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HIV Oral Testing Infographic Experiment (HOTIE)

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Infographic Intervention
Paper-based HIV self-testing information
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV/AIDS focused on measuring HIV Prevention, Sexual and Gender Minorities, Consumer Health Informatics

Eligibility Criteria

18 Years - 34 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • New York University Rory Meyers College of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Infographic Intervention

Control

Arm Description

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

Participants in the control arm will read paper-based HIV self-testing instructions.

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

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)

Full Information

First Posted
July 17, 2019
Last Updated
October 25, 2022
Sponsor
New York University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04061915
Brief Title
HIV Oral Testing Infographic Experiment
Acronym
HOTIE
Official Title
HIV Oral Testing Infographic Experiment (HOTIE)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
November 6, 2019 (Actual)
Study Completion Date
November 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV Prevention, Sexual and Gender Minorities, Consumer Health Informatics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
322 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infographic Intervention
Arm Type
Experimental
Arm Description
Participants in the intervention arm will view an HIV self-testing infographic.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants in the control arm will read paper-based HIV self-testing instructions.
Intervention Type
Behavioral
Intervention Name(s)
Infographic Intervention
Intervention Description
The intervention consists of participants viewing an HIV self-testing infographic.
Intervention Type
Behavioral
Intervention Name(s)
Paper-based HIV self-testing information
Intervention Description
The control arm will read paper-based HIV self-testing instructions.
Primary Outcome Measure Information:
Title
HIV Self-testing Knowledge
Description
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)
Time Frame
1 day
Title
Usefulness, Ease of Use, Ease of Learning and Satisfaction of the HIV Self-testing Infographic
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Health Literacy
Description
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)
Time Frame
1 day

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Self-reported assigned male sex at birth.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. Raquel Ramos, PhD, MBA, MSN, FNP-BC
Organizational Affiliation
New York University Rory Meyers College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Rory Meyers College of Nursing
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34831644
Citation
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.
Results Reference
result
PubMed Identifier
34101701
Citation
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.
Results Reference
derived
PubMed Identifier
34066948
Citation
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.
Results Reference
derived
PubMed Identifier
33670796
Citation
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.
Results Reference
derived

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HIV Oral Testing Infographic Experiment

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