Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Sexually Transmitted Diseases; Stigma, Social
• Intervention / Treatment: Behavioral: Information Resources; Behavioral: HIV Testing; Behavioral: Social Support

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 Type: Interventional
• Enrollment (Actual): 750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina - Chapel Hill
    • Durham, North Carolina, United States, 27708
      • Duke University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 29 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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: HIV Testing; The investigators will provide opportunities for participants to get tested through HIV home test kits.; Behavioral: Social Support; The investigators will provide evidence-based answers to users' health questions, including linkage to care.
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: HIV Testing; The investigators will provide opportunities for participants to get tested through HIV home test kits.; Behavioral: Social Support; The investigators will provide evidence-based answers to users' health questions, including linkage to care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HIV Testing Behavior	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.	3-month, 6-month, 9-month, and 12-month follow-up assessments
Change in Viral Suppression	The investigators will estimate the proportion of participants living with HIV who achieve viral suppression by intervention group and by time on study.	3-month, 6-month, 9-month, and 12-month follow-up assessments

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Duke University; University of North Carolina
• Investigators: Principal Investigator: Kate Muessig, PhD, University of North Carolina; Principal Investigator: Jose A Bauermeister, PhD, University of Pennsylvania; Study Director: Lisa Hightow-Weidman, MD, University of North Carolina

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): October 15, 2023
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: September 18, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Prevention; Adolescence; Internet; Sexuality; LGBT; Young Adulthood
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases
• Other Study ID Numbers: R01MD013623 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No