Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment

Not Applicable

Completed

• Conditions: Sexually Transmitted Diseases; Stigma, Social; HIV Infections
• Interventions: Behavioral: Information Resources; Behavioral: Social Support; Behavioral: HIV Testing

• Registration Number: NCT03678181
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-19
• Study Start: 2020-07-07
• Primary Completion: 2023-10-15
• Study Completion: 2023-10-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 750

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Information-Only Arm	Information Resources	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.
HMP 2.0 Arm	Social Support	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.
Information-Only Arm	HIV Testing	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.
HMP 2.0 Arm	Information Resources	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.
HMP 2.0 Arm	HIV Testing	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.
Peer-referred HMP network arm	Information Resources	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.
Peer-referred HMP network arm	HIV Testing	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.
Peer-referred HMP network arm	Social Support	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.

Primary Outcome Measures

Name	Time	Method
Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires	12 month	The investigators will estimate the proportion of participants who test at least twice for HIV over a 12-month period by intervention group.
Percent of Participants Reporting Viral Suppression Using Self-Report Questionnaires	12 month	The investigators will estimate the proportion of participants living with HIV who achieve viral suppression over a 12-month period by intervention group.

Secondary Outcome Measures

Name	Time	Method
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	The investigators will test the proportion of the HIV-positive sample that adheres to their HIV care regimen during the 12-month follow-up.
Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires	12 month	The investigators will test the proportion of the HIV-negative sample that reports using PrEP by the 12-month follow-up.

Trial Locations

Locations (3)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of North Carolina - Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Duke University; 🇺🇸 Durham, North Carolina, United States