Examining the Health Effects of iTHRIVE 365 Among Black Same Gender Loving Men

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Medication Adherence; Depressive Symptoms; Anxiety Symptoms; Social Stigma; Sexual and Gender Minorities
• Intervention / Treatment: Behavioral: iTHRIVE 365 HIV care intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Devin English, Ph.D.; Phone Number: 973-972-1755; Email: Devin.English@rutgers.edu
• Study Contact Backup: Name: Emmanuel Chavez, MS; Phone Number: 23324 973-972-3324; Email: E.Chavez@rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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) with mHealth interventions, iTHRIVE 365 deploys intervention elements that serve to accomplish intervention strategies. iTHRIVE 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. iTHRIVE 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 Black SGLM-affirming providers; and 4)Housing and economic resources through THRIVE SS's direct support and referral network.	Behavioral: iTHRIVE 365 HIV care intervention; 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) with mHealth interventions, iTHRIVE 365 deploys intervention elements that serve to accomplish intervention strategies. iTHRIVE 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. iTHRIVE 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 Black SGLM-affirming providers; and 4)Housing and economic resources through THRIVE SS's direct support and referral network.
No Intervention: Control Arm; The 6-month waitlist control group will only have access to THRIVE SS services not encompassed by iTHRIVE 365, such as in-person events. The investigators will ensure the control group does not access the iTHRIVE 365 mHealth app portion by screening all new app users, giving the intervention group unique private log-ins, and explaining the importance of securing those log-ins to ensure the accuracy of study results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiretroviral (ART) Medication Use	For daily surveys, participants will report ART adherence on a single binary item ("In the past 24 hours did the participant take ART medication?")	24 hours
ART adherence-Long Lag Assessments	The investigators will use the NAME scale that assesses barriers to ART adherence.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substance Use-Long Lag Assessments	For long lags (i.e., 2 week assessment to 6 month assessment), participants will complete an online, automated retrospective assessment of substance use in the past 2 weeks.	2 weeks
COPE	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.	24 hours
Daily Diary Substance Use	The investigators will measure daily substance use with single-item binary measures of various substances (e.g.,alcohol, marijuana).	24 hours
Depressive Symptoms	The Patient Health Questionnaire-4 assesses anxiety and depressive symptoms. Participants rate the extent to which the participants 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 (entirely). The investigators used an average across all items for each time point.	24 hours
Depressive Symptoms-Long Lag	The Brief Symptom Inventory assesses anxiety and depressive symptoms. Participants rate the extent to which the participants had been experiencing each item the past two weeks (e.g., "Feeling hopeless about the future") on a scale from 0 (not at all) to 4 (Extremely). The investigators will use an average across all items for each time point.	2 weeks
Anxiety Symptoms	The Patient Health Questionnaire-4 assesses anxiety and depressive symptoms. Participants rate the extent to which the participants 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
Anxiety Symptoms-Long Lag	The Brief Symptom Inventory assesses anxiety and depressive symptoms. Participants rate the extent to which the participants had been experiencing each item the past 2 weeks (e.g., "Feeling tense or keyed up") on a scale from 0 (not at all) to 4 (Extremely). The investigators will use an average across all items for each time point.	2 weeks
Emotion Regulation Emotion Regulation	A validated four-item version of the Difficulties with Emotion Regulation Scale assesses emotion regulation. Participants rated the extent to which the participants 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 (entirely). The investigators used an average across all items for each time point.	24 hours
Emotion Regulation-Long Lag Assessments	The investigators will use the Difficulties with Emotion Regulation Scale- Short Form (DERS-SF) for long lags	2 weeks
COPE-Long Lag Assessments	The investigators will use the Brief-COPE measure to assess past 2-week coping, which assesses the following coping approaches in 28 items: Self-distraction, active coping, denial, substance use, use of emotional social support, use of instrumental social support, Behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame.	2 weeks

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Columbia University; Emory University; George Washington University; Arizona State University; Carnegie Mellon University; Positive Impact Health Centers; THRIVE Social Services Inc
• Investigators: Principal Investigator: Devin English, Ph.D., Rutgers University; Principal Investigator: Justin Smith, MS, MPH, Positive Impact Health Centers

Publications and helpful links

General Publications

• 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.
• English, D., & Smith, J.C., & Scott-Walker, L., Lopez, F.G., Morris, M., Reid, M., Lashay, C., Bridges, D., Rosales, A., & Cunningham, D.J. (2023). iTHRIVE 365: A community-led, multicomponent health promotion intervention for Black same gender loving men. Annals of LGBTQ Public and Population Health. doi:10.1891/LGBTQ-2022-0009

Helpful Links

• iTHRIVE 365: A Community-Led, Multicomponent Health Promotion Intervention for Black Same Gender Loving Men

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: Pro2023000968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Outside researchers will be able to request access to these de-identified data through email to the PI in order to conduct analyses for which the PI and study team do not have expertise. This request will be considered by the PI, the appropriate officers at Rutgers University for processing. As such, the PI will initiate a DTA, and seek the legal advice of Rutgers University regarding the adequacy of compliance with any relevant laws, policies, or regulations. If approved, data will be completely de-identified and shared through a secure sharing mechanism (e.g., password protected and encrypted online database for electronic data). No participant codes will be shared with external researchers.
• IPD Sharing Time Frame: Data will only be shared with other researchers who have received IRB approval and who will destroy or return dataset information after completing their analyses.
• IPD Sharing Access Criteria: Data will only be shared with other researchers who have received IRB approval and who will destroy or return dataset information after completing their analyses.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No