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Cancer Vaccine

CDC 4 Pillars Program for HPV Vaccination in HIV-Positive Adults (CHAMPS Trial)

N/A

Recruiting

Led By Jessica Wells, PhD, RN

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capable of providing informed consent

Has not previously received three series HPV vaccine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months post baseline

Awards & highlights

CHAMPS Trial Summary

This trial aims to increase HPV vaccine uptake in HIV-positive people, who are 28x more likely to get HPV-related cancer. It will use the CDC's 4 Pillars Program and test it in 3 HIV clinics in Georgia.

Who is the study for?

The CHAMPS Study is for HIV positive adults aged 18-45 who can read and speak English, are able to consent, and haven't had the full series of HPV vaccines. They must not be allergic to latex or yeast, severely ill at present, or pregnant.Check my eligibility

What is being tested?

This study tests the CDC's 4 Pillars Program tailored for HIV patients in rural Georgia clinics. It aims to increase HPV vaccination rates among these high-risk individuals through provider training and educational resources.See study design

What are the potential side effects?

While specific side effects aren't listed for this program since it focuses on education and training rather than a medical intervention, general side effects of the HPV vaccine may include pain at injection site, headache, fever, nausea, dizziness.

CHAMPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to understand and agree to the study's procedures and risks.

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I have not completed the HPV vaccine series.

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I am not allergic to latex or yeast, not severely ill, and not pregnant.

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I am HIV positive.

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I am between 18 and 45 years old.

CHAMPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months post baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months post baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients initiating the HPV vaccine

Secondary outcome measures

Change in uptake rate of vaccination

Number of participants completing the HPV vaccine

CHAMPS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 4 Pillars ProgramExperimental Treatment1 Intervention

Patients at study clinics who consent to have their HPV vaccination history verified with the Georgia Registry of Immunization Transactions and Services (GRITS).

Group II: Adjacent time-period Control GroupActive Control1 Intervention

The background HPV update rate among PLWH will be obtained by using the electronic medical record (EMR) and GRITS to identify HPV vaccination uptake 18 months prior to the intervention. These data are collected retrospectively and no study participants are prospectively assigned to this study arm.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Nursing Research (NINR)NIH

580 Previous Clinical Trials

10,376,196 Total Patients Enrolled

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,292 Total Patients Enrolled

Jessica Wells, PhD, RNPrincipal InvestigatorEmory University

Media Library

Human Papillomavirus Clinical Trial 2023: CDC 4 Pillars Program Highlights & Side Effects. Trial Name: NCT05065840 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still able to join this experiment?

"Affirmative. The clinical trial's information on the clinicaltrials.gov website confirms it is currently recruiting patients, with its initial posting being dated May 22nd 2023 and latest update June 6th 2023. This medical study seeks to enrol 365 people from 1 location."

Answered by AI

What is the total sum of participants involved with this clinical examination?

"Affirmative. The clinicaltrials.gov database indicates that recruitment for this trial is ongoing, with the first posting occuring on May 22nd 2023 and lastly edited June 6th 2023. This experiment requires 365 participants from a single location to participate."

Answered by AI

Is this research endeavor seeking out participants that are 75 and older?

"This study is open to individuals age 18-45 and seperate trials are being conducted for minors as well as elderly patients. Specifically, 23 studies exist for participants below the age of majority while 60 additional clinical sites are dedicated to those over 65 years old."

Answered by AI

Who is qualified to participate in this scientific investigation?

"Candidates to this research endeavour must have received the human papillomavirus vaccine and be between 18 - 45 years old. This study is looking for a total of 365 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Advancing HPV Vaccination Among HIV Positive Adults: The CHAMPS Study

Jessica Wells 2023. "Advancing HPV Vaccination Among HIV Positive Adults: The CHAMPS Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05065840.

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