CDC 4 Pillars Program for HPV Vaccination in HIV-Positive Adults
(CHAMPS Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Emory University
Disqualifiers: Pregnancy, Severe illness, Anaphylactic allergy, others
No Placebo Group
Approved in 1 Jurisdiction
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 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.
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.
12345Is 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.
12467How 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.
24789Eligibility 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.
+3 more
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
Trial 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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
AHF LithoniaLithonia, GA
Albany Rural Model ClinicAlbany, GA
AHF MidtownAtlanta, GA
AID AtlantaAtlanta, GA
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Who Is Running the Clinical Trial?
Emory UniversityLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
Human papillomavirus vaccination in HIV-infected women: need for increased coverage. [2018]Human immunodeficiency virus (HIV)-infected women carry a significant burden on human papillomavirus (HPV) infection and associated diseases. As HIV-infected individuals are living longer, the prevalence of HPV infection is rising and HPV-associated cytological abnormalities remain high despite successful treatments of HIV infection. Several HPV vaccines are currently available and recommended for adolescents and adults up to age 26. The vaccines are safe, immunogenic and effective in preventing diseases due to HPV types included in the vaccines, particularly among persons without prior HPV exposure. This review summarizes available data on the use of the HPV vaccines among HIV-infected women. The immunogenicity and safety of the vaccines are highlighted and in particular, barriers to vaccination among HIV-infected women are discussed.
A systematic review of immunogenicity, clinical efficacy and safety of human papillomavirus vaccines in people living with the human immunodeficiency virus. [2023]The human papillomavirus (HPV) is the most prevalent sexually transmitted infection worldwide. People living with the human immunodeficiency virus (HIV) are at high risk of HPV infection. This systematic review evaluates the immunogenicity, clinical efficacy, and safety of prophylactic HPV vaccines in people living with HIV. We registered the protocol for this review in the International Prospective Register of Systematic Reviews (CRD42018109898) and prepared the review following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA). Five randomized trials with 1042 participants are included in this review. One trial with 120 participants compared the bivalent HPV vaccine to placebo, three trials with 830 participants compared the quadrivalent vaccine to placebo, and another trial with 92 participants compared the quadrivalent to the bivalent vaccine. There was low to moderate certainty evidence suggesting that seroconversion was higher among participants in the vaccine arms compared to the placebo arms for both vaccines. In one study with very low certainty evidence, participants who received the bivalent vaccine had higher anti-HPV-18 geometric mean titers (GMTs) compared to those who received the quadrivalent vaccine, despite little difference in anti-HPV-16 GMTs between the two vaccines. There were no differences in the incident and persistent HPV infections in both groups. None of the studies reported data on the incidence of precancerous lesions, or cancer. There were no reports of serious adverse events following vaccination in any of the trials. None of the included studies assessed the effects of HPV vaccines in adolescents living with HIV. Very limited evidence suggests lower immunogenicity of HPV vaccines in HIV positive compared to HIV-negative people. Finally, the long-term effect of the HPV vaccine in the incidence of cervical precancerous lesions and cervical cancer needs to be monitored. There is an urgent need for more high-quality randomized controlled trials that can address these gaps.
Chapter 16: HPV vaccines in immunocompromised women and men. [2006]HIV-positive as well as other immunocompromised women and men have increased risk of human papillomavirus (HPV)-associated anogenital and oral cancers. The effectiveness of a HPV vaccine to reduce the incidence of these tumors in immunocompromised individuals may depend on several factors, including the effects of immunocompromise on the response to vaccination, the extent of prior infection with the HPV types included in the vaccine, whether immunocompromised women and men have tumors that contain types of HPV not in the vaccines more often than the general population, and whether or not immunization occurs before immunocompromise is severe. Clinical studies are needed to determine HPV vaccine safety and effectiveness in different populations of immunocompromised women and men.
Vaccination against oncogenic human papillomavirus infection in HIV-infected populations: review of current status and future perspectives. [2019]Background Men and women with HIV infection are at increased risk of developing cancers associated with human papillomavirus (HPV). The two licensed prophylactic HPV vaccines protect against de novo infection with HPV-16 and HPV-18, which cause the majority of HPV-associated cancers. Currently, no vaccine efficacy data are available for persons with HIV infection. Nevertheless, some countries have implemented specific HPV vaccination recommendations for HIV-positive populations. To specifically recommend prophylactic HPV vaccination in people with HIV, the vaccines must be safe and immunogenic in immunosuppressed people at a high risk of HPV infection. This review aims to summarise the current knowledge from published HPV vaccine trials in HIV-infected populations, to compile scheduled and ongoing HPV vaccine trials with HIV-positive study populations and to extrapolate the relevant knowledge about HPV vaccine efficacy in HIV-negative populations to an HIV context.
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]Gay, bisexual, and other men who have sex with men (MSM) and transgender women, particularly those who are living with HIV, are disproportionately affected by human papillomavirus (HPV). For this narrative review of HPV health outcomes and vaccination for gay, bisexual, and other MSM and transgender women in the United States, we highlighted 71 publications regarding 1) burden of HPV infections and related diseases; 2) HPV vaccine efficacy; 3) HPV vaccination recommendations; 4) HPV vaccination coverage; 5) real-world vaccine effectiveness and health impacts; and 6) HPV vaccination acceptability. Vaccination is effective at reducing HPV infections among MSM; in the United States, routine HPV vaccination is recommended for all adolescents at age 11-12 years and for all persons through age 26 years. Efforts are ongoing to increase vaccination coverage and monitor health impacts of vaccination. Increasing vaccination coverage before sexual exposure to HPV is expected to reduce the burden of HPV-related disease.
