HIV/AIDSHOTIENCT04061915
HIV Oral Testing Infographic Experiment
A study testing Infographic Intervention and Paper-based HIV self-testing information in people with HIV/AIDS, run by New York University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 34 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Infographic Intervention and Paper-based HIV self-testing information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2019to 6 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Persons with a known HIV diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Rory Meyers College of Nursing
New York, New York, 10010
About this study
Official title: HIV Oral Testing Infographic Experiment (HOTIE)
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Infographic Intervention, Paper-based HIV self-testing information
- Keywords
- HIV Prevention, Sexual and Gender Minorities, Consumer Health Informatics
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infographic InterventionBehavioural
The intervention consists of participants viewing an HIV self-testing infographic.
Paper-based HIV self-testing informationBehavioural
The control arm will read paper-based HIV self-testing instructions.
| Study group | Role | What they receive |
|---|---|---|
| Infographic Intervention | Experimental | Participants in the intervention arm will view an HIV self-testing infographic. Receives: Behavioral: Infographic Intervention |
| Control | Active comparator | Participants in the control arm will read paper-based HIV self-testing instructions. Receives: Behavioral: Paper-based HIV self-testing information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 day
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.
Measured: 1 day
Secondary outcomes (1)
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)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start13 May 2019
- Primary completion6 Nov 2019
- Study completion6 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- S. Raquel Ramos, PhD, MBA, MSN, FNP-BC, Principal investigator, New York University Rory Meyers College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061915
- Sponsor's protocol ID
- 2018-1573
- Other IDs
- R25MH087217, P30MH062294
- Acronym
- HOTIE
- Status last verified
- Mar 2022
- First submitted
- 17 Jul 2019
- Last updated
- 27 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34831644Ramos SR, Reynolds H, Johnson C, Melkus G, Kershaw T, Thayer JF, Vorderstrasse A. Perceptions of HIV-Related Comorbidities and Usability of a Virtual Environment for Cardiovascular Disease Prevention Education in Sexual Minority Men With HIV: Formative Phases of a Pilot Randomized Controlled Trial. J Med Internet Res. 2024 Aug 22;26:e57351. doi: 10.2196/57351.
PubMed 38924481Ramos 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.
PubMed 34101701Ramos 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.
PubMed 34066948Ramos 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.
PubMed 33670796
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Oral Testing Infographic Experiment (HOTIE)
- ClinicalTrials.gov ID
- NCT04061915
- Acronym / sponsor ID
- HOTIE / 2018-1573
- Conditions
- HIV/AIDS
- Keywords
- HIV Prevention, Sexual and Gender Minorities, Consumer Health Informatics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 13 May 2019 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 6 Nov 2019 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Posted 23 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infographic Intervention | Experimental | Behavioral: Infographic InterventionParticipants in the intervention arm will view an HIV self-testing infographic. |
| Control | Active comparator | Behavioral: Paper-based HIV self-testing informationParticipants in the control arm will read paper-based HIV self-testing instructions. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Persons with a known HIV diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infographic InterventionThe intervention consists of participants viewing an HIV self-testing infographic. | Behavioural | Infographic Intervention |
| Paper-based HIV self-testing informationThe control arm will read paper-based HIV self-testing instructions. | Behavioural | Control |
Primary outcome
HIV Self-testing Knowledge
Time frame: 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
Time frame: 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.
1 secondary outcome
Health Literacy
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34831644Ramos 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.
- Derived from this study: PubMed 38924481Ramos SR, Reynolds H, Johnson C, Melkus G, Kershaw T, Thayer JF, Vorderstrasse A. Perceptions of HIV-Related Comorbidities and Usability of a Virtual Environment for Cardiovascular Disease Prevention Education in Sexual Minority Men With HIV: Formative Phases of a Pilot Randomized Controlled Trial. J Med Internet Res. 2024 Aug 22;26:e57351. doi: 10.2196/57351.
- Derived from this study: PubMed 34101701Ramos 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.
- Derived from this study: PubMed 34066948Ramos 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.
- Derived from this study: PubMed 33670796Ramos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S. Raquel Ramos, PhD, MBA, MSN, FNP-BC principal investigator
New York University Rory Meyers College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infographic Intervention and Paper-based HIV self-testing information in people with HIV/AIDS, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Self-testing Knowledge (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04061915, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.