HIV InfectionsNCT03678181
Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment
A study testing Information Resources, Social Support and HIV Testing in people with HIV Infections and Sexually Transmitted Diseases, run by University of Pennsylvania at 3 sites in United States.
Trial summary
The overall goal of this 3-arm randomized trial is to test whether a network-driven online intervention tailored for intersectional stigma amelioration can elicit online social support, promote intervention engagement, and mitigate the impact of multiple stigmas on HIV-related outcomes among young Black and/or Latino… Read more about this study
- Who is it for?
- Ages 15 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases, Stigma, Social
- What is being tested?
- Information Resources, Social Support and HIV Testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Jul 2020to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 29 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages 15-29 (inclusive);
- Identify as Black/African American and/or Latino/Hispanic;
- Be U.S. residents (verified by zip code);
- Report at least one episode of condomless anal sex act with a man in prior 6 months;
- Assigned male sex at birth;
- Currently identifies as male or as woman
- Have access to internet
- Reports owning or having regular access to a smartphone device or laptop/tablet through which to log onto the study site.
Who cannot join
- Assigned female sex at birth
- Aged 14 years or younger or 30 years or older at time of screening
- Does not speak or read English or Spanish
- Did not have consensual anal sex with a male partner in the prior 6 months
- Does not reside in the United States
- Currently incarcerated
- Planning to move out of the United States in next 12 months
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Duke University
Durham, North Carolina, 27708
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Increasing Engagement and Improving HIV Care Outcomes Via Stigma Reduction in an Online Social Networking Intervention Among Racially Diverse Young Men Who Have Sex With Men and Transgender Women
The overall goal of this 3-arm randomized trial is to test whether a network-driven online intervention tailored for intersectional stigma amelioration can elicit online social support, promote intervention engagement, and mitigate the impact of multiple stigmas on HIV-related outcomes among young Black and/or Latino men who have sex with men and transgender women.
Read the detailed description
Multiple stigmas related to sexuality, race, and HIV infection negatively impact HIV testing, engagement in HIV care, and consistent viral suppression (VS) among young Black or Latino men who have sex with men and transgender women (YBLMT). At present, few interventions have addressed the effects of intersectional stigma among people living with HIV and HIV affected populations. This study tests whether an online intervention tailored for intersectional stigma amelioration can elicit online social support, promote intervention engagement, and mitigate the impact of multiple stigmas on HIV-related outcomes. This study will recruit and enroll 1,050 young (ages 15-29), racially and ethnically diverse men who have sex with men and transgender women affected by HIV across the United States. Using a HIV-status stratified randomized trial design, participants will be assigned into one of three conditions (information-only control, a researcher-driven social network intervention, or a peer-driven social network intervention). Behavioral assessments will occur at baseline, 3, 6, 9 and 12 months; biomarkers (viral load) are scheduled for baseline, 6 and 12 months. The primary outcome is stratified by HIV status and defined as successful engagement in care (consistent VS for HIV-positive participants and routine testing for HIV-negative participants). The specific aims are: 1) Test whether an online intervention that promotes user-generated content and engagement to address intersectional stigma is associated with improvements in the HIV prevention and care continuum (HIV testing, antiretroviral adherence, VS) as compared to an information-only control arm; 2) Explore whether user engagement, as measured by quantitative and qualitative paradata, mediates the intervention's stigma- and HIV care-related outcomes; and, 3) Examine how changes in intersectional stigma and improvements across the HIV care continuum vary between the researcher-driven vs. peer-driven social network intervention conditions. The research study is innovative given its focus on intersectional stigma as a key target of intervention, and its ability to assess how different kinds of online social network structures influence participants' engagement over time, reduce experiences of intersectional stigma, and improve successful engagement in care. This research addresses a critical need to reduce the effects of multiple stigmas in a priority population using an intervention delivered through a highly appealing, widely-utilized technology. If effective, this form of stigma amelioration via online support can be broadly disseminated to reduce HIV transmission and improve care among YBLMT.
