Clinical trial NCT05065840: Advancing HPV Vaccination Among HIV Positive Adults: The CHAMPS Study
Official title: Implementing an Evidence-Based, Multilevel Intervention to Promote HPV Vaccination Among HIV Positive Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Papilloma Virus
Human Papilloma Virus Vaccine
Keywords: Human Immunodeficiency Virus
Vaccination
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-10-04
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Number of patients initiating the HPV vaccine
timeFrame: 24 months post baseline
Secondary outcomes:
measure: Number of participants completing the HPV vaccine
timeFrame: 24 months post baseline
measure: Change in uptake rate of vaccination
timeFrame: Baseline and 24 months post baseline
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Rural Model Clinic
state: Georgia
city: Atlanta
country: United States
facility: AID Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Faebris
state: Georgia
city: Lithonia
country: United States
facility: AHF Lithonia
state: Georgia
Study officials:
affiliation: Emory University
name: Jessica Wells, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.