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Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment

Primary Purpose

HIV Infections, Sexually Transmitted Diseases, Stigma, Social

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Information Resources
Social Support
HIV Testing
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Prevention, Internet, Adolescence, LGBT, Sexuality, Young Adulthood

Eligibility Criteria

15 Years - 29 Years (Child, Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of North Carolina - Chapel Hill
  • Duke University
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Information-Only Arm

HMP 2.0 Arm

Peer-referred HMP network arm

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 18, 2018
Last Updated
January 9, 2023
Sponsor
University of Pennsylvania
Collaborators
University of North Carolina, Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03678181
Brief Title
Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
University of North Carolina, Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Diseases, Stigma, Social
Keywords
Prevention, Internet, Adolescence, LGBT, Sexuality, Young Adulthood

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1050 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Information-Only Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HMP 2.0 Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Peer-referred HMP network arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Information Resources
Intervention Description
The investigators will provide a HIV-related content as the attention-control condition.
Intervention Type
Behavioral
Intervention Name(s)
Social Support
Intervention Description
The investigators will provide evidence-based answers to users' health questions, including linkage to care.
Intervention Type
Behavioral
Intervention Name(s)
HIV Testing
Intervention Description
The investigators will provide opportunities for participants to get tested through HIV home test kits.
Primary Outcome Measure Information:
Title
Change in HIV Testing Behavior
Description
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.
Time Frame
3-month, 6-month, 9-month, and 12-month follow-up assessments
Title
Change in Viral Suppression
Description
The investigators will estimate the proportion of participants living with HIV who achieve viral suppression by intervention group and by time on study.
Time Frame
3-month, 6-month, 9-month, and 12-month follow-up assessments
Secondary Outcome Measure Information:
Title
Changes in Treatment Adherence
Description
he investigators will test the proportion of the HIV-positive sample that adheres to their HIV care regimen during the 12-month follow-ups.
Time Frame
3-month, 6-month, 9-month, and 12-month follow-up assessments
Title
Changes in Pre-Exposure Prophylaxis (PrEP) uptake
Description
The investigators will test the proportion of the HIV-negative sample that begins PrEP during the 12-month follow-ups.
Time Frame
3-month, 6-month, 9-month, and 12-month follow-up assessments

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Cisgender men and transgender women are eligible.
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Muessig, PhD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose A Bauermeister, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Hightow-Weidman, MD
Organizational Affiliation
University of North Carolina
Official's Role
Study Director
Facility Information:
Facility Name
University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
33325838
Citation
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.
Results Reference
derived

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Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment

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