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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04155502
Other study ID # CTN-0083, STUDY00031899
Secondary ID UG1DA040309
Status Completed
Phase
First received
Last updated
Start date January 6, 2020
Est. completion date September 25, 2020

Study information

Verified date December 2020
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Culturally appropriate advertisements (designed specifically for the study population and advertisement method) for promoting HIV testing and PrEP uptake will be created by the study team. These advertisements will be placed on social media sites (Facebook, Instagram, Twitter), informational sites (Google, Bing, Yahoo) and dating apps (Grindr, Hornet, Jack'd) in the form of blast advertisements ("ads"). The advertisements will display on specific days and times (e.g., high traffic utilization) in the geographical locations selected for participation in the study. Upon clicking the ad, users will land on the study informational page on Qualtrics, where they will receive information about the study, undergo eligibility screening and, if eligible, electronically sign the informed consent. Participants will receive information about HIV testing and PrEP and will be asked to complete the baseline assessment and order their HIV home self-test kit. Participants will be followed up at two intervals after the baseline assessment. The first will occur 14 days post-baseline, where participants will be asked about their test use and may be asked if they visited a PrEP provider and/or if they started PrEP and about PrEP opinions and facilitators and barriers. If they tested positive for HIV on the home self-test kit, they will be asked whether they have visited an HIV treatment provider. Participants will be asked to upload a picture of their test result for validation on the secure Qualtrics server during the 14-day follow-up assessment. Photographs will be interpreted by the study team and the result will be entered into the study database; photographs will then be deleted. At the 60-day follow-up, all participants will be asked to respond to study evaluation questions. Additionally, participants may respond to a subset of the questions that is the same as the 14-day follow-up, based on their responses on the first follow-up survey. Those who reported that they received a negative HIV self-test result and started PrEP at the 14-day follow-up will not be asked to answer these questions at the 60-day follow-up. Participants who either did not take the HIV test or did not start PrEP by the 14-day follow-up may be asked about PrEP facilitators and barriers, their self-test use, if they visited a PrEP provider, whether they started PrEP, and if applicable, whether they have visited an HIV treatment provider, depending on their responses during the 14-day follow-up. Participants will be asked to upload a picture of their test result (unless provided at the 14-day follow-up) for validation on the secure Qualtrics server during the 60-day follow-up assessment. Photographs will be interpreted by the study team and the result will be entered into the study database; photographs will then be deleted. Participants who report a preliminary positive, invalid, or indeterminate result on the HIV home self-test kit will be referred to local brick-and-mortar clinics for additional services and asked to continue participating in follow-up assessments. Regardless of their result, all participants will be offered information on HIV and STD prevention, and locations of clinics and PrEP providers near them. Data will be collected both indirectly from each website's metrics and directly from the online questionnaires that the participants will complete.


Recruitment information / eligibility

Status Completed
Enrollment 272
Est. completion date September 25, 2020
Est. primary completion date September 20, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: 1. Have clicked on one of the study-specific advertisements posted on the platforms/ websites; 2. Have been biologically born male (cis-gender man), per participant self-report; 3. Report condomless anal intercourse and more than one male sex partner in the 90 days prior to the date of the screening questionnaire; 4. Be between the ages of 18-30 years old, inclusive; 5. Self-identify as Latino and/or Black/African American; 6. 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); 7. Have not tested for HIV in the last 3 months prior to the date of the screening questionnaire (per participant self-report); 8. Have a Facebook account (for identity validation to reduce duplicate attempts at enrollment); and 9. Be willing to provide contact information (phone number, email) to the study team. Exclusion Criteria: 1. Are unwilling or unable to provide informed consent. 2. Are unwilling to provide contact information (phone number, email address). 3. 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States UCLA David Geffen School of Medicine Los Angeles California

Sponsors (5)

Lead Sponsor Collaborator
Lisa A. Marsch Dartmouth College, National Drug Abuse Treatment Clinical Trials Network, National Institute on Drug Abuse (NIDA), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Self-test kit use The number of participants who used the study-provided HIV home self-test kit by 60-day follow-up will be collected via self-report at the time of follow-up (either 14-day or 60-day). 60 days
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