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

NCT05376397 | Completed Results

• 2 other identifiers: Pro2021001082K01MH118091
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 treatment 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.

Conditions

Medication Adherence; Depressive Symptoms; Anxiety Symptoms; Emotion Regulation

Outcome Measures

Primary Outcomes (4)

• Antiretroviral (ART) Medication Use

  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?"

  24 Hours

• Depressive Symptoms

  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 down, depressed, or hopeless") on a scale from 0 (not at all) to 3 (completely). We used an average across all items for each time point.

  24 Hours

• Anxiety Symptoms

  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.

  24 Hours

• Emotion Regulation

  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.

  24 Hours

Secondary Outcomes (1)

• Coping

  24 Hours

Study Arms (1)

iTHRIVE 365

EXPERIMENTAL

Behavioral: iTHRIVE 365

Interventions

iTHRIVE 365 BEHAVIORAL

iTHRIVE 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.

iTHRIVE 365

Eligibility Criteria

• Age: 16 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older ;
• Identifying as masculine
• Identifying as Black/African American
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Thrive Social Services: collaborator
• Positive Impact Health Centers: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Devin English

Newark, New Jersey, 07102-0301, United States

Location

Related Publications (1)

• English D, Smith JC, Scott-Walker L, Lopez FG, Morris M, Reid M, Lashay C, Bridges D, McNeish D. Feasibility, Acceptability, and Preliminary HIV Care and Psychological Health Effects of iTHRIVE 365 for Black Same Gender Loving Men. J Acquir Immune Defic Syndr. 2023 May 1;93(1):55-63. doi: 10.1097/QAI.0000000000003167.

  PMID: 36706362 DERIVED

MeSH Terms

Conditions

Medication Adherence; Depression; Anxiety Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Behavioral Symptoms; Mental Disorders; Self-Control; Social Behavior

Results Point of Contact

• Title: Dr. Devin English, Prinicipal Investigator
• Organization: Rutgers School of Public Health

devin.english@rutgers.edu

19739727212

Study Officials

• Devin English, PhD

  Rutgers School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 17, 2022
• Study Start: September 30, 2021
• Primary Completion: August 30, 2022
• Study Completion: November 30, 2023
• Last Updated: March 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following study publication
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)