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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by HIV Prevention Trials Network
Sponsor:
Collaborator:
Information provided by (Responsible Party):
HIV Prevention Trials Network
ClinicalTrials.gov Identifier:
NCT01152918
First received: June 28, 2010
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

This is a five-part study that will take place in the Bronx, NY, and Washington, D.C. 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.


Condition Intervention
HIV Infection
Behavioral: Linkage-to-Care Component: Financial Incentive (FI)
Behavioral: Linkage-to-Care Component: Standard of Care (SOC)
Behavioral: Viral Suppression Component: FI
Behavioral: Viral Suppression Component: SOC
Behavioral: Prevention for Positives Component: Counseling and SOC
Behavioral: Prevention for Positives Component: SOC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by HIV Prevention Trials Network:

Primary Outcome Measures:
  • Expanded HIV Testing Component: Number and results of HIV tests per month in publicly funded testing sites (local health department data) [ Time Frame: Measured at Month 36 ] [ Designated as safety issue: No ]
  • Expanded HIV Testing Component: Number, transmission category, and testing source of newly identified cases in HIV surveillance data [ Time Frame: Measured at Month 36 ] [ Designated as safety issue: No ]
  • Expanded HIV Testing Component: Initial CD4 cell count of newly identified HIV cases in surveillance data [ Time Frame: Measured at Month 36 ] [ Designated as safety issue: No ]
  • Expanded HIV Testing Component: Number of newly identified HIV cases concomitantly diagnosed with AIDS in surveillance data [ Time Frame: Measured at Month 36 ] [ Designated as safety issue: No ]
  • Expanded HIV Testing Component: Proportion of persons in the community tested for HIV in the last year (local population-based behavioral surveys) [ Time Frame: Measured at Month 36 ] [ Designated as safety issue: No ]
  • Expanded HIV Testing Component: Proportion and number of total ED visits and admissions to hospital where patients receive HIV testing [ Time Frame: Measured at Month 36 ] [ Designated as safety issue: No ]
  • Expanded HIV Testing Component: Number of HIV tests in EDs where HIV infection is newly identified [ Time Frame: Measured at Month 36 ] [ Designated as safety issue: No ]
  • Expanded HIV Testing Component: Number of HIV tests in hospital admissions where patients receive HIV testing [ Time Frame: Measured at Month 36 ] [ Designated as safety issue: No ]
  • Expanded HIV Testing Component: Proportion of hospital admissions who have newly identified HIV infection [ Time Frame: Measured at Month 36 ] [ Designated as safety issue: No ]
  • Expanded HIV Testing Component: Number of tested patients identified with previously diagnosed HIV who are not in care [ Time Frame: Measured at Month 36 ] [ Designated as safety issue: No ]
  • Expanded HIV Testing Component: Cost of support for additional staff and HIV tests [ Time Frame: Measured at Month 36 ] [ Designated as safety issue: No ]
  • Linkage-to-Care Component: Number of individuals eligible for incentives and number of individuals receiving incentives (upon linkage to HIV care) at participating sites [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Linkage-to-Care Component: Cost of the program, including staffing, infrastructure, and incentives [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Viral Suppression Component: Number of individuals eligible for incentives and receiving incentives at a select subset of sites for select time points [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Viral Suppression Component: Cost of program, including staffing, infrastructure, and incentives [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Viral Suppression Component: Number of identified HIV-infected patients in care who have sustained viral suppression [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Prevention for Positives Component: Proportion of participants reporting any unprotected vaginal or anal sex in the previous 3 months [ Time Frame: Measured at Month 12 and 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Measured at Month 12 and 18 ] [ Designated as safety issue: No ]
  • Prevention for Positives Component: Number of sex partners with whom the participant had unprotected sex in the previous 3 months [ Time Frame: Measured at Month 12 and 18 ] [ Designated as safety issue: No ]
  • Prevention for Positives Component: Number of persons with whom the participant shared needles after self use in the previous 3 months [ Time Frame: Measured at Month 12 and 18 ] [ Designated as safety issue: No ]

Estimated Enrollment: 22000
Study Start Date: September 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Linkage-to-Care Component: Financial Incentive (FI)
HIV test sites will provide financial incentives to encourage linkage to HIV care.
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.
Active Comparator: Linkage-to-Care Component: Standard of Care (SOC)
HIV test sites will provide the standard-of-care to their patients for linkage to HIV care.
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.
Experimental: Viral Suppression Component: FI
HIV care sites will provide financial incentives to encourage viral load suppression.
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).
Active Comparator: Viral Suppression Component: SOC
HIV care sites will provide the standard-of-care to their patients for viral load suppression.
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.
Experimental: Prevention for Positives Component: Counseling and SOC
Participants will take part in a computerized HIV risk reduction counseling program and receive SOC for HIV infection.
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.
Active Comparator: Prevention for Positives Component: SOC
Participants will receive SOC for HIV infection.
Behavioral: Prevention for Positives Component: SOC
Participants will receive SOC from their HIV care site.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Expanded HIV Testing Component:

  • People who are permitted to consent for HIV testing according to New York State or Washington, D.C. law
  • Capacity to understand and provide consent for HIV testing
  • Admission to a Bronx, NY or Washington, D.C. emergency department and/or a Bronx, NY or Washington, D.C. hospital

Exclusion Criteria for Expanded HIV Testing Component:

  • Lacks the capacity to provide consent for HIV testing
  • Acute or urgent medical condition that might be adversely affected by the process of obtaining consent or performing HIV test

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

Inclusion Criteria for Patient Surveys 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
  • Participation in the Prevention for Positives component of the study

Exclusion Criteria for Patient Surveys 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

Inclusion Criteria for Provider Surveys Component:

  • Prescribing clinical providers (e.g., physician, nurse practitioner/nurse-midwife, physician assistant) at select HIV care sites
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152918

Locations
United States, District of Columbia
DC clinics Recruiting
Washington, District of Columbia, United States
Contact: Theresa Gamble    919-544-7040    tgamble@fhi360.org   
United States, New York
Bronx clinics Recruiting
New York City, New York, United States
Contact: Theresa Gamble    919-544-7040    tgamble@fhi360.org   
Sponsors and Collaborators
HIV Prevention Trials Network
Investigators
Study Chair: Wafaa El-Sadr, MD, MPH Columbia University and Harlem Hospital
Study Chair: Bernard Branson, MD Centers for Disease Control and Prevention
  More Information

Publications:
Responsible Party: HIV Prevention Trials Network
ClinicalTrials.gov Identifier: NCT01152918     History of Changes
Other Study ID Numbers: HPTN 065, 1U01AI068619
Study First Received: June 28, 2010
Last Updated: March 27, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: HPTN Study Monitoring Committee (SMC)

Keywords provided by HIV Prevention Trials Network:
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 29, 2014