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| ID | Type | Description | Link |
|---|---|---|---|
| K01MH118091 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Thrive Social Services | OTHER |
| Positive Impact Health Centers | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iTHRIVE 365 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTHRIVE 365 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Antiretroviral (ART) Medication Use | A single dichotomous no(0)/yes(1) item assesses ART use over the past 24 hours: "In the past 24 hours, did you take ART medication?" | 24 Hours |
| Depressive Symptoms | 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 down, depressed, or hopeless") 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 | 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. | 24 Hours |
| Emotion Regulation | 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. | 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Coping | A modified version of the Brief-COPE assesses coping approaches to stress over the last 24 hour. It includes the 3 items from the interconnectedness and 3 items problem-oriented subscales (Greer, 2007), and 3 original items assessing specific interconnectedness with Black LGBTQ people and problem-oriented action against injustice ("I've connected with another Black LGBTQ person for support", "I've spoken out against negative treatment", "I've posted about injustice on social media"). Participant indicate all the coping approaches among the 9 total that they utilized over the last 24 hours (Range: 0-9 coping approaches). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Devin English, PhD | Rutgers School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Devin English | Newark | New Jersey | 07102-0301 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36706362 | Derived | 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. |
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We will share individual participant data that underlie the results reported in the article after deindentification (text, tables, figures, and appendices).
Beginning 3 months and ending 5 years following study publication
Researchers who provide a methodologically sound proposal.
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| ID | Title | Description |
|---|---|---|
| FG000 | iTHRIVE 365 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Inclusion Criteria:
16 years old or older ; Identifying as masculine 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.
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| ID | Title | Description |
|---|---|---|
| BG000 | iTHRIVE 365 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antiretroviral (ART) Medication Use | A single dichotomous no(0)/yes(1) item assesses ART use over the past 24 hours: "In the past 24 hours, did you take ART medication?" | Men in the sample living with HIV | Posted | Mean | Standard Deviation | units on a scale | 24 Hours |
|
Two weeks
This was classified as minimal risk in IRB review. As such, there were no participants at-risk for serious adverse events, all-cause mortality, or other adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | iTHRIVE 365 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Devin English, Prinicipal Investigator | Rutgers School of Public Health | 19739727212 | devin.english@rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2023 | Dec 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 18, 2023 | Dec 18, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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|
| 24 Hours |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Depressive Symptoms | 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 down, depressed, or hopeless") on a scale from 0 (not at all) to 3 (completely). We used an average across all items for each time point. | All Participants | Posted | Mean | Standard Deviation | Score on a scale | 24 Hours |
|
|
|
| Primary | Anxiety Symptoms | 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. | All participants | Posted | Mean | Standard Deviation | units on a scale | 24 Hours |
|
|
|
| Primary | Emotion Regulation | 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. | All participants | Posted | Mean | Standard Deviation | units on a scale | 24 Hours |
|
|
|
| Secondary | Coping | A modified version of the Brief-COPE assesses coping approaches to stress over the last 24 hour. It includes the 3 items from the interconnectedness and 3 items problem-oriented subscales (Greer, 2007), and 3 original items assessing specific interconnectedness with Black LGBTQ people and problem-oriented action against injustice ("I've connected with another Black LGBTQ person for support", "I've spoken out against negative treatment", "I've posted about injustice on social media"). Participant indicate all the coping approaches among the 9 total that they utilized over the last 24 hours (Range: 0-9 coping approaches). | All participants | Posted | Mean | Standard Deviation | units on a scale | 24 Hours |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
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| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
| D001523 | Mental Disorders |
| D000068356 | Self-Control |
| D012919 | Social Behavior |