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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06315218
Other study ID # Pro2023000968
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date April 2028

Study information

Verified date March 2024
Source Rutgers, The State University of New Jersey
Contact Devin English, Ph.D.
Phone 973-972-1755
Email Devin.English@rutgers.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (8)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey Arizona State University, Carnegie Mellon University, Columbia University, Emory University, George Washington University, Positive Impact Health Centers, THRIVE Social Services Inc

References & Publications (2)

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 S — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary ART adherence-Long Lag Assessments The investigators will use the NAME scale that assesses barriers to ART adherence. 2 weeks
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Emotion Regulation-Long Lag Assessments The investigators will use the Difficulties with Emotion Regulation Scale- Short Form (DERS-SF) for long lags 2 weeks
Secondary 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
Secondary 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
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