Pre-Exposure ProphylaxisNCT03078153
Effect of Social Media Support and Financial Incentives on PrEP Adherence
A study testing Financial Incentive and Social Media Group in people with Pre-Exposure Prophylaxis, run by George Washington University at 1 site in United States.
Trial summary
The purpose of this study is to determine if social media support and financial incentives improve adherence to Truvada as PrEP in African American, Latino and Asian MSM aged 18 to 24 living in the Washington, DC area who are at high risk for HIV acquisition. Read more about this study
- Who is it for?
- Ages 18 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Exposure Prophylaxis
- What is being tested?
- Financial Incentive and Social Media Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 15 Dec 2020
- Phase
- Interventional
- 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 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male assigned at birth (regardless of current gender identity)
- Age 18-24
- Black/African American, Latino or Asian
- HIV negative
- History of unprotected anal sex with a man in the last 6 months
- Living within the DC metropolitan statistical area and anticipate remaining within the DC area for the next 6 months
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- Not enrolled in any other HIV prevention trial
- Interested in taking PrEP
- Not a current PrEP user and have not taken PrEP in the last 30 days
- Able to provide informed consent
Who cannot join
- Female sex at birth
- Age younger than 18 or older than 24
- Caucasian
- HIV positive
- Actively taking PrEP or having taken PrEP within 30 days of enrollment
- Chronic hepatitis B infection
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- Known renal insufficiency
- On probation or parole
- Any other conditions that the Principal Investigator may consider a contraindication to enrolling in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: The Effect of Social Media Support and Financial Incentives on Adherence to HIV Pre-exposure Prophylaxis in Young MSM of Color in Washington, DC
The purpose of this study is to determine if social media support and financial incentives improve adherence to Truvada as PrEP in African American, Latino and Asian MSM aged 18 to 24 living in the Washington, DC area who are at high risk for HIV acquisition.
- Conditions
- Pre-Exposure Prophylaxis
- Being tested
- Financial Incentive, Social Media Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial IncentiveBehavioural
Participants will receive a $50 gift card at 3- and 6- month follow-up visits.
Social Media GroupBehavioural
Participants will be invited to a study Facebook group which will have links to PrEP information and provide a forum for participants to ask questions and communicate their experience with PrEP
| Study group | Role | What they receive |
|---|---|---|
| Financial Incentive | Experimental | Provided financial incentive at 3-month and 6-month follow-up visits Receives: Behavioral: Financial Incentive |
| Social Media Group | Experimental | Provided social media support through a facebook group for 6 months Receives: Behavioral: Social Media Group |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence To Truvada
Level of Truvada drug levels inside red blood cells (performed by dried blood spots)
Measured: 6 months
Secondary outcomes (2)
New Cases of HIV
Number of reactive HIV rapid and 4th generation tests
Measured: 6 months
Incidence of STIs
Positive RPR, oropharyngeal/rectal/penile chlamydia and gonorrhea during study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start1 Apr 2017
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Exposure ProphylaxisStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc O. Siegel, George Washington University
- Investigators
- Marc Siegel, MD, Principal investigator, The GW Medical Faculty Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078153
- Sponsor's protocol ID
- 111642
- Other IDs
- 1P30AI117970
- Status last verified
- Feb 2021
- First submitted
- 7 Mar 2017
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Social Media Support and Financial Incentives on Adherence to HIV Pre-exposure Prophylaxis in Young MSM of Color in Washington, DC
- ClinicalTrials.gov ID
- NCT03078153
- Acronym / sponsor ID
- 111642
- Conditions
- Pre-Exposure Prophylaxis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Gilead Sciences
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 13 Mar 2017 (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 purpose of this study is to determine if social media support and financial incentives improve adherence to Truvada as PrEP in African American, Latino and Asian MSM aged 18 to 24 living in the Washington, DC area who are at high risk for HIV acquisition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Financial Incentive | Experimental | Behavioral: Financial IncentiveProvided financial incentive at 3-month and 6-month follow-up visits |
| Social Media Group | Experimental | Behavioral: Social Media GroupProvided social media support through a facebook group for 6 months |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male assigned at birth (regardless of current gender identity)
- Age 18-24
- Black/African American, Latino or Asian
- HIV negative
- History of unprotected anal sex with a man in the last 6 months
Key exclusion criteria (9 listed)
- Female sex at birth
- Age younger than 18 or older than 24
- Caucasian
- HIV positive
- Actively taking PrEP or having taken PrEP within 30 days of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial IncentiveParticipants will receive a $50 gift card at 3- and 6- month follow-up visits. | Behavioural | Financial Incentive |
| Social Media GroupParticipants will be invited to a study Facebook group which will have links to PrEP information and provide a forum for participants to ask questions and communicate their experience with PrEP | Behavioural | Social Media Group |
Primary outcome
Adherence To Truvada
Time frame: 6 months
Level of Truvada drug levels inside red blood cells (performed by dried blood spots)
2 secondary outcomes
New Cases of HIV
Time frame: 6 months
Incidence of STIs
Time frame: 6 months
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 2 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Marc Siegel, MD principal investigator
The GW Medical Faculty Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Incentive and Social Media Group in people with Pre-Exposure Prophylaxis, run by George Washington University 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 10 inclusion and 9 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 2 Feb 2021. 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?
Adherence To Truvada (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2021.