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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03078153
Other study ID # 111642
Secondary ID 1P30AI117970
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2017
Est. completion date December 15, 2020

Study information

Verified date February 2021
Source George Washington University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date December 15, 2020
Est. primary completion date December 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 24 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Financial Incentive
Participants will receive a $50 gift card at 3- and 6- month follow-up visits.
Social Media Group
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

Locations

Country Name City State
United States The GW Medical Faculty Associates Washington District of Columbia

Sponsors (3)

Lead Sponsor Collaborator
George Washington University Gilead Sciences, National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence To Truvada Level of Truvada drug levels inside red blood cells (performed by dried blood spots) 6 months
Secondary New Cases of HIV Number of reactive HIV rapid and 4th generation tests 6 months
Secondary Incidence of STIs Positive RPR, oropharyngeal/rectal/penile chlamydia and gonorrhea during study 6 months
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