Trials / Not Yet Recruiting

Not Yet RecruitingNCT06315218

Examining the Health Effects of NPOWER365 Among Black Same Gender Loving Men

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 350 (estimated)

Sponsor: Rutgers, The State University of New Jersey · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

Detailed description

This research study aims to test the effectiveness, reach, and maintenance over time of the NPOWER365 HIV care intervention for Black men who have sex with men (BMSM) living with HIV. NPOWER365 is a BMSM community-developed multicomponent intervention that aims to: 1) Support daily health promotion via HIV health education and health maintenance reminders; 2) Foster positive social connections among BMSM via online moderated forums, interpersonal chats, and community calendars; 3) Connect clients to BMSM-affirming healthcare, including HIV treatment and mental healthcare; 4) Provide resources for housing, transportation, and other economic empowerment. Participants will be recruited in collaboration with NAESM INC, our community partner and the largest BMSM-led social service organization for BMSM in the Atlanta, GA metro area. We will recruit 8 participants per month. After completing an online screener to assess for 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 NPOWER365 paradata (i.e., app engagement data) and HIV viral suppression results. Once consented, participants will complete a computerized timeline follow-back 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. They will also be guided through a practice daily diary. Finally, intervention group participants will be registered for the mHealth (e.g., online forums) and institutional (e.g., linkage to care) aspects of NPOWER365(see Research Strategy of the appended NIH R01 application for additional details on these procedures). 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 NPOWER365effectiveness. Upon completion of 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 as well as compensation based on the number of daily surveys they completed. There will then be online follow-up surveys at 1-, 2-, 4-, and 6-months post baseline. These assessments will include identical measures to the baseline and 2-week assessments. As with the baseline, participants will receive virtual gift-card compensation directly after they 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 have the opportunity to provide feedback on the NPOWER365intervention and the research process. As with the initial daily diary period, participants will receive virtual gift-card compensation based on the number of surveys they completed. The primary analytic aims of the study will be to: 1) Test the effectiveness of NPOWER365 in improving daily and longer-term (1-6 month) ART adherence; 2) Test the effectiveness of NPOWER365 in improving daily and longer-term (1-6 month) secondary outcomes (i.e., substance use, depressive symptoms, anxiety symptoms, emotion regulation, social support coping, ART information and motivation, and multilevel barriers to ART adherence) and exploratory outcome (viral load); 3) Examine the moderating effect of NPOWER365 on associations between intersectional stigma and primary and secondary HIV-related behavioral and psychological health outcomes; 4) Evaluate user-level and setting-level maintenance and reach data including how the effects of, and engagement with, NPOWER365are sustained across the 6-month period within individual participants, how the effects of NPOWER365 are sustained across the 50-month period for participants who participate at different times, how engagement with NPOWER365 is sustained 1-year post-study (as observed via paradata), how is the intervention adapted over the 50-month study period, and what are the characteristics of the individuals who participate and use NPOWER365. We will estimate all analytic models in Mplus and SPSS. We will test the effectiveness of NPOWER365 on daily primary and secondary HIV 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. We will test the effectiveness of NPOWER365 on longer-term primary and secondary HIV 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. We will examine the main effects of intersectional stigma on primary and secondary HIV outcomes using DSEM in autoregressive models (VAR (1)). We will build off these VAR (1) models to examine the moderating effects of NPOWER365 on the intersectional stigma HIV outcomes associations using multiple group moderation analyses. If we find significant intervention group differences we will examine the associations between specific mHealth components (e.g., mHealth forums) and theoretically relevant mediators (e.g., social support coping) and outcomes (e.g., depressive symptoms). We will run all descriptive analyses for reach and maintenance in SPSS. Effects maintenance analyses with build off the DSEM and VAR (1) models to observe time as a predictor of within-participants and across-participants changes in NPOWER365 effects.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	NPOWER365 HIV care intervention	NPOWER365 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, NPOWER365 deploys intervention elements that serve to accomplish intervention strategies. NPOWER365 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. NPOWER365 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 NAESM's network of Black SGLM-affirming providers; and 4)Housing and economic resources through NAESM's direct support and referral network.

Timeline

Start date: 2026-03-01
Primary completion: 2028-04-01
Completion: 2028-04-01
First posted: 2024-03-18
Last updated: 2026-02-19

Source: ClinicalTrials.gov record NCT06315218. Inclusion in this directory is not an endorsement.