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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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HIV Infection

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Linkage-to-Care Component: Financial Incentive (FI)<br>HIV test sites will provide financial incentives to encourage linkage to HIV care. | Behavioral: Linkage-to-Care Component: Financial Incentive (FI)<br>* 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.<br>|
| Active Comparator: Linkage-to-Care Component: Standard of Care (SOC)<br>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)<br>* 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.<br>|
| Experimental: Viral Suppression Component: FI<br>HIV care sites will provide financial incentives to encourage viral load suppression. | Behavioral: Viral Suppression Component: FI<br>* 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).<br>|
| Active Comparator: Viral Suppression Component: SOC<br>HIV care sites will provide the standard-of-care to their patients for viral load suppression. | Behavioral: Viral Suppression Component: SOC<br>* 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.<br>|
| Experimental: Prevention for Positives Component: Counseling and SOC<br>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<br>* Participants will complete a computer-delivered counseling program that emphasizes HIV prevention strategies for HIV-infected people.<br>|
| Active Comparator: Prevention for Positives Component: SOC<br>Participants will receive SOC for HIV infection. | Behavioral: Prevention for Positives Component: SOC<br>* Participants will receive SOC from their HIV care site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expanded HIV Testing Component: Number and results of HIV tests per month in publicly funded testing sites (local health department data) |  | Measured at Month 36 | 
| Expanded HIV Testing Component: Number, transmission category, and testing source of newly identified cases in HIV surveillance data |  | Measured at Month 36 | 
| Expanded HIV Testing Component: Initial CD4 cell count of newly identified HIV cases in surveillance data |  | Measured at Month 36 | 
| Expanded HIV Testing Component: Number of newly identified HIV cases concomitantly diagnosed with AIDS in surveillance data |  | Measured at Month 36 | 
| Expanded HIV Testing Component: Proportion of persons in the community tested for HIV in the last year (local population-based behavioral surveys) |  | Measured at Month 36 | 
| Expanded HIV Testing Component: Proportion and number of total ED visits and admissions to hospital where patients receive HIV testing |  | Measured at Month 36 | 
| Expanded HIV Testing Component: Number of HIV tests in EDs where HIV infection is newly identified |  | Measured at Month 36 | 
| Expanded HIV Testing Component: Number of HIV tests in hospital admissions where patients receive HIV testing |  | Measured at Month 36 | 
| Expanded HIV Testing Component: Proportion of hospital admissions who have newly identified HIV infection |  | Measured at Month 36 | 
| Expanded HIV Testing Component: Number of tested patients identified with previously diagnosed HIV who are not in care |  | Measured at Month 36 | 
| Expanded HIV Testing Component: Cost of support for additional staff and HIV tests |  | Measured at Month 36 | 
| Linkage-to-Care Component: Number of individuals eligible for incentives and number of individuals receiving incentives (upon linkage to HIV care) at participating sites |  | Measured at Month 24 | 
| Linkage-to-Care Component: Cost of the program, including staffing, infrastructure, and incentives |  | Measured at Month 24 | 
| 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 |  | Measured at Month 24 | 
| 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 |  | Measured at Month 24 | 
| 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 |  | Measured at Month 24 | 
| Viral Suppression Component: Number of individuals eligible for incentives and receiving incentives at a select subset of sites for select time points |  | Measured at Month 24 | 
| Viral Suppression Component: Cost of program, including staffing, infrastructure, and incentives |  | Measured at Month 24 | 
| 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 |  | Measured at Month 24 | 
| Viral Suppression Component: Number of identified HIV-infected patients in care who have sustained viral suppression |  | Measured at Month 24 | 
| Prevention for Positives Component: Proportion of participants reporting any unprotected vaginal or anal sex in the previous 3 months |  | Measured at Month 12 and 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Measured at Month 12 and 18 | 
| Prevention for Positives Component: Number of sex partners with whom the participant had unprotected sex in the previous 3 months |  | Measured at Month 12 and 18 | 
| Prevention for Positives Component: Number of persons with whom the participant shared needles after self use in the previous 3 months |  | Measured at Month 12 and 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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