Anxiety Symptoms, Depressive Symptoms, Emotion Regulation, Medication Adherence
Conditions
Brief summary
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.
Interventions
BEHAVIORALiTHRIVE 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.
Sponsors
Thrive Social Services
Positive Impact Health Centers
National Institute of Mental Health (NIMH)
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 16 years old or older ; * Identifying as masculine * Identifying as Black/African American * 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.
Exclusion criteria
* evidence of unstable, unmanaged, or serious psychiatric symptoms that could be made worse by participation; * evidence of gross cognitive impairment that would interfere with successful completion of study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antiretroviral (ART) Medication Use | 24 Hours | 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? |
| Depressive Symptoms | 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 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. |
| Anxiety Symptoms | 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. |
| Emotion Regulation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coping | 24 Hours | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | iTHRIVE 365 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 44 years STANDARD_DEVIATION 13.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
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?
Time frame: 24 Hours
Population: Men in the sample living with HIV
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iTHRIVE 365 | Antiretroviral (ART) Medication Use | .94 units on a scale | Standard Deviation 0.24 |
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.
Time frame: 24 Hours
Population: All participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iTHRIVE 365 | Anxiety Symptoms | .43 units on a scale | Standard Deviation 0.66 |
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.
Time frame: 24 Hours
Population: All Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iTHRIVE 365 | Depressive Symptoms | .39 Score on a scale | Standard Deviation 0.62 |
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.
Time frame: 24 Hours
Population: All participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iTHRIVE 365 | Emotion Regulation | .48 units on a scale | Standard Deviation 0.51 |
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).
Time frame: 24 Hours
Population: All participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iTHRIVE 365 | Coping | 2.14 units on a scale | Standard Deviation 1.83 |