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Completed

NCT Number: NCT05376397

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

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.

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Key information

Conditions

Medication Adherence Anxiety Disorders Anxiety Symptoms Behavior Behavioral Symptoms Depression Depressive Symptoms Emotion Regulation Emotional Regulation Health Behavior Mental Disorders Patient Acceptance of Health Care Patient Compliance Self-Control Social Behavior Treatment Adherence and Compliance

Age range

16 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Devin English

Newark, New Jersey, 07102-0301, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 16 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.

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.

Treatment and study plan

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.

Primary outcomes

  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 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.

  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 outcomes

  1. Coping

    Time frame: 24 Hours

    A modified version of the Brief-COPE assesses coping approaches to stress over the last 24 hour. It includes the 3 items from the interconnectedness and 3 items problem-oriented subscales (Greer, 2007), and 3 original items assessing specific interconnectedness with Black LGBTQ people and problem-oriented action against injustice ("I've connected with another Black LGBTQ person for support", "I've spoken out against negative treatment", "I've posted about injustice on social media"). Participant indicate all the coping approaches among the 9 total that they utilized over the last 24 hours (Range: 0-9 coping approaches).

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Positive Impact Health Centers
  • Thrive Social Services

Registry information

Official study title

Addressing Intersectional Stigma: Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)

Acronym: OTD

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 17, 2022
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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