NCT03527654

Brief Summary

Hispanic immigrants to the U.S. are more likely to experience negative health outcomes the longer they live in the U.S. For example, over time Hispanic immigrants engage in riskier behaviors such as substance abuse, violence, and risky sex, and experience more depressive symptoms. The stress associated with the acculturation process, acculturation stress, and resilience at the individual, family, community, and societal levels appear to play important roles in influencing risks. However, little is known about the causal mechanisms linking acculturation stress, resilience, and health outcomes among Hispanic immigrants. Further, little is known about what precise types of stressors (e.g., occupational stress vs. discrimination) and resilience factors (e.g., individual coping vs. family support) have the most important influence on health trajectories of Hispanic immigrants. The proposed longitudinal study (N = 385) will investigate the effects of acculturation stress and resilience on co-occurring substance abuse, intimate partner violence, HIV risk, and depression (i.e., syndemic conditions) and biological stress among young adult Hispanic immigrants in the U.S. More specifically, the proposed project aims to: 1) test theoretical links between the cumulative impact of acculturation stress and resilience on syndemic conditions and biological stress among recent young adult Hispanic immigrants over a two-year period, and 2) identify the specific types of acculturation stressors and resilience factors at the individual, family, community, and societal levels that are most important in predicting syndemic conditions and biological stress among this population over time. Young adult low-income Hispanic immigrant men and women within the first 10 years of immigration will be followed for two years. Biopsychosocial data will be collected from participants at baseline, and then 6 months (FU1), 12 months (FU2), 18 months (FU3), and 24 months later (FU4). Culturally specific measures of acculturation stress and resilience will be used to assess for individual, family, community, and societal risk and protective factors for syndemic conditions. Blood and urine samples will be obtained from participants to measure systemic inflammation (IL 6, IL8, and IL 18) and oxidative stress (F2 isoprostanes), previously validated biomarkers for psychological stress. Various descriptive, univariate and multivariate statistics, including latent growth curve modeling, will be used to address aims 1-2. The findings from this study have the potential to identify risk and protective factors for the decay in heath among Hispanic immigrants. A precise and culturally informed understanding of these phenomena is foundational for designing interventions that can ultimately promote the health and wellbeing of Hispanic immigrants, the largest immigrant group in the U.S. This study also has the potential to lay the theoretical foundation for biopsychosocial health disparities research in other populations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

May 2, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

3.7 years

First QC Date

April 27, 2018

Last Update Submit

May 25, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline, 6 months, 12 months, 18 months, 24 months

  • Change in biological stress markers

    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.

    Baseline, 6 months, 12 months, 18 months, 24 months

Study Arms (1)

Hispanic Immigrants

Other: Observational

Interventions

Surveys, blood and urine collected prospectively over 24 months.

Hispanic Immigrants

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male and female Hispanic immigrants participants between the ages of 18 and 44 living in Durham, Wake, and Orange counties.

You may qualify if:

  • identifying as Hispanic or Latino,
  • between 18 and 44 years of age,
  • immigrating to the U.S., and
  • residing in the the U.S. for at least 1 year.

You may not qualify if:

  • \. acute illness (e.g., cold, flu).
  • Participants do not need to be able to read, as the questions and responses will be read to the participants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke School of Nursing

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Gonzalez-Guarda RM, McCabe BE, Nagy GA, Stafford AM, Matos L, Lu M, Felsman I, Rocha-Goldberg P, Cervantes RC. Acculturative Stress, Resilience, and a Syndemic Factor Among Latinx Immigrants. Nurs Res. 2023 Jul-Aug 01;72(4):249-258. doi: 10.1097/NNR.0000000000000655. Epub 2023 Mar 11.

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Urine

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Rosa Gonzalez-Guarda, PhD

    Duke University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2018

First Posted

May 17, 2018

Study Start

May 2, 2018

Primary Completion

January 2, 2022

Study Completion

January 2, 2022

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations