HIV/AIDS
Conditions
Keywords
HIV Prevention, Sexual and Gender Minorities, Consumer Health Informatics
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.
Interventions
BEHAVIORALInfographic Intervention
The intervention consists of participants viewing an HIV self-testing infographic.
BEHAVIORALPaper-based HIV self-testing information
The control arm will read paper-based HIV self-testing instructions.
Sponsors
National Institute of Mental Health (NIMH)
New York University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 34 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 161 |
| 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. | 161 |
| Total | 322 |
Baseline characteristics
| Characteristic | Control | Total | Infographic Intervention |
|---|---|---|---|
| Age, Continuous | 26.4 years STANDARD_DEVIATION 4.5 | 26.35 years STANDARD_DEVIATION 4.66 | 26.2 years STANDARD_DEVIATION 4.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 78 Participants | 157 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants | 165 Participants | 82 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| HIV Knowledge | 11.74 units on a scale STANDARD_DEVIATION 4.58 | 11.51 units on a scale STANDARD_DEVIATION 4.76 | 11.29 units on a scale STANDARD_DEVIATION 4.94 |
| Sex/Gender, Customized Male Participants | 161 Participants | 322 Participants | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 161 | 0 / 161 |
| other Total, other adverse events | 0 / 161 | 0 / 161 |
| serious Total, serious adverse events | 0 / 161 | 0 / 161 |
Outcome results
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)
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infographic Intervention | HIV Self-testing Knowledge | 3.24 score on a scale | Standard Deviation 1.16 |
| Control | HIV Self-testing Knowledge | 3.79 score on a scale | Standard Deviation 1.26 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infographic Intervention | 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
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)
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infographic Intervention | Health Literacy | 15.9 score on a scale | Standard Deviation 2.96 |
| Control | Health Literacy | 14.9 score on a scale | Standard Deviation 3.98 |