- Being tested
- Information Resources, Social Support, HIV Testing
- Keywords
- Prevention, Internet, Adolescence, LGBT, Sexuality, Young Adulthood
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Social Stigma, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information ResourcesBehavioural
The investigators will provide a HIV-related content as the attention-control condition.
Social SupportBehavioural
The investigators will provide evidence-based answers to users' health questions, including linkage to care.
HIV TestingBehavioural
The investigators will provide opportunities for participants to get tested through HIV home test kits.
| Study group | Role | What they receive |
|---|---|---|
| Information-Only Arm | Active comparator | The HMP 2.0 Information-Only Control Arm will feature a streamlined version of the website that provides tailored information and content for YBLMT. This follows the design of HMP 1.0 where control arm participants had access to HIV-related Knowledge Center articles of the main intervention without access to the engagement features, interactive forums, or doctor Q\&A. HIV-negative and sero-unknown participants also will be able to request HIV home test kits. The choice of control arm balances equipoise with research study design; in HMP 1.0, control arm participants also experienced a statistically significant intervention benefit. Receives: Behavioral: Information Resources; Behavioral: HIV Testing |
| HMP 2.0 Arm | Experimental | Participants in this experimental arm will receive access to HMP 2.0, an interactive site that includes a Knowledge Center focused on HIV prevention content, interactive forums, and a provider question \& answer platform. Receives: Behavioral: Information Resources; Behavioral: Social Support; Behavioral: HIV Testing |
| Peer-referred HMP network arm | Experimental | Participants randomized to Intervention Arm 2 (peer-created network) will be enrolled into a parallel (but separate) version of HMP 2.0. The only difference between the two intervention arms is that the peer-referred HMP network arm will allow participants to refer and enroll 2 peers of their choosing into the study. Receives: Behavioral: Information Resources; Behavioral: Social Support; Behavioral: HIV Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires
The investigators will estimate the proportion of participants who test at least twice for HIV over a 12-month period by intervention group.
Measured: 12 month
Percent of Participants Reporting Viral Suppression Using Self-Report Questionnaires
The investigators will estimate the proportion of participants living with HIV who achieve viral suppression over a 12-month period by intervention group.
Measured: 12 month
Secondary outcomes (2)
Number of Days in the Prior Week That Participants Self-report Missing at Least One Dose of Their Adherence to Antiretroviral Therapy (ART) Using a Self-Reported Questionnaire
The investigators will test the proportion of the HIV-positive sample that adheres to their HIV care regimen during the 12-month follow-up.
Measured: 12 month
Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires
The investigators will test the proportion of the HIV-negative sample that reports using PrEP by the 12-month follow-up.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start7 Jul 2020
- Primary completion15 Oct 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Duke University
- Responsible party
- Sponsor
- Investigators
- Kate Muessig, PhD, Principal investigator, University of North CarolinaJose A Bauermeister, PhD, Principal investigator, University of PennsylvaniaLisa Hightow-Weidman, MD, Study director, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678181
- Sponsor's protocol ID
- R01MD013623
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2018
- Last updated
- 27 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset. Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the dataset. The de-identified data from this project will be available through individual requests directed to the Principal Investigators.
Publications
Lin WY, Choi SK, Hirshfield S, Mulawa MI, Watson DL, Hightow-Weidman LB, Muessig KE, Bauermeister JA. Recruitment Source and Participant Retention in a Digital HIV Prevention Intervention for Young Black and Latino Men and Transgender Women: Secondary Analysis of the HealthMpowerment 2.0 Randomized Controlled Trial. JMIR Form Res. 2026 Aug 26;10:e75793. doi: 10.2196/75793.
PubMed 42647085Owens C. Preferences for HIV/STI Prevention mHealth Features Among Rural Sexual Minority Men in the South. AIDS Educ Prev. 2025 Oct;37(5):364-378. doi: 10.1521/aeap.2025.37.5.364.
PubMed 41086043Muessig KE, Golinkoff JM, Hightow-Weidman LB, Rochelle AE, Mulawa MI, Hirshfield S, Rosengren AL, Aryal S, Buckner N, Wilson MS, Watson DL, Houang S, Bauermeister JA. Increasing HIV Testing and Viral Suppression via Stigma Reduction in a Social Networking Mobile Health Intervention Among Black and Latinx Young Men and Transgender Women Who Have Sex With Men (HealthMpowerment): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Dec 16;9(12):e24043. doi: 10.2196/24043.
PubMed 33325838
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Engagement and Improving HIV Care Outcomes Via Stigma Reduction in an Online Social Networking Intervention Among Racially Diverse Young Men Who Have Sex With Men and Transgender Women
- ClinicalTrials.gov ID
- NCT03678181
- Acronym / sponsor ID
- R01MD013623
- Keywords
- Prevention, Internet, Adolescence, LGBT, Sexuality, Young Adulthood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of North Carolina, Duke University
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Posted 27 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this 3-arm randomized trial is to test whether a network-driven online intervention tailored for intersectional stigma amelioration can elicit online social support, promote intervention engagement, and mitigate the impact of multiple stigmas on HIV-related outcomes among young Black and/or Latino men who have sex with men and transgender women.
Detailed description
Multiple stigmas related to sexuality, race, and HIV infection negatively impact HIV testing, engagement in HIV care, and consistent viral suppression (VS) among young Black or Latino men who have sex with men and transgender women (YBLMT). At present, few interventions have addressed the effects of intersectional stigma among people living with HIV and HIV affected populations. This study tests whether an online intervention tailored for intersectional stigma amelioration can elicit online social support, promote intervention engagement, and mitigate the impact of multiple stigmas on HIV-related outcomes. This study will recruit and enroll 1,050 young (ages 15-29), racially and ethnically diverse men who have sex with men and transgender women affected by HIV across the United States. Using a HIV-status stratified randomized trial design, participants will be assigned into one of three conditions (information-only control, a researcher-driven social network intervention, or a peer-driven social network intervention). Behavioral assessments will occur at baseline, 3, 6, 9 and 12 months; biomarkers (viral load) are scheduled for baseline, 6 and 12 months. The primary outcome is stratified by HIV status and defined as successful engagement in care (consistent VS for HIV-positive participants and routine testing for HIV-negative participants). The specific aims are: 1) Test whether an online intervention that promotes user-generated content and engagement to address intersectional stigma is associated with improvements in the HIV prevention and care continuum (HIV testing, antiretroviral adherence, VS) as compared to an information-only control arm; 2) Explore whether user engagement, as measured by quantitative and qualitative paradata, mediates the intervention's stigma- and HIV care-related outcomes; and, 3) Examine how changes in intersectional stigma and improvements across the HIV care continuum vary between the researcher-driven vs. peer-driven social network intervention conditions. The research study is innovative given its focus on intersectional stigma as a key target of intervention, and its ability to assess how different kinds of online social network structures influence participants' engagement over time, reduce experiences of intersectional stigma, and improve successful engagement in care. This research addresses a critical need to reduce the effects of multiple stigmas in a priority population using an intervention delivered through a highly appealing, widely-utilized technology. If effective, this form of stigma amelioration via online support can be broadly disseminated to reduce HIV transmission and improve care among YBLMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Information-Only Arm | Active comparator | Behavioral: Information Resources, Behavioral: HIV TestingThe HMP 2.0 Information-Only Control Arm will feature a streamlined version of the website that provides tailored information and content for YBLMT. This follows the design of HMP 1.0 where control arm participants had access to HIV-related Knowledge Center articles of the main intervention without access to the engagement features, interactive forums, or doctor Q\&A. HIV-negative and sero-unknown participants also will be able to request HIV home test kits. The choice of control arm balances equipoise with research study design; in HMP 1.0, control arm participants also experienced a statistically significant intervention benefit. |
| HMP 2.0 Arm | Experimental | Behavioral: Information Resources, Behavioral: Social Support, Behavioral: HIV TestingParticipants in this experimental arm will receive access to HMP 2.0, an interactive site that includes a Knowledge Center focused on HIV prevention content, interactive forums, and a provider question \& answer platform. |
| Peer-referred HMP network arm | Experimental | Behavioral: Information Resources, Behavioral: Social Support, Behavioral: HIV TestingParticipants randomized to Intervention Arm 2 (peer-created network) will be enrolled into a parallel (but separate) version of HMP 2.0. The only difference between the two intervention arms is that the peer-referred HMP network arm will allow participants to refer and enroll 2 peers of their choosing into the study. |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Ages 15-29 (inclusive);
- Identify as Black/African American and/or Latino/Hispanic;
- Be U.S. residents (verified by zip code);
- Report at least one episode of condomless anal sex act with a man in prior 6 months;
- Assigned male sex at birth;
Key exclusion criteria (7 listed)
- Assigned female sex at birth
- Aged 14 years or younger or 30 years or older at time of screening
- Does not speak or read English or Spanish
- Did not have consensual anal sex with a male partner in the prior 6 months
- Does not reside in the United States
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 |
|---|---|---|
| Information ResourcesThe investigators will provide a HIV-related content as the attention-control condition. | Behavioural | HMP 2.0 Arm, Information-Only Arm, Peer-referred HMP network arm |
| Social SupportThe investigators will provide evidence-based answers to users' health questions, including linkage to care. | Behavioural | HMP 2.0 Arm, Peer-referred HMP network arm |
| HIV TestingThe investigators will provide opportunities for participants to get tested through HIV home test kits. | Behavioural | HMP 2.0 Arm, Information-Only Arm, Peer-referred HMP network arm |
Primary outcome
Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires
Time frame: 12 month
The investigators will estimate the proportion of participants who test at least twice for HIV over a 12-month period by intervention group.
Percent of Participants Reporting Viral Suppression Using Self-Report Questionnaires
Time frame: 12 month
The investigators will estimate the proportion of participants living with HIV who achieve viral suppression over a 12-month period by intervention group.
2 secondary outcomes
Number of Days in the Prior Week That Participants Self-report Missing at Least One Dose of Their Adherence to Antiretroviral Therapy (ART) Using a Self-Reported Questionnaire
Time frame: 12 month
Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires
Time frame: 12 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42647085Lin WY, Choi SK, Hirshfield S, Mulawa MI, Watson DL, Hightow-Weidman LB, Muessig KE, Bauermeister JA. Recruitment Source and Participant Retention in a Digital HIV Prevention Intervention for Young Black and Latino Men and Transgender Women: Secondary Analysis of the HealthMpowerment 2.0 Randomized Controlled Trial. JMIR Form Res. 2026 Aug 26;10:e75793. doi: 10.2196/75793.
- Derived from this study: PubMed 41086043Owens C. Preferences for HIV/STI Prevention mHealth Features Among Rural Sexual Minority Men in the South. AIDS Educ Prev. 2025 Oct;37(5):364-378. doi: 10.1521/aeap.2025.37.5.364.
- Derived from this study: PubMed 33325838Muessig KE, Golinkoff JM, Hightow-Weidman LB, Rochelle AE, Mulawa MI, Hirshfield S, Rosengren AL, Aryal S, Buckner N, Wilson MS, Watson DL, Houang S, Bauermeister JA. Increasing HIV Testing and Viral Suppression via Stigma Reduction in a Social Networking Mobile Health Intervention Among Black and Latinx Young Men and Transgender Women Who Have Sex With Men (HealthMpowerment): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Dec 16;9(12):e24043. doi: 10.2196/24043.
- Individual participant dataSharing planned: No. The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset. Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the dataset. The de-identified data from this project will be available through individual requests directed to the Principal Investigators.
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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. This study is not recruiting at the moment.
Kate Muessig, PhD principal investigator
University of North Carolina
Jose A Bauermeister, PhD principal investigator
University of Pennsylvania
Lisa Hightow-Weidman, MD study director
University of North Carolina
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information Resources, Social Support and HIV Testing in people with HIV Infections and Sexually Transmitted Diseases, run by University of Pennsylvania at 3 sites in United States.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 27 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires (time frame: 12 month). 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 NCT03678181, 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 27 Sep 2024.