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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

322

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

Study Start

First participant enrolled

May 13, 2019

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed

1 month until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2019

Completed

2.4 years until next milestone

Results Posted

Study results publicly available

March 23, 2022

Completed

Last Updated

October 27, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

July 17, 2019

Results QC Date

June 23, 2021

Last Update Submit

October 25, 2022

Conditions

HIV/AIDS

Keywords

HIV PreventionSexual and Gender MinoritiesConsumer Health Informatics

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (1)

Health Literacy
1 day

Study Arms (2)

Infographic Intervention

EXPERIMENTAL

Participants in the intervention arm will view an HIV self-testing infographic.

Behavioral: Infographic Intervention

Control

ACTIVE COMPARATOR

Participants in the control arm will read paper-based HIV self-testing instructions.

Behavioral: Paper-based HIV self-testing information

Interventions

Infographic InterventionBEHAVIORAL

The intervention consists of participants viewing an HIV self-testing infographic.

Infographic Intervention

Paper-based HIV self-testing informationBEHAVIORAL

The control arm will read paper-based HIV self-testing instructions.

Control

Eligibility Criteria

Age18 Years - 34 Years

Sexmale(Gender-based eligibility)

Gender Eligibility DetailsSelf-reported assigned male sex at birth.

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

Persons with a known HIV diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

New York Universitylead
National Institute of Mental Health (NIMH)collaborator

Study Sites (1)

New York University Rory Meyers College of Nursing

New York, New York, 10010, United States

Location

Related Publications (5)

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.
PMID: 34831644RESULT
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.
PMID: 38924481DERIVED
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.
PMID: 34101701DERIVED
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.
PMID: 34066948DERIVED
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.
PMID: 33670796DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeCoitus

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexual BehaviorBehavior

Results Point of Contact

Title: S. Raquel Ramos
Organization: New York University

Study Officials

S. Raquel Ramos, PhD, MBA, MSN, FNP-BC
New York University Rory Meyers College of Nursing
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 17, 2019

First Posted

August 20, 2019

Study Start

May 13, 2019

Primary Completion

November 6, 2019

Study Completion

November 6, 2019

Last Updated

October 27, 2022

Results First Posted

March 23, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing: Will not share

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Infographic Intervention

Control

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations