Human Papilloma VirusCHAMPSNCT05065840
Advancing HPV Vaccination Among HIV Positive Adults: The CHAMPS Study
A study testing CDC 4 Pillars Program in people with Human Papilloma Virus and Human Papilloma Virus Vaccine, run by Emory University at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Human Papilloma Virus, Human Papilloma Virus Vaccine
- What is being tested?
- CDC 4 Pillars Program
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 May 2023to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
Albany Rural Model Clinic
Albany, Georgia, 31705
AID Atlanta
Atlanta, Georgia, 30309
Faebris
Atlanta, Georgia, 30311
AHF Lithonia
Lithonia, Georgia, 30058
About this study
Official title: Implementing an Evidence-Based, Multilevel Intervention to Promote HPV Vaccination Among HIV Positive Adults
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.
Read the detailed 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, significant gaps were 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.
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 assessments.
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 that 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).
- Being tested
- CDC 4 Pillars Program
- Keywords
- Human Immunodeficiency Virus, Vaccination
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDC 4 Pillars ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months post baseline
Secondary outcomes (2)
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.
Measured: 24 months post baseline
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.
Measured: Baseline and 24 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start22 May 2023
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Jessica Wells, Emory University
- Investigators
- Jessica Wells, PhD, RN, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065840
- Sponsor's protocol ID
- STUDY00002469
- Other IDs
- R01NR020154-01, 2025P009279
- Acronym
- CHAMPS
- Status last verified
- May 2026
- First submitted
- 22 Sep 2021
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual data that underlie the results of the study's specific aims. All reported data, including text, tables, figures, and appendices, will be de-identified.
Publications
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.
PubMed 36071389
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing an Evidence-Based, Multilevel Intervention to Promote HPV Vaccination Among HIV Positive Adults
- ClinicalTrials.gov ID
- NCT05065840
- Acronym / sponsor ID
- CHAMPS / STUDY00002469
- Keywords
- Human Immunodeficiency Virus, Vaccination
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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, significant gaps were 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.
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 assessments.
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 that 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 4 Pillars Program | Experimental | Behavioral: CDC 4 Pillars ProgramPatients at study clinics who consent to have their HPV vaccination history verified with the Georgia Registry of Immunization Transactions and Services (GRITS). |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDC 4 Pillars ProgramThe 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. | Behavioural | 4 Pillars Program |
Primary outcome
Number of patients initiating the HPV vaccine
Time frame: 24 months post baseline
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.
2 secondary outcomes
Number of participants completing the HPV vaccine
Time frame: 24 months post baseline
Change in uptake rate of vaccination
Time frame: Baseline and 24 months post baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Derived from this study: PubMed 36071389Wells 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.
- Individual participant dataSharing planned: Yes. Individual data that underlie the results of the study's specific aims. All reported data, including text, tables, figures, and appendices, will be de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Wells, PhD, RN principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDC 4 Pillars Program in people with Human Papilloma Virus and Human Papilloma Virus Vaccine, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients initiating the HPV vaccine (time frame: 24 months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05065840, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.