CDC 4 Pillars Program for HPV Vaccination in HIV-Positive Adults

(CHAMPS Trial)

Recruiting at 4 trial locations

Overseen By Robert Knott

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Pregnancy, Severe illness, Anaphylactic allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

365 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the CDC 4 Pillars Program for HPV Vaccination in HIV-Positive Adults?

The HPV vaccines are shown to be safe and effective in preventing diseases caused by HPV types included in the vaccines, especially in people without prior HPV exposure. Although specific data on the CDC 4 Pillars Program is not available, the general effectiveness of HPV vaccines in reducing infections among HIV-positive individuals suggests potential benefits. ^{1 2 3 4 5}

Is the HPV vaccine safe for HIV-positive adults?

The HPV vaccine is generally safe and well tolerated in HIV-positive individuals, with common side effects being local pain and headache. No serious adverse events were reported in the studies reviewed. ^{1 2 4 6 7}

How is the CDC 4 Pillars Program for HPV Vaccination in HIV-Positive Adults different from other treatments?

The CDC 4 Pillars Program is unique because it focuses on improving HPV vaccination rates among HIV-positive adults through a structured approach that includes education, reminders, and community engagement, rather than being a direct medical treatment like a vaccine or drug. ^{2 4 7 8 9}

Research Team

Jessica Wells, PhD, RN

Principal Investigator

Emory University

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 45 years old.

Can read and speak English

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual or in-person)

Intervention

Participants receive education and resources on the 4 Pillars program and HPV vaccination. Providers and clinic staff recommend and administer the HPV vaccine during routine clinic visits.

24 months

Routine clinic visits

Follow-up

Participants are monitored for HPV vaccination uptake and completion through electronic medical records and GRITS.

24 months

Treatment Details

Interventions

• CDC 4 Pillars Program

Trial Overview 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.

Participant Groups

Group I: 4 Pillars Program Experimental Treatment 1 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 Group Active Control 1 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.

CDC 4 Pillars Program is already approved in United States for the following indications:

Approved in United States as CDC 4 Pillars Program for:

• Increasing HPV vaccination uptake among HIV-positive adults

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

HPV infection and related diseases are increasingly prevalent among HIV-infected women, highlighting the need for effective prevention strategies as these individuals live longer lives.

HPV vaccines are safe and effective in preventing HPV-related diseases, especially in those without prior HPV exposure, but there are significant barriers to vaccination that need to be addressed for HIV-infected women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccination in HIV-infected women: need for increased coverage. Kojic, EM., Rana, AI., Cu-Uvin, S.[2018]

Prophylactic HPV vaccines show higher seroconversion rates in people living with HIV compared to placebo, based on a systematic review of five randomized trials involving 1042 participants, indicating their potential efficacy in this high-risk group.

No serious adverse events were reported following vaccination, suggesting that HPV vaccines are safe for individuals living with HIV, although further high-quality studies are needed to assess long-term effects on cervical health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of immunogenicity, clinical efficacy and safety of human papillomavirus vaccines in people living with the human immunodeficiency virus. Mavundza, EJ., Wiyeh, AB., Mahasha, PW., et al.[2023]

Immunocompromised individuals, including HIV-positive people, are at a higher risk for HPV-related cancers, highlighting the need for effective prevention strategies like vaccination.

The effectiveness of HPV vaccines in these populations may be influenced by factors such as their immune response to the vaccine, prior HPV infections, and the timing of vaccination relative to the severity of their immunocompromise, indicating a need for targeted clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chapter 16: HPV vaccines in immunocompromised women and men. Palefsky, JM., Gillison, ML., Strickler, HD.[2006]

Prophylactic HPV vaccines are shown to be safe and immunogenic in various HIV-positive populations, including children and adults, suggesting they can be effectively used in these high-risk groups.

Increased immunogenicity was observed in HIV-positive individuals receiving antiretroviral therapy, indicating that these vaccines may be particularly effective for those undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccination against oncogenic human papillomavirus infection in HIV-infected populations: review of current status and future perspectives. Toft, L., Tolstrup, M., Storgaard, M., et al.[2019]

Gay, bisexual, and other men who have sex with men (MSM) and transgender women, especially those living with HIV, are at a higher risk for HPV infections and related diseases, highlighting the need for targeted health interventions.

