Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03678181 |
Recruitment Status :
Recruiting
First Posted : September 19, 2018
Last Update Posted : January 21, 2022
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Condition or disease | Intervention/treatment | Phase |
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HIV Infections Sexually Transmitted Diseases Stigma, Social | Behavioral: Information Resources Behavioral: Social Support Behavioral: HIV Testing | Not Applicable |
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 |
Actual Study Start Date : | July 7, 2020 |
Estimated Primary Completion Date : | August 1, 2024 |
Estimated Study Completion Date : | August 1, 2024 |
Arm | Intervention/treatment |
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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.
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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.
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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.
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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. |
- 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.
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

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
Contact: Jose A Bauermeister, PhD | 215-898-9993 | bjose@upenn.edu | |
Contact: Jesse M Golinkoff, MPH | 215-898-0570 | agolinko@upenn.edu |
United States, North Carolina | |
University of North Carolina - Chapel Hill | 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 | Recruiting |
Durham, North Carolina, United States, 27708 | |
Contact: Marta Mulawa, PhD 919-681-3540 marta.mulawa@duke.edu | |
Contact: PhD | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Jose A Bauermeister, PhD 215-898-9993 bjose@nursing.upenn.edu | |
Contact: Jesse M Golinkoff, MPH 215-898-0570 agolinko@nursing.upenn.edu | |
Principal Investigator: Jose A Bauermeister, PhD |
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 |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT03678181 |
Other Study ID Numbers: |
R01MD013623 ( U.S. NIH Grant/Contract ) |
First Posted: | September 19, 2018 Key Record Dates |
Last Update Posted: | January 21, 2022 |
Last Verified: | January 2022 |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Prevention Internet Adolescence |
LGBT Sexuality Young Adulthood |
Sexually Transmitted Diseases Communicable Diseases Infections Disease Attributes Pathologic Processes |