Safety and immunogenicity of a quadrivalent human papillomavirus vaccine in HIV-infected and HIV-negative adolescents and young adults. [2015]Human papillomavirus (HPV) infection is highly prevalent and can lead to cancer; the development of safe and efficacious vaccines for HPV is a major public health concern. The two licensed HPV vaccines contain recombinant virus-like particles of HPV 16 and 18; one of such vaccines also protects against HPV types 6 and 11 which cause genital warts. We determined safety and immunogenicity of quadrivalent HPV vaccine in HIV-infected and HIV-negative adolescents and young adults, aged 13-27 years. The seroconversion rate, assessed by antibody titers, 1 month after the administration of the third vaccine dose was 0.85 (95% CI 0.75-0.95) in the HIV-infected group and 0.91 (0.83-0.99) in the HIV-negative subjects (p=0.52). The vaccine was generally safe and well tolerated; the most common side effect was local pain and the most frequent systemic side effect was headache. This is the first report on response to HPV vaccination in both female and male HIV-infected adolescents and young adults and highlights that this population may benefit from HPV immunoprophylaxis. Further studies are needed to examine the long term efficacy of this vaccine in HIV-infected individuals.
Current and future vaccine clinical research with the licensed 2-, 4-, and 9-valent VLP HPV vaccines: What's ongoing, what's needed? [2021]Prophylactic HPV vaccination has been a great public health success. For >20 years, clinical trials were conducted with the 2-, 4-, and/or 9-valent vaccines in young-adult females, mid-adult women, males, and adolescents. In all studies, the vaccines were highly efficacious, immunogenic, and well tolerated. Following vaccine licensure and utilization in national vaccine programs globally (real-world settings primarily in high income countries), numerous studies demonstrated that the vaccines continue to have an excellent safety profile and have dramatically reduced the incidence of genital warts, HPV vaccine-type prevalence, and precancerous lesions. Thirty-eight clinical trials with the currently licensed HPV vaccines are ongoing. Key questions being addressed in new trials include: efficacy against persistent infection and immunogenicity of a 1-dose regimen; efficacy of 3 doses in 20-45-year-old females; use in postpartum women and immunocompromised individuals (HIV, liver and kidney transplants); dose sparing via intradermal administration; use in combination with a PD1 monoclonal antibody in patients with cervical cancer; impact on recurrent disease in women undergoing cervical conization; persistence of protection; and use to prevent oropharyngeal cancer. Additional clinical research that should be conducted includes: long-term follow-up, particularly of 1- and 2-dose regimens; further evaluation of flexible 2-dose regimens; immunogenicity of 1- or 2-dose regimens in persons ≥15 years old and immunocompromised populations; safety and immunogenicity of 1 or 2 doses in children
HPV-Related Cancer Prevention and Control Programs at Community-Based HIV/AIDS Service Organizations: Implications for Future Engagement. [2020]Background: People living with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) and, men who have sex with men (MSM) are disproportionately affected by genital warts and cancers caused by human papillomavirus (HPV). We assessed community-based HIV/AIDS service organizations' (ASOs) staff awareness, knowledge, attitudes, and beliefs about HPV and effective cancer prevention tools, namely HPV vaccination, Pap, and HPV tests. The potential engagement of ASO staff in future efforts to reduce the disproportionate burden of genital warts and HPV-related cancers among HIV-positive women and MSM was explored. Methods: In May-June 2016, staff were recruited from three ASOs located in the South United States Census region-a geographical area disproportionately affected by HIV/AIDS. Participants completed a 30-min self-administered, 118-item paper and pencil survey about HPV and cancer. Data analysis was conducted using Stata/SE 14.2. Results: ASO staff (n = 30) were 83% non-Hispanic Black, 40% lesbian/gay, and worked with people living with HIV for an average of 11.4 ± 7.7 years. All reported hearing of HPV and 77% had heard of the HPV vaccine (n = 23). While all knew HPV can cause cervical cancer, only 67% knew HPV can cause anal cancer. Most (61%) thought the HPV vaccine could prevent cervical cancer. Fewer (39-48%) thought the HPV vaccine could prevent anal, oral, penile, vaginal, and vulvar cancers. All were willing to encourage MSM and female clients to talk to a healthcare provider about HPV vaccination. Almost all were willing to promote HPV vaccination to clients (91-95%) and navigate clients to adult safety net HPV vaccine providers (86-95%). More than half (59-67%) thought they could positively influence their MSM and female clients' HPV vaccine decision-making. Conclusion: HPV vaccination and the Pap and HPV tests are effective cancer prevention tools that can reduce the disproportionate burden of genital warts and HPV-related cancers among HIV-positive women and MSM. Engaging ASO staff in cancer prevention efforts may increase HPV vaccination rates and early detection of HPV-related cancers among HIV-positive women and MSM. Exploring ASOs as community-based settings for promoting effective cancer prevention tools may foster opportunities to reduce the disproportionate burden of genital warts and HPV-related cancers among HIV-positive women and MSM.
Anogenital human papillomavirus virus DNA and sustained response to the quadrivalent HPV vaccine in women living with HIV-1. [2019]People living with HIV have increased Human Papillomavirus (HPV) related lesions and malignancies. We describe HPV DNA recovered from the cervix and anal canal, explore the effect of vaccination on HPV detection, and examine the durability of vaccine titers in women living with HIV-1 who were vaccinated with the quadrivalent HPV vaccine.