HIV Oral Testing Infographic Experiment

NCT ID: NCT04061915

Last Updated: 2022-10-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2019-11-06

Brief Summary

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Premised on the National AIDS Strategy's focus on identifying new HIV infections through increased HIV testing, the purpose of this formative pilot study is to develop and test an integrated HIV self-testing strategy that utilizes a simplicity-model approach to HIV self-testing in emerging adult sexual minority men of color.

Detailed Description

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In the United States, approximately 1.1 million persons are living with HIV. Despite novel pharmacological breakthroughs, comprehensive models of health care, and targeted HIV testing initiatives, over 160,000 persons are still unaware of their HIV serostatus. Emerging adult, sexual minority, men of color are disproportionately affected. Premised on the National AIDS Strategy's focus on identifying new HIV infections through increased HIV testing, the purpose of this formative pilot study is to develop and test an integrated HIV self-testing strategy that utilizes a simplicity-model approach to HIV self-testing in emerging adult sexual minority men of color.

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

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Infographic Intervention

Participants in the intervention arm will view an HIV self-testing infographic.

Group Type EXPERIMENTAL

Infographic Intervention

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Paper-based HIV self-testing information

Intervention Type BEHAVIORAL

The control arm will read paper-based HIV self-testing instructions.

Interventions

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Infographic Intervention

The intervention consists of participants viewing an HIV self-testing infographic.

Intervention Type BEHAVIORAL

Paper-based HIV self-testing information

The control arm will read paper-based HIV self-testing instructions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Understand and read English
* 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

• Persons with a known HIV diagnosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

New York University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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S. Raquel Ramos, PhD, MBA, MSN, FNP-BC

Role: PRINCIPAL_INVESTIGATOR

New York University Rory Meyers College of Nursing

Locations

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New York University Rory Meyers College of Nursing

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 34831644 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38924481 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34101701 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34066948 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33670796 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R25MH087217

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30MH062294

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2018-1573

Identifier Type: -

Identifier Source: org_study_id

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