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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.


Clinical Trial 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 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. Thus, 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. To be included in the study, interested participants must meet the following criteria: Patients enrolled in the study will meet the following criteria: 1) HIV positive; 2) 18-45 years of age; 3) read and speak English; 4) capable of informed consent; 5) have not been previously received the three series HPV vaccine; 6) no contraindications to receiving the HPV vaccine. 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 who are 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 participate in an 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 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 that 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


Related Conditions & MeSH terms


NCT number NCT05065840
Study type Interventional
Source Emory University
Contact Jessica Wells, PhD, RN
Phone 404-727-0518
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 2022
Completion date May 2026

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