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Public Health Targeting of PrEP at HIV Positives' Bridging Networks (SOPHOCLES)

Primary Purpose

HIV

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
PrEP Intervention
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV focused on measuring HIV prevention, men who have sex with men, pre-exposure prophylaxis, PrEP, Greece, people who inject drugs

Eligibility Criteria

18 Years - 39 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

-

Sites / Locations

  • Angelos Hatzakis

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 26, 2016
Last Updated
January 6, 2020
Sponsor
University of Chicago
Collaborators
University of Athens, National Development and Research Institutes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02676167
Brief Title
Public Health Targeting of PrEP at HIV Positives' Bridging Networks
Acronym
SOPHOCLES
Official Title
Public Health Targeting of PrEP at HIV Positives' Bridging Networks
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
University of Athens, National Development and Research Institutes, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. As HIV epidemics in most settings globally have plateaued or are in decline, emerging epidemics, re-emerging epidemics or outbreaks will become more common, particularly when social, political or other "shocks" that impact HIV prevention resources occur. One well characterized example is the recent epidemic among people who inject drugs (PWID) that started in Athens following austerity measures in 2010. While some success in limiting the epidemic within PWID has been observed, recent phylogenetic and surveillance analysis demonstrates that the HIV strain from this most recent PWID epidemic (CRF35_AD, CRF14_BG, subtypes A and B) has spilled over into MSM in 2013 (see Preliminary Studies). In emerging epidemics, oral chemoprophylaxis is a commonly-used public health strategy to prevent infectious diseases in susceptible persons. For example, among US and European MSM, antibiotic prophylaxis for sex-partners in outbreaks of invasive meningococcal disease has limited emerging outbreaks. Similarly, pre-exposure prophylaxis (PrEP) has the potential to be used in emerging epidemics to prevent onwards HIV transmission. While this approach would seem intuitive, current conceptualizations of PrEP implementation narrowly use a clinical model focused on individualized intervention between health provider and client. This is problematic because the public health impact of PrEP may be limited due to lack of proper targeting. In fact, evidence from "real-world" PrEP use suggests that lower risk clients are accessing PrEP. As compared to resource intensive clinical trials or demonstration studies, careful modeling approaches can provide insight into who within a new HIV epidemic should be targeted for PrEP to prevent onward transmission as well as the strategies used to identify these individuals and link them to care. 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. Specifically the investigators aim to: 1) Characterize a bridging MSM network (n=308) by measuring individual-level risk factors, network-level connections, and HIV phylogenetic clusters; 2) Measure early PrEP cascade outcomes (HIV testing, PrEP linkage to care) of a sub-sample (n=50) of HIV uninfected MSM over the short term; and 3) Model the effects of this targeted public health PrEP intervention on HIV transmission in Athens. Agent-based models that account for empirical network structure are state-of-the-art in modeling HIV transmission and are flexible enough to address fundamental questions of who should receive PrEP and ultimately how a network-PrEP intervention can impact emerging/reemerging HIV epidemics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
HIV prevention, men who have sex with men, pre-exposure prophylaxis, PrEP, Greece, people who inject drugs

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
308 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
PrEP Intervention
Primary Outcome Measure Information:
Title
PrEP prescription within 6 months of referral
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Schneider, MD, MPH
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Angelos Hatzakis
City
Athens
ZIP/Postal Code
11527
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

Public Health Targeting of PrEP at HIV Positives' Bridging Networks

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