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NCT04061915: HOTIE

HIV Oral Testing Infographic Experiment

Completed NA Results posted Last updated 27 October 2022
What this trial tests

NA trial testing Infographic Intervention in HIV/AIDS in 322 participants. Completed in 6 November 2019.

Timeline
13 May 2019
Primary endpoint
6 November 2019
6 November 2019

Quick facts

Lead sponsorNew York University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment322
Start date13 May 2019
Primary completion6 November 2019
Estimated completion6 November 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

New York University

Who can join

Adults 18 to 34, male only, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

HIV Self-testing Knowledge Primary · 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)

GroupValue95% CI
Infographic Intervention3.24± 1.16
Control3.79± 1.26
Usefulness, Ease of Use, Ease of Learning and Satisfaction of the HIV Self-testing Infographic Primary · 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.

GroupValue95% CI
Infographic Intervention76.47± 16.62
Health Literacy Secondary · 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)

GroupValue95% CI
Infographic Intervention15.9± 2.96
Control14.9± 3.98

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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.
    Ramos SR, Lardier DT, Opara I, Turpin RE, et al · · 2021 · cited 20× · PMID 34101701 · DOI 10.1097/jnc.0000000000000274
  2. Profiles of HIV Risk, Sexual Power, and Decision-Making among Sexual Minority Men of Color Who Engage in Transactional Sex: A Latent Profile Analysis.
    Ramos SR, Lardier DT, Boyd DT, Gutierrez JI, et al · · 2021 · cited 7× · PMID 34066948 · DOI 10.3390/ijerph18094961
  3. 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.
    Ramos SR, Lardier DT, Bond KT, Boyd DT, et al · · 2021 · cited 6× · PMID 34831644 · DOI 10.3390/ijerph182211881
  4. Substance Use, General Health and Health Literacy as Predictors of Oral Health in Emerging Adult Sexual Minority Men of Color: A Secondary Data Analysis.
    Ramos SR, Lardier DT, Warren RC, Cherian M, et al · · 2021 · cited 6× · PMID 33670796 · DOI 10.3390/ijerph18041987
  5. 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.
    Ramos SR, Reynolds H, Johnson C, Melkus G, et al · · 2024 · cited 4× · PMID 38924481 · DOI 10.2196/57351
  6. Racism-related stress, health outcomes, substance use, and PrEP attitudes among Asian sexual minority men.
    Chin LL, Kershaw T, Hernandez-Ramirez RU, Ramos SR. · · 2025 · cited 1× · PMID 40016341 · DOI 10.1038/s41598-025-91794-3

Verify or expand the search:

Other recruiting trials for HIV/AIDS

Currently open trials in the same condition.

Other New York University trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04061915.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing