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

Primary Purpose

HIV Infection

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

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

Viral Suppression Component: FI

Viral Suppression Component: SOC

Prevention for Positives Component: Counseling and SOC

Prevention for Positives Component: SOC

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

DC clinics
Bronx clinics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

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

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

Viral Suppression Component: FI

Viral Suppression Component: SOC

Prevention for Positives Component: Counseling and SOC

Prevention for Positives Component: SOC

Arm Description

HIV test sites will provide financial incentives to encourage linkage to HIV care.

HIV test sites will provide the standard-of-care to their patients for linkage to HIV care.

HIV care sites will provide financial incentives to encourage viral load suppression.

HIV care sites will provide the standard-of-care to their patients for viral load suppression.

Participants will take part in a computerized HIV risk reduction counseling program and receive SOC for HIV infection.

Participants will receive SOC for HIV infection.

Outcomes

Primary Outcome Measures

Expanded HIV Testing Component: Number and results of HIV tests per month in publicly funded testing sites (local health department data)

Expanded HIV Testing Component: Number, transmission category, and testing source of newly identified cases in HIV surveillance data

Expanded HIV Testing Component: Initial CD4 cell count of newly identified HIV cases in surveillance data

Expanded HIV Testing Component: Number of newly identified HIV cases concomitantly diagnosed with AIDS in surveillance data

Expanded HIV Testing Component: Proportion of persons in the community tested for HIV in the last year (local population-based behavioral surveys)

Expanded HIV Testing Component: Proportion and number of total ED visits and admissions to hospital where patients receive HIV testing

Expanded HIV Testing Component: Number of HIV tests in EDs where HIV infection is newly identified

Expanded HIV Testing Component: Number of HIV tests in hospital admissions where patients receive HIV testing

Expanded HIV Testing Component: Proportion of hospital admissions who have newly identified HIV infection

Expanded HIV Testing Component: Number of tested patients identified with previously diagnosed HIV who are not in care

Expanded HIV Testing Component: Cost of support for additional staff and HIV tests

Linkage-to-Care Component: Number of individuals eligible for incentives and number of individuals receiving incentives (upon linkage to HIV care) at participating sites

Linkage-to-Care Component: Cost of the program, including staffing, infrastructure, and incentives

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

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

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

Viral Suppression Component: Number of individuals eligible for incentives and receiving incentives at a select subset of sites for select time points

Viral Suppression Component: Cost of program, including staffing, infrastructure, and incentives

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

Viral Suppression Component: Number of identified HIV-infected patients in care who have sustained viral suppression

Prevention for Positives Component: Proportion of participants reporting any unprotected vaginal or anal sex in the previous 3 months

Secondary Outcome Measures

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

Prevention for Positives Component: Number of sex partners with whom the participant had unprotected sex in the previous 3 months

Prevention for Positives Component: Number of persons with whom the participant shared needles after self use in the previous 3 months

Full Information

NCT ID

NCT01152918

First Posted

June 28, 2010

Last Updated

April 24, 2017

Sponsor

HIV Prevention Trials Network

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT01152918

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HIV Prevention Trials Network

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infection

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

299038 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

HIV test sites will provide financial incentives to encourage linkage to HIV care.

Arm Title

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

Arm Type

Active Comparator

Arm Description

HIV test sites will provide the standard-of-care to their patients for linkage to HIV care.

Arm Title

Viral Suppression Component: FI

Arm Type

Experimental

Arm Description

HIV care sites will provide financial incentives to encourage viral load suppression.

Arm Title

Viral Suppression Component: SOC

Arm Type

Active Comparator

Arm Description

HIV care sites will provide the standard-of-care to their patients for viral load suppression.

Arm Title

Prevention for Positives Component: Counseling and SOC

Arm Type

Experimental

Arm Description

Participants will take part in a computerized HIV risk reduction counseling program and receive SOC for HIV infection.

Arm Title

Prevention for Positives Component: SOC

Arm Type

Active Comparator

Arm Description

Participants will receive SOC for HIV infection.

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Viral Suppression Component: FI

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Viral Suppression Component: SOC

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Prevention for Positives Component: Counseling and SOC

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Prevention for Positives Component: SOC

Intervention Description

Participants will receive SOC from their HIV care site.

