Trial Outcomes & Findings for CRISOL Contigo: a Multi-level Intervention to Reduce the Disproportionate Toll of COVID-19 Among Latino Communities in Philadelphia. (NCT NCT04646616)

Last Updated: 2023-07-05

Results Overview

This measure is the sum of the five protective COVID-19 risk measures: Use of mask, frequent hand washing, social distancing (including the ability to telework, and avoid crowded indoor spaces), and avoidance of contact with high-risk individuals. Scale ranged (0-5). The higher the score, the higher the number of protective behaviors

Recruitment status

COMPLETED

Study phase

Target enrollment

178 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2023-07-05

Participant Flow

Participant milestones

Participant milestones
Measure	Community Popular Opinion Leader (POL) After successful completion of the new COVID-19 training module, POLs will reach out to members of their social networks to model and diffuse social norms to reduce the risk of COVID-19 infection and transmission, screen for symptoms and counsel regarding COVID-19, SAVAME syndemic factors, and refer at-risk or affected individuals to appropriate community services (e.g. free COVID-19 testing and treatment, mental health services, substance use services, violence prevention, support groups, etc.). The first 300 community contacts will be invited to complete a baseline and 3-month follow up surveys (via internet or phone).
Overall Study STARTED	178
Overall Study COMPLETED	139
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CRISOL Contigo: a Multi-level Intervention to Reduce the Disproportionate Toll of COVID-19 Among Latino Communities in Philadelphia.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Community Popular Opinion Leader (POL) n=178 Participants A community popular opinion leader (POL) based intervention to promote measures to reduce COVID-19 risk, transmission, access to testing and treatment, reduction of the impact of COVID-19, and addressing the Substance Abuse, Violence, HIV/AIDS, and MEntal health (SAVAME) syndemic in the community. POLs will interact within their networks counseling regarding COVID-19 and SAVAME factors. The POLs will refer individuals to appropriate community services. POLs will record basic sociodemographic characteristics of all community contacts, the issue addressed, and their response to it. The first 300 community contacts will be invited to complete a baseline and 3-month follow up surveys (via internet or phone). The content of the surveys includes: 1) COVID-19 related questions (knowledge, impact, symptoms, risk factors, access to testing and care, acceptability contact tracing, vaccine) 2) Biological risk factors, 3) Social determinants of health, 4) SAVAME outcomes and access to services.
Age, Continuous	38.4 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	135 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Race/Ethnicity, Customized Latino Black	4 Participants n=5 Participants
Race/Ethnicity, Customized Latino White	12 Participants n=5 Participants
Race/Ethnicity, Customized Latino Other	119 Participants n=5 Participants
Race/Ethnicity, Customized Latino Native American	11 Participants n=5 Participants
Race/Ethnicity, Customized Prefer not to answer, Unknown, More than one	39 Participants n=5 Participants
Region of Enrollment United States	178 participants n=5 Participants
Education Category Primary or below	33 Participants n=5 Participants
Education Category More than Primary & <= High School	111 Participants n=5 Participants
Education Category High school or more	32 Participants n=5 Participants
Education Category Missing	2 Participants n=5 Participants
Baseline Income Category <$1000 usd	86 Participants n=5 Participants
Baseline Income Category $1000-$2000 usd	38 Participants n=5 Participants
Baseline Income Category >$2000 usd	21 Participants n=5 Participants
Baseline Income Category Missing/Don't know	33 Participants n=5 Participants
Prevalence of COVID-19 positive	51 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: Each of the rows indicates the mean (SD) of protective behaviors at baseline and 3 months follow up

Outcome measures

Outcome measures
Measure	Community Popular Opinion Leader (POL) n=139 Participants A community popular opinion leader (POL) based intervention to promote measures to reduce COVID-19 risk, transmission, access to testing and treatment, reduction of the impact of COVID-19, and addressing the Substance Abuse, Violence, HIV/AIDS, and MEntal health (SAVAME) syndemic in the community. POLs will interact within their networks counseling regarding COVID-19 and SAVAME factors. The POLs will refer individuals to appropriate community services. POLs will record basic sociodemographic characteristics of all community contacts, the issue addressed, and their response to it. The first 300 community contacts will be invited to complete a baseline and 3-month follow up surveys (via internet or phone). The content of the surveys includes: 1) COVID-19 related questions (knowledge, impact, symptoms, risk factors, access to testing and care, acceptability contact tracing, vaccine) 2) Biological risk factors, 3) Social determinants of health, 4) SAVAME outcomes and access to services.
Mean Number of Five Protective COVID-19 Risk Measures Baseline	2.79 score on a scale Standard Deviation 1.23
Mean Number of Five Protective COVID-19 Risk Measures 3 Months	2.66 score on a scale Standard Deviation 1.33

PRIMARY outcome

Timeframe: Baseline and 3 months

This measure is a composite dichotomous outcome variable, that indicates not having health insurance or not having a regular primary care provider.

