Sexual and Gender MinoritiesNCT06315218
Examining the Health Effects of NPOWER365 Among Black Same Gender Loving Men
A study testing NPOWER365 HIV care intervention in people with Sexual and Gender Minorities and Social Stigma, run by Rutgers, The State University of New Jersey.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sexual and Gender Minorities, Social Stigma, Medication Adherence
- What is being tested?
- NPOWER365 HIV care intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Lack of English fluency
- Past participation in the pilot.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Sexual and Gender Minorities, Social Stigma, Medication Adherence, Depressive Symptoms, Anxiety Symptoms
- Being tested
- NPOWER365 HIV care intervention
- Medical subject headings
- Coitus, Social Stigma, Medication Adherence, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPOWER365 HIV care interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Behavioral: NPOWER365 HIV care intervention |
| Control Arm | No intervention | The 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?")
Measured: 24 hours
ART adherence-Long Lag Assessments
The investigators will use the NAME scale that assesses barriers to ART adherence.
Measured: 2 weeks
Secondary outcomes (10)
Daily Diary Substance Use
The investigators will measure daily substance use with single-item binary measures of various substances (e.g.,alcohol, marijuana).
Measured: 24 hours
Substance Use-Long Lag Assessments
For long lags (i.e., 2 week assessment to 6 month assessment), participants will complete an online, automated retrospective assessment of substance use in the past 2 weeks.
Measured: 2 weeks
Depressive Symptoms
The Patient Health Questionnaire-4 assesses anxiety and depressive symptoms. Participants rate the extent to which the participants 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 (entirely). The investigators used an average across all items for each time point.
Measured: 24 hours
Depressive Symptoms-Long Lag
The Brief Symptom Inventory assesses anxiety and depressive symptoms. Participants rate the extent to which the participants had been experiencing each item the past two weeks (e.g., "Feeling hopeless about the future") on a scale from 0 (not at all) to 4 (Extremely). The investigators will use an average across all items for each time point.
Measured: 2 weeks
Anxiety Symptoms
The Patient Health Questionnaire-4 assesses anxiety and depressive symptoms. Participants rate the extent to which the participants 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.
Measured: 24 hours
Anxiety Symptoms-Long Lag
The Brief Symptom Inventory assesses anxiety and depressive symptoms. Participants rate the extent to which the participants had been experiencing each item the past 2 weeks (e.g., "Feeling tense or keyed up") on a scale from 0 (not at all) to 4 (Extremely). The investigators will use an average across all items for each time point.
Measured: 2 weeks
Emotion Regulation Emotion Regulation
A validated four-item version of the Difficulties with Emotion Regulation Scale assesses emotion regulation. Participants rated the extent to which the participants 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 (entirely). The investigators used an average across all items for each time point.
Measured: 24 hours
Emotion Regulation-Long Lag Assessments
The investigators will use the Difficulties with Emotion Regulation Scale- Short Form (DERS-SF) for long lags
Measured: 2 weeks
COPE
A modified version of the Brief-COPE assesses coping approaches to stress over the last 24 hour. It includes the 6 items from the interconnectedness and problem-oriented subscales, and 3 original items assessing specific interconnectedness with Black LGBTQ people and problem-oriented action against injustice.
Measured: 24 hours
COPE-Long Lag Assessments
The investigators will use the Brief-COPE measure to assess past 2-week coping, which assesses the following coping approaches in 28 items: Self-distraction, active coping, denial, substance use, use of emotional social support, use of instrumental social support, Behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study startAug 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sexual and Gender MinoritiesStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Positive Impact Health Centers, George Washington University, Carnegie Mellon University, Emory University, Columbia University, Arizona State University, NAESM, Inc.
- Responsible party
- Principal investigator, Devin English, PhD, Rutgers, The State University of New Jersey
- Investigators
- Devin English, Ph.D., Principal investigator, Rutgers UniversityJustin Smith, MS, MPH, Principal investigator, Positive Impact Health Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315218
- Sponsor's protocol ID
- Pro2023000968
- Other IDs
- 1R01MH134265-01
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 36706362English 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.
PubMed 39055282English 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):939. doi: 10.1186/s12889-026-26245-3.
PubMed 41688950
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Health Effects of NPOWER365 Among Black Same Gender Loving Men
- ClinicalTrials.gov ID
- NCT06315218
- Acronym / sponsor ID
- Pro2023000968
- Conditions
- Sexual and Gender Minorities, Social Stigma, Medication Adherence, Depressive Symptoms, Anxiety Symptoms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Positive Impact Health Centers, George Washington University, Carnegie Mellon University, Emory University, Columbia University, Arizona State University, NAESM, Inc.
- Study start
- Aug 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: NPOWER365 HIV care interventionNPOWER365 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 intervention | –The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Lack of English fluency
- Past participation in the pilot.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPOWER365 HIV care interventionNPOWER365 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. | Behavioural | Intervention Arm |
Primary outcome
Antiretroviral (ART) Medication Use
Time frame: 24 hours
For daily surveys, participants will report ART adherence on a single binary item ("In the past 24 hours did the participant take ART medication?")
ART adherence-Long Lag Assessments
Time frame: 2 weeks
The investigators will use the NAME scale that assesses barriers to ART adherence.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Results publication: PubMed 36706362English 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.
- Results publication: PubMed 39055282English 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.
- Derived from this study: PubMed 41688950English 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):939. doi: 10.1186/s12889-026-26245-3.
- iTHRIVE 365: A Community-Led, Multicomponent Health Promotion Intervention for Black Same Gender Loving MenLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Devin English, Ph.D. principal investigator
Rutgers University
Justin Smith, MS, MPH principal investigator
Positive Impact Health Centers
Questions about this trial
What is this clinical trial studying?
A study testing NPOWER365 HIV care intervention in people with Sexual and Gender Minorities and Social Stigma, run by Rutgers, The State University of New Jersey.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devin English, Ph.D. (973-972-1755, Devin.English@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antiretroviral (ART) Medication Use (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06315218, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.