Transmission Reduction Intervention Project (TRIP)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier:
NCT01827228
First received: March 22, 2013
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
HIV
Other: Assays
Other: HIV medical care
Other: Social network and venue tracing
Other: Community alerts
Other: Community education
Behavioral: HIV counseling

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preventing HIV Transmission by Recently-Infected Drug Users

Resource links provided by NLM:


Further study details as provided by National Development and Research Institutes, Inc.:

Primary Outcome Measures:
  • Reduction in estimated HIV transmission [ Time Frame: The investigators will evaluate this 1, 2, 3 & 4 years after recruitment begins ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Numbers of people with recent and acute HIV infection enrolled into the study and then intervened with [ Time Frame: The investigators will evaluate this 1 year, 2 years, 3 years and 4 years after recruitment starts ] [ Designated as safety issue: No ]
    Comparison will be of numbers in the intervention group as compared with the numbers enrolled and intervened with in a comparison arm where index cases will be non-recent HIV positives. This is a measure of our success in enrolling recently and acutely infected people; and then additional records over the duration of the study of how well we did in getting them into and keeping them into treatment.


Other Outcome Measures:
  • Transmission behaviors among people with recent or acute HIV infection [ Time Frame: from intake to intended-6 month follow up ] [ Designated as safety issue: No ]
    This is an exploratory and developmental study, so the investigators will be using a range of risk behaviors and metrics on risk behaviors as outcome variables. The behaviors include numbers of female and male partners of various categories, condom use with each category; use of drugs before or during sex; group sex behaviors; and a range of injection drug use behaviors and partnership characteristics for those who inject drugs.


Estimated Enrollment: 3000
Study Start Date: April 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Primary Recent infection network tracing
Subjects: 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.
Other: Assays
May vary across sites
Other Names:
  • Sedia Limited Avidity Assay
  • HIV antibody tests
  • HIV RNA testing
Other: HIV medical care
This will be expedited and assisted via community outreach for Recents and Acutes
Other Names:
  • Treatment for HIV to reduce viral load and to improve health
  • Treatment as prevention
Other: Social network and venue tracing
This is described in Arms 1 and 2
Other Name: This is described in Arms 1 and 2
Other: Community alerts
When we find recently or acutely infected participants, we will issue community alerts as described in Arm descriptions
Other: Community education
Throughout the study we will educate affected communities about recent and acute HIV infection and about the importance of avoiding stigma
Behavioral: HIV counseling
As part of HIV testing, we will provide participants with standard counseling
Active Comparator: Contact tracing of long-term HIV+ people
We 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.
Other: Assays
May vary across sites
Other Names:
  • Sedia Limited Avidity Assay
  • HIV antibody tests
  • HIV RNA testing
Other: HIV medical care
This will be expedited and assisted via community outreach for Recents and Acutes
Other Names:
  • Treatment for HIV to reduce viral load and to improve health
  • Treatment as prevention
Other: Social network and venue tracing
This is described in Arms 1 and 2
Other Name: This is described in Arms 1 and 2
Other: Community alerts
When we find recently or acutely infected participants, we will issue community alerts as described in Arm descriptions
Other: Community education
Throughout the study we will educate affected communities about recent and acute HIV infection and about the importance of avoiding stigma
Behavioral: HIV counseling
As part of HIV testing, we will provide participants with standard counseling
Active Comparator: HIV negative comparison arm
This 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.
Other: Assays
May vary across sites
Other Names:
  • Sedia Limited Avidity Assay
  • HIV antibody tests
  • HIV RNA testing
Other: Community alerts
When we find recently or acutely infected participants, we will issue community alerts as described in Arm descriptions
Other: Community education
Throughout the study we will educate affected communities about recent and acute HIV infection and about the importance of avoiding stigma
Behavioral: HIV counseling
As part of HIV testing, we will provide participants with standard counseling

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be able to answer questionnaire and qualify for one of the Arms

Exclusion Criteria:

  • Inability to answer questionnaire
  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: NCT01827228

Locations
United States, Illinois
NORC
Chicago, Illinois, United States, 60637
Greece
Hellenic Scientific Society for the Study of AIDS and STDs
Athens, Greece
Ukraine
International HIV/AIDS Alliance Ukraine
Odessa, Ukraine, 65020
Sponsors and Collaborators
National Development and Research Institutes, Inc.
Investigators
Principal Investigator: Samuel R Friedman, PhD National Development and Research Institutes, Inc.
  More Information

No publications provided

Responsible Party: National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier: NCT01827228     History of Changes
Other Study ID Numbers: DP1 DA034989
Study First Received: March 22, 2013
Last Updated: December 17, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board
Ukraine: Institutional Review Board
Greece: Institutional Review Board of Hellenic Scientific Society for the Study of AIDS and STDs

Keywords provided by National Development and Research Institutes, Inc.:
HIV
transmission prevention
social network and venue
community intervention
treatment as prevention
recent infection
phylogenetics
infection chains

ClinicalTrials.gov processed this record on September 22, 2014