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

Primary Purpose

Medication Adherence, Depressive Symptoms, Anxiety Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iTHRIVE 365
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medication Adherence

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Devin EnglishRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

iTHRIVE 365

Arm Description

Outcomes

Primary Outcome Measures

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?"
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 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.
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.
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.

Secondary Outcome Measures

Coping
A modified version of the Brief-COPE assesses coping approaches to stress over the last 24 hour. It includes the 6 items from the interconnectedness and problem-oriented subscales, and 3 original items assessing specific interconnectedness with Black LGBTQ people and problem-oriented action against injustice.

Full Information

First Posted
May 12, 2022
Last Updated
July 25, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
THRIVE Social Services Inc. (THRIVE SS), Positive Impact Health Centers, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05376397
Brief Title
Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)
Acronym
OTD
Official Title
Addressing Intersectional Stigma: Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
THRIVE Social Services Inc. (THRIVE SS), Positive Impact Health Centers, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Depressive Symptoms, Anxiety Symptoms, Emotion Regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iTHRIVE 365
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
iTHRIVE 365
Intervention Description
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 Outcome Measure Information:
Title
Antiretroviral (ART) Medication Use
Description
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?"
Time Frame
24 Hours
Title
Depressive Symptoms
Description
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.
Time Frame
24 Hours
Title
Anxiety Symptoms
Description
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.
Time Frame
24 Hours
Title
Emotion Regulation
Description
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.
Time Frame
24 Hours
Secondary Outcome Measure Information:
Title
Coping
Description
A modified version of the Brief-COPE assesses coping approaches to stress over the last 24 hour. It includes the 6 items from the interconnectedness and problem-oriented subscales, and 3 original items assessing specific interconnectedness with Black LGBTQ people and problem-oriented action against injustice.
Time Frame
24 Hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Devin English, PhD
Phone
9739727212
Email
devin.english@rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devin English, PhD
Organizational Affiliation
Rutgers School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Devin English
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102-0301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devin English, PhD
Phone
973-972-7212
Email
devin.english@rutgers.edu
First Name & Middle Initial & Last Name & Degree
Devin English, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share individual participant data that underlie the results reported in the article after deindentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following study publication
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal.

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

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