HIV Infections, Sexually Transmitted Diseases, Stigma, Social
Conditions
Keywords
Prevention, Internet, Adolescence, LGBT, Sexuality, Young Adulthood
Brief 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 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.
Interventions
BEHAVIORALSocial Support
The investigators will provide evidence-based answers to users' health questions, including linkage to care.
BEHAVIORALInformation Resources
The investigators will provide a HIV-related content as the attention-control condition.
BEHAVIORALHIV Testing
The investigators will provide opportunities for participants to get tested through HIV home test kits.
Sponsors
University of North Carolina
Duke University
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
15 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 month | The investigators will test the proportion of the HIV-positive sample that adheres to their HIV care regimen during the 12-month follow-up. |
| Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires | 12 month | The investigators will test the proportion of the HIV-negative sample that reports using PrEP by the 12-month follow-up. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 332 |
| 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. | 333 |
| 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. | 85 |
| Total | 750 |
Baseline characteristics
| Characteristic | Information-Only Arm | Total | Peer-referred HMP Network Arm | HMP 2.0 Arm |
|---|---|---|---|---|
| Age, Continuous | 24.72 years STANDARD_DEVIATION 3.2 | 24.84 years STANDARD_DEVIATION 3.33 | 26.18 years STANDARD_DEVIATION 2.77 | 24.62 years STANDARD_DEVIATION 3.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 140 Participants | 318 Participants | 26 Participants | 152 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 192 Participants | 432 Participants | 59 Participants | 181 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HIV Status HIV negative | 258 Participants | 520 Participants | 4 Participants | 258 Participants |
| HIV Status HIV positive | 74 Participants | 230 Participants | 81 Participants | 75 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants | 12 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 208 Participants | 453 Participants | 64 Participants | 181 Participants |
| Race (NIH/OMB) More than one race | 32 Participants | 68 Participants | 7 Participants | 29 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 63 Participants | 145 Participants | 8 Participants | 74 Participants |
| Race (NIH/OMB) White | 20 Participants | 65 Participants | 5 Participants | 40 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 332 Participants | 750 Participants | 85 Participants | 333 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 332 | 0 / 333 | 0 / 85 |
| other Total, other adverse events | 0 / 332 | 0 / 333 | 0 / 85 |
| serious Total, serious adverse events | 0 / 332 | 0 / 333 | 0 / 85 |
Outcome results
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.
Time frame: 12 month
Population: HIV Testing outcome focuses on HIV-negative participants in the trial
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Information-Only Arm | Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires | 185 Participants |
| HMP 2.0 Arm | Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires | 171 Participants |
| Peer-referred HMP Network Arm | Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires | 2 Participants |
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.
Time frame: 12 month
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Information-Only Arm | Percent of Participants Reporting Viral Suppression Using Self-Report Questionnaires | Virally Suppressed | 45 Participants |
| Information-Only Arm | Percent of Participants Reporting Viral Suppression Using Self-Report Questionnaires | Not Virally Suppressed | 29 Participants |
| HMP 2.0 Arm | Percent of Participants Reporting Viral Suppression Using Self-Report Questionnaires | Virally Suppressed | 60 Participants |
| HMP 2.0 Arm | Percent of Participants Reporting Viral Suppression Using Self-Report Questionnaires | Not Virally Suppressed | 15 Participants |
| Peer-referred HMP Network Arm | Percent of Participants Reporting Viral Suppression Using Self-Report Questionnaires | Virally Suppressed | 60 Participants |
| Peer-referred HMP Network Arm | Percent of Participants Reporting Viral Suppression Using Self-Report Questionnaires | Not Virally Suppressed | 21 Participants |
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.
Time frame: 12 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Information-Only Arm | 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 | 0.92 days | Standard Deviation 1.65 |
| HMP 2.0 Arm | 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 | 0.96 days | Standard Deviation 1.75 |
| Peer-referred HMP Network Arm | 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 | 1.21 days | Standard Deviation 2.06 |
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.
Time frame: 12 month
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Information-Only Arm | Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires | Yes, I was in the past, but I'm not on PrEP anymore | 50 Participants |
| Information-Only Arm | Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires | Yes, I am on PrEP right now | 77 Participants |
| Information-Only Arm | Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires | No, I've never taken PrEP | 78 Participants |
| HMP 2.0 Arm | Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires | Yes, I was in the past, but I'm not on PrEP anymore | 42 Participants |
| HMP 2.0 Arm | Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires | Yes, I am on PrEP right now | 74 Participants |
| HMP 2.0 Arm | Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires | No, I've never taken PrEP | 73 Participants |
| Peer-referred HMP Network Arm | Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires | Yes, I am on PrEP right now | 0 Participants |
| Peer-referred HMP Network Arm | Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires | No, I've never taken PrEP | 1 Participants |
| Peer-referred HMP Network Arm | Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires | Yes, I was in the past, but I'm not on PrEP anymore | 1 Participants |