Primary Outcome Measure Information:

Title

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

Title

Expanded HIV Testing Component: Number, transmission category, and testing source of newly identified cases in HIV surveillance data

Time Frame

Measured at Month 36

Title

Expanded HIV Testing Component: Initial CD4 cell count of newly identified HIV cases in surveillance data

Time Frame

Measured at Month 36

Title

Expanded HIV Testing Component: Number of newly identified HIV cases concomitantly diagnosed with AIDS in surveillance data

Time Frame

Measured at Month 36

Title

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

Title

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

Title

Expanded HIV Testing Component: Number of HIV tests in EDs where HIV infection is newly identified

Time Frame

Measured at Month 36

Title

Expanded HIV Testing Component: Number of HIV tests in hospital admissions where patients receive HIV testing

Time Frame

Measured at Month 36

Title

Expanded HIV Testing Component: Proportion of hospital admissions who have newly identified HIV infection

Time Frame

Measured at Month 36

Title

Expanded HIV Testing Component: Number of tested patients identified with previously diagnosed HIV who are not in care

Time Frame

Measured at Month 36

Title

Expanded HIV Testing Component: Cost of support for additional staff and HIV tests

Time Frame

Measured at Month 36

Title

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

Title

Linkage-to-Care Component: Cost of the program, including staffing, infrastructure, and incentives

Time Frame

Measured at Month 24

Title

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

Title

Time Frame

Measured at Month 24

Title

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

Title

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

Title

Viral Suppression Component: Cost of program, including staffing, infrastructure, and incentives

Time Frame

Measured at Month 24

Title

Time Frame

Measured at Month 24

Title

Viral Suppression Component: Number of identified HIV-infected patients in care who have sustained viral suppression

Time Frame

Measured at Month 24

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wafaa El-Sadr, MD, MPH

Organizational Affiliation

Columbia University and Harlem Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Bernard Branson, MD

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Study Chair

Facility Information:

Facility Name

DC clinics

City

Washington, D.C.

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Bronx clinics

City

New York

State/Province

New York

ZIP/Postal Code

10453

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21406980

Citation

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.

Results Reference

background

PubMed Identifier

22479154

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

Citation

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.

Results Reference

background

PubMed Identifier

23049660

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

Citation

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

Results Reference

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Citation

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.

Results Reference

result

Citation

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.

Results Reference

result

Citation

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.

Results Reference

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Citation

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.

Results Reference

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Citation

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.

Results Reference

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Citation

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.

Results Reference

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Citation

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.

Results Reference

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PubMed Identifier

23183150

Citation

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.. Erratum In: J Acquir Immune Defic Syndr. 2015 Apr 1;68(4):e68.

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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.

Results Reference

result

Citation

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.

Results Reference

result

Citation

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.

Results Reference

result

Citation

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.

Results Reference

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PubMed Identifier

26862232

Citation

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.

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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.

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PubMed Identifier

28966842

Citation

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.

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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.

Results Reference

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Citation

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)

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PubMed Identifier

27708115

Citation

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.

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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.

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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.

Results Reference

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PubMed Identifier

28182706

Citation

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.

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35393864

Citation

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.

Results Reference

derived

PubMed Identifier

28628702

Citation

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.

Results Reference

derived

Links:

URL

https://www.youtube.com/watch?v=yYrlMLb9FTs

Description

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

URL

https://www.hptn.org/sites/default/files/inline-files/THPE120_065EGreene.pdf

Description

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

URL

https://www.hptn.org/sites/default/files/inline-files/TUPE411_065GKing.pdf

Description

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.

URL

https://www.hptn.org/sites/default/files/inline-files/TUPE293_065KGray.pdf

Description

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.

URL

https://www.hptn.org/sites/default/files/inline-files/WEPW115_065DDonnell.pdf

Description

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.

URL

https://www.hptn.org/sites/default/files/2016-05/R4Punderstandingviral.pdf

Description

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.

URL

https://www.hptn.org/sites/default/files/2016-05/R4Punanticipated.pdf

Description

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.

URL

https://www.hptn.org/sites/default/files/2016-05/R4Pacceptabilityvs.pdf

Description

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.

URL

https://www.hptn.org/sites/default/files/2016-05/R4Pimpactincentives.pdf

Description

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.

URL

https://www.hptn.org/sites/default/files/2016-05/R4Pgiftcarduse.pdf

Description

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.

URL

http://www.croiwebcasts.org/console/player/25546?mediaType=audio&

Description

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

URL

https://www.hptn.org/sites/default/files/2016-05/CROI15Providers.pdf

Description

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.

URL

https://www.hptn.org/sites/default/files/2016-05/CROI15EHT.pdf

Description

Expanding HIV Testing in Hospital Emergency Departments and Inpatient Admissions. Poster 1100 at CROI 2015, Seattle, Washington: February 25, 2015, Session P-Y3.

URL

https://www.hptn.org/sites/default/files/2016-05/Poster989_Abstract%2016-643_0.pdf

Description

Prevention for HIV-infected Persons in HPTN 065: Room for Improvement. Poster 989 at CROI 2016, Boston, MA: February 24, 2016, Session P-X4.

URL

https://www.hptn.org/sites/default/files/2016-05/Poster997_Abstract%2016-731_0.pdf

Description

Computer-based Prevention Counseling for HIV-infected Persons (HPTN 065). Poster 997 at CROI 2016, Boston, MA: February 24, 2016, Session P-X4.

URL

https://www.hptn.org/sites/default/files/2016-05/Poster1038_Abstract%2016-377_0.pdf

Description

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.

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

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