Trial Outcomes & Findings for COVID-19: Healthy Oregon (Oregon Saludable): Together We Can (Juntos Podemos) Phase II (NCT NCT05082935)

Last Updated: 2024-07-22

Results Overview

This measure is built around the following question: "Did you have any of the following concerns or face any of the following challenges when deciding to get tested today? Select all that apply." Participants are asked to indicate 'yes', 'somewhat', or 'no' in response to a list of 13 options. Scale ranges from 0-2 with higher scores indicating a higher number of barriers faced. This measure is adapted from the paper Development and psychometric testing of a barriers to HIV testing scale among individuals with HIV infection in Sweden; The Barriers to HIV testing scale-Karolinska version (Wiklander et al., 2015).

Recruitment status

COMPLETED

Study phase

Target enrollment

1463 participants

Primary outcome timeframe

Change from baseline to 30 days

Results posted on

2024-07-22

Participant Flow

1463 participants enrolled in this Clinical Trial. The active comparator group was all participants enrolled in the Phase I study (Clinical Trial ID: NCT04793464).

Participant milestones

Participant milestones
Measure	Partner-optimized Venue Placement Strategy The Phase II intervention involves outreach from community partners to attend testing at existing events organized by community partners, such as the Mexican Consulate. At the event, it includes the on-site Promotores de Salud psychoeducation related to SARS-CoV-2 health related behaviors. Phase II Promotores de Salud: Community partners (e.g., Mexican Consulate) select events for testing and use their usual outreach methods to attract participants to the site and their event. Then, at the community partner's event, the research team holds COVID-19 testing events and the Promotores de Salud health behavior intervention is delivered by bilingual research staff. The health behavior intervention includes: 1) psychoeducation to promote hand-washing, social distancing, mask wearing if unvaccinated, and continued testing to mitigate the spread of COVID-19 and psychoeducation to address vaccine hesitancy; 2) information support and service navigation to address logistical challenges associated with testing and vaccination (e.g., scheduling health care visits, transportation, language barriers); 3) motivational interviewing to explore personal, social, and behavioral barriers to testing and vaccination, and to discuss available resources.	Active Comparator, Residential Density-located Venue Placement Strategy This is the Phase I study (Clinical Trial ID: NCT04793464) and is comprised of the "Promotores", "Control", and "Unknown Treatment Status" Arms/Groups from the Phase I study. For all Phase I study activities, testing events re-occurred every two weeks at the same location and time, based on census density on Latinx individuals for site selection. Promotores de Salud intervention arm consists of outreach to promote testing and vaccination at re-occurring testing events that have been selected for sites that have a high residential density of Latinx persons. At the testing events, it includes the on-site Promotores de Salud psychoeducation related to SARS-CoV-2 health related behaviors. Outreach conducted by promotores occurs to increase attendance at the testing events. Outreach is culturally responsive (e.g., culturally tailored radio announcements, social media posts, community canvassing, referral by community leaders). Control treatment status sites consisted of sites with "business as usual" outreach methods. No additional outreach activities were completed and promotores were not on site to deliver the Promotores de Salud intervention. Unknown treatment status participants had data collected at an intervention or control site, but their exposure status is unknown.
Overall Study STARTED	1463	1623
Overall Study COMPLETED	887	934
Overall Study NOT COMPLETED	576	689

Reasons for withdrawal

Reasons for withdrawal
Measure	Partner-optimized Venue Placement Strategy The Phase II intervention involves outreach from community partners to attend testing at existing events organized by community partners, such as the Mexican Consulate. At the event, it includes the on-site Promotores de Salud psychoeducation related to SARS-CoV-2 health related behaviors. Phase II Promotores de Salud: Community partners (e.g., Mexican Consulate) select events for testing and use their usual outreach methods to attract participants to the site and their event. Then, at the community partner's event, the research team holds COVID-19 testing events and the Promotores de Salud health behavior intervention is delivered by bilingual research staff. The health behavior intervention includes: 1) psychoeducation to promote hand-washing, social distancing, mask wearing if unvaccinated, and continued testing to mitigate the spread of COVID-19 and psychoeducation to address vaccine hesitancy; 2) information support and service navigation to address logistical challenges associated with testing and vaccination (e.g., scheduling health care visits, transportation, language barriers); 3) motivational interviewing to explore personal, social, and behavioral barriers to testing and vaccination, and to discuss available resources.	Active Comparator, Residential Density-located Venue Placement Strategy This is the Phase I study (Clinical Trial ID: NCT04793464) and is comprised of the "Promotores", "Control", and "Unknown Treatment Status" Arms/Groups from the Phase I study. For all Phase I study activities, testing events re-occurred every two weeks at the same location and time, based on census density on Latinx individuals for site selection. Promotores de Salud intervention arm consists of outreach to promote testing and vaccination at re-occurring testing events that have been selected for sites that have a high residential density of Latinx persons. At the testing events, it includes the on-site Promotores de Salud psychoeducation related to SARS-CoV-2 health related behaviors. Outreach conducted by promotores occurs to increase attendance at the testing events. Outreach is culturally responsive (e.g., culturally tailored radio announcements, social media posts, community canvassing, referral by community leaders). Control treatment status sites consisted of sites with "business as usual" outreach methods. No additional outreach activities were completed and promotores were not on site to deliver the Promotores de Salud intervention. Unknown treatment status participants had data collected at an intervention or control site, but their exposure status is unknown.
Overall Study Lost to Follow-up	549	631
Overall Study Withdrawal by Subject	27	58

Baseline Characteristics

Number analyzed is the number of participants with valid baseline data.