HIV InfectionNCT01152918
Evaluating Methods to Increase HIV Testing, Access to HIV Care, and HIV Prevention Strategies
A study testing Linkage-to-Care Component: Financial Incentive (FI), Viral Suppression Component: FI and Viral Suppression Component: SOC in people with HIV Infection, run by HIV Prevention Trials Network at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infection
- What is being tested?
- Linkage-to-Care Component: Financial Incentive (FI), Viral Suppression Component: FI and Viral Suppression Component: SOC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,442 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- Inclusion/Exclusion Criteria for Viral Suppression Component:
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bronx clinics
New York, New York, 10453
DC clinics
Washington D.C., District of Columbia, 20007
About this study
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
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.)
Read the 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.
- Conditions
- HIV Infection
- Being tested
- 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
- 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
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linkage-to-Care Component: Financial Incentive (FI)Behavioural
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)Behavioural
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: FIBehavioural
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: SOCBehavioural
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 SOCBehavioural
Participants will complete a computer-delivered counseling program that emphasizes HIV prevention strategies for HIV-infected people.
Prevention for Positives Component: SOCBehavioural
Participants will receive SOC from their HIV care site.
| Study group | Role | What they receive |
|---|---|---|
| Linkage-to-Care Component: Financial Incentive (FI) | Experimental | Provide financial incentives for linkage to HIV care. Receives: 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 Receives: Behavioral: Linkage-to-Care Component: Standard of Care (SOC) |
| Viral Suppression Component: FI | Experimental | Provide financial incentives for viral load suppression Receives: Behavioral: Viral Suppression Component: FI |
| Viral Suppression Component: SOC | Active comparator | Provide the SoC to patients for viral load suppression Receives: Behavioral: Viral Suppression Component: SOC |
| Prevention for Positives Component: Intervention | Experimental | Computerized HIV risk reduction counseling program Receives: Behavioral: Prevention for Positives Component: Counseling and SOC |
| Prevention for Positives Component: SOC | Active comparator | Receive SOC for HIV infection Receives: Behavioral: Prevention for Positives Component: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded HIV Testing Component: Number and results of HIV tests per month in publicly funded testing sites (local health department data)
Measured: Measured at Month 36
Expanded HIV Testing Component: Number, transmission category, and testing source of newly identified cases in HIV surveillance data
Measured: Measured at Month 36
Expanded HIV Testing Component: Initial CD4 cell count of newly identified HIV cases in surveillance data
Measured: Measured at Month 36
Expanded HIV Testing Component: Number of newly identified HIV cases concomitantly diagnosed with AIDS in surveillance data
Measured: 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: 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: Measured at Month 36
Expanded HIV Testing Component: Number of HIV tests in EDs where HIV infection is newly identified
Measured: Measured at Month 36
Expanded HIV Testing Component: Number of HIV tests in hospital admissions where patients receive HIV testing
Measured: Measured at Month 36
Expanded HIV Testing Component: Proportion of hospital admissions who have newly identified HIV infection
Measured: Measured at Month 36
Expanded HIV Testing Component: Number of tested patients identified with previously diagnosed HIV who are not in care
Measured: Measured at Month 36
Expanded HIV Testing Component: Cost of support for additional staff and HIV tests
Measured: 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: Measured at Month 24
Linkage-to-Care Component: Cost of the program, including staffing, infrastructure, and incentives
Measured: 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: 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: 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: 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: Measured at Month 24
Viral Suppression Component: Cost of program, including staffing, infrastructure, and incentives
Measured: 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: Measured at Month 24
Viral Suppression Component: Number of identified HIV-infected patients in care who have sustained viral suppression
Measured: Measured at Month 24
Prevention for Positives Component: Proportion of participants reporting any unprotected vaginal or anal sex in the previous 3 months
Measured: 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: 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: 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: Measured at Month 12 and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18,442 participants (actual)
Sponsor and investigators
- Lead sponsor
- HIV Prevention Trials Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Wafaa El-Sadr, MD, MPH, Study chair, Columbia University and Harlem HospitalBernard Branson, MD, Study chair, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152918
- Sponsor's protocol ID
- HPTN 065
- Other IDs
- 1U01AI068619
- Status last verified
- Mar 2025
- First submitted
- 28 Jun 2010
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21406980London 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.
