Newswires
Examining the Health Effects of iTHRIVE 365 Among Black Same Gender Loving Men: Immune System Diseases and Conditions – HIV/AIDS
2024 APR 01 (NewsRx) -- By a
As a matter of record, on
Tracking Information
| Trial Identifier | NCT06315218 |
| First Submitted Date | |
| First Posted Date | |
| Results First Submitted Date | Not Provided |
| Results First Posted Date | Not Provided |
| Last Update Submitted Date | |
| Last Update Posted Date | |
| Primary Completion Date | |
| Start Date | |
| Current Primary Outcome Measures | •Antiretroviral (ART) Medication Use [ Time Frame: 24 hours ] -- For daily surveys, participants will report ART adherence on a single binary item (“In the past 24 hours did you take ART medication?”) |
| •ART adherence-Long Lag Assessments [ Time Frame: 2 weeks ] -- We will use the |
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| Current Secondary Outcome Measures | •Daily Diary Substance Use [ Time Frame: 24 hours ] -- We will measure daily substance use with single-item binary measures of various substances (e.g.,alcohol, marijuana). |
| •Substance Use-Long Lag Assessments [ Time Frame: 2 weeks ] -- 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. | |
| •Depressive Symptoms [ Time Frame: 24 hours ] -- 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. | |
| •Depressive Symptoms-Long Lag [ Time Frame: 2 weeks ] -- The Brief Symptom Inventory assesses anxiety and depressive symptoms. Participants rate the extent to which they had been experiencing each item the past 2 weeks (e.g., “Feeling hopeless about the future”) on a scale from 0 (not at all) to 4 (Extremely). We will use an average across all items for each time point. | |
| •Anxiety Symptoms [ Time Frame: 24 hours ] -- 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-Long Lag [ Time Frame: 2 weeks ] -- The Brief Symptom Inventory assesses anxiety and depressive symptoms. Participants rate the extent to which they 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). We will use an average across all items for each time point. | |
| •Emotion Regulation Emotion Regulation [ Time Frame: 24 hours ] -- 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. | |
| •Emotion Regulation-Long Lag Assessments [ Time Frame: 2 weeks ] -- We will use the Difficulties with Emotion Regulation Scale- Short Form (DERS-SF) for long lags | |
| •COPE [ Time Frame: 24 hours ] -- 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. | |
| •COPE-Long Lag Assessments [ Time Frame: 2 weeks ] -- We 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. | |
| Other Outcome Measures | Not Provided |
| Change History | Complete list of historical revisions of study NCT06315218 |
Descriptive Information
| Brief Title | Examining the Health Effects of iTHRIVE 365 Among Black Same Gender |
| Official Title | Examining the Health Effects of iTHRIVE 365 Among Black Same Gender |
| 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. iTHRIVE 365 is a 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. We will pursue the following aims: 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 |
| Study Type | Interventional |
| Study Phase | Not Applicable |
| Study Design | Allocation: Randomized |
| Intervention Model: Parallel Assignment | |
| Primary Purpose: Supportive Care | |
| Masking: Single | |
| Condition | Sexual and Gender Minorities |
| Social Stigma | |
| Medication Adherence | |
| Depressive Symptoms | |
| Anxiety Symptoms | |
| 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. | |
| Study Arms | •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) | |
| Interventions: | |
| ⚬Behavioral: iTHRIVE 365 HIV care intervention | |
| Publications* | *Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline |
| PubMed Link - English D, Smith JC, |
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| 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 |
Recruitment Information
| Recruitment Status | Not yet recruiting |
| Estimated Enrollment | 350 |
| Estimated Completion Date | |
| Primary Completion Date | |
| Eligibility | Inclusion Criteria: Identify as Black or |
| Sex/Gender | Sexes Eligible for Study: All |
| Ages | 18 years and older |
| No | |
| Contacts | Primary contact: |
| Backup contact: |
|
| Listed Location Countries | Not Provided |
| Removed Location Countries |
Administrative Information
| NCT Number | NCT06315218 |
| Other Study ID Numbers | Pro2023000968 |
| Has Data Monitoring Committee | Not Provided |
| Not Provided | |
| Plan to Share Data | Yes |
| Plan to Share Data (IPD) 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 |
| Collaborators | ⚬Positive Impact Health Centers |
| ⚬George Washington University | |
| ⚬Carnegie Mellon University | |
| ⚬Emory University | |
| ⚬Columbia University | |
| ⚬Arizona State University | |
| ⚬THRIVE Social Services Inc | |
| Investigators | Principal Investigator: |
| Principal Investigator: |
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| Information Provided By | |
| Verification Date |
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