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Using Social Media to Deliver HIV Self-Testing Kits and Link to Online PrEP Services (CTN-0083)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155502
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : June 26, 2020
Sponsor:
Collaborators:
National Drug Abuse Treatment Clinical Trials Network
University of California, Los Angeles
Dartmouth College
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Lisa A. Marsch, Dartmouth-Hitchcock Medical Center

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.

Condition or disease
HIV Infections

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using Social Media to Deliver HIV Self-Testing Kits and Link to Online PrEP Services
Actual Study Start Date : January 6, 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
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.



Primary Outcome Measures :
  1. Self-test kit orders [ Time Frame: 180 days ]
    The bi-weekly rate (number of study participants per 2-week period) requesting an HIV home self-test kit by promotional platform (social media, informational, dating sites).


Secondary Outcome Measures :
  1. Self-test kit use [ Time Frame: 60 days ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study will be recruiting individuals who were biologically born male and identify as men.
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study is recruiting men who have sex with men who actively use social media sites, dating apps, or informational sites.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155502


Contacts
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Contact: Shea M Lemley, PhD 603-646-7041 shea.m.lemley@dartmouth.edu

Locations
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United States, California
UCLA David Geffen School of Medicine Recruiting
Los Angeles, California, United States, 90024
Contact: Jeffrey D Klausner, MD    310-557-2273    JDKlausner@mednet.ucla.edu   
Sponsors and Collaborators
Lisa A. Marsch
National Drug Abuse Treatment Clinical Trials Network
University of California, Los Angeles
Dartmouth College
National Institute on Drug Abuse (NIDA)
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Responsible Party: Lisa A. Marsch, Professor, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT04155502    
Other Study ID Numbers: CTN-0083, STUDY00031899
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A de-identified dataset will be posted on the funder's datashare website. This plan will be described in the study's consent procedures.
Supporting Materials: 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."

URL: https://datashare.nida.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa A. Marsch, Dartmouth-Hitchcock Medical Center:
HIV
Pre-exposure prophylaxis
Social media
Online advertising
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases