HIV InfectionsCTN-0083NCT04155502
Using Social Media to Deliver HIV Self-Testing Kits and Link to Online PrEP Services
An observational study of HIV Infections, run by Lisa A. Marsch at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men only
- Conditions the study is for
- HIV Infections
- How many people
- 272 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 25 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- No healthy volunteers
- Adult
Study population: This study is recruiting men who have sex with men who actively use social media sites, dating apps, or informational sites.
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA David Geffen School of Medicine
Los Angeles, California, 90024
About this study
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.
Read the 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.
- Conditions
- HIV Infections
- Keywords
- HIV, Pre-exposure prophylaxis, Social media, Online advertising
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 60 days
Secondary outcomes (1)
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).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start6 Jan 2020
- Primary completion20 Sep 2020
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisa A. Marsch
- Sponsor type
- University, hospital or other
- Collaborators
- National Drug Abuse Treatment Clinical Trials Network, University of California, Los Angeles, Dartmouth College, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Lisa A. Marsch, Dartmouth-Hitchcock Medical Center
- Investigators
- Jeffrey D. Klausner, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155502
- Sponsor's protocol ID
- CTN-0083, STUDY00031899
- Other IDs
- UG1DA040309
- Acronym
- CTN-0083
- Status last verified
- Dec 2020
- First submitted
- 5 Nov 2019
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified dataset will be posted on the funder's datashare website. This plan will be described in the study's consent procedures.
Publications
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.
PubMed 36149729Lemley 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.
PubMed 33074164
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Social Media to Deliver HIV Self-Testing Kits and Link to Online PrEP Services
- ClinicalTrials.gov ID
- NCT04155502
- Acronym / sponsor ID
- CTN-0083 / CTN-0083, STUDY00031899
- Conditions
- HIV Infections
- Keywords
- HIV, Pre-exposure prophylaxis, Social media, Online advertising
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Lisa A. MarschUniversity, hospital or other
- Collaborators
- National Drug Abuse Treatment Clinical Trials Network, University of California, Los Angeles, Dartmouth College, National Institute on Drug Abuse (NIDA)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study is recruiting men who have sex with men who actively use social media sites, dating apps, or informational sites.
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-test kit orders
Time frame: 60 days
The daily rate (number of study participants per day) requesting an HIV home self-test kit by promotional platform (social media, informational, dating sites).
1 secondary outcome
Self-test kit use
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Derived from this study: PubMed 36149729Stafylis 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.
- Derived from this study: PubMed 33074164Lemley 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.
- Individual participant dataSharing planned: Yes. A de-identified dataset will be posted on the funder's datashare website. This plan will be described in the study's consent procedures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey D. Klausner, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Lisa A. Marsch at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-test kit orders (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04155502, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.