HPV vaccination is effective in reducing infections among MSM, with recommendations for routine vaccination starting at ages 11-12 and up to age 26, aiming to increase coverage and decrease HPV-related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of human papillomavirus (HPV) burden and HPV vaccination for gay, bisexual, and other men who have sex with men and transgender women in the United States. Meites, E., Wilkin, TJ., Markowitz, LE.[2022]

The quadrivalent HPV vaccine demonstrated high immunogenicity in both HIV-infected (85% seroconversion) and HIV-negative adolescents and young adults (91% seroconversion), indicating it is effective for both populations.

The vaccine was found to be generally safe and well tolerated, with local pain and headache being the most common side effects, suggesting it can be a beneficial preventive measure against HPV-related diseases in HIV-infected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a quadrivalent human papillomavirus vaccine in HIV-infected and HIV-negative adolescents and young adults. Giacomet, V., Penagini, F., Trabattoni, D., et al.[2015]

Prophylactic HPV vaccination has proven to be highly effective and well-tolerated over 20 years of clinical trials, significantly reducing the incidence of genital warts, HPV-related diseases, and precancerous lesions in various populations.

Ongoing clinical trials are exploring important questions about the vaccine's efficacy with fewer doses, its use in different age groups and health conditions, and its potential to prevent other cancers, indicating a continued commitment to optimizing HPV vaccination strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future vaccine clinical research with the licensed 2-, 4-, and 9-valent VLP HPV vaccines: What's ongoing, what's needed? Kuter, BJ., Garland, SM., Giuliano, AR., et al.[2021]

A survey of 30 staff members from HIV/AIDS service organizations revealed that while all were aware of HPV, only 67% recognized its link to anal cancer, highlighting a gap in knowledge that could impact cancer prevention efforts.

The majority of staff expressed willingness to promote HPV vaccination and assist clients in accessing vaccination services, indicating that engaging these organizations could enhance HPV vaccination rates and reduce the burden of HPV-related cancers among HIV-positive women and MSM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV-Related Cancer Prevention and Control Programs at Community-Based HIV/AIDS Service Organizations: Implications for Future Engagement. Wigfall, LT., Bynum, SA., Brandt, HM., et al.[2020]

The quadrivalent HPV vaccine elicits a durable immune response in HIV-infected women, with antibody levels remaining above the seroconversion cut-off for most HPV types, although levels decreased significantly by week 72, especially for HPV type 18.

HPV DNA was more frequently detected in the anal canal than in the cervix, indicating a higher prevalence of HPV-related lesions in that area, and suggesting the potential benefit of using a broader nonavalent vaccine to cover additional high-risk HPV types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anogenital human papillomavirus virus DNA and sustained response to the quadrivalent HPV vaccine in women living with HIV-1. Cespedes, MS., Kang, M., Kojic, EM., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccination in HIV-infected women: need for increased coverage. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

A systematic review of immunogenicity, clinical efficacy and safety of human papillomavirus vaccines in people living with the human immunodeficiency virus. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Chapter 16: HPV vaccines in immunocompromised women and men. [2006]

4. Australia pubmed.ncbi.nlm.nih.gov

Vaccination against oncogenic human papillomavirus infection in HIV-infected populations: review of current status and future perspectives. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Review of human papillomavirus (HPV) burden and HPV vaccination for gay, bisexual, and other men who have sex with men and transgender women in the United States. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a quadrivalent human papillomavirus vaccine in HIV-infected and HIV-negative adolescents and young adults. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Current and future vaccine clinical research with the licensed 2-, 4-, and 9-valent VLP HPV vaccines: What's ongoing, what's needed? [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

HPV-Related Cancer Prevention and Control Programs at Community-Based HIV/AIDS Service Organizations: Implications for Future Engagement. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Anogenital human papillomavirus virus DNA and sustained response to the quadrivalent HPV vaccine in women living with HIV-1. [2019]