NCT05065840: CHAMPS

Advancing HPV Vaccination Among HIV Positive Adults: The CHAMPS Study

Recruiting now NA Last updated 24 April 2025

What this trial tests

NA trial testing CDC 4 Pillars Program in Human Papilloma Virus in 365 participants. Currently enrolling.

Timeline

22 May 2023

Primary endpoint
1 June 2027

1 June 2027

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	365
Start date	22 May 2023
Primary completion	1 June 2027
Estimated completion	1 June 2027
Sites	4 locations across United States

Drugs / interventions tested

• CDC 4 Pillars Program

Conditions studied

• Human Papilloma Virus — all drugs for Human Papilloma Virus →
• Human Papilloma Virus Vaccine — all drugs for Human Papilloma Virus Vaccine →

Sponsor

Emory University

Who can join

Adults 18 to 45, any sex, with Human Papilloma Virus or Human Papilloma Virus Vaccine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

People living with HIV (PLWH) are 28 times more likely to be diagnosed with Human Papillomavirus (HPV) - associated anal cancer than the general population. The HPV vaccine is an effective and safe approach to prevent and reduce the risk of HPV-related disease among PLWH. HPV vaccine programs tailored and implemented in the HIV population are lagging for this high-risk group. The CDC's 4 Pillars Transformation Program is a multi-level, evidence-based intervention that has been successfully used to increase HPV vaccination in the general population and is ready to be tested in the high-risk HIV population, particularly PLWH in the rural South. This program offers providers and clinic staff evidence-based strategies to increase HPV vaccination uptake via training and educational resources. This study proposes to tailor and refine the 4 Pillars Program and conduct this project in three HIV clinics in Georgia.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. State-of-the-Science of human papillomavirus vaccination in women with human immunodeficiency Virus: Summary of a scientific workshop.
   Schuind AE, Rees H, Schiller J, Mugo N, et al · · 2023 · cited 3× · PMID 37576844 · DOI 10.1016/j.pmedr.2023.102331
2. An overview of implementing an evidence based program to increase HPV vaccination in HIV community clinics.
   Wells J, Klosky JL, Liu Y, Gillespie TW. · · 2022 · cited 1× · PMID 36071389 · DOI 10.1186/s12889-022-14100-0