SER Hispano Longitudinal Study
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|ClinicalTrials.gov Identifier: NCT03527654|
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : July 4, 2019
|Condition or disease||Intervention/treatment|
|Stress Acculturation Health||Other: Observational|
|Study Type :||Observational|
|Estimated Enrollment :||385 participants|
|Official Title:||SER Study: Salud, Estrés, y Resilencia (Health, Stress, and Resilience) Among Young Adult Hispanic Immigrants in the U.S.|
|Actual Study Start Date :||May 2, 2018|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Surveys, blood and urine collected prospectively over 24 months.
- Change in syndemic conditions, as measured by the AUDIT, DAST, Revised Conflict Tactics Scale, the Partner table and STI History, the PHQ-9, and the GAD-7. [ Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months ]The AUDIT (Babor et. al., 2001) measure has 10 items that assess frequency of drinking and alcohol use disorder symptoms. The DAST (Skinner, 1982) measure, has 10 items that measure drug abuse symptoms. The Revised Conflict Tactics Scale (Strauss & Douglas, 2004) has 24 items that assess conflict between partners and intimate partner violence. The Partner Table & STI History (Gonzalez-Guarda et. al., 2011) has 25 items that assess current sexual practices and risk for sexually transmitted infections including HIV. The PHQ-9 (Kroenke et al., 2002) has 9 items that assess severity depression. The GAD-7 (Spitzer et. al., 2006) contains 7 items that assess anxiety for the individual.
- Change in biological stress markers [ Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months ]The Inflammatory Cytokines lab test, measures systemic inflammation in body fluid samples (blood and Urine) specifically cytokines IL6, IL8 and IL18. The F2 Isoprostanes measures oxidative stress markers in body fluid samples (blood and Urine) within cells.
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527654
|Contact: Maralis B Mercado Emerson, MPH, MACSfirstname.lastname@example.org|
|Contact: Norma Garcia Ortiz, BAemail@example.com|
|United States, North Carolina|
|Duke School of Nursing||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Maralis Mercado Emerson, MPH 919-684-9410 firstname.lastname@example.org|
|Principal Investigator:||Rosa Gonzalez-Guarda, PhD||Duke University School of Nursing|