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

• 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 ]
  

• 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 ]
  

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.