral cavity at 12 months after vaccination between groups

Time frame: 18 months to achieve 12-month follow-up in group 1 MSM and competition of all the interviews

Invalid results in each self-collected sample type: vaginal, anal and urine

Number of invalid results in each self-collected sample type: vaginal, anal and urine

Time frame: 18 months to achieve 12-month follow-up in group 1 MSM

Barriers to and facilitators of the introduction of a combined HPV vaccination and primary screening strategy with tests for high-risk HPV subtypes in the study groups.

For the qualitative intervention component, individuals from the five vulnerable groups will be selected for voluntary participation in qualitative semi-structured interviews. This sub-sample will be purposely selected to include the maximum variation of characteristics, and 12 to 16 semi-structured individual interviews will be conducted for each study group. These interviews will explore perceptions of HPV, experiences as users of preventive care for HPV and related cancers, acceptability of and meanings related to HPV vaccination and barriers to and facilitators of primary prevention (vaccination) and secondary prevention (screening and treatment) of HPV. The transcripts of individual interviews will be analyzed with through coding transcribed material, which implies the classification of pieces of the interviews into a priori and emerging categories to systematize the information and search for patterns, similarities, and differences.

Time frame: Up to 18 months

Locations

Instituto Nacional de Salud Publica, Cuernavaca, Mexico

Linked Papers

2025-11-24

Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis

Cervical cancer is the fourth most common cause of cancer-related death amongst females worldwide. Persistent infection with high-risk human papillomavirus (HPV) is the key factor in cervical cancer development. HPV vaccines aim to prevent cancer by generating antibodies against HPV infection. To evaluate the safety and efficacy of HPV vaccines, in females and males, to prevent cervical cancer and other HPV-related diseases, in standard (pairwise) and network meta-analysis (NMA) of randomised controlled trials. On 10 January 2022, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase. We searched Epistemonikos, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, the Health Technology Assessment database and vaccine manufacturer websites, and we checked reference lists from other relevant systematic reviews. We applied for Clinical Study Reports (CSRs) from the European Medicines Agency. An update search of electronic databases was done on 18 September 2024. We included randomised controlled trials (RCTs) regardless of language or publication status, assessing HPV vaccines pre-qualified by the World Health Organization (WHO) (Cervarix, Gardasil, Gardasil-9 and Cecolin). We used methods recommended by Cochrane. We primarily used CSRs to collect data, and we included outcome data irrespective of participants' baseline HPV infection or serostatus. We assessed risk of bias using the Cochrane tool (RoB 2). All outcomes were dichotomous, and we estimated risk ratios (RR) with 95% confidence intervals (CI). We used pairwise analysis for all outcomes. Where data were available, we carried out NMA for critical outcomes for networks in females and males in three age groups, ranking the vaccines using surface under the cumulative ranking curve (SUCRA) and mean ranks. We assessed the certainty of evidence using the GRADE approach. We included 60 individual studies with 157,414 participants ranging in follow-up from seven months to 11 years. Few participants were under 15. There were no studies for males under 15 years and males over 25 years. We obtained CSRs for 33 of the included studies. We assessed the risk of bias as low to 'some concerns' for the critical outcomes. Cancer and pre-cancer outcomes The studies were not of sufficient duration for cancers to develop. Four studies reported on cancer. No cancers were detected. Critical pre-cancer outcomes were reported in 15- to 25-year-old populations by 11 studies and in > 25-year-old females by three studies with up to seven years follow-up. None were reported in the under 15 years age group. In 15- to 25-year-old females, there was a reduction in CIN2+ irrespective of HPV type after six years (RR 0.70, 95% CI 0.56 to 0.88) (moderate-certainty) and a larger reduction in CIN2+ from vaccine-matched HPV types after six years (RR 0.40, 95% CI 0.30 to 0.54) (moderate-certainty). In females over 25 years old, there was little to no difference between Cervarix and Gardasil compared with control (moderate-certainty). There was no evidence on CIN2+ irrespective of HPV type from studies assessing Cecolin, or from studies assessing different dose schedules. In 15- to 25-year-old females, there was a slight reduction in vaccine-matched HPV-type high-grade vulval (VIN) or vaginal (VaIN) intraepithelial neoplasia following vaccination with Gardasil or Gardasil-9 (moderate-certainty). The NMA found a slight reduction of 1 case per 1000 following Gardasil (RR 0.21, 95% CI 0.1 to 0.45) and 0 cases per 1000 following Gardasil-9 (RR 0.16, 95% CI 0.05 to 0.51). Little to no difference was found in the NMA for Cervarix compared with control (RR 0.28, 95% CI 0.06 to 1.37), or for Cervarix, Gardasil and Gardasil-9 compared to each other. There was a reduction in high-grade anal intraepithelial neoplasia (AIN) irrespective of HPV type in the Gardasil group in one study in men who have sex with men (RR 0.75, 95% CI 0.53 to 1.07) (low-certainty). For both high-grade penile intraepithelial neoplasia (PeIN) irrespective of HPV type and vaccine-matched HPV-type high-grade PeIN, little to no difference per 1000 participants was reported in the Gardasil group in one study with 3880 participants at 36 months follow-up (RR 1.00, 95% CI 0.20 to 4.93) (low-certainty). Serious adverse events In a pairwise analysis of serious adverse events in 39 studies across all vaccine types with 97,272 participants, there was little to no difference in the HPV vaccine groups compared with the control group at up to 72 months follow-up (RR 0.99, 95% CI 0.94 to 1.04) (high-certainty). Treatment rates for HPV-related pre-invasive disease In pairwise analysis of five studies with 38,606 participants, there were 12 fewer people that needed to seek treatment per 1000 participants (95% CI 5 to 17 fewer per 1000) in the HPV vaccine groups compared with the control group rate at up to 84 months follow-up (RR 0.76, 95% CI 0.65 to 0.89) (moderate-certainty). Anogenital warts In pairwise analysis of three studies with 21,271 participants, there were 25 fewer cases of anogenital warts irrespective of HPV type per 1000 participants (95% CI 22 to 28 fewer per 1000) in the HPV vaccine groups compared with the control group rate at up to 48 months follow-up (RR 0.38, 95% CI 0.32 to 0.46) (high-certainty). In the NMA for females 15 to 25 years old, Gardasil-9 was most likely to reduce the risk of developing anogenital warts. The evidence in this network meta-analysis of HPV vaccines is based on extensive searches and analyses. There is evidence from randomised controlled trials that HPV vaccination reduces the risk of pre-cancerous outcomes such as CIN2+ and anogenital warts. No data were available for cervical cancer or other cancer outcomes, and no data on pre-cancer outcomes were available for vaccination under age 15 years. There were no safety concerns noted in the studies.

Linked Investigators

Hanna Bergman