Outcome measures

Outcome measures
Measure	Community Popular Opinion Leader (POL) n=139 Participants A community popular opinion leader (POL) based intervention to promote measures to reduce COVID-19 risk, transmission, access to testing and treatment, reduction of the impact of COVID-19, and addressing the Substance Abuse, Violence, HIV/AIDS, and MEntal health (SAVAME) syndemic in the community. POLs will interact within their networks counseling regarding COVID-19 and SAVAME factors. The POLs will refer individuals to appropriate community services. POLs will record basic sociodemographic characteristics of all community contacts, the issue addressed, and their response to it. The first 300 community contacts will be invited to complete a baseline and 3-month follow up surveys (via internet or phone). The content of the surveys includes: 1) COVID-19 related questions (knowledge, impact, symptoms, risk factors, access to testing and care, acceptability contact tracing, vaccine) 2) Biological risk factors, 3) Social determinants of health, 4) SAVAME outcomes and access to services.
Number of Participants Who Lack Access to Health Care 3 Months	122 Participants
Number of Participants Who Lack Access to Health Care Baseline	121 Participants

SECONDARY outcome

Timeframe: Baseline and 3 months

Substance abuse (yes/no), defined as binge drinking (\>=4 or \>=5 drinks on one occasion for women, and men, respectively), or use of drugs other than those required for medical reasons (at least once a week). Intimate partner violence (yes/no), defined as experiencing verbal or physical violence, categorized using answers to the following questions: In the 30 days, how often has a partner or spouse, "Yelled at you or said things to you that made you feel bad about yourself, embarrassed you in front of others, or frightened you?", "Done things like push, grab, hit, slap, kick, or throw things at you during an argument or because they were angry with you?". Any answer other than never was considered yes. HIV/AIDS (yes/no), defined as having a history of a positive test. Mental health (Yes/no), defined as depressive (CES-D-10 \>=10) or anxiety (GAD-7 \>=5) symptoms.

Outcome measures

Outcome measures
Measure	Community Popular Opinion Leader (POL) n=139 Participants A community popular opinion leader (POL) based intervention to promote measures to reduce COVID-19 risk, transmission, access to testing and treatment, reduction of the impact of COVID-19, and addressing the Substance Abuse, Violence, HIV/AIDS, and MEntal health (SAVAME) syndemic in the community. POLs will interact within their networks counseling regarding COVID-19 and SAVAME factors. The POLs will refer individuals to appropriate community services. POLs will record basic sociodemographic characteristics of all community contacts, the issue addressed, and their response to it. The first 300 community contacts will be invited to complete a baseline and 3-month follow up surveys (via internet or phone). The content of the surveys includes: 1) COVID-19 related questions (knowledge, impact, symptoms, risk factors, access to testing and care, acceptability contact tracing, vaccine) 2) Biological risk factors, 3) Social determinants of health, 4) SAVAME outcomes and access to services.
Number of Participants With SAVAME (Substance Abuse, Violence, HIV/AIDS, Mental Health)-Related Factors Baseline	64 Participants
Number of Participants With SAVAME (Substance Abuse, Violence, HIV/AIDS, Mental Health)-Related Factors 3 Months	48 Participants

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Defined as self-report lack of access to any SAVAME services, overall among all the participants

Self-report lack of access to any SAVAME (Substance abuse, Intimate partner violence, HIV/AIDS, or Mental health symptomatology) services, overall among all the participants

Outcome measures

Outcome measures
Measure	Community Popular Opinion Leader (POL) n=139 Participants A community popular opinion leader (POL) based intervention to promote measures to reduce COVID-19 risk, transmission, access to testing and treatment, reduction of the impact of COVID-19, and addressing the Substance Abuse, Violence, HIV/AIDS, and MEntal health (SAVAME) syndemic in the community. POLs will interact within their networks counseling regarding COVID-19 and SAVAME factors. The POLs will refer individuals to appropriate community services. POLs will record basic sociodemographic characteristics of all community contacts, the issue addressed, and their response to it. The first 300 community contacts will be invited to complete a baseline and 3-month follow up surveys (via internet or phone). The content of the surveys includes: 1) COVID-19 related questions (knowledge, impact, symptoms, risk factors, access to testing and care, acceptability contact tracing, vaccine) 2) Biological risk factors, 3) Social determinants of health, 4) SAVAME outcomes and access to services.
Lack of Access to SAVAME Services 3 Months	43 Participants
Lack of Access to SAVAME Services Baseline	52 Participants

Adverse Events

Community Popular Opinion Leader (POL)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mariana Lazo

Drexel University School of Public Health

Phone: 2673596058

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place