Advancing HPV Vaccination Among HIV Positive Adults: The CHAMPS Study

NCT05065840 | Active Not Recruiting

• 3 other identifiers: STUDY00002469R01NR020154-012025P009279
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Human Papilloma Virus; Human Papilloma Virus Vaccine

Keywords

Human Immunodeficiency Virus; Vaccination

Outcome Measures

Primary Outcomes (1)

• Number of patients initiating the HPV vaccine

  Initiation of the HPV vaccine is defined as receiving the first or second immunization from the series. This variable will be measured by electronic medical records and GRITS at 24 months post baseline.

  24 months post baseline

Secondary Outcomes (2)

• Number of participants completing the HPV vaccine

  24 months post baseline

• Change in uptake rate of vaccination

  Baseline and 24 months post baseline

Study Arms (2)

4 Pillars Program

EXPERIMENTAL

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

Behavioral: CDC 4 Pillars Program

Adjacent time-period Control Group

NO 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.

Interventions

CDC 4 Pillars Program BEHAVIORAL

The CDC's 4 Pillars Transformation Program (4 Pillars Program) is a robust and empirically supported strategic approach that promotes the uptake of adult vaccinations and addresses facilitators and barriers at the patient, provider, and clinic level. This multi-level, evidence-based intervention has been successfully utilized to increase HPV vaccination in the general population and is primed to be tested in the high-risk HIV population, particularly PLWH in the rural South. This proposal seeks to expand the success of the 4 Pillars Program and tailor, refine, and implement in the HIV positive population who are at extraordinarily high risk for HPV-related cancers and can obtain the most benefit from the vaccine.

4 Pillars Program

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HIV positive
• years of age
• Can read and speak English
• Capable of providing informed consent
• Has not previously received three series HPV vaccine
• No contraindications to receiving HPV vaccine (i.e. history of anaphylactic allergy to later, an immediate hypersensitivity to yeast, current moderate or severe acute illness, and/or are currently pregnant).

You may not qualify if:

• Has contraindications to receiving the HPV vaccine i.e., history of an anaphylactic allergy to latex, an immediate hypersensitivity to yeast, current moderate or severe acute illness, and/or are currently pregnant)

Sponsors & Collaborators

• Emory University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (4)

Albany Rural Model Clinic

Albany, Georgia, 31705, United States

Location

AID Atlanta

Atlanta, Georgia, 30309, United States

Location

Faebris

Atlanta, Georgia, 30311, United States

Location

AHF Lithonia

Lithonia, Georgia, 30058, United States

Location

Related Publications (1)

• Wells J, Klosky JL, Liu Y, Gillespie TW. An overview of implementing an evidence based program to increase HPV vaccination in HIV community clinics. BMC Public Health. 2022 Sep 7;22(1):1696. doi: 10.1186/s12889-022-14100-0.

  PMID: 36071389 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jessica Wells, PhD, RN

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study will be implemented at the clinic, Provider, and Patient levels. Every level will receive a different intervention or none in the case of the control. Clinic and Provider level will receive training on recommending and administering the vaccine at the clinic. Patient level will accept or decline the recommendation for the HPV vaccine. The Control arm will be collected from EMR and the GRITS database from patients not receiving the vaccine before the intervention period.

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 4, 2021
• Study Start: May 22, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee, for individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata

Locations

US (4)