Evaluating Methods to Increase HIV Testing, Access to HIV Care, and HIV Prevention Strategies
NCT ID: NCT01152918
Last Updated: 2025-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18442 participants
INTERVENTIONAL
2010-09-30
2014-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Linkage-to-Care Component: Financial Incentive (FI)
Provide financial incentives for linkage to HIV care.
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.
Linkage-to-Care Component: Standard of Care (SOC)
Provide the SoC to patients for linkage to HIV care
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.
Viral Suppression Component: FI
Provide financial incentives for viral load suppression
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).
Viral Suppression Component: SOC
Provide the SoC to patients for viral load suppression
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.
Prevention for Positives Component: Intervention
Computerized HIV risk reduction counseling program
Prevention for Positives Component: Counseling and SOC
Participants will complete a computer-delivered counseling program that emphasizes HIV prevention strategies for HIV-infected people.
Prevention for Positives Component: SOC
Receive SOC for HIV infection
Prevention for Positives Component: SOC
Participants will receive SOC from their HIV care site.
Interventions
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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.
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.
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).
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.
Prevention for Positives Component: Counseling and SOC
Participants will complete a computer-delivered counseling program that emphasizes HIV prevention strategies for HIV-infected people.
Prevention for Positives Component: SOC
Participants will receive SOC from their HIV care site.
Eligibility Criteria
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Inclusion Criteria
* 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
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.
* 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
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
HIV Prevention Trials Network
NETWORK
Responsible Party
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Principal Investigators
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Wafaa El-Sadr, MD, MPH
Role: STUDY_CHAIR
Columbia University and Harlem Hospital
Bernard Branson, MD
Role: STUDY_CHAIR
Centers for Disease Control and Prevention
Locations
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DC clinics
Washington D.C., District of Columbia, United States
Bronx clinics
New York, New York, United States
Countries
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References
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El-Sadr WM, Affrunti M, Gamble T, Zerbe A. Antiretroviral therapy: a promising HIV prevention strategy? J Acquir Immune Defic Syndr. 2010 Dec;55 Suppl 2(Suppl 2):S116-21. doi: 10.1097/QAI.0b013e3181fbca6e.
London AJ, Borasky DA Jr, Bhan A; Ethics Working Group of the HIV Prevention Trials Network. Improving ethical review of research involving incentives for health promotion. PLoS Med. 2012;9(3):e1001193. doi: 10.1371/journal.pmed.1001193. Epub 2012 Mar 27.
El Sadr W, Branson BM, Donnell DJ; Hall HI, Gamble TR, Farrior JH, Watkins PS, Greene E, Zerbe A, Buchacz K, Kurth A. TLC-Plus (HPTN 065): Test, Link to Care Plus Treat HPTN 065. (Oral Presentation). 2nd International HIV Treatment as Prevention Workshop, Vancouver BC; April 24, 2012
King GM, Sista N, Richards-Clarke C, Turner M, Gamble T, Lucas J. Community Engagement for HPTN 065 (TLC-Plus) study, a community-based study evaluating the feasibility of a combination of interventions to prevent HIV transmission in the US. Poster at the XIX International AIDS Conference, Washington, DC: July 24, 2012. TUPE411.
Donnell DJ, Hall HI, Gamble T, Beauchamp G, Griffin AB, Torian LV, Branson B, El-Sadr WM. Use of HIV case surveillance system to design and evaluate site-randomized interventions in an HIV prevention study: HPTN 065. Open AIDS J. 2012;6:122-30. doi: 10.2174/1874613601206010122. Epub 2012 Sep 7.
Adamson B, Donnell D, Dimitrov D, Garrison L, Beauchamp G, Gamble T, Branson B, El Sadr W. The Cost Effectiveness of the Financial Incentives intervention for Viral Suppression in HPTN 065. Poster 1045 at CROI 2017, Seattle, WA: February 16, 2017, Session P-X4
Greene E, Buchacz K, Gamble T, Beauchamp G, McKinstry L, Wood A, Telzak E, Branson B, El-Sadr W. Linkage-to-Care and ART Adherence Practices at Participating Sites in HPTN 065 (TLC-Plus) Study. Poster at the XIX International AIDS Conference, Washington, DC: July 26, 2012. THPE120
Gray KM, Branson B, Donnell DJ, Beauchamp G, Hu X, Wang Z, El Sadr W, Hall HI. HIV testing in six cities using behavioral surveillance data for the TLC-Plus (HPTN 065) study. Poster at the XIX International AIDS Conference, Washington, DC: July 24, 2012. TUPE293.
