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Completed

NCT Number: NCT07166770

Community-Led COVID-19 Testing Intervention to Address Mistrust

The goal of this adapted intervention study is to assess how community-led group discussions about health-related topics may alter beliefs and intentions regarding healthcare recommendations, such as COVID-19 testing and vaccination.

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Key information

Conditions

COVID-19 Behavior Coronaviridae Infections Coronavirus Infections Health Behavior Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Treatment Adherence and Compliance Treatment Refusal Trust Vaccination Hesitancy Vaccination Refusal Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Macon & Joan Brock Virginia Health Institute at Old Dominion University

Norfolk, Virginia, 23507, United States

About this study

Eligible participants were randomized to intervention or control group. Intervention group participants met virtually with other community member participants in small discussion groups once a week for 75 minutes over the course of 14 weeks. The online discussion groups were led by peer mentor facilitators and supported by a research team member. Discussion topics included current events and other health related topics. Control group participants did not meet in weekly discussion groups. At approximately the 0 weeks, 14 weeks, and 18 weeks time points, all participants answered online surveys about health related topics. At the 14 weeks and 18 weeks time points, all participants were asked to self-administer a COVID-19 test that investigators provide.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Resident of one of the 9 housing authority agencies
  • Willing to participate in Zoom meetings and complete online assessments at baseline, 14-week, and 18-week timepoints
  • Ability to read, speak, and understand English

Exclusion criteria

  • May not have participated in Study 1

Treatment and study plan

Community-led discussion

Behavioral

Participants engage in weekly community-led small group discussions about health related topics

Primary outcomes

  1. Openness to COVID-19 Testing

    Time frame: 0 weeks, 14 weeks, 18 weeks

    The COVID-19 Testing Openness Questionnaire is an 7-item self-report measure designed to assess participants' openness to getting tested for COVID-19. Each item is rated on a 5-point scale, from 1 "Strongly Disagree" to 5 "Strongly Agree," with the sum of scores ranging from 7 to 35. Higher scores indicate greater openness to COVID-19 testing.

  2. COVID-19 Testing Efficacy

    Time frame: 0 weeks, 14 weeks, 18 weeks

    The COVID-19 Testing Efficacy Scale is a 6-item self-report measure that will assess participants' perceived self- and response-efficacy related to COVID-19 testing. Each item is rated on a 5-point scale ranging from 1 "Strongly Disagree" to 5 "Strongly Agree," with the sum of scores ranging between 6 and 30. Higher scores indicate greater efficacy.

  3. COVID-19 Trust

    Time frame: 0 weeks, 14 weeks, 18 weeks

    Two items assessing (1) trust in the safety of the COVID-19 vaccine, and (2) trust in the efficacy of the COVID-19 vaccine were used to assess participants' trust relating to COVID-19. Each item is rated on a 5-point Likert scale. Higher scores indicate greater trust.

Secondary outcomes

  1. COVID-19 Vaccine Hesitancy

    Time frame: 0 weeks, 14 weeks, 18 weeks

    Vaccine Hesitancy was assessed by an item that asked, "Overall, how hesitant about the COVID-19 vaccine would you consider yourself to be?." This question was adapted from the Parent Attitudes about Childhood Vaccines (PACV) survey. The item is scored on a 5-point Likert scale, ranging from "1 - not at all hesitant" to "5 = very hesitant" with higher scores indicating greater hesitancy.

  2. Social Connectedness

    Time frame: 0 weeks, 14 weeks, 18 weeks

    The Social Connectedness Scale Revised is a 20-item scale that measures a participant's feeling of connection with other people and their community. Each item is rated on a 6-point scale ranging from 1 "Strongly Disagree" to 6 "Strongly Agree," with the sum of scores ranging between 20 and 120. Higher scores indicate greater connectedness.

  3. Health Literacy

    Time frame: 0 weeks, 14 weeks, 18 weeks

    The Health Literacy Scale (HLS-14) for Adults is a 14-item scale adapted for use in the US that measures an individual's ability to understand, access, and apply health-related information. Each item is rated on a 5-point scale ranging from 1 "Strongly Disagree" to 5 "Strongly Agree," with the sum of scores ranging between 14 and 70. Higher scores indicate greater health literacy.

Sponsors and collaborators

Lead sponsor

Old Dominion University

Other

Registry information

Official study title

Evaluating a Community-Led COVID-19 Testing Intervention to Address Mistrust - Study 2

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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