- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03078153
Effect of Social Media Support and Financial Incentives on PrEP Adherence
February 1, 2021 updated by: Marc O. Siegel, George Washington University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20037
- The GW Medical Faculty Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 24 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- Known renal insufficiency
- On probation or parole
- Any other conditions that the Principal Investigator may consider a contraindication to enrolling in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
No intervention
|
|
|
Experimental: Financial Incentive
Provided financial incentive at 3-month and 6-month follow-up visits
|
Participants will receive a $50 gift card at 3- and 6- month follow-up visits.
|
|
Experimental: Social Media Group
Provided social media support through a facebook group for 6 months
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence To Truvada
Time Frame: 6 months
|
Level of Truvada drug levels inside red blood cells (performed by dried blood spots)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
New Cases of HIV
Time Frame: 6 months
|
Number of reactive HIV rapid and 4th generation tests
|
6 months
|
|
Incidence of STIs
Time Frame: 6 months
|
Positive RPR, oropharyngeal/rectal/penile chlamydia and gonorrhea during study
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marc Siegel, MD, The GW Medical Faculty Associates
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2017
Primary Completion (Actual)
December 15, 2020
Study Completion (Actual)
December 15, 2020
Study Registration Dates
First Submitted
March 7, 2017
First Submitted That Met QC Criteria
March 7, 2017
First Posted (Actual)
March 13, 2017
Study Record Updates
Last Update Posted (Actual)
February 2, 2021
Last Update Submitted That Met QC Criteria
February 1, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 111642
- 1P30AI117970 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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