Advancing HPV Vaccination Among HIV Positive Adults: The CHAMPS Study

Human Papilloma Virus Clinical Trial

— CHAMPS  

Official title:

Implementing an Evidence-Based, Multilevel Intervention to Promote HPV Vaccination Among HIV Positive Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05065840
• Other study ID #: STUDY00002469
• Secondary ID: R01NR020154-01
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: June 1, 2027

Study information

• Verified date: April 2024
• Source: Emory University
• Contact: Jessica Wells, PhD, RN
• Phone: 404-727-0518
• Email: jholme3[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 do this project in three HIV clinics in Georgia (AID Atlanta, AID Newnan, and Albany Model Rural HIV Clinic) and enroll n=365 PLWH who are age 18-45 years from those clinics.

Description:

People living with HIV (PLWH) are 28 times more likely to be diagnosed with 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. However, in previous pilot studies, there were significant gaps found in knowledge and awareness of the HPV vaccine as well as low receipt of the HPV vaccine (13.5%) in our population of rural PLWH.

HPV vaccine programs tailored and implemented in the HIV population are lagging for this high-risk group. The Center for Disease Control's (CDC) 4 Pillars Transformation Program is a multi-level, evidence-based intervention 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. Thus, this study proposes to tailor and refine the 4 Pillars Program and do this project in four HIV clinics in Georgia (AID Atlanta, AHF Midtown, AHF Lithonia, and Albany Model Rural HIV Clinic).

The 4 Pillars Program offers providers and clinic staff evidence-based strategies to increase HPV vaccination uptake via training and educational resources. Providers and clinic staff interested in participating will "enroll" online and complete an electronic informed consent before participating in the focus groups and completing the evaluation surveys. Providers and clinic staff will be offered an opportunity to participate in in-service training (CE units will be available) that will provide education and resources on the 4 Pillars program and will learn more about HPV, HPV vaccination, and HPV-associated cancers. Providers and clinic staff will be asked to recommend and administer the HPV vaccine during each routine clinic visit. Consenting providers and clinic staff will be asked to complete pre-intervention evaluations, an intervention evaluation every 3 months, a post-evaluation, and post-intervention evaluations.

For patient enrollment, the research coordinator, with assistance from a clinic-designated Immunization Champion (IC), will review the clinic's appointment schedule to call patients in the target age range (18- 45 years of age) one week in advance of their appointments to inform them of the study and to determine eligibility. If eligible and interested in the proposed study, the individual will be given an overview of the research study, including its purpose, what participation entails, potential risks and benefits of participation, and measures that will be used to ensure confidentiality. Participants will be assured participation is completely voluntary and they may withdraw from the study at any time without consequences. If the individual volunteers to participate in the study, an electronic informed consent will be obtained by the research assistant(s) via REDCap. Participants will be asked to consent to have their HPV vaccination status confirmed via electronic medical records and GRITS. Participants will then watch a short video on HPV and HPV vaccines that can be viewed on their phones (or the clinic's iPad) while waiting to be seen. Potential participants will be asked to "follow" the study's private Facebook page which will offer additional educational information tailored towards individuals with HIV on HPV-related disease and general health promotion and risk reduction tips. A post-intervention evaluation will be provided after the third immunization is given or due (if missed).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 365
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria

• HIV positive

• 18-45 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).

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Human Papilloma Virus
• Human Papilloma Virus Vaccine
• Papilloma

Intervention

Behavioral:
• CDC 4 Pillars Program
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.

Locations

Country	Name	City	State
United States	Albany Rural Model Clinic	Albany	Georgia
United States	AHF Midtown	Atlanta	Georgia
United States	AID Atlanta	Atlanta	Georgia
United States	AHF Lithonia	Lithonia	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants completing the HPV vaccine	Completion is defined as receiving all 3 immunizations from the series, regardless of time. This variable will be measured by electronic medical records and GRITS 24 months post baseline.	24 months post baseline
Secondary	Change in uptake rate of vaccination	The team will calculate the percent change in initiation of the vaccine and percent change in completion of the vaccine from the control phase and 24 months post intervention, after adjusting for demographics differences in population.	Baseline and 24 months post baseline