Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-03-11
Brief Title:
Examining the Health Effects of iTHRIVE 365 Among Black Same Gender Loving Men
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Examining the Health Effects of iTHRIVE 365 Among Black Same Gender Loving Men
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 I thrive 365 is an 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
The investigators will pursue the following aims
1 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 eg 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 Atlanta-area Ending the HIV Epidemic EHE jurisdictions
2 Examine the moderating effect of THRIVE365 on associations between intersectional stigma eg intersectional racist heterosexist and HIV stigma and our primary and secondary HIV outcomes
3 Evaluate THRIVE365 maintenance and reach the user level eg within-user changes in engagement and daily effects and setting level eg intervention adaptations Black SGLM community uptake
Participants will be recruited in collaboration with THRIVE SS the most prominent Black SGLM-led social service organization for Black SGLM in the Atlanta GA metro area After completing an online screener to assess basic eligibility requirements participants will be scheduled for an online Health Insurance Portability and Accountability Act HIPPA---compliant Zoom consent and baseline survey process All online assessments will be completed using HIPAA-compliant Qualtrics surveys Participants will review study information and complete informed consent procedures with study staff including agreeing to provide access to their iTHRIVE 365 paradata and HIV viral suppression results Once consented participants will complete a computerized retrospective interview to assess HIV anti-retroviral treatment ART adherence and substance use as well as measures of intersectional stigma depressive symptoms anxiety symptoms emotion regulation social support coping ART information and motivation and multilevel barriers to ART adherence Participants will also be guided through a practice daily diary Finally intervention group participants will be registered for the mHealth eg online forums and institutional eg linkage to care aspects of iTHRIVE 365 Control group participants will remain on the registration waitlist until after the 6-month study is over All participants will receive virtual gift card compensation directly following the baseline
All participants will complete brief daily measures of intersectional stigma ART adherence substance use depressive and anxiety symptoms emotion regulation and social support coping for 14 days after baseline to assess daily iTHRIVE 365 effectiveness Upon completing the 2-week cycle participants will complete a 2-week follow-up online survey including identical measures to those received at baseline All participants will receive compensation for their participation in the 2-week assessment and compensation based on the number of daily surveys the participants completed
There will be online follow-up surveys at 1- 2- 4- and 6-months post baseline These assessments will include measures identical to the baseline and 2-week assessments As with the baseline participants will receive virtual gift card compensation directly after participants complete their surveys Following the 6-month assessment all participants will participate in a second 2-week daily diary study At the end of the 2-week process participants will engage in a debriefing session and be able to provide feedback on the iTHRIVE 365 intervention and the research process As with the initial daily diary period participants will receive virtual gift card compensation based on the number of surveys completed
To accomplish study aims the investigators will estimate all analytic models in Mplus and SPSS The investigators will test the effectiveness of iTHRIVE 365 on daily primary and secondary HIV and psychological outcomes by examining a series of two-level dynamic structural equation models DSEMs that test differences in within-participant changes in our outcomes across intervention groups The investigators will test the effectiveness of iTHRIVE 365 on longer-term primary and secondary outcomes through between- and within-group analyses estimated as latent growth curve models that test changes in the outcomes across intervention groups during the 6-month study period The investigators will examine the main effects of intersectional stigma on primary and secondary outcomes using DSEM in autoregressive models VAR 1 The investigators will build off these VAR 1 models to examine the moderating effects of iTHRIVE 365 on the intersectional stigma HIV outcomes associations using multiple group moderation analyses The investigators will run all descriptive analyses in SPSS for reach and maintenance Effects maintenance analyses will build off the DSEM and VAR 1 models to observe time as a predictor of changes within and across participants in the iTHRIVE 365 effects
The investigators will pursue the following aims
1 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 eg 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 Atlanta-area Ending the HIV Epidemic EHE jurisdictions
2 Examine the moderating effect of THRIVE365 on associations between intersectional stigma eg intersectional racist heterosexist and HIV stigma and our primary and secondary HIV outcomes
3 Evaluate THRIVE365 maintenance and reach the user level eg within-user changes in engagement and daily effects and setting level eg intervention adaptations Black SGLM community uptake
Participants will be recruited in collaboration with THRIVE SS the most prominent Black SGLM-led social service organization for Black SGLM in the Atlanta GA metro area After completing an online screener to assess basic eligibility requirements participants will be scheduled for an online Health Insurance Portability and Accountability Act HIPPA---compliant Zoom consent and baseline survey process All online assessments will be completed using HIPAA-compliant Qualtrics surveys Participants will review study information and complete informed consent procedures with study staff including agreeing to provide access to their iTHRIVE 365 paradata and HIV viral suppression results Once consented participants will complete a computerized retrospective interview to assess HIV anti-retroviral treatment ART adherence and substance use as well as measures of intersectional stigma depressive symptoms anxiety symptoms emotion regulation social support coping ART information and motivation and multilevel barriers to ART adherence Participants will also be guided through a practice daily diary Finally intervention group participants will be registered for the mHealth eg online forums and institutional eg linkage to care aspects of iTHRIVE 365 Control group participants will remain on the registration waitlist until after the 6-month study is over All participants will receive virtual gift card compensation directly following the baseline
All participants will complete brief daily measures of intersectional stigma ART adherence substance use depressive and anxiety symptoms emotion regulation and social support coping for 14 days after baseline to assess daily iTHRIVE 365 effectiveness Upon completing the 2-week cycle participants will complete a 2-week follow-up online survey including identical measures to those received at baseline All participants will receive compensation for their participation in the 2-week assessment and compensation based on the number of daily surveys the participants completed
There will be online follow-up surveys at 1- 2- 4- and 6-months post baseline These assessments will include measures identical to the baseline and 2-week assessments As with the baseline participants will receive virtual gift card compensation directly after participants complete their surveys Following the 6-month assessment all participants will participate in a second 2-week daily diary study At the end of the 2-week process participants will engage in a debriefing session and be able to provide feedback on the iTHRIVE 365 intervention and the research process As with the initial daily diary period participants will receive virtual gift card compensation based on the number of surveys completed
To accomplish study aims the investigators will estimate all analytic models in Mplus and SPSS The investigators will test the effectiveness of iTHRIVE 365 on daily primary and secondary HIV and psychological outcomes by examining a series of two-level dynamic structural equation models DSEMs that test differences in within-participant changes in our outcomes across intervention groups The investigators will test the effectiveness of iTHRIVE 365 on longer-term primary and secondary outcomes through between- and within-group analyses estimated as latent growth curve models that test changes in the outcomes across intervention groups during the 6-month study period The investigators will examine the main effects of intersectional stigma on primary and secondary outcomes using DSEM in autoregressive models VAR 1 The investigators will build off these VAR 1 models to examine the moderating effects of iTHRIVE 365 on the intersectional stigma HIV outcomes associations using multiple group moderation analyses The investigators will run all descriptive analyses in SPSS for reach and maintenance Effects maintenance analyses will build off the DSEM and VAR 1 models to observe time as a predictor of changes within and across participants in the iTHRIVE 365 effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None