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Testing THRIVE 365 for Black Sexual Minority Men (On The Daily) (OTD)

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ClinicalTrials.gov Identifier: NCT05376397
Recruitment Status : Recruiting
First Posted : May 17, 2022
Last Update Posted : May 17, 2022
Sponsor:
Collaborators:
THRIVE Social Services Inc. (THRIVE SS)
Positive Impact Health Centers
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Devin English, PhD, Rutgers, The State University of New Jersey

Brief Summary:
The primary goal of this study is to test a minority stress model of psychological health outcomes for Black sexual minority men (BSMM) while using and not using a novel intervention named THRIVE 365. THRIVE 365 combines mHealth and institutional support elements to provide four areas of support for BSMM: 1) Promote HIV and psychological health knowledge and motivation; 2) Foster a sense of community and positive social connections among BSMM; 3) Connect clients to BSMM-affirming healthcare, including HIV treatment and mental healthcare; 4) Provide resources for housing, transportation, and other economic empowerment. To examine the effects of the intervention, we will utilize a 14-day daily diary study to capture daily intervention engagement, HIV and psychological health outcomes, coping, and experiences of racial and sexual minority stressors. We will first examine main associations between intervention engagement and HIV (antiretroviral [ART] use) and psychological health (depressive symptoms, anxiety symptoms, emotion regulation difficulties outcomes) outcomes, then consider how intervention engagement affects coping and attenuates the impacts of racial and sexual minority stressors during the 14 day period.

Condition or disease Intervention/treatment Phase
Medication Adherence Depressive Symptoms Anxiety Symptoms Emotion Regulation Behavioral: THRIVE 365 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Addressing Intersectional Stigma: Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)
Actual Study Start Date : September 14, 2021
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: THRIVE 365 Behavioral: THRIVE 365
THRIVE 365 is a multicomponent intervention that combines mHealth features and institutional to support community priorities identified in formative CBPR. In line with best-practices for trials of intervention principles (TIPs) of interventions with mHealth features, THRIVE 365 deploys intervention elements that serve to accomplish intervention strategies. THRIVE 365 intervention strategies are to promote: 1)Health knowledge and motivation; 2)Social support coping; 3)Access to culturally-affirming healthcare; and 4)Housing and other economic resources. THRIVE 365 pursues these strategies via these intervention elements: 1)Weekly HIV and psychological health information and motivation content and daily health notifications; 2)Online moderated forums, interpersonal chats, and community calendars; 3)Linkage to biopsychosocial healthcare via THRIVE SS's network of BSMM-affirming providers; and 4)Housing and economic resources through THRIVE SS's direct support and referral network.




Primary Outcome Measures :
  1. Antiretroviral (ART) Medication Use [ Time Frame: 24 Hours ]
    A single dichotomous no(0)/yes(1) item assesses ART use over the past 24 hours: "In the past 24 hours, did you take ART medication?"

  2. Depressive Symptoms [ Time Frame: 24 Hours ]
    The Patient Health Questionnaire-4 assesses anxiety and depressive symptoms. Participants rate the extent to which they had been experiencing each item the past day (e.g., "In the past 24 hours, I've been feeling nervous, anxious, or on edge") on a scale from 0 (not at all) to 3 (completely). We used an average across all items for each time point.

  3. Anxiety Symptoms [ Time Frame: 24 Hours ]
    The Patient Health Questionnaire-4 assesses anxiety and depressive symptoms. Participants rate the extent to which they had been experiencing each item the past day (e.g., "In the past 24 hours, I've been feeling nervous, anxious, or on edge") on a scale from 0 (not at all) to 3 (completely). We used an average across all items for each time point.

  4. Emotion Regulation [ Time Frame: 24 Hours ]
    A validated four-item version of the Difficulties with Emotion Regulation Scale assesses emotion regulation. Participants rated the extent to which they had been experiencing each item (e.g., "In the past 24 hours, I've been experiencing my emotions as overwhelming") in the past day on a scale from 0 (not at all) to 3 (completely). We used an average across all items for each time point.


Secondary Outcome Measures :
  1. Coping [ Time Frame: 24 Hours ]
    A modified version of the Brief-COPE assesses coping approaches to stress over the last 24 hours



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 16 years old or older ;
  • Identifying as masculine
  • Reporting being attracted to and/or sexually active with men;
  • Able to complete all procedures in English.
  • Mobile access to the internet in order to complete the once-daily survey procedures.

Exclusion Criteria:

  • evidence of unstable, unmanaged, or serious psychiatric symptoms that could be made worse by participation;
  • evidence of gross cognitive impairment that would interfere with successful completion of study procedures.

Information from the National Library of Medicine

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): NCT05376397


Contacts
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Contact: Devin English, PhD 9739727212 devin.english@rutgers.edu

Locations
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United States, New Jersey
Devin English Recruiting
Newark, New Jersey, United States, 07102-0301
Contact: Devin English, PhD    973-972-7212    devin.english@rutgers.edu   
Principal Investigator: Devin English, PhD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
THRIVE Social Services Inc. (THRIVE SS)
Positive Impact Health Centers
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Devin English, PhD Rutgers School of Public Health
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Responsible Party: Devin English, PhD, Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT05376397    
Other Study ID Numbers: Pro2021001082
K01MH118091 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2022    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share individual participant data that underlie the results reported in the article after deindentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Beginning 3 months and ending 5 years following study publication
Access Criteria: Researchers who provide a methodologically sound proposal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms