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| Name | Class |
|---|---|
| University of North Carolina | OTHER |
| Duke University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Information Resources | Behavioral | The investigators will provide a HIV-related content as the attention-control condition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 month |
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Inclusion Criteria:
Exclusion Criteria:
Cisgender men and transgender women are eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Kate Muessig, PhD | University of North Carolina | Principal Investigator |
| Jose A Bauermeister, PhD | University of Pennsylvania | Principal Investigator |
| Lisa Hightow-Weidman, MD | University of North Carolina | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | United States | ||
| Duke University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33325838 | Derived | Muessig 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. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Information-Only Arm | 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. Information Resources: The investigators will provide a HIV-related content as the attention-control condition. HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits. |
| FG001 | HMP 2.0 Arm | 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. Information Resources: The investigators will provide a HIV-related content as the attention-control condition. Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care. HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits. |
| FG002 | Peer-referred HMP Network Arm | 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. Information Resources: The investigators will provide a HIV-related content as the attention-control condition. Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care. HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Information-Only Arm | 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. Information Resources: The investigators will provide a HIV-related content as the attention-control condition. HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | HIV Testing outcome focuses on HIV-negative participants in the trial | Posted | Count of Participants | Participants | 12 month |
|
Adverse event data were collected over the year of study participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Information-Only Arm | 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. Information Resources: The investigators will provide a HIV-related content as the attention-control condition. HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jose Bauermeister | University of Pennsylvania | 215-898-9993 | bjose@upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2024 | Sep 19, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 17, 2018 | Aug 24, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D012749 | Sexually Transmitted Diseases |
| D057545 | Social Stigma |
| D019529 | Sexuality |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000082922 | HIV Testing |
| ID | Term |
|---|---|
| D008828 | Microbiological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Social Support | Behavioral | The investigators will provide evidence-based answers to users' health questions, including linkage to care. |
|
| HIV Testing | Behavioral | The investigators will provide opportunities for participants to get tested through HIV home test kits. |
|
| 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. |
| 12 month |
| Durham |
| North Carolina |
| 27708 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| BG001 | HMP 2.0 Arm | 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. Information Resources: The investigators will provide a HIV-related content as the attention-control condition. Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care. HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits. |
| BG002 | Peer-referred HMP Network Arm | 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. Information Resources: The investigators will provide a HIV-related content as the attention-control condition. Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care. HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| HIV Status | Participant self-reported HIV status | Count of Participants | Participants |
|
| OG001 | HMP 2.0 Arm | 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. Information Resources: The investigators will provide a HIV-related content as the attention-control condition. Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care. HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits. |
| OG002 | Peer-referred HMP Network Arm | 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. Information Resources: The investigators will provide a HIV-related content as the attention-control condition. Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care. HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits. |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 12 month |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | days | 12 month |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 month |
|
|
|
| 0 |
| 332 |
| 0 |
| 332 |
| 0 |
| 332 |
| EG001 | HMP 2.0 Arm | 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. Information Resources: The investigators will provide a HIV-related content as the attention-control condition. Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care. HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits. | 0 | 333 | 0 | 333 | 0 | 333 |
| EG002 | Peer-referred HMP Network Arm | 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. Information Resources: The investigators will provide a HIV-related content as the attention-control condition. Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care. HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits. | 0 | 85 | 0 | 85 | 0 | 85 |
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| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D012725 | Sexual Behavior |
| D008919 | Investigative Techniques |
| No, I've never taken PrEP |
|