Clinical trial NCT01152918: Evaluating Methods to Increase HIV Testing, Access to HIV Care, and HIV Prevention Strategies
Official title: TLC-Plus: A Study to Evaluate the Feasibility of an Enhanced Test, Link to Care, Plus Treat Approach for HIV Prevention in the United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Keywords: HIV Prevention
HIV Treatment
HIV Test and Treat Model of Prevention
ART for Prevention
Prevention for HIV Positives
Financial Incentives
Computer-delivered risk-reduction counseling
Lead sponsor: HIV Prevention Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2010-06-29
Enrollment: 18442
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.)

Detailed description: The five components of the study include the following:

Expanded HIV Testing: The purpose of this part of the study is to increase the number of people being tested for HIV. In select study sites in the Bronx, NY, and Washington, D.C., HIV testing will be expanded in emergency departments (EDs) and upon hospital admission. The study will provide additional resources to expand outreach and marketing efforts in these communities. This part of the study will take place over 36 months.

Linkage-to-Care: This part of the study will take place over a 24-month period. The purpose is to compare the effectiveness of a financial incentive (FI) program to link HIV-infected people from HIV test sites to HIV care sites versus standard of care (SOC). Each HIV test site will be randomly assigned to either the FI program or SOC. At the FI sites, people who receive an HIV positive test result will receive a coupon that can be redeemed for gift cards at participating HIV care sites.

Viral Suppression: This part of the study will assess the effectiveness of an FI program at helping HIV-infected people achieve and maintain a viral load of less than 400 copies/mL compared to SOC. Each HIV care site will be randomly assigned to either the FI program or SOC. At the FI sites, HIV-infected people will receive gift cards if their viral load remains below 400 copies/mL. People are eligible to receive FIs once every 3 months throughout the 24-month study period.

Prevention for Positives: The purpose of this component of the study is to evaluate the effectiveness of a computer-delivered counseling program that focuses on HIV risk reduction behaviors for HIV-infected people. Participants will be randomly assigned to the counseling program and SOC or SOC alone. All participants will answer questions on the computer about HIV testing and care at baseline and Months 3, 6, 9, 12, and 18. Study researchers will review participants' medical records at study entry and every 3 months up to Month 18.

Survey of Patients and Providers: Participants in the Prevention for Positives component of the study will complete a computerized survey at the baseline and Month 12 visit, which will assess knowledge and attitudes about ART. Health care providers at the HIV care sites will complete Web-based surveys before and after the Viral Suppression component of the study.

Eligibility criteria: Inclusion/Exclusion Criteria for Linkage-to-Care Component:

The Linkage-to-Care component of the study will include all individuals ages 12 and older who are permitted to consent, or can be consented for HIV care by a parent/legal guardian according to New York State or Washington, D.C. law, and who are newly found to be HIV-positive at HIV test sites participating in the study. This study component will also include individuals who have been previously diagnosed with HIV but have been out of care for at least a year and are reconfirmed for HIV infection by standard laboratory tests

Inclusion/Exclusion Criteria for Viral Suppression Component:

The study population for the viral suppression component of the study will include all individuals ages 12 and older who are permitted to consent, or can be consented for HIV care by a parent/legal guardian according to New York State or Washington, D.C. law, who have initiated care at participating HIV care sites.

Inclusion Criteria for Prevention for Positives Component:

* All people who are permitted to consent for HIV care according to New York State or Washington, D.C. law
* Receiving care at the selected HIV care sites in the Bronx or Washington, D.C.
* Have attended the clinic one or more times in the 7 months before study entry
* Able to understand either spoken English or Spanish
* Able and willing to provide informed consent
* Participants enrolled into the Prevention for Positives component of the study will participate in the Patient Survey Component

Exclusion Criteria for Prevention for Positives Component:

* Not seen in the clinic in the 7 months before study entry
* History or evidence of altered mentation, inebriation, or substance use that would interfere with participation in the study
* Unable or unwilling to provide informed consent
* Participation in another study focusing on HIV prevention for positives

