Clinical trial NCT06315218: Examining the Health Effects of iTHRIVE 365 Among Black Same Gender Loving Men
Official title: Examining the Health Effects of iTHRIVE 365 Among Black Same Gender Loving Men
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sexual and Gender Minorities
Social Stigma
Medication Adherence
Depressive Symptoms
Anxiety Symptoms
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Positive Impact Health Centers
name: George Washington University
name: Carnegie Mellon University
name: Emory University
name: Columbia University
name: Arizona State University
name: Thrive Social Services
First posted: 2024-03-18
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study aims to test the effectiveness, reach, and maintenance over time of the iTHRIVE 365 intervention for Black same gender loving men (SGLM) living with HIV. iTHRIVE 365 is a SGLM community-developed multicomponent mHealth intervention that aims to: 1) Support daily health promotion via HIV and psychological health education and health maintenance reminders; 2) Foster positive social connections among SGLM via online moderated forums, interpersonal chats, and community calendars; 3) Connect clients to SGLM-affirming healthcare, including HIV treatment and mental healthcare; 4) Provide resources for housing, transportation, and other economic empowerment.

Detailed description: This research study aims to test the effectiveness, reach, and maintenance over time of the iTHRIVE 365 intervention for Black same-gender loving men (SGLM) living with HIV. I thrive 365 is an SGLM community-developed multicomponent intervention that aims to: 1) Support daily health promotion via HIV and psychological health education and health maintenance reminders; 2) Foster positive social connections among SGLM via online moderated forums, interpersonal chats, and community calendars; 3) Connect clients to SGLM-affirming healthcare, including HIV treatment and mental healthcare; 4) Provide resources for housing, transportation, and other economic empowerment.

The investigators will pursue the following aims:

1. Test the effectiveness of THRIVE365 in improving daily and longer-term (1-6 months) HIV-related behavioral health (primary outcome: ART adherence) and psychological health (e.g., secondary outcomes: lower depressive and anxiety symptoms) in a 6-month waitlist randomized controlled trial with 350 Black SGLM living with HIV in the four Atlanta-area Ending the HIV Epidemic (EHE) jurisdictions.
2. Examine the moderating effect of THRIVE365 on associations between intersectional stigma (e.g., intersectional racist, heterosexist, and HIV stigma) and our primary and secondary HIV outcomes.
3. Evaluate THRIVE365 maintenance and reach the user level (e.g., within-user changes in engagement and daily effects) and setting level (e.g., intervention adaptations, Black SGLM community uptake).

Participants will be recruited in collaboration with THRIVE SS, the most prominent Black SGLM-led social service organization for Black SGLM in the Atlanta, GA metro area. After completing an online screener to assess basic eligibility requirements, participants will be scheduled for an online Health Insurance Portability and Accountability Act (HIPPA)---compliant Zoom consent and baseline survey process. All online assessments will be completed using HIPAA-compliant Qualtrics surveys. Participants will review study information and complete informed consent procedures with study staff, including agreeing to provide access to their iTHRIVE 365 paradata and HIV viral suppression results. Once consented, participants will complete a computerized retrospective interview to assess HIV anti-retroviral treatment (ART) adherence and substance use, as well as measures of intersectional stigma, depressive symptoms, anxiety symptoms, emotion regulation, social support coping, ART information and motivation, and multilevel barriers to ART adherence. Participants will also be guided through a practice daily diary. Finally, intervention group participants will be registered for the mHealth (e.g., online forums) and institutional (e.g., linkage to care) aspects of iTHRIVE 365. Control group participants will remain on the registration waitlist until after the 6-month study is over. All participants will receive virtual gift card compensation directly following the baseline.

All participants will complete brief daily measures of intersectional stigma, ART adherence, substance use, depressive and anxiety symptoms, emotion regulation, and social support coping for 14 days after baseline to assess daily iTHRIVE 365 effectiveness. Upon completing the 2-week cycle, participants will complete a 2-week follow-up online survey, including identical measures to those received at baseline. All participants will receive compensation for their participation in the 2-week assessment and compensation based on the number of daily surveys the participants completed.

There will be online follow-up surveys at 1-, 2-, 4-, and 6-months post baseline. These assessments will include measures identical to the baseline and 2-week assessments. As with the baseline, participants will receive virtual gift card compensation directly after participants complete their surveys. Following the 6-month assessment, all participants will participate in a second 2-week daily diary study. At the end of the 2-week process, participants will engage in a debriefing session and be able to provide feedback on the iTHRIVE 365 intervention and the research process. As with the initial daily diary period, participants will receive virtual gift card compensation based on the number of surveys completed.

To accomplish study aims, the investigators will estimate all analytic models in Mplus and SPSS. The investigators will test the effectiveness of iTHRIVE 365 on daily primary and secondary HIV and psychological outcomes by examining a series of two-level dynamic structural equation models (DSEMs) that test differences in within-participant changes in our outcomes across intervention groups. The investigators will test the effectiveness of iTHRIVE 365 on longer-term primary and secondary outcomes through between- and within-group analyses estimated as latent growth curve models that test changes in the outcomes across intervention groups during the 6-month study period. The investigators will examine the main effects of intersectional stigma on primary and secondary outcomes using DSEM in autoregressive models (VAR (1)). The investigators will build off these VAR (1) models to examine the moderating effects of iTHRIVE 365 on the intersectional stigma HIV outcomes associations using multiple group moderation analyses. The investigators will run all descriptive analyses in SPSS for reach and maintenance. Effects maintenance analyses will build off the DSEM and VAR (1) models to observe time as a predictor of changes within and across participants in the iTHRIVE 365 effects.

Eligibility criteria: Inclusion Criteria:

1. Identify as Black or African American, regardless of ethnicity
2. Identify as male, regardless of sex assigned at birth
3. Are living with HIV and prescribed a daily ART regimen
4. Are age ≥ 18;
5. Have sex with men
6. Own an internet-connected device (e.g., smartphone, tablet)
7. Reside in the Atlanta-area EHE jurisdictions.

Exclusion Criteria:

1. Lack of English fluency
2. Past participation in the pilot.

Primary outcomes:
measure: Antiretroviral (ART) Medication Use
timeFrame: 24 hours
measure: ART adherence-Long Lag Assessments
timeFrame: 2 weeks
Secondary outcomes:
measure: Daily Diary Substance Use
timeFrame: 24 hours
measure: Substance Use-Long Lag Assessments
timeFrame: 2 weeks
measure: Depressive Symptoms
timeFrame: 24 hours
measure: Depressive Symptoms-Long Lag
timeFrame: 2 weeks
measure: Anxiety Symptoms
timeFrame: 24 hours
measure: Anxiety Symptoms-Long Lag
timeFrame: 2 weeks
measure: Emotion Regulation Emotion Regulation
timeFrame: 24 hours
measure: Emotion Regulation-Long Lag Assessments
timeFrame: 2 weeks
measure: COPE
timeFrame: 24 hours
measure: COPE-Long Lag Assessments
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Rutgers University
name: Devin English, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Positive Impact Health Centers
name: Justin Smith, MS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: English D, Smith JC, Scott-Walker L, Lopez FG, Morris M, Reid M, Lashay C, Bridges D, Rosales A, Cunningham DJ. iTHRIVE 365: A Community-Led, Multicomponent Health Promotion Intervention for Black Same Gender Loving Men. Ann LGBTQ Public Popul Health. 2023 Dec;4(4):363-383. doi: 10.1891/lgbtq-2022-0009.