- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02528773
Efficacy of ART to Interrupt HIV Transmission Networks (ART-NET)
November 2, 2020 updated by: Susan Little, MD, University of California, San Diego
The investigators are conducting a study to learn more about the spread of HIV infection within different geographic regions and populations in San Diego County, with the goal of demonstrating that early use of HIV treatment can reduce the number of new infections in our community.
At the study visits, participants will be examined by the study staff and asked to donate some blood.
Participants will also be asked several questions about themselves, their background, behaviors, health, and the general geographic area in which they live.
By collecting information about antiretroviral treatment choices that are made by study participants, the investigators will be better able to measure how effectively HIV treatment can interrupt (i.e., block) the spread of HIV.
All of the information gathered at the study visits will be de-identified and analyzed.
Study staff will use the information to better understand in which groups of people, and in what areas of San Diego, HIV is spreading most quickly.
This information will be used to determine how well Antiretroviral Therapy (HIV treatment) by certain individuals can control the spread of HIV within the population.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
256
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92103
- UCSD Antiviral Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Persons with newly diagnosed HIV infection
Description
Inclusion Criteria:
- Age ≥18 years of age
- Newly diagnosed HIV infection
- ART naïve (≤7 days ART, previous use of PEP or PrEP are not exclusions)
- Subject must be able to provide written consent
- Subject must agree to study specific specimen collections and visit schedule.
- Subjects with newly diagnosed HIV infection who were identified on or after May 1, 2014 will be eligible for enrollment as long as they are co-enrolled to either AEH020 (project 08-0278) or AEH030 (project 140093) and DID meet the above study inclusion criteria (items at the time of enrollment to protocols AEH020 or AEH030).
Exclusion Criteria:
- Any factor or factors that in the opinion of the local investigator that could prevent compliance with study requirements.
- Contraindication to phlebotomy or specimen collection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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HIV positive
Persons newly diagnosed with HIV.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Network-level efficacy of ART as measured by the number of newly infected persons and network cluster growth over time
Time Frame: 5 Years
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5 Years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Susan J Little, MD, UCSD
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 9, 2014
Primary Completion (Actual)
February 14, 2020
Study Completion (Actual)
February 14, 2020
Study Registration Dates
First Submitted
May 13, 2015
First Submitted That Met QC Criteria
August 17, 2015
First Posted (Estimate)
August 19, 2015
Study Record Updates
Last Update Posted (Actual)
November 4, 2020
Last Update Submitted That Met QC Criteria
November 2, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 141105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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