Trial Outcomes & Findings for HIV Oral Testing Infographic Experiment (NCT NCT04061915)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

322 participants

Primary outcome timeframe

1 day

Results posted on

2022-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	Infographic Intervention 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.	Control 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.
Overall Study STARTED	161	161
Overall Study COMPLETED	161	161
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HIV Oral Testing Infographic Experiment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infographic Intervention n=161 Participants 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.	Control n=161 Participants 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 n=322 Participants Total of all reporting groups
Age, Continuous	26.2 years STANDARD_DEVIATION 4.74 • n=5 Participants	26.4 years STANDARD_DEVIATION 4.5 • n=7 Participants	26.35 years STANDARD_DEVIATION 4.66 • n=5 Participants
Sex/Gender, Customized Male Participants	161 Participants n=5 Participants	161 Participants n=7 Participants	322 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	79 Participants n=5 Participants	78 Participants n=7 Participants	157 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=5 Participants	83 Participants n=7 Participants	165 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
HIV Knowledge	11.29 units on a scale STANDARD_DEVIATION 4.94 • n=5 Participants	11.74 units on a scale STANDARD_DEVIATION 4.58 • n=7 Participants	11.51 units on a scale STANDARD_DEVIATION 4.76 • n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Infographic Intervention n=161 Participants 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	Control n=161 Participants 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.
HIV Self-testing Knowledge	3.24 score on a scale Standard Deviation 1.16	3.79 score on a scale Standard Deviation 1.26

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Infographic Intervention n=161 Participants 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	Control 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.
Usefulness, Ease of Use, Ease of Learning and Satisfaction of the HIV Self-testing Infographic	76.47 score on a scale Standard Deviation 16.62	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Infographic Intervention n=161 Participants 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	Control n=161 Participants 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.
Health Literacy	15.9 score on a scale Standard Deviation 2.96	14.9 score on a scale Standard Deviation 3.98

Adverse Events

Infographic Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

S. Raquel Ramos

New York University

Phone: 212-992-5994

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place