Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment

NCT ID: NCT03678181

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-07
• Study Completion Date: 2023-10-15

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.

Conditions

HIV Infections; Sexually Transmitted Diseases; Stigma, Social

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Information Resources

Intervention Type: BEHAVIORAL

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

HIV Testing

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Information Resources

Intervention Type: BEHAVIORAL

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

Social Support

Intervention Type: BEHAVIORAL

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

HIV Testing

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Information Resources

Intervention Type: BEHAVIORAL

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

Social Support

Intervention Type: BEHAVIORAL

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

HIV Testing

Intervention Type: BEHAVIORAL

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

Interventions

Information Resources

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

Intervention Type: BEHAVIORAL

Social Support

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

Intervention Type: BEHAVIORAL

HIV Testing

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kate Muessig, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Jose A Bauermeister, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Lisa Hightow-Weidman, MD

Role: STUDY_DIRECTOR

University of North Carolina

Locations

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33325838 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01MD013623

Identifier Type: NIH

Identifier Source: org_study_id

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