Donnell DJ, Hall HI, Beauchamp G, Gray KM, Griffin AB, Brady KA, Meyer J, Benbow N, Torian LV, Branson B, El Sadr W. Assessing viral suppression amongst HIV patients accessing care in five cities using US HIV surveillance data for the TLC-Plus (HPTN 065) study. Poster at the XIX International AIDS Conference, Washington, DC: July 25, 2012. WEPE115.
Greene E, Taylor J, Pack A, Stanton J, Shelus V, Tolley E, D'Angelo L, El-Sadr W, and Gamble T. Understanding of Viral Load among Participants Receiving Financial Incentives for ART Adherence: Findings from a Qualitative Substudy of HPTN 065. Poster at HIV R4P 2014, Cape Town, South Africa: October 29, 2014. A-671-0004-00749. Poster P06.04.
Pack A, Stanton J, Greene E, Taylor J, Shelus V, Tolley EE, Brown ST, El-Sadr W, and Gamble T. Unanticipated Impact of Financial Incentives on HIV Patients and Providers: Findings from a Qualitative Substudy (HPTN 065). Poster at HIV R4P 2014, Cape Town, South Africa: October 29, 2014. A-671-0004-00774. Poster P06.02.
Pack A, Stanton J, Greene E, Taylor J, Shelus V, Tolley E, Rakhmanina N, El-Sadr W, and Gamble T. Acceptability of Financial Incentives for HIV Viral Suppression: A Qualitative Substudy of HPTN 065. Poster at HIV R4P 2014, Cape Town, South Africa: October 29, 2014. A-671-0005-00765, Poster P23.14.
Greene E, Gamble T, Tolley E, Pack A, Stanton J, Taylor J, Shelus V, Leider J, El- Sadr W, and Branson B. The Impact of Implementing a Financial Incentive Program for Viral Suppression on the Clinic Environment: Findings from a Qualitative Substudy of HPTN 065. Poster at HIV R4P 2014, Cape Town, South Africa: October 29, 2014. A-671-0026-00085, Poster P06.03.
Gamble T, Corcoran P, Stanton J, Watkins P, Greene E, Farrior J, Elion R, Amenichi-Enahoro S, and El-Sadr W. Geographic Utilization of Gift Cards Used for Financial Incentives to Encourage Viral Suppression: Findings from HPTN 065. Poster at HIV R4P 2014, Cape Town, South Africa: October 29, 2014. A-671-0030-00852, Poster P52.04.
Kurth AE, Mayer K, Beauchamp G, McKinstry L, Farrior J, Buchacz K, Donnell D, Branson B, El-Sadr W; HPTN (065) TLC-Plus Study Team. Clinician practices and attitudes regarding early antiretroviral therapy in the United States. J Acquir Immune Defic Syndr. 2012 Dec 15;61(5):e65-9. doi: 10.1097/QAI.0b013e31826a184c..
El-Sadr W, Branson B, Hall HI, Beauchamp G, Donnell D, Torian L, Zingman B, Lum G, Elion R, Gamble T. Effect of Financial Incentives on Linkage to Care and Viral Suppression: HPTN 065. Oral presentation at CROI 2015, Seattle, Washington: February 24, 2015. Oral abstract 29, Session O-1.
Buchacz K, Branson B, Farrior J, Beauchamp G, McKinstry L, Donnell D, Kurth A, Zingman B, Gordin F, El-Sadr W. Providers' Attitudes and Practices Related to ART Use for HIV Care and Prevention. Poster at CROI 2015, Seattle, Washington: February 25, 2015. Poster 1095, Session P-Y2.
Chavez P, Buchacz K, Ethridge S, Branson B, Greene E, Gamble T, McKinstry L, Beauchamp G, Connor M, El-Sadr W. Expanding HIV Testing in Hospital Emergency Departments and Inpatient Admissions. Poster 1100 at CROI 2015, Seattle, Washington: February 25, 2015, Session P-Y3.
