Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT03678181

Collaborator

University of North Carolina (Other), Duke University (Other)

1,050

Enrollment

Locations

Arms

48.8

Anticipated Duration (Months)

350

Patients Per Site

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Sexually Transmitted Diseases Stigma, Social	Behavioral: Information Resources Behavioral: Social Support Behavioral: HIV Testing	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

1050 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 7, 2020

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: Information Resources The investigators will provide a HIV-related content as the attention-control condition. Behavioral: HIV Testing The investigators will provide opportunities for participants to get tested through HIV home test kits.
Experimental: 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.	Behavioral: Information Resources The investigators will provide a HIV-related content as the attention-control condition. Behavioral: Social Support The investigators will provide evidence-based answers to users' health questions, including linkage to care. Behavioral: HIV Testing The investigators will provide opportunities for participants to get tested through HIV home test kits.
Experimental: 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.	Behavioral: Information Resources The investigators will provide a HIV-related content as the attention-control condition. Behavioral: Social Support The investigators will provide evidence-based answers to users' health questions, including linkage to care. Behavioral: HIV Testing The investigators will provide opportunities for participants to get tested through HIV home test kits.

Arm

Intervention/Treatment

Active Comparator: 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.

Behavioral: Information Resources

The investigators will provide a HIV-related content as the attention-control condition.

Behavioral: HIV Testing

The investigators will provide opportunities for participants to get tested through HIV home test kits.

Experimental: 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.

Behavioral: Information Resources

The investigators will provide a HIV-related content as the attention-control condition.

Behavioral: Social Support

The investigators will provide evidence-based answers to users' health questions, including linkage to care.

Behavioral: HIV Testing

The investigators will provide opportunities for participants to get tested through HIV home test kits.

Experimental: 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.

Behavioral: Information Resources

The investigators will provide a HIV-related content as the attention-control condition.

Behavioral: Social Support

The investigators will provide evidence-based answers to users' health questions, including linkage to care.

Behavioral: HIV Testing

The investigators will provide opportunities for participants to get tested through HIV home test kits.

Outcome Measures

Primary Outcome Measures

Change in HIV Testing Behavior [3-month, 6-month, 9-month, and 12-month follow-up assessments]
The investigators will estimate the proportion of participants of HIV-negative and HIV-unknown who test for HIV by intervention group and by time on study. For participants living with HIV, the investigators will estimate the proportion of participants receiving viral load tests by intervention group and by time on study.
Change in Viral Suppression [3-month, 6-month, 9-month, and 12-month follow-up assessments]
The investigators will estimate the proportion of participants living with HIV who achieve viral suppression by intervention group and by time on study.

Secondary Outcome Measures

Changes in Treatment Adherence [3-month, 6-month, 9-month, and 12-month follow-up assessments]
he investigators will test the proportion of the HIV-positive sample that adheres to their HIV care regimen during the 12-month follow-ups.
Changes in Pre-Exposure Prophylaxis (PrEP) uptake [3-month, 6-month, 9-month, and 12-month follow-up assessments]
The investigators will test the proportion of the HIV-negative sample that begins PrEP during the 12-month follow-ups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 29 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599
2	Duke University	Durham	North Carolina	United States	27708
3	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104