NCT03078153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

3.7 years

First QC Date

March 7, 2017

Last Update Submit

February 1, 2021

Conditions

Pre-Exposure Prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Adherence To Truvada

    Level of Truvada drug levels inside red blood cells (performed by dried blood spots)

    6 months

Secondary Outcomes (2)

  • New Cases of HIV

    6 months

  • Incidence of STIs

    6 months

Study Arms (3)

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

Financial IncentiveBEHAVIORAL

Participants will receive a $50 gift card at 3- and 6- month follow-up visits.

Financial Incentive
Social Media GroupBEHAVIORAL

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

Social Media Group

Eligibility Criteria

Age18 Years - 24 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale at birth (regardless of current gender identity)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The GW Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Study Officials

  • Marc Siegel, MD

    The GW Medical Faculty Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 13, 2017

Study Start

April 1, 2017

Primary Completion

December 15, 2020

Study Completion

December 15, 2020

Last Updated

February 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)