Greene E, Hanscom B, Gamble T, Buchacz K, Jennings A, Naab T, Belloise R, El-Sadr W, Branson B. Evaluation of Process Indicators for Expanded HIV Testing at Hospitals in HPTN 065. Poster CP63 at NHPC 2015, Atlanta, GA: December 8, 2015, Session B.
Schackman BR, Eggman AA, Leff JA, Braunlin M, Felsen UR, Fitzpatrick L, Telzak EE, El-Sadr W, Branson BM. Costs of Expanded Rapid HIV Testing in Four Emergency Departments. Public Health Rep. 2016 Jan-Feb;131 Suppl 1(Suppl 1):71-81. doi: 10.1177/00333549161310S109.
El-Sadr WM, Kurth A, Farrior J, Buchacz K, Hansom B, McKinstry L, Elion R, Patel V, Donnell D, Branson B. Prevention for HIV-infected Persons in HPTN 065: Room for Improvement. Poster 989 at CROI 2016, Boston, MA: February 24, 2016, Session P-X4.
McKinstry LA, Zerbe A, Hanscom B, Farrior J, Kurth AE, Stanton J, Li M, Elion R, Leider J, Branson B, El-Sadr WM. A Randomized-Controlled Trial of Computer-based Prevention Counseling for HIV-Positive Persons (HPTN 065). J AIDS Clin Res. 2017 Jul;8(7):714. doi: 10.4172/2155-6113.1000714. Epub 2017 Jul 26.
Farrior J, Zerbe A, Kurth A, Hanscom B, McKinstry L, Zingman BS, Gordin F, Donnell D, Branson B, El-Sadr WM. Clinician and Patient Attitudes toward Financial Incentives for HIV care (HPTN 065). Poster 1038 at CROI 2016, Boston, MA: February 25, 2016, Session P-X8.
Beauchamp G, El Sadr W, and Donnell D. A Cluster Randomized Analysis of Site-Level HIV Surveillance Data in HPTN 065 (TLC-Plus) Study. Society of Clinical Trials 2016 (May 15-17, 2016)
Buchacz K, Farrior J, Beauchamp G, McKinstry L, Kurth AE, Zingman BS, Gordin FM, Donnell D, Mayer KH, El-Sadr WM, Branson B; HPTN 065 Study Team. Changing Clinician Practices and Attitudes Regarding the Use of Antiretroviral Therapy for HIV Treatment and Prevention. J Int Assoc Provid AIDS Care. 2017 Jan/Feb;16(1):81-90. doi: 10.1177/2325957416671410. Epub 2016 Oct 5.
Tolley E, Taylor J, Pack A, Greene E, Stanton J, El-Sadr W, and Gamble T. Role of Financial Incentives along the ART Adherence Continuum: A Qualitative Analysis from the HPTN 065 (TLC-Plus) Study. HIV Research for Prevention 2016 (October 17-21, 2016). Chicago, IL. P15.05.
Donnell D, Grey KM, Li J, Wu B, Benbow N, Schuette S, Brady K, Torian L, Xia Q, Callaway BS, Opoku J, Lum G, Meyer J, Hanscom B, Hall I. Encouraging Trends in HIV Diagnoses, Care and Viral Suppression in 5 US Cities, 2009 - 2013: Surveillance-based data from HPTN065 (TLC-Plus). HIV Research for Prevention 2016 (October 17-21, 2016). Chicago, IL. P09.06.
Greene E, Pack A, Stanton J, Shelus V, Tolley EE, Taylor J, El Sadr WM, Branson BM, Leider J, Rakhmanina N, Gamble T. "It Makes You Feel Like Someone Cares" acceptability of a financial incentive intervention for HIV viral suppression in the HPTN 065 (TLC-Plus) study. PLoS One. 2017 Feb 9;12(2):e0170686. doi: 10.1371/journal.pone.0170686. eCollection 2017.
Donnell D. Practical issues in operationalizing the design and outcome evaluation of cluster randomized trials. Clin Trials. 2022 Aug;19(4):407-415. doi: 10.1177/17407745221087465. Epub 2022 Apr 8.
