Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03678181
• Other study ID #: R01MD013623
• Status: Completed
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: October 15, 2023

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: October 15, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Sexually Transmitted Diseases
• Stigma, Social

Intervention

Behavioral:
• Information Resources
The investigators will provide a HIV-related content as the attention-control condition.
• Social Support
The investigators will provide evidence-based answers to users' health questions, including linkage to care.
• HIV Testing
The investigators will provide opportunities for participants to get tested through HIV home test kits.

Locations

Country	Name	City	State
United States	University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Duke University	Durham	North Carolina
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Duke University, University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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