Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment

NCT03678181 | Completed Results DMC

• 1 other identifier: R01MD013623
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV Infections; Sexually Transmitted Diseases; Stigma, Social

Keywords

Prevention; Internet; Adolescence; LGBT; Sexuality; Young Adulthood

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• 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

• Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires

  12 month

Study Arms (3)

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.

Behavioral: Information Resources; Behavioral: HIV Testing

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.

Behavioral: Information Resources; Behavioral: Social Support; Behavioral: HIV Testing

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.

Behavioral: Information Resources; Behavioral: Social Support; Behavioral: HIV Testing

Interventions

Information Resources BEHAVIORAL

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

HMP 2.0 Arm; Information-Only Arm; Peer-referred HMP network arm

Social Support BEHAVIORAL

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

HMP 2.0 Arm; Peer-referred HMP network arm

HIV Testing BEHAVIORAL

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

HMP 2.0 Arm; Information-Only Arm; Peer-referred HMP network arm

Eligibility Criteria

• Age: 15 Years - 29 Years
• Gender Eligibility Details: Cisgender men and transgender women are eligible.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of North Carolina: collaborator
• Duke University: collaborator

Study Sites (3)

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 33325838 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases; Social Stigma; Sexuality

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior; Sexual Behavior

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Results Point of Contact

• Title: Dr. Jose Bauermeister
• Organization: University of Pennsylvania

bjose@upenn.edu

215-898-9993

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 19, 2018
• Study Start: July 7, 2020
• Primary Completion: October 15, 2023
• Study Completion: October 15, 2023
• Last Updated: September 27, 2024
• Results First Posted: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)