HIVART-NETNCT02528773
Efficacy of ART to Interrupt HIV Transmission Networks
An observational study of HIV, run by University of California, San Diego at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2014to 14 Feb 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with newly diagnosed HIV infection
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD AntiViral Research Center
San Diego, California, 92103
About this study
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.
- Conditions
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV positive | Persons newly diagnosed with HIV. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Network-level efficacy of ART as measured by the number of newly infected persons and network cluster growth over time
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study start9 Sep 2014
- Primary completion14 Feb 2020
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Little, MD, University of California, San Diego
- Investigators
- Susan J Little, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528773
- Sponsor's protocol ID
- 141105
- Acronym
- ART-NET
- Status last verified
- Nov 2020
- First submitted
- 13 May 2015
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of ART to Interrupt HIV Transmission Networks
- ClinicalTrials.gov ID
- NCT02528773
- Acronym / sponsor ID
- ART-NET / 141105
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 9 Sep 2014 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV positive | – | –Persons newly diagnosed with HIV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with newly diagnosed HIV infection
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Network-level efficacy of ART as measured by the number of newly infected persons and network cluster growth over time
Time frame: 5 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- AntiViral Research Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan J Little, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University of California, San Diego at 1 site in United States.
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 6 inclusion and 2 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 4 Nov 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 United States. 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?
Network-level efficacy of ART as measured by the number of newly infected persons and network cluster growth over time (time frame: 5 Years). 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 4 Nov 2020.