Not yet recruiting NCT06315218

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

No phase Interventional Sexual and Gender Minorities Social Stigma Medication Adherence Depressive Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: NPOWER365 HIV care intervention.
Who it may be relevant to: Registry conditions: Sexual and Gender Minorities, Social Stigma, Medication Adherence, Depressive Symptoms. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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.

Interventions

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;

Primary outcome measures

Antiretroviral (ART) Medication Use [Time frame: 24 hours]
ART adherence-Long Lag Assessments [Time frame: 2 weeks]

Secondary outcome measures (10)

Daily Diary Substance Use [Time frame: 24 hours]
Substance Use-Long Lag Assessments [Time frame: 2 weeks]
Depressive Symptoms [Time frame: 24 hours]
Depressive Symptoms-Long Lag [Time frame: 2 weeks]
Anxiety Symptoms [Time frame: 24 hours]
Anxiety Symptoms-Long Lag [Time frame: 2 weeks]
Emotion Regulation Emotion Regulation [Time frame: 24 hours]
Emotion Regulation-Long Lag Assessments [Time frame: 2 weeks]
COPE [Time frame: 24 hours]
COPE-Long Lag Assessments [Time frame: 2 weeks]

Eligibility criteria

Inclusion criteria

Identify as Black or African American, regardless of ethnicity
Identify as male, regardless of sex assigned at birth
Are living with HIV and prescribed a daily ART regimen
Are age ≥ 18;
Have sex with men
Own an internet-connected device (e.g., smartphone, tablet)
Reside in the Atlanta-area EHE jurisdictions.

Exclusion criteria

Lack of English fluency
Past participation in the pilot.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

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. PMID 36706362
English D, Smith JC, Scott-Walker L, Lopez FG, Morris M, Reid M, Lashay C, Bridges D, Rosales A, Cunningham DJ. iTHRIVE 365: A Community-Led, Multicomponent Health Promotion Intervention for Black Same Gender Loving Men. Ann LGBTQ Public Popul Health. 2023 Dec;4(4):363-383. doi: 10.1891/lgbtq-2022-0009. PMID 39055282
English D, Smith JC, Scott-Walker L, Chavez E, Quamina A, Woodson W, Miles A, Pickett D, Reid M, Folkes D, Harrington CN, Hussen SA, Lelutiu-Weinberger C, McNeish D, Bowleg L. Examining a multicomponent health promotion intervention among Black same gender loving men in southern ending the HIV epidemic in the U.S. jurisdictions: a randomized controlled trial. BMC Public Health. 2026 Feb 13;26(1):9 PMID 41688950

Identifiers

NCT: NCT06315218 · Pro2023000968 · 1R01MH134265-01

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