Evaluating Methods to Increase HIV Testing, Access to HIV Care, and HIV Prevention Strategies
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
2 other identifiers
interventional
18,442
1 country
2
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.)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2010
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 29, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 1, 2025
March 1, 2025
4.3 years
June 28, 2010
March 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (21)
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 Outcomes (3)
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
Study Arms (6)
Linkage-to-Care Component: Financial Incentive (FI)
EXPERIMENTALProvide financial incentives for linkage to HIV care.
Linkage-to-Care Component: Standard of Care (SOC)
ACTIVE COMPARATORProvide the SoC to patients for linkage to HIV care
Viral Suppression Component: FI
EXPERIMENTALProvide financial incentives for viral load suppression
Viral Suppression Component: SOC
ACTIVE COMPARATORProvide the SoC to patients for viral load suppression
Prevention for Positives Component: Intervention
EXPERIMENTALComputerized HIV risk reduction counseling program
Prevention for Positives Component: SOC
ACTIVE COMPARATORReceive SOC for HIV infection
Interventions
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.
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.
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).
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.
Participants will complete a computer-delivered counseling program that emphasizes HIV prevention strategies for HIV-infected people.
Participants will receive SOC from their HIV care site.
Eligibility Criteria
You may not qualify if:
- 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
- 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.
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
DC clinics
Washington D.C., District of Columbia, 20007, United States
Bronx clinics
New York, New York, 10453, United States
Related Publications (30)
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.
PMID: 21406980BACKGROUNDLondon 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.
PMID: 22479154BACKGROUNDEl 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
BACKGROUNDKing 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.
BACKGROUNDDonnell 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.
PMID: 23049660BACKGROUNDAdamson 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
BACKGROUNDGreene 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
RESULTGray 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.
RESULTDonnell 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.
RESULTGreene 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.
RESULTPack 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.
RESULTPack 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.
RESULTGreene 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.
RESULTGamble 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.
RESULTKurth 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..
PMID: 23183150RESULTEl-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.
RESULTBuchacz 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.
RESULTChavez 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.
RESULTGreene 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.
RESULTSchackman 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.
PMID: 26862232RESULTEl-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.
RESULTMcKinstry 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.
PMID: 28966842RESULTFarrior 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.
RESULTBeauchamp 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)
RESULTBuchacz 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.
PMID: 27708115RESULTTolley 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.
RESULTDonnell 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.
RESULTGreene 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.
PMID: 28182706RESULTDonnell 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.
PMID: 35393864DERIVEDEl-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.
PMID: 28628702DERIVED
Related Links
- 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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wafaa El-Sadr, MD, MPH
Columbia University and Harlem Hospital
- STUDY CHAIR
Bernard Branson, MD
Centers for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2010
First Posted
June 29, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
April 1, 2025
Record last verified: 2025-03