Evaluating Methods to Increase HIV Testing, Access to HIV Care, and HIV Prevention Strategies

Summary

This is a five-part study that will take place in the Bronx, New York (NY), and Washington, District of Columbia (DC). The different components of the study will focus on increasing the number of people being tested for HIV, evaluating ways to link HIV-infected people to HIV care sites, evaluating methods to reinforce antiretroviral therapy (ART) adherence, and evaluating a counseling program that focuses on HIV prevention. (Details for only three components of this study are included in ClinicalTrials.gov (Linkage-to-Care, Viral Suppression and Prevention for Positives) because they are the only ones that were randomized and had prescriptive interventions.)

Conditions

• HIV Infection

Interventions

BEHAVIORAL

Linkage-to-Care Component: Financial Incentive (FI)

Test sites assigned to this arm will provide coupons to all people who are found to be HIV-infected after testing and who are not already linked to HIV care. The coupons can be redeemed at a participating HIV care site for gift cards.

BEHAVIORAL

Linkage-to-Care Component: Standard of Care (SOC)

Each person who receives an HIV positive test result, and is not currently in care, will be directed to HIV care sites using the site's SOC procedures.

BEHAVIORAL

Viral Suppression Component: FI

HIV-infected participants who are receiving ART will be offered FIs upon the confirmation of each suppressed viral load measurement (less than 400 copies/mL).

BEHAVIORAL

Viral Suppression Component: SOC

HIV-infected participants who are receiving ART will be offered support via the site's SOC procedures to attend HIV care site visits and remain adherent to their ART regimen in order to achieve and maintain viral load suppression.

BEHAVIORAL

Prevention for Positives Component: Counseling and SOC

Participants will complete a computer-delivered counseling program that emphasizes HIV prevention strategies for HIV-infected people.

BEHAVIORAL

Prevention for Positives Component: SOC

Participants will receive SOC from their HIV care site.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• HIV Prevention Trials Network

  lead NETWORK

Principal Investigators

• Wafaa El-Sadr, MD, MPH · Columbia University and Harlem Hospital

• Bernard Branson, MD · Centers for Disease Control and Prevention

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-09-30

Primary Completion

2014-12-31

Completion

2014-12-31

Countries

• United States

Study Locations