Primary outcomes:
measure: Expanded HIV Testing Component: Number and results of HIV tests per month in publicly funded testing sites (local health department data)
timeFrame: Measured at Month 36
measure: Expanded HIV Testing Component: Number, transmission category, and testing source of newly identified cases in HIV surveillance data
timeFrame: Measured at Month 36
measure: Expanded HIV Testing Component: Initial CD4 cell count of newly identified HIV cases in surveillance data
timeFrame: Measured at Month 36
measure: Expanded HIV Testing Component: Number of newly identified HIV cases concomitantly diagnosed with AIDS in surveillance data
timeFrame: Measured at Month 36
measure: Expanded HIV Testing Component: Proportion of persons in the community tested for HIV in the last year (local population-based behavioral surveys)
timeFrame: Measured at Month 36
measure: Expanded HIV Testing Component: Proportion and number of total ED visits and admissions to hospital where patients receive HIV testing
timeFrame: Measured at Month 36
measure: Expanded HIV Testing Component: Number of HIV tests in EDs where HIV infection is newly identified
timeFrame: Measured at Month 36
measure: Expanded HIV Testing Component: Number of HIV tests in hospital admissions where patients receive HIV testing
timeFrame: Measured at Month 36
measure: Expanded HIV Testing Component: Proportion of hospital admissions who have newly identified HIV infection
timeFrame: Measured at Month 36
measure: Expanded HIV Testing Component: Number of tested patients identified with previously diagnosed HIV who are not in care
timeFrame: Measured at Month 36
measure: Expanded HIV Testing Component: Cost of support for additional staff and HIV tests
timeFrame: Measured at Month 36
measure: Linkage-to-Care Component: Number of individuals eligible for incentives and number of individuals receiving incentives (upon linkage to HIV care) at participating sites
timeFrame: Measured at Month 24
measure: Linkage-to-Care Component: Cost of the program, including staffing, infrastructure, and incentives
timeFrame: Measured at Month 24
measure: Linkage-to-Care Component: Proportion of HIV-infected people at each site with newly detected HIV infection or who were previously diagnosed but were out of care, and who are presently linked to care
timeFrame: Measured at Month 24
measure: Linkage-to-Care Component: Mean time interval at each site from HIV diagnosis (Western Blot confirmation) to first CD4 cell count or viral load for those with newly detected HIV infection and those who were previously diagnosed but were out of care
timeFrame: Measured at Month 24
measure: Linkage-to-Care Component: Proportion of HIV-infected people at a testing site with at least two CD4 cell count and viral load measurements in the prior year
timeFrame: Measured at Month 24
measure: Viral Suppression Component: Number of individuals eligible for incentives and receiving incentives at a select subset of sites for select time points
timeFrame: Measured at Month 24
measure: Viral Suppression Component: Cost of program, including staffing, infrastructure, and incentives
timeFrame: Measured at Month 24
measure: Viral Suppression Component: Probability of an HIV-infected patient in care at a site having a suppressed viral load (less than 400 copies/mL) in the 12-month calendar assessment period beginning 12 months after initiation of the assessment period
timeFrame: Measured at Month 24
measure: Viral Suppression Component: Number of identified HIV-infected patients in care who have sustained viral suppression
timeFrame: Measured at Month 24
measure: Prevention for Positives Component: Proportion of participants reporting any unprotected vaginal or anal sex in the previous 3 months
timeFrame: Measured at Month 12 and 18
Secondary outcomes:
measure: Prevention for Positives Component: Number of sex partners of discordant or unknown HIV status with whom participant had unprotected vaginal or anal sex in the previous 3 months
timeFrame: Measured at Month 12 and 18
measure: Prevention for Positives Component: Number of sex partners with whom the participant had unprotected sex in the previous 3 months
timeFrame: Measured at Month 12 and 18
measure: Prevention for Positives Component: Number of persons with whom the participant shared needles after self use in the previous 3 months
timeFrame: Measured at Month 12 and 18
Other outcomes:
Locations:
city: Washington
country: United States
facility: DC clinics
state: District of Columbia
city: New York
country: United States
facility: Bronx clinics
state: New York
Study officials:
affiliation: Columbia University and Harlem Hospital
name: Wafaa El-Sadr, MD, MPH
role: STUDY_CHAIR
affiliation: Centers for Disease Control and Prevention
name: Bernard Branson, MD
role: STUDY_CHAIR
References:
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