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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

No Placebo-Only Group

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients initiating the HPV vaccine

Secondary study objectives

Change in uptake rate of vaccination

Number of participants completing the HPV vaccine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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