HIV Oral Testing Infographic Experiment

HIV/AIDS Clinical Trial

— HOTIE  

Official title:

HIV Oral Testing Infographic Experiment (HOTIE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04061915
• Other study ID #: 2018-1573
• Secondary ID: R25MH087217P30MH
• Status: Completed
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: November 6, 2019

Study information

• Verified date: March 2022
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: November 6, 2019
• Est. primary completion date: November 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	New York University Rory Meyers College of Nursing	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV Self-testing Knowledge	Self-report comprehension questionnaire based on accurate completion of HIV-self testing steps. Measure of participants understanding of the text and pictures on how to perform an HIV self-test.; Questions asked about using the test stick, oral swabbing, what to do with the test stick after swabbing, minutes of wait time before interpretation of result, comprehension of result. Range: 0 to 5 (5 indicates all correct responses)	1 day
Primary	Usefulness, Ease of Use, Ease of Learning and Satisfaction of the HIV Self-testing Infographic	USE Questionnaire: Usefulness, Satisfaction, and Ease Measures the subjective usability of the HIV self-testing infographic. We used 14-items, using a 7-point Likert, and the minimum score is 14 and maximum 98 to examine dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction. Scores for each dimension are averaged together to get a composite score.We report the overall usability of the infographic.	1 day
Secondary	Health Literacy	Standard Assessment Health Literacy - English (SAHL-E). 18 test items designed to assess an English-speaking adult's ability to read and understand common medical terms. The test could help health professionals estimate the adult's health literacy level. Range - 0 to 18 (Higher score is higher health literacy)	1 day