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Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment

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ClinicalTrials.gov Identifier: NCT03678181
Recruitment Status : Not yet recruiting
First Posted : September 19, 2018
Last Update Posted : September 21, 2018
Sponsor:
Collaborators:
University of North Carolina
Duke University
Information provided by (Responsible Party):
University of Pennsylvania

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 Not Applicable

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 HIV-infected and uninfected 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. Change in HIV Testing Behavior [ Time Frame: 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.

  2. Change in Viral Suppression [ Time Frame: 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 :
  1. Changes in Treatment Adherence [ Time Frame: 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.

  2. Changes in Pre-Exposure Prophylaxis (PrEP) uptake [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cisgender men and transgender women are eligible.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678181


Contacts
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Contact: Jose A Bauermeister, PhD 215-898-9993 bjose@upenn.edu
Contact: Jesse M Golinkoff, MPH 215-898-0570 agolinko@upenn.edu

Locations
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United States, North Carolina
University of North Carolina - Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kate Muessig, PhD    919-962-5059    kmuessig@med.unc.edu   
Sub-Investigator: Lisa Hightow-Weidman, MD         
Duke University Not yet recruiting
Durham, North Carolina, United States, 27708
Contact: Sara LeGrand, PhD    919-438-0448    sara.legrand@duke.edu   
Contact: Marta Mulawa, PhD    919-681-3540    marta.mulawa@duke.edu   
Sub-Investigator: James Moody, PhD         
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
University of North Carolina
Duke University
Investigators
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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

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03678181     History of Changes
Other Study ID Numbers: R01MD013623 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Pennsylvania:
Prevention
Internet
Adolescence
LGBT
Sexuality
Young Adulthood

Additional relevant MeSH terms:
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HIV Infections
Sexually Transmitted Diseases
Virus Diseases
Sexually Transmitted Diseases, Viral
Immune System Diseases
Genital Diseases, Male
Genital Diseases, Female
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Immunologic Deficiency Syndromes
Infection