Clinical trial NCT03678181: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Sexually Transmitted Diseases
Stigma, Social
Keywords: Prevention
Internet
Adolescence
LGBT
Sexuality
Young Adulthood
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of North Carolina
name: Duke University
First posted: 2018-09-19
Enrollment: 750
Sex: MALE
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires
timeFrame: 12 month
measure: Percent of Participants Reporting Viral Suppression Using Self-Report Questionnaires
timeFrame: 12 month
Secondary outcomes:
measure: 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
timeFrame: 12 month
measure: Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires
timeFrame: 12 month
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of North Carolina
name: Kate Muessig, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Jose A Bauermeister, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Lisa Hightow-Weidman, MD
role: STUDY_DIRECTOR
References:
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.