PubMed 22479154El 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.
PubMed 23049660Adamson 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..
PubMed 23183150
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01152918
- Acronym / sponsor ID
- HPTN 065
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,442 participants (actual)
- Lead sponsor
- HIV Prevention Trials NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Linkage-to-Care Component: Financial Incentive (FI) | Experimental | Behavioral: Linkage-to-Care Component: Financial Incentive (FI)Provide financial incentives for linkage to HIV care. |
| Linkage-to-Care Component: Standard of Care (SOC) | Active comparator | Behavioral: Linkage-to-Care Component: Standard of Care (SOC)Provide the SoC to patients for linkage to HIV care |
| Viral Suppression Component: FI | Experimental | Behavioral: Viral Suppression Component: FIProvide financial incentives for viral load suppression |
| Viral Suppression Component: SOC | Active comparator | Behavioral: Viral Suppression Component: SOCProvide the SoC to patients for viral load suppression |
| Prevention for Positives Component: Intervention | Experimental | Behavioral: Prevention for Positives Component: Counseling and SOCComputerized HIV risk reduction counseling program |
| Prevention for Positives Component: SOC | Active comparator | Behavioral: Prevention for Positives Component: SOCReceive SOC for HIV infection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Linkage-to-Care Component: Financial Incentive (FI) |
| 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. | Behavioural | Linkage-to-Care Component: Standard of Care (SOC) |
| Viral Suppression Component: FIHIV-infected participants who are receiving ART will be offered FIs upon the confirmation of each suppressed viral load measurement (less than 400 copies/mL). | Behavioural | Viral Suppression Component: FI |
| Viral Suppression Component: SOCHIV-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. | Behavioural | Viral Suppression Component: SOC |
| Prevention for Positives Component: Counseling and SOCParticipants will complete a computer-delivered counseling program that emphasizes HIV prevention strategies for HIV-infected people. | Behavioural | Prevention for Positives Component: Intervention |
| Prevention for Positives Component: SOCParticipants will receive SOC from their HIV care site. | Behavioural | Prevention for Positives Component: SOC |
Primary outcome
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
Expanded HIV Testing Component: Number, transmission category, and testing source of newly identified cases in HIV surveillance data
Time frame: Measured at Month 36
Expanded HIV Testing Component: Initial CD4 cell count of newly identified HIV cases in surveillance data
Time frame: Measured at Month 36
Expanded HIV Testing Component: Number of newly identified HIV cases concomitantly diagnosed with AIDS in surveillance data
Time frame: 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)
Time frame: Measured at Month 36
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
Expanded HIV Testing Component: Number of HIV tests in EDs where HIV infection is newly identified
Time frame: Measured at Month 36
Expanded HIV Testing Component: Number of HIV tests in hospital admissions where patients receive HIV testing
Time frame: Measured at Month 36
Expanded HIV Testing Component: Proportion of hospital admissions who have newly identified HIV infection
Time frame: Measured at Month 36
Expanded HIV Testing Component: Number of tested patients identified with previously diagnosed HIV who are not in care
Time frame: Measured at Month 36
Expanded HIV Testing Component: Cost of support for additional staff and HIV tests
Time frame: 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
Time frame: Measured at Month 24
Linkage-to-Care Component: Cost of the program, including staffing, infrastructure, and incentives
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured at Month 24
Viral Suppression Component: Cost of program, including staffing, infrastructure, and incentives
Time frame: 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
Time frame: Measured at Month 24
Viral Suppression Component: Number of identified HIV-infected patients in care who have sustained viral suppression
Time frame: Measured at Month 24
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Background: PubMed 21406980El-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.
- Background: PubMed 22479154London 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.
- BackgroundEl 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.
- Background: PubMed 23049660Donnell 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.
- BackgroundAdamson 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 publicationGreene 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 publicationGray 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 publicationDonnell 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 publicationGreene 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 publicationPack 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 publicationPack 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.
- 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, 2012Link provided by the sponsor.
- 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. THPE120Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wafaa El-Sadr, MD, MPH study chair
Columbia University and Harlem Hospital
Bernard Branson, MD study chair
Centers for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linkage-to-Care Component: Financial Incentive (FI), Viral Suppression Component: FI and Viral Suppression Component: SOC in people with HIV Infection, run by HIV Prevention Trials Network at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01152918, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.