NCT02371525

Brief Summary

To test the effectiveness of Prepmate, a novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support among young men who have sex with men (MSM).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Apr 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1.6 years

First QC Date

February 19, 2015

Last Update Submit

October 24, 2017

Conditions

HIV

Keywords

adherenceprevention

Outcome Measures

Primary Outcomes (1)

  • PrEP adherence among young MSM over time based on dried blood spot (DBS)

    PrEP adherence during follow-up based on dried blood spot (DBS) concentrations.

    DBS measured through week 36

Secondary Outcomes (8)

  • Change in PrEP knowledge assessed via computer-assisted self-interview (CASI)

    baseline and week 36

  • Change in risk behaviors administered via CASI

    baseline through week 36

  • Change in risk perception administered by CASI

    baseline through week 36

  • Acceptability of Prepmate as measured by an acceptability index collected via CASI

    Month 9 (or early termination)

  • Perceptions of Prepmate provided via individual exit interviews

    Month 10

  • +3 more secondary outcomes

Study Arms (2)

Standard of Care

NO INTERVENTION

Prepmate

EXPERIMENTAL
Behavioral: Prepmate

Interventions

PrepmateBEHAVIORAL

A novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support .

Prepmate

Eligibility Criteria

Age18 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • HIV-uninfected as determined by a negative/non-reactive laboratory test within 7 days of Enrollment (as defined in the study-specific procedures (SSP) Manual).
  • Interested in initiating PrEP
  • Eligible to initiate PrEP
  • Creatinine clearance \> 60 ml/min as estimated by the Cockcroft-Gault equation within 6 weeks of enrollment
  • Hepatitis B surface antigen (HBsAg) negative within 6 weeks Enrollment
  • No other medical contraindications to PrEP
  • Age 18 years - 29 years
  • Willing and able to provide written informed consent
  • Report having had anal sex with a man in the previous 6 months
  • Meet any of the following risk criteria for the prior 6 months:
  • Any condomless anal sex
  • Three or more anal sex partners
  • Self-reported new STI
  • Known HIV-infected sex partner
  • Have regular access to a computer and/or a smart phone to access the internet and/or apps
  • +2 more criteria

You may not qualify if:

  • PrEP use within the past year (PrEP naïve participants will be prioritized).
  • Any reactive or positive HIV test at Screening, even if subsequent testing indicates that the person is HIV-uninfected
  • Prior or current participation in the active arm of an HIV vaccine trial
  • At Enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent, make participation in the project unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the project objectives.
  • Signs or symptoms of acute HIV infection (as described in the SSP Manual)
  • History of pathological bone fracture not related to trauma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stroger Hospital and the CORE Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • Liu AY, Vittinghoff E, von Felten P, Rivet Amico K, Anderson PL, Lester R, Andrew E, Estes I, Serrano P, Brothers J, Buchbinder S, Hosek S, Fuchs JD. Randomized Controlled Trial of a Mobile Health Intervention to Promote Retention and Adherence to Preexposure Prophylaxis Among Young People at Risk for Human Immunodeficiency Virus: The EPIC Study. Clin Infect Dis. 2019 May 30;68(12):2010-2017. doi: 10.1093/cid/ciy810.

    PMID: 30239620DERIVED

Study Officials

  • Albert Liu, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2015

First Posted

February 25, 2015

Study Start

April 1, 2015

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

US(1)