HOTIE: HIV Oral Testing Infographic Experiment

• Sponsor: New York University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04061915
• Collaborator: Yale University Center for Interdisciplinary Research on AIDS (Other), National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 322
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.8
• Patients Per Site Per Month: 55.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS	Behavioral: Infographic Intervention; Behavioral: Paper-based HIV self-testing information	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 322 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: HIV Oral Testing Infographic Experiment (HOTIE)
• Actual Study Start Date: May 13, 2019
• Actual Primary Completion Date: Nov 6, 2019
• Actual Study Completion Date: Nov 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Infographic Intervention Participants in the intervention arm will view an HIV self-testing infographic.	Behavioral: Infographic Intervention; The intervention consists of participants viewing an HIV self-testing infographic.
Active Comparator: Control Participants in the control arm will read paper-based HIV self-testing instructions.	Behavioral: Paper-based HIV self-testing information; The control arm will read paper-based HIV self-testing instructions.

Outcome Measures

Primary Outcome Measures

1. HIV Self-testing Knowledge [1 day]

   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)

2. Usefulness, Ease of Use, Ease of Learning and Satisfaction of the HIV Self-testing Infographic [1 day]

   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

1. Health Literacy [1 day]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 34 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University Rory Meyers College of Nursing	New York	New York	United States	10010

Sponsors and Collaborators

• New York University
• Yale University Center for Interdisciplinary Research on AIDS
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: S. Raquel Ramos, PhD, MBA, MSN, FNP-BC, New York University Rory Meyers College of Nursing

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 23, 2021

More Information

Publications

None provided.

• Responsible Party: Silvia Raquel Ramos, Assistant Professor, New York University
• ClinicalTrials.gov Identifier: NCT04061915
• Other Study ID Numbers: 2018-1573; R25MH087217; P30MH062294
• First Posted: Aug 20, 2019
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Silvia Raquel Ramos, Assistant Professor, New York University: HIV Prevention; Sexual and Gender Minorities; Consumer Health Informatics
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections

Study Results

Participant Flow

Arm/Group Title	Infographic Intervention	Control
Arm/Group Description	Participants randomized to the online intervention arm will review the HIV self-testing infographic. Once reviewed, participants will answer comprehension and preference questions about the self-testing infographic. Infographic Intervention: A HIV self-testing infographic that utilizes a simplicity model of pictures with limited text.	Participants randomized to the control arm will text-based HIV self-testing instructions. Text-based HIV self-testing information: The online control arm will consist of text-based, HIV self-testing information.
Period Title: Overall Study
STARTED	161	161
COMPLETED	161	161
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Infographic Intervention	Control	Total
Arm/Group Description	Participants randomized to the online intervention arm will review the HIV self-testing infographic. Once reviewed, participants will answer comprehension and preference questions about the self-testing infographic. Infographic Intervention: A HIV self-testing infographic that utilizes a simplicity model of pictures with limited text.	Participants randomized to the control arm will text-based HIV self-testing instructions. Text-based HIV self-testing information: The online control arm will consist of text-based, HIV self-testing information.	Total of all reporting groups
Overall Participants	161	161	322
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.2 (4.74)	26.4 (4.5)	26.35 (4.66)
Sex/Gender, Customized (Count of Participants)
Male Participants	161 100%	161 100%	322 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	79 49.1%	78 48.4%	157 48.8%
Not Hispanic or Latino	82 50.9%	83 51.6%	165 51.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
HIV Knowledge (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	11.29 (4.94)	11.74 (4.58)	11.51 (4.76)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Infographic Intervention	Control
Arm/Group Description	Emerging adults randomized to the online intervention arm will review the self-testing infographic. Once participants finish reviewing, they will answer comprehension and preference questions about the self-testing infographic. Infographic Intervention: A HIV self-testing infographic that utilizes a simplicity model collaboratively designed by a leadership group of HIV community members	Emerging adults randomized to the online control arm will read paper-based HIV self-testing information. Paper-based HIV self-testing information: The online control arm will consist of paper-based, HIV self-testing information that the emerging adults will read.
Measure Participants	161	161
Mean (Standard Deviation) [score on a scale]	3.24 (1.16)	3.79 (1.26)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Infographic Intervention
Arm/Group Description	Participants randomized to the online intervention arm will review the HIV self-testing infographic. Once reviewed, participants will answer comprehension and preference questions about the self-testing infographic. Infographic Intervention: A HIV self-testing infographic that utilizes a simplicity model of pictures with limited text.
Measure Participants	161
Mean (Standard Deviation) [score on a scale]	76.47 (16.62)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Infographic Intervention	Control
Arm/Group Description	Emerging adults randomized to the online intervention arm will review the self-testing infographic. Once participants finish reviewing, they will answer comprehension and preference questions about the self-testing infographic. Infographic Intervention: A HIV self-testing infographic that utilizes a simplicity model collaboratively designed by a leadership group of HIV community members	Emerging adults randomized to the online control arm will read paper-based HIV self-testing information. Paper-based HIV self-testing information: The online control arm will consist of paper-based, HIV self-testing information that the emerging adults will read.
Measure Participants	161	161
Mean (Standard Deviation) [score on a scale]	15.9 (2.96)	14.9 (3.98)

Adverse Events

Time Frame	Data collection took place over 6 months. For each participant, adverse event data were collected over the duration of 1 day, which was the amount of total time a participant completed all measures.
Adverse Event Reporting Description	This was an online pilot RCT to test the feasibility, acceptability, and comprehension of an HIV self-testing infographic. The risk of serious adverse events, all-cause mortality, and other adverse risks associated with this study was low.
Arm/Group Title	Infographic Intervention		Control
Arm/Group Description	Participants randomized to the online intervention arm will review the HIV self-testing infographic. Once reviewed, participants will answer comprehension and preference questions about the self-testing infographic. Infographic Intervention: A HIV self-testing infographic that utilizes a simplicity model of pictures with limited text.		Participants randomized to the control arm will text-based HIV self-testing instructions. Text-based HIV self-testing information: The online control arm will consist of text-based, HIV self-testing information.
All Cause Mortality
	Infographic Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/161 (0%)		0/161 (0%)
Serious Adverse Events
	Infographic Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/161 (0%)		0/161 (0%)
Other (Not Including Serious) Adverse Events
	Infographic Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/161 (0%)		0/161 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.