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AzTrials

HIVSOPHOCLESNCT02676167

Public Health Targeting of PrEP at HIV Positives' Bridging Networks

A study testing PrEP Intervention in people with HIV, run by University of Chicago at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 39 years, men only
Conditions the study is for
HIV
What is being tested?
PrEP Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
308 participants
Where
1 siteGreece
Study dates
Jan 2017to May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • Angelos Hatzakis

    Athens, 11527

Other trials in Greece

About this study

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.

Read the 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.

Conditions
HIV
Being tested
PrEP Intervention
Keywords
HIV prevention, men who have sex with men, pre-exposure prophylaxis, PrEP, Greece, people who inject drugs
Medical subject headings
Homosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrEP InterventionBehavioural

Study groups in NCT02676167
Study groupRoleWhat they receive
InterventionOtherNot described
Receives: Behavioral: PrEP Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionMay 2019
  4. Study completionMay 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
308 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02676167
Sponsor's protocol ID
IRB15-0327
Acronym
SOPHOCLES
Status last verified
Jan 2020
First submitted
26 Jan 2016
Last updated
9 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing PrEP Intervention in people with HIV, run by University of Chicago at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PrEP prescription within 6 months of referral (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.

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