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| ID | Type | Description | Link |
|---|---|---|---|
| R25MH087217 | U.S. NIH Grant/Contract | View source | |
| P30MH062294 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infographic Intervention | Experimental | Participants in the intervention arm will view an HIV self-testing infographic. |
|
| Control | Active Comparator | Participants in the control arm will read paper-based HIV self-testing instructions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infographic Intervention | Behavioral | The intervention consists of participants viewing an HIV self-testing infographic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
• Persons with a known HIV diagnosis
Self-reported assigned male sex at birth.
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| Name | Affiliation | Role |
|---|---|---|
| S. Raquel Ramos, PhD, MBA, MSN, FNP-BC | New York University Rory Meyers College of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Rory Meyers College of Nursing | New York | New York | 10010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34831644 | Result | 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. | |
| 38924481 | Derived | Ramos 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 1 day |
|
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| S. Raquel Ramos | New York University | 212-992-5994 | TheHOTIEStudy@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2021 | Mar 18, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Paper-based HIV self-testing information | Behavioral | The control arm will read paper-based HIV self-testing instructions. |
|
| 34101701 | Derived | 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. |
| 34066948 | Derived | 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. |
| 33670796 | Derived | 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. |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| HIV Knowledge | 18-item dichotomous response (true/false) measure that detects an individual's knowledge about HIV transmission, prevention, and consequences. Range = 0 to 18 (higher score indicates higher HIV knowledge) | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1 day |
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 1 day |
|
|
|
| 0 |
| 161 |
| 0 |
| 161 |
| 0 |
| 161 |
| EG001 | 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. | 0 | 161 | 0 | 161 | 0 | 161 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012725 | Sexual Behavior |
| D001519 | Behavior |