NCT01152918

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,442

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

4.3 years

First QC Date

June 28, 2010

Last Update Submit

March 28, 2025

Conditions

Keywords

HIV PreventionHIV TreatmentHIV Test and Treat Model of PreventionART for PreventionPrevention for HIV PositivesFinancial IncentivesComputer-delivered risk-reduction counseling

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)

EXPERIMENTAL

Provide financial incentives for linkage to HIV care.

Behavioral: Linkage-to-Care Component: Financial Incentive (FI)

Linkage-to-Care Component: Standard of Care (SOC)

ACTIVE COMPARATOR

Provide the SoC to patients for linkage to HIV care

Behavioral: Linkage-to-Care Component: Standard of Care (SOC)

Viral Suppression Component: FI

EXPERIMENTAL

Provide financial incentives for viral load suppression

Behavioral: Viral Suppression Component: FI

Viral Suppression Component: SOC

ACTIVE COMPARATOR

Provide the SoC to patients for viral load suppression

Behavioral: Viral Suppression Component: SOC

Prevention for Positives Component: Intervention

EXPERIMENTAL

Computerized HIV risk reduction counseling program

Behavioral: Prevention for Positives Component: Counseling and SOC

Prevention for Positives Component: SOC

ACTIVE COMPARATOR

Receive SOC for HIV infection

Behavioral: Prevention for Positives Component: SOC

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.

Linkage-to-Care Component: Financial Incentive (FI)

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.

Linkage-to-Care Component: Standard of Care (SOC)

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: FI

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.

Viral Suppression Component: SOC

Participants will complete a computer-delivered counseling program that emphasizes HIV prevention strategies for HIV-infected people.

Prevention for Positives Component: Intervention

Participants will receive SOC from their HIV care site.

Prevention for Positives Component: SOC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

Bronx clinics

New York, New York, 10453, United States

Location

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: 21406980BACKGROUND
  • 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.

    PMID: 22479154BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 23049660BACKGROUND
  • 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

    BACKGROUND
  • 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

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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)

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Wafaa El-Sadr, MD, MPH

    Columbia University and Harlem Hospital

    STUDY CHAIR
  • Bernard Branson, MD

    Centers for Disease Control and Prevention

    STUDY CHAIR

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

Locations