El-Sadr WM, Donnell D, Beauchamp G, Hall HI, Torian LV, Zingman B, Lum G, Kharfen M, Elion R, Leider J, Gordin FM, Elharrar V, Burns D, Zerbe A, Gamble T, Branson B; HPTN 065 Study Team. Financial Incentives for Linkage to Care and Viral Suppression Among HIV-Positive Patients: A Randomized Clinical Trial (HPTN 065). JAMA Intern Med. 2017 Aug 1;177(8):1083-1092. doi: 10.1001/jamainternmed.2017.2158.
Related Links
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TLC-Plus (HPTN 065): Test, Link to Care Plus Treat HPTN 065. (Oral Presentation). 2nd International HIV Treatment as Prevention Workshop, Vancouver BC; April 24, 2012
Linkage-to-Care and ART Adherence Practices at Participating Sites in HPTN 065 (TLC-Plus) Study. Poster at the XIX International AIDS Conference, Washington, DC: July 26, 2012. THPE120
Community Engagement for HPTN 065 study, a community-based study evaluating the feasibility of a combination of interventions to prevent HIV transmission in the US. Poster at the XIX International AIDS Conference, Washington, DC: July 24, 2012.
HIV testing in six cities using behavioral surveillance data for the TLC-Plus (HPTN 065) study. Poster at the XIX International AIDS Conference, Washington, DC: July 24, 2012. TUPE293.
Assessing viral suppression amongst HIV patients accessing care in six cities using US HIV surveillance data for the TLC-Plus (HPTN 065) study. Poster at the XIX International AIDS Conference, Washington, DC: July 25, 2012. WEPE115.
Understanding of Viral Load among Participants Receiving Financial Incentives for ART Adherence: Findings from a Qualitative Substudy of HPTN 065. Poster at HIV R4P 2014, Cape Town, South Africa: October 29, 2014. A-671-0004-00749. Poster P06.04.
Unanticipated Impact of Financial Incentives on HIV Patients and Providers: Findings from a Qualitative Substudy (HPTN 065). Poster at HIV R4P 2014, Cape Town, South Africa: October 29, 2014. A-671-0004-00774. Poster P06.02.
Acceptability of Financial Incentives for HIV Viral Suppression: A Qualitative Substudy of HPTN 065. Poster at HIV R4P 2014, Cape Town, South Africa: October 29, 2014. A-671-0005-00765, Poster P23.14.
The Impact of Implementing a Financial Incentive Program for VS on the Clinic Environment: Findings from a Qualitative Substudy of HPTN 065. Poster at HIV R4P 2014, Cape Town, South Africa: October 29, 2014. A-671-0026-00085, Poster P06.03.
Geographic Utilization of Gift Cards Used for Financial Incentives to Encourage Viral Suppression: Findings from HPTN 065. Poster at HIV R4P 2014, Cape Town, South Africa: October 29, 2014. A-671-0030-00852, Poster P52.04.
Effect of Financial Incentives on Linkage to Care and Viral Suppression: HPTN 065. Oral presentation at CROI 2015, Seattle, Washington: February 24, 2015. Oral abstract 29, Session O-1
Providers' Attitudes and Practices Related to ART Use for HIV Care and Prevention. Poster at CROI 2015, Seattle, Washington: February 25, 2015. Poster 1095, Session P-Y2.
Expanding HIV Testing in Hospital Emergency Departments and Inpatient Admissions. Poster 1100 at CROI 2015, Seattle, Washington: February 25, 2015, Session P-Y3.
Prevention for HIV-infected Persons in HPTN 065: Room for Improvement. Poster 989 at CROI 2016, Boston, MA: February 24, 2016, Session P-X4.
Computer-based Prevention Counseling for HIV-infected Persons (HPTN 065). Poster 997 at CROI 2016, Boston, MA: February 24, 2016, Session P-X4.
Clinician and Patient Attitudes toward Financial Incentives for HIV care (HPTN 065). Poster 1038 at CROI 2016, Boston, MA: February 25, 2016, Session P-X8.
Other Identifiers
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HPTN 065
Identifier Type: -
Identifier Source: org_study_id
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