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Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)
NA trial testing iTHRIVE 365 in Medication Adherence in 34 participants. Completed in 30 November 2023.
| Lead sponsor | Rutgers, The State University of New Jersey |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 34 |
| Start date | 30 September 2021 |
| Primary completion | 30 August 2022 |
| Estimated completion | 30 November 2023 |
| Sites | 1 location across United States |
Rutgers, The State University of New Jersey
16 and older, male only, with Medication Adherence or Depressive Symptoms. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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?"
| Group | Value | 95% CI |
|---|---|---|
| iTHRIVE 365 | .94 | ± .24 |
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.
| Group | Value | 95% CI |
|---|---|---|
| iTHRIVE 365 | .39 | ± .62 |
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.
| Group | Value | 95% CI |
|---|---|---|
| iTHRIVE 365 | .43 | ± .66 |
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.
| Group | Value | 95% CI |
|---|---|---|
| iTHRIVE 365 | .48 | ± .51 |
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 (Ran
| Group | Value | 95% CI |
|---|---|---|
| iTHRIVE 365 | 2.14 | ± 1.83 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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