NCT04155502

Brief Summary

The primary objective of this study is to compare the relative effectiveness of three web-based platforms: social media sites (e.g., Facebook), dating applications \[apps\] (e.g., Grindr), and informational sites (e.g., Google) to promote self-testing of Human Immunodeficiency Virus (HIV) infection among men who have sex with men (MSM) who are at increased risk of HIV exposure and/or infection. In addition, we will measure Pre-Exposure Prophylaxis (PrEP) uptake and evaluate the degree to which substance use and, separately, the participant's intention to test affect HIV self-testing and PrEP uptake. Through this research, we will also examine how participants' social media use, attitudes on HIV testing, perceptions of sexual risk behavior, medical mistrust, and stigma impact HIV testing and PrEP uptake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

November 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 6, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

9 months

First QC Date

November 5, 2019

Last Update Submit

December 16, 2020

Conditions

Keywords

HIVPre-exposure prophylaxisSocial mediaOnline advertising

Outcome Measures

Primary Outcomes (1)

  • Self-test kit orders

    The daily rate (number of study participants per day) requesting an HIV home self-test kit by promotional platform (social media, informational, dating sites).

    60 days

Secondary Outcomes (1)

  • Self-test kit use

    60 days

Study Arms (3)

Social media sites.

These participants will be recruited from advertisements posted on social media websites. Participants who complete the baseline assessment will receive a code to order a free HIV self-test kit. Participants will be asked to complete two online follow-up questionnaires at 14-days and 60-days post-baseline. These questionnaires will ask questions related to HIV self-test kit use and PrEP uptake.

Informational sites

These participants will be recruited from advertisements posted on informational websites. Participants who complete the baseline assessment will receive a code to order a free HIV self-test kit. Participants will be asked to complete two online follow-up questionnaires at 14-days and 60-days post-baseline. These questionnaires will ask questions related to HIV self-test kit use and PrEP uptake.

Dating applications

These participants will be recruited from advertisements posted on dating applications. Participants who complete the baseline assessment will receive a code to order a free HIV self-test kit. Participants will be asked to complete two online follow-up questionnaires at 14-days and 60-days post-baseline. These questionnaires will ask questions related to HIV self-test kit use and PrEP uptake.

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThis study will be recruiting individuals who were biologically born male and identify as men.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

This study is recruiting men who have sex with men who actively use social media sites, dating apps, or informational sites.

You may qualify if:

  • Have clicked on one of the study-specific advertisements posted on the platforms/ websites;
  • Have been biologically born male (cis-gender man), per participant self-report;
  • Report condomless anal intercourse and more than one male sex partner in the 90 days prior to the date of the screening questionnaire;
  • Be between the ages of 18-30 years old, inclusive;
  • Self-identify as Latino and/or Black/African American;
  • Not currently on PrEP and haven't taken PrEP in the last six months prior to the date of the screening questionnaire (per participant self-report);
  • Have not tested for HIV in the last 3 months prior to the date of the screening questionnaire (per participant self-report);
  • Have a Facebook account (for identity validation to reduce duplicate attempts at enrollment); and
  • Be willing to provide contact information (phone number, email) to the study team.

You may not qualify if:

  • Are unwilling or unable to provide informed consent.
  • Are unwilling to provide contact information (phone number, email address).
  • Report having a preliminary positive or positive HIV result in a test completed less than 30 days prior to the date of screening or report being currently under treatment for HIV infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA David Geffen School of Medicine

Los Angeles, California, 90024, United States

Location

Related Publications (2)

  • Stafylis C, Vavala G, Wang Q, McLeman B, Lemley SM, Young SD, Xie H, Matthews AG, Oden N, Revoredo L, Shmueli-Blumberg D, Hichborn EG, McKelle E, Moran LM, Jacobs P, Marsch LA, Klausner JD. Relative Effectiveness of Social Media, Dating Apps, and Information Search Sites in Promoting HIV Self-testing: Observational Cohort Study. JMIR Form Res. 2022 Sep 23;6(9):e35648. doi: 10.2196/35648.

  • Lemley SM, Klausner JD, Young SD, Stafylis C, Mulatya C, Oden N, Xie H, Revoredo L, Shmueli-Blumberg D, Hichborn E, McKelle E, Moran L, Jacobs P, Marsch LA. Comparing Web-Based Platforms for Promoting HIV Self-Testing and Pre-Exposure Prophylaxis Uptake in High-Risk Men Who Have Sex With Men: Protocol for a Longitudinal Cohort Study. JMIR Res Protoc. 2020 Oct 19;9(10):e20417. doi: 10.2196/20417.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jeffrey D. Klausner, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 7, 2019

Study Start

January 6, 2020

Primary Completion

September 20, 2020

Study Completion

September 25, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

A de-identified dataset will be posted on the funder's datashare website. This plan will be described in the study's consent procedures.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be provided to NIDA CCTN-designated parties for posting on the NIDA Data Share website after completion of the study and data lock.
Access Criteria
Per the NIDA Data Share 2.0 website: "Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the NIDA Data Share Agreement."
More information

Locations