NCT02676167

Brief Summary

This developmental research grant award (R21) requests funds to explore the feasibility and impact of a public health system PrEP intervention in a recently emerging HIV epidemic in Athens Greece. The investigators propose a modeling approach using an Agent Based Model (ABM) that moves beyond basic pathogen and transmission patterns to dealing with complex social interactions, including overlapping social and sexual networks as well as implementation realities, like finite PrEP resources, delayed linkage to PrEP care and early PreP care retention based upon empirically collected data in Athens Greece.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
308

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Jan 2017

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

January 26, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

2.3 years

First QC Date

January 26, 2016

Last Update Submit

January 6, 2020

Conditions

HIV

Keywords

HIV preventionmen who have sex with menpre-exposure prophylaxisPrEPGreecepeople who inject drugs

Outcome Measures

Primary Outcomes (1)

  • PrEP prescription within 6 months of referral

    A first clinic visit where PrEP is prescribed within 6 months of referral. Clinic visit will be measured by abstracted clinical records and referral date will be collected by the field interviewer.

    6 months

Study Arms (1)

Intervention

OTHER
Behavioral: PrEP Intervention

Interventions

PrEP InterventionBEHAVIORAL
Intervention

Eligibility Criteria

Age18 Years - 39 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • identify as male,
  • are between the ages of 18-39,
  • report sex with a man (oral or anal sex) in the past 12 months,
  • are willing/able to provide informed consent,
  • are willing to provide biological samples,
  • are Greek or English speakers and
  • are able to lucidly respond to interview questions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angelos Hatzakis

Athens, 11527, Greece

Location

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehavior

Study Officials

  • John Schneider, MD, MPH

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 8, 2016

Study Start

January 1, 2017

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

January 9, 2020

Record last verified: 2020-01

Locations

GR(1)