Efficacy of ART to Interrupt HIV Transmission Networks

NCT02528773 | Completed

• 1 other identifier: 141105
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Network-level efficacy of ART as measured by the number of newly infected persons and network cluster growth over time

  5 Years

Study Arms (1)

HIV positive

Persons newly diagnosed with HIV.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons with newly diagnosed HIV infection

You may qualify if:

• Age ≥18 years of age
• Newly diagnosed HIV infection
• Subject must be able to provide written consent
• Subject must agree to study specific specimen collections and visit schedule.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD AntiViral Research Center

San Diego, California, 92103, United States

Location

Related Links

• AntiViral Research Center website

Biospecimen

Retention: SAMPLES WITH DNA

Blood Draws: Approximately 2 tablespoons (30 mL) of blood will be taken for blood tests and storage at each visit. Participants' blood will be tested for: * CD4+/CD8+ T-cell Count. This is a measure of the immune system; T-cells help the immune system fight infections. * HIV-1 RNA (Viral Load). This measures the amount of HIV in the blood. * HIV pol sequence. This measures the type of HIV in your blood. * Blood will be collected for storage for future HIV testing, studies to measure the amount of residual HIV that remains in people who are doing well on HIV treatment, genetic testing of the HIV virus and possible HLA genotype testing as determined by the results of this and future studies.

Study Officials

• Susan J Little, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: August 19, 2015
• Study Start: September 9, 2014
• Primary Completion: February 14, 2020
• Study Completion: February 14, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

US (1)