Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
322 participants
INTERVENTIONAL
2019-05-13
2019-11-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Home Self-Testing for HIV to Increase HIV Testing Frequency in Men Who Have Sex With Men (The iTest Study)
NCT01161446
Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection
NCT05833074
HIV Self Testing of Male Partners of Women in PMTCT
NCT03484533
The Test-to-PrEP Study
NCT06927856
Experiential HIV Testing Increasing Testing Related Knowledge and Practice, and Reduce Stigma Toward HIV of Nurses.
NCT05615935
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The overall study will focus on: (a) understanding facilitators and barriers to HIV self-testing among emerging adult MSM, (b) designing a HIV self-testing infographic that utilizes a simplicity model, (c) finalizing the HIV self-testing infographic with input from a leadership group of HIV community members, (d) conducting a pilot clinical trial with 300 emerging adult (ages 18-34), sexual minority, men of color to test if a collaboratively-designed HIV self-testing infographic can facilitate accurate and effective understanding of how to self-test for HIV when compared to paper-based, HIV self-testing information.
By conducting this study, we will gain beneficial insights necessary for presenting HIV self-testing instructions in a meaningful, relevant, and comprehensible way. The results of this pilot study have the potential to inform strategies regarding how self-testing instructions can be worded or visually presented in order to break both literacy and language barriers that affect testing utilization and results accuracy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Infographic Intervention
Participants in the intervention arm will view an HIV self-testing infographic.
Infographic Intervention
The intervention consists of participants viewing an HIV self-testing infographic.
Control
Participants in the control arm will read paper-based HIV self-testing instructions.
Paper-based HIV self-testing information
The control arm will read paper-based HIV self-testing instructions.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Infographic Intervention
The intervention consists of participants viewing an HIV self-testing infographic.
Paper-based HIV self-testing information
The control arm will read paper-based HIV self-testing instructions.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Assigned male sex at birth
* Self-identify as gay, same-gender-loving, or MSM
* Self-report being HIV-negative or unknown HIV serostatus
Exclusion Criteria
18 Years
34 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
New York University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
S. Raquel Ramos, PhD, MBA, MSN, FNP-BC
Role: PRINCIPAL_INVESTIGATOR
New York University Rory Meyers College of Nursing
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
New York University Rory Meyers College of Nursing
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ramos SR, Lardier DT Jr, Bond KT, Boyd DT, O'Hare OM, Nelson LE, Guthrie BJ, Kershaw T. Participatory Design of a Web-Based HIV Oral Self-Testing Infographic Experiment (HOTIE) for Emerging Adult Sexual Minority Men of Color: A Mixed Methods Randomized Control Trial. Int J Environ Res Public Health. 2021 Nov 12;18(22):11881. doi: 10.3390/ijerph182211881.
Ramos SR, Reynolds H, Johnson C, Melkus G, Kershaw T, Thayer JF, Vorderstrasse A. Perceptions of HIV-Related Comorbidities and Usability of a Virtual Environment for Cardiovascular Disease Prevention Education in Sexual Minority Men With HIV: Formative Phases of a Pilot Randomized Controlled Trial. J Med Internet Res. 2024 Aug 22;26:e57351. doi: 10.2196/57351.
Ramos SR, Lardier DT Jr, Opara I, Turpin RE, Boyd DT, Gutierrez JI Jr, Williams CN, Nelson LE, Kershaw T. Intersectional Effects of Sexual Orientation Concealment, Internalized Homophobia, and Gender Expression on Sexual Identity and HIV Risk Among Sexual Minority Men of Color: A Path Analysis. J Assoc Nurses AIDS Care. 2021 Jul-Aug 01;32(4):495-511. doi: 10.1097/JNC.0000000000000274.
Ramos SR, Lardier DT Jr, Boyd DT, Gutierrez JI Jr, Carasso E, Houng D, Kershaw T. Profiles of HIV Risk, Sexual Power, and Decision-Making among Sexual Minority Men of Color Who Engage in Transactional Sex: A Latent Profile Analysis. Int J Environ Res Public Health. 2021 May 7;18(9):4961. doi: 10.3390/ijerph18094961.
Ramos SR, Lardier DT Jr, Warren RC, Cherian M, Siddiqui S, Kershaw T. Substance Use, General Health and Health Literacy as Predictors of Oral Health in Emerging Adult Sexual Minority Men of Color: A Secondary Data Analysis. Int J Environ Res Public Health. 2021 Feb 18;18(4):1987. doi: 10.3390/ijerph18041987.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.