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Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2017 by University of Chicago

Sponsor
University of Chicago

Collaborator
University of Athens
National Development and Research Institutes, Inc.

Information provided by (Responsible Party)
University of Chicago
ClinicalTrials.gov Identifier
NCT02676167

First received: January 26, 2016
Last updated: May 2, 2017
Last Verified: May 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV

Behavioral : PrEP Intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Public Health Targeting of PrEP at HIV Positives' Bridging Networks

Further study details as provided by University of Chicago:

Primary Outcome Measures

  • PrEP prescription within 6 months of referral [ Time Frame: 6 months ]
    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.

Estimated Enrollment: 250
Study Start Date: January 2017
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: Intervention

Behavioral: PrEP Intervention

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=250) 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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 39 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  

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:

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02676167

Contacts

Contact:   John Schneider, MD, MPH 773-702-8349 jschnei1@medicine.bsd.uchicago.edu

Locations

Greece
Angelos Hatzakis Recruiting
Athens, Greece, 11527
Contact: Angelos Hatzakis, MD    00302107462090    ahatzak@med.uoa.gr

Sponsors and Collaborators

University of Chicago
University of Athens
National Development and Research Institutes, Inc.

Investigators

Principal Investigator: John Schneider, MD, MPH University of Chicago
More Information

More Information


Responsible Party: University of Chicago  
ClinicalTrials.gov Identifier: NCT02676167   History of Changes  
Other Study ID Numbers: IRB15-0327  
Study First Received: January 26, 2016  
Last Updated: May 2, 2017  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by University of Chicago:

HIV prevention
men who have sex with men
pre-exposure prophylaxis
PrEP
Greece
people who inject drugs

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.