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

NCT ID: NCT05376397

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2023-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iTHRIVE 365

Group Type: EXPERIMENTAL

iTHRIVE 365

Intervention Type: 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.

Interventions

iTHRIVE 365

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Thrive Social Services

OTHER

Sponsor Role: collaborator

Positive Impact Health Centers

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Devin English, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Devin English, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers School of Public Health

Locations

Devin English

Newark, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36706362 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

K01MH118091

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2021001082

Identifier Type: -

Identifier Source: org_study_id