Effect of Social Media Support and Financial Incentives o... | NCT03078153

Studies
Effect of Social Media Support and Financial Incentives on PrEP Adherence

NCT03078153

Sponsor

George Washington University

Status

Completed

Last Update Posted

Feb 2, 2021Actual

Enrollment

57Actual

Phase

Not Applicable

Conditions

Pre-Exposure Prophylaxis

Interventions

Financial Incentive
Social Media Group

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1P30AI117970	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Dec 15, 2020Actual

Completion Date

Dec 15, 2020Actual

First Submitted Date

Mar 7, 2017

First Submission Date that Met QC Criteria

Mar 7, 2017

First Posted Date

Mar 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2021

Last Update Posted Date

Feb 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marc O. Siegel, Principal Investigator, George Washington UniversityPrincipal Investigator

Lead Sponsor

George Washington UniversityOTHER

Collaborators

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH
Gilead Sciences	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Financial Incentive	Experimental	Provided financial incentive at 3-month and 6-month follow-up visits	Behavioral: Financial Incentive
Social Media Group	Experimental	Provided social media support through a facebook group for 6 months	Behavioral: Social Media Group
Control	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Financial Incentive	Behavioral	Participants will receive a $50 gift card at 3- and 6- month follow-up visits.	Financial Incentive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adherence To Truvada	Level of Truvada drug levels inside red blood cells (performed by dried blood spots)	6 months

Secondary Outcomes

Measure	Description	Time Frame
New Cases of HIV	Number of reactive HIV rapid and 4th generation tests	6 months
Incidence of STIs	Positive RPR, oropharyngeal/rectal/penile chlamydia and gonorrhea during study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

male at birth (regardless of current gender identity)

Minimum Age

18 Years

Maximum Age

24 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Siegel, MD	The GW Medical Faculty Associates	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The GW Medical Faculty Associates		Washington D.C.	District of Columbia	20037	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided