NCT05027464 (CoVAcS).

Study name	Developing and testing a COVID‐19 Vaccination Acceptance intervention (CoVAcS)
Starting date	30 August 2021
Contact information	Yasmin Jolly, Yasmin.Jolly@va.gov Nicole McCamish, Nicole.McCamish@va.gov
Methods	Study design: randomised controlled trial Type of publication: trial registration Setting: VA Medical Centers, NR Country: USA Language:NR
Intervention	Outreach calls multi‐pronged approach, research team will train Health Behavior Co‐ordinators (HBCs), HBCs will then train PACT teams at their site and Whole Health Coaches, Peer Specialists and other VA Staff in VAI strategies to use with unvaccinated Veterans, will conduct outreach calls, using strategies, with unvaccinated Veterans) No intervention: usual care (no specific trial intervention requirements beyond their usual level of participation in national and local initiatives to improve COVID‐19 vaccine acceptance)
Population	Population: veterans Inclusion criteria by aim: For all aims: 18 years and older Aim 1: primary care clinic visit in VISN 16 or 21 Aim 2: =1 visit(s) at a participating VISN 16 or 21 primary care clinic or CBOC after the start of the trial at their site, and at the time of recruitment, COVID‐19 vaccination status is verified as one of the following: has not initiated COVID‐19 vaccination has initiated one of the two mRNA vaccines and is outside the window for the second dose recently completed COVID‐19 vaccination (has completed two doses of mRNA vaccination or has completed the single‐dose Janssen/Johnson & Johnson vaccine within the past 60 days) Aim 3: Implementation‐focused Interviews with VISN 16 and 21 Staff and HCPs Exclusion criteria by aim:  Aim 1: Per VISN or VAMC leadership, the clinic or CBOC has extreme staffing shortages such that it would not be feasible or in the best interests of patient care to allow clinic or CBOC staff release time to participate in training or other meetings related to the trial Aim 2: Has initiated COVID‐19 vaccination with one of the mRNA vaccines and is within the window to complete the second dose on schedule (< 42 days since dose 1) Serious allergic reaction or other contraindication to COVID‐19 vaccination or other vaccines (e.g. flu vaccine) Currently in hospice care or < 6 months to live No consistent ability to be contacted by phone Participating in another COVID‐19 trial or study (research study flag) Moderate to severe dementia as documented in the patient's VA medical record Increased suicide risk as indicated by behavioral health flag Aim 3: Staff or HCPs declines invitation to participate in the interview
Outcomes	Primary outcome Vaccine uptake (COVID‐19 vaccination status) Secondary outcomes Seasonal Influenza vaccination status Survey of Vvterans from intervention and usual care who did and did not receive COVID‐19 vaccination Qualitative Interview with purposive subset of Veterans from Intervention and usual care who did and did not receive COVID‐19 vaccination Qualitative Interviews with VA staff and healthcare providers Secondary analysis of VA National Data
Estimated completion date and number of participants	30 September 2023, 2500 participants
Notes	COI: NR Funding: VA Office of Research and Development