Examining the Health Effects of NPOWER365 Among Black Same Gender Loving Men
2 other identifiers
interventional
350
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2024
CompletedFirst Posted
Study publicly available on registry
March 18, 2024
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
February 19, 2026
February 1, 2026
2.1 years
March 11, 2024
February 17, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Antiretroviral (ART) Medication Use
For daily surveys, participants will report ART adherence on a single binary item ("In the past 24 hours did the participant take ART medication?")
24 hours
ART adherence-Long Lag Assessments
The investigators will use the NAME scale that assesses barriers to ART adherence.
2 weeks
Secondary Outcomes (10)
Daily Diary Substance Use
24 hours
Substance Use-Long Lag Assessments
2 weeks
Depressive Symptoms
24 hours
Depressive Symptoms-Long Lag
2 weeks
Anxiety Symptoms
24 hours
- +5 more secondary outcomes
Study Arms (2)
Intervention Arm
EXPERIMENTALNPOWER365 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.
Control Arm
NO INTERVENTIONThe 6-month waitlist control group will have access only to NAESM services not covered by NPOWER365, such as in-person events. The investigators will ensure the control group does not access the NPOWER365 mHealth app portion by screening all new app users, giving the intervention group unique private log-ins, and explaining the importance of securing those log-ins to ensure the accuracy of study results.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Lack of English fluency
- Past participation in the pilot.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rutgers, The State University of New Jerseylead
- Positive Impact Health Centerscollaborator
- George Washington Universitycollaborator
- Carnegie Mellon Universitycollaborator
- Emory Universitycollaborator
- Columbia Universitycollaborator
- Arizona State Universitycollaborator
- NAESM, Inc.collaborator
Related Publications (2)
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: 36706362RESULTEnglish 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: 39055282RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Devin English, Ph.D.
Rutgers University
- PRINCIPAL INVESTIGATOR
Justin Smith, MS, MPH
Positive Impact Health Centers
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Devin English, PhD; Assistant Professor
Study Record Dates
First Submitted
March 11, 2024
First Posted
March 18, 2024
Study Start
March 1, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will only be shared with other researchers who have received IRB approval and who will destroy or return dataset information after completing their analyses.
- Access Criteria
- Data will only be shared with other researchers who have received IRB approval and who will destroy or return dataset information after completing their analyses.
Outside researchers will be able to request access to these de-identified data through email to the PI in order to conduct analyses for which the PI and study team do not have expertise. This request will be considered by the PI, the appropriate officers at Rutgers University for processing. As such, the PI will initiate a DTA, and seek the legal advice of Rutgers University regarding the adequacy of compliance with any relevant laws, policies, or regulations. If approved, data will be completely de-identified and shared through a secure sharing mechanism (e.g., password protected and encrypted online database for electronic data). No participant codes will be shared with external researchers.