Clinical Trials Logo

Clinical Trial Summary

Human Papillomavirus (HPV) is a common sexually transmitted infection that can cause cancer (anal, penile, oropharyngeal) and genital warts in men. Due to their sexual practices (e.g., receptive anal intercourse), men who have sex with men (MSM) are at particularly high risk for HPV infection and are disproportionately affected by HPV-related cancers. A safe and effective vaccine is available to prevent HPV infection, yet HPV vaccination rates in the U.S. have been low, particularly among males. To remedy this gap, the goal of this study is to develop and pilot test a text messaging intervention to increase HPV vaccination in young MSM.

The study has two specific aims:

1. Develop, iteratively refine, and pre-test messages using a formative research procedure for designing targeted health interventions. The procedure consists of the following steps: 1) conduct online focus groups, an online survey, and in-depth interviews to inform message content, 2) draft initial messages based on focus group findings and pilot data, 3) refine message content and assess acceptability using content advisory teams, 4) conduct internal alpha testing to ensure software functionality, and 5) beta test the protocol.

2. Test the feasibility, acceptability, and preliminary efficacy of the txt2protect (t2p) text messaging intervention in a pilot randomized controlled trial (RCT). To achieve this aim, 460 unvaccinated MSM (ages 18-25) who live in the Chicago metro area will be randomly assigned to the treatment (t2p) or control condition. The treatment condition will receive a culturally appropriate text messaging-based HPV vaccination intervention based on the Information, Motivation, and Behavioral Skills model, whereas the control condition will receive a text messaging-based sexual health intervention that includes basic facts about HPV vaccination readily accessible online.

Primary outcome measures include intervention feasibility (e.g., retention in the trial), acceptability (satisfaction with the intervention), and preliminary efficacy as determined by initiation (receipt of the first dose) and completion of the 3-dose HPV vaccine series at the end of the 9-month trial.

The study team hypothesizes that participants in the t2p condition (vs. control) will report greater acceptability of the intervention and will be significantly more likely to initiate and complete the 3-dose HPV vaccine series by the end of the trial.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02994108
Study type Interventional
Source Northwestern University
Contact
Status Completed
Phase N/A
Start date January 3, 2018
Completion date June 30, 2019

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04901351 - Multi-site HPV Screening by High-throughput Sequencing in Patients With Chronic HPV-HR Infection Followed by Gynecology N/A
Active, not recruiting NCT02740790 - Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 Vaccine in Healthy Females Phase 2
Completed NCT01845779 - Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal N/A
Completed NCT01422356 - Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men N/A
Completed NCT01159834 - Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital) N/A
Completed NCT02808832 - An HPV Vaccine Provider Intervention in Safety Net Clinics N/A
Completed NCT01456715 - Immunogenicity of Gardasil and Twinrix and the Effect of a Dose of Gardasil or Cervarix Given 42 Months Later. Phase 3
Completed NCT02968420 - Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine Phase 4
Completed NCT02007421 - Study of the Prevention of Anal Cancer N/A
Completed NCT02267876 - Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
Recruiting NCT01459289 - Psychosocial Effect of HPV Positivity N/A
Completed NCT01358097 - Role of Immune Activation in Response of Head and Neck Squamous Cell Carcinoma to Therapy N/A
Completed NCT01342978 - Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time N/A
Active, not recruiting NCT02576561 - Safety and Efficacy Study of TVGV-1 Vaccine to Treat HPV Induced Cervical HSIL Phase 2
Enrolling by invitation NCT02503111 - The HPV-SAVE Study Team: HPV Screening and Vaccine Evaluation in Men Who Have Sex With Men N/A
Recruiting NCT02126189 - The Princess Alexandra Hospital and the QIMR Berghofer Medical Research Institute Head and Neck Cancer Study N/A
Completed NCT01766284 - Study of the Diagnostic Efficacy of "Real Time" Niris 1300e Optical Coherence Tomography (OCT) Imaging System in the Management of Pre-invasive and Invasive Neoplasia of the Uterine Cervix N/A
Completed NCT01524003 - Chinese Cancer Prevention Study(CHICAPS) N/A
Recruiting NCT03742869 - HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma
Completed NCT01289873 - Prevalence, Persistence, and Risk Factors for Oral Human Papillomavirus (HPV) Infections in College Women N/A