Transmission Reduction Intervention Project
TRIP
Preventing HIV Transmission by Recently-Infected Drug Users
1 other identifier
interventional
3,000
3 countries
3
Brief Summary
Half or more of HIV transmission events may occur within the period of high infectivity (and often high risk behavior) that can last 11 months or more after a person is initially infected. Unfortunately, neither test-and-treat intervention methods nor Acute HIV Infection projects have found effective ways to intervene against transmission during this risky "recent infection" period. The investigators seek to develop effective intervention techniques against HIV transmission during the recent infection period using a combination of injection-, sexual- and social-network-based contact tracing methods; community alerts in the networks and venues of recent infectees; and the logic of going "up" and "down" infection chains. The investigators first Aim is to develop and evaluate ways to locate "seeds," defined as drug users and other people who have recently been infected. The investigators second Aim targets members of seeds' networks and people who attend their venues. The investigators will test them for acute and for recent infection, and alert them to the probability that their networks contain highly-infectious members so they should reduce their risk and transmission behaviors for the next several months to minimize their chances of getting infected. This may also reduce transmission by untested people with recent infection. Community, network and venue education about the need and value of supporting those with recent infection should reduce stigma. The investigators third Aim is to reduce HIV transmission and to develop new ways to evaluate "prevention for positives" generally as well as The investigators own success in reducing transmission. The investigators will do this using a combination of follow-up interviews and testing, including of viral loads; phylogenetic techniques; and discrete event simulation modeling to assess The investigators effectiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Apr 2013
Longer than P75 for not_applicable hiv
3 active sites
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
March 22, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedApril 7, 2016
April 1, 2016
4.1 years
March 22, 2013
April 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in estimated HIV transmission
Using phylogenetic techniques and network-based simulation modeling, teh investigators will analyze whether transmission of HIV got reduced in the city (or its key populations) as a whole. Phylogenetic analysis is not limited to study participants.
The investigators will evaluate this 1, 2, 3 & 4 years after recruitment begins
Secondary Outcomes (1)
Numbers of people with recent and acute HIV infection enrolled into the study and then intervened with
The investigators will evaluate this 1 year, 2 years, 3 years and 4 years after recruitment starts
Other Outcomes (1)
Transmission behaviors among people with recent or acute HIV infection
from intake to intended-6 month follow up
Study Arms (3)
Primary Recent infection network tracing
EXPERIMENTALSubjects: LAg+ recent HIV infection testees \& referrals with recent/acute infection; those in social/risk networks of index subjects; people who go to their venues. We'll network trace direct contacts of Index Cases \& network/venue members of contacts; and maybe 3rd ring as exploratory part of project. We'll test network/venue members for recent \& acute HIV. If they have recent/acute HIV infection, their network/venue contacts will be traced. We'll refer HIV+ Primary arm participants for medical/social evaluation and treatment; those with recent/acute infection on expedited scheduling and case management. We will distribute "community alerts" to warn people in the social environments of recent/acute infectees to be super-careful in their behaviors for the next 6 months; to tell them how to be safer; and to repeat the importance of assisting rather than stigmatizing anyone they suspect has recently become infected.
Contact tracing of long-term HIV+ people
ACTIVE COMPARATORWe will start with 50 subjects in each city who test HIV+ but LAg negative-and who report they have just learned they are HIV+. We will recruit their sexual and injection partners, and other risk environment contacts, for two steps, as in Primary Arm. HIV+ will be referred for treatment; recent/acutes on expedited and assisted basis.
HIV negative comparison arm
ACTIVE COMPARATORThis comparison arm will consist of 150 uninfected people in each city whom we screen in the course of testing. The key comparisons here are on two of the central variables: adverse/supportive events and behavior change. This comparison arm will help mitigate social desirability effects that can lead to inaccurate reporting and/or Hawthorne effects and related processes that can lead to behavior changes simply based on the interview. Participants in this arm will be matched on age (within five years), risk group, and gender with an Arm 1 member.
Interventions
May vary across sites
This will be expedited and assisted via community outreach for Recents and Acutes
This is described in Arms 1 and 2
When we find recently or acutely infected participants, we will issue community alerts as described in Arm descriptions
Throughout the study we will educate affected communities about recent and acute HIV infection and about the importance of avoiding stigma
As part of HIV testing, we will provide participants with standard counseling
Eligibility Criteria
You may qualify if:
- Must be able to answer questionnaire and qualify for one of the Arms
You may not qualify if:
- Inability to answer questionnaire
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
NORC
Chicago, Illinois, 60637, United States
Hellenic Scientific Society for the Study of AIDS and STDs
Athens, Greece
International HIV/AIDS Alliance Ukraine
Odesa, 65020, Ukraine
Related Publications (2)
Giallouros G, Pantavou K, Pampaka D, Pavlitina E, Piovani D, Bonovas S, Nikolopoulos GK. Drug Injection-Related and Sexual Behavior Changes in Drug Injecting Networks after the Transmission Reduction Intervention Project (TRIP): A Social Network-Based Study in Athens, Greece. Int J Environ Res Public Health. 2021 Mar 1;18(5):2388. doi: 10.3390/ijerph18052388.
PMID: 33804500DERIVEDSmyrnov P, Williams LD, Korobchuk A, Sazonova Y, Nikolopoulos GK, Skaathun B, Morgan E, Schneider J, Vasylyeva TI, Friedman SR. Risk network approaches to locating undiagnosed HIV cases in Odessa, Ukraine. J Int AIDS Soc. 2018 Jan;21(1):e25040. doi: 10.1002/jia2.25040.
PMID: 29356365DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel R Friedman, PhD
National Development and Research Institutes, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2013
First Posted
April 9, 2013
Study Start
April 1, 2013
Primary Completion
May 1, 2017
Study Completion
July 1, 2017
Last Updated
April 7, 2016
Record last verified: 2016-04