HIVNCT02363387
Suppression of HIV 1 RNA in People Living With HIV
A study testing Incentives for Viral Suppression and Standard HIV Medical Care in people with HIV, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators propose to evaluate a novel incentive intervention to promote suppression of viral load in people living with HIV that will employ empirically-based parameters that have been proven critical to the effectiveness of incentive interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Incentives for Viral Suppression and Standard HIV Medical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- living with HIV
Who cannot join
- report current suicidal or homicidal ideation;
- have a severe psychiatric disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142
Baltimore, Maryland, 21224
About this study
The investigators propose to evaluate a novel incentive intervention to promote suppression of viral load in people living with HIV that will employ empirically-based parameters that have been proven critical to the effectiveness of incentive interventions. Participants (N = 200) from medical clinics that serve adults living with HIV in Baltimore will be randomly assigned to an Incentive or a Usual Care Control group. Incentive group participants will receive incentives for maintaining suppressed and undetectable viral loads. The incentive program will employ high magnitude incentives, provide incentives for decreases in viral load early in treatment before a patient's viral load has reached undetectable levels, arrange frequent incentives early in treatment and reduce the frequency of incentives as participants achieve progressively longer periods of viral load suppression, arrange a schedule of escalating incentives for sustained suppression of viral load, and the intervention will be maintained for two years. Usual Care Control participants will only receive the standard HIV medical care offered in their clinic. Assessments will be conducted every 3 months throughout the two years of treatment and every 6 months throughout the year following treatment. The primary outcome measure will be the percentage of participants that have undetectable viral loads at the 3-month assessments conducted throughout the 2-year intervention period. Secondary measures will include adherence to HIV care and post-treatment outcomes. The investigators will also assess moderators and mediators of the effects of the incentives on the suppression of viral load, and conduct cost-effectiveness and cost-benefit analyses. If the incentive intervention maintains suppressed viral load and is economically sound, it could be used to improve the health of adults living with HIV, reduce health care costs, and reduce HIV transmission in the community.
Read the detailed description
Experimental Design. Participants (N = 200) will be randomly assigned to a Usual Care Control group or the Incentive group. A computerized urn randomization procedure (Wei \& Lachin, 1988) will be used to balance groups on five baseline characteristics that may influence outcome: (1) Diagnostic and Statistical Manual (DSM) V dependence on cocaine or opiates assessed on the Composite International Diagnostic Interview (CIDI) (Y/N); (2) DSM V alcohol dependence assessed on the CIDI (Y/N); (3) health literacy as assessed on the Test of Functional Health Literacy in Adults (TOFHLA) (score ≤ the rolling median, Y/N); (4) impulsivity as assessed by delay discounting (k value from the raw discounting data for each participant, which is an index of impulsivity (≤ the rolling median of k, Y/N); and (5) depression as assessed by the Beck Depression Inventory (score ≤ the rolling median, Y/N). Participants will be stratified by DSM V cocaine, opiate and alcohol dependence, health literacy, and depression at intake because drug use, health literacy, and depression has each been associated with poor Anti-Retroviral Therapy (ART) adherence. Participants will be stratified based on measures of impulsivity because high levels of impulsivity have been associated with poor health decision making and adverse health behaviors.
Standard HIV Medical Care.
Upon enrollment, participants will be taught about the benefits of ART adherence and the need to maintain nearly perfect adherence. All participants will receive their HIV medical care in their clinic.
Incentive Group.
The Incentive group will receive the novel empirically-based incentive intervention to promote long term suppression of HIV-1 RNA (viral load) being evaluated in this study. The incentive intervention will employ features and parameters that have been shown critically important to promote therapeutic behavior change in drug users and other populations. participants will be taught the details of the incentive program with written instructions and quizzes.
Usual Care Control Group.
Usual Care Control Only participants will receive the standard HIV medical care described above offered in their medical clinic. Participants in this group will not receive added viral load testing, feedback or incentives, beyond the viral load testing conducted as a routine part of their medical care.
- Conditions
- HIV
- Being tested
- Incentives for Viral Suppression, Standard HIV Medical Care
- Keywords
- HIV, antiretroviral medications, incentives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentives for Viral SuppressionBehavioural
Incentive group participants will receive incentives for maintaining suppressed and undetectable viral loads. The incentive program will employ high magnitude incentives, provide incentives for decreases in viral load early in treatment before a patient's viral load has reached undetectable levels, arrange frequent incentives early in treatment and reduce the frequency of incentives as participants achieve progressively longer periods of viral load suppression, arrange a schedule of escalating incentives for sustained suppression of viral load, and the intervention will be maintained for two years.
Standard HIV Medical CareBehavioural
The best HIV medical care available in each participant's medical clinic.
| Study group | Role | What they receive |
|---|---|---|
| Incentive Group | Experimental | Incentive group participants will receive the standard HIV medical care offered in their clinic. In addition, Incentive group participants will receive incentives for viral suppression. These incentives will be presented if the participants maintain suppressed and undetectable viral loads. The incentive program will employ high magnitude incentives, provide incentives for decreases in viral load early in treatment before a patient's viral load has reached undetectable levels, arrange frequent incentives early in treatment and reduce the frequency of incentives as participants achieve progressively longer periods of viral load suppression, arrange a schedule of escalating incentives for sustained suppression of viral load, and the intervention will be maintained for two years. Receives: Behavioral: Incentives for Viral Suppression; Behavioral: Standard HIV Medical Care |
| Usual Care Group | Other | Usual Care Control participants will receive the standard HIV medical care offered in their clinic. Receives: Behavioral: Standard HIV Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable Viral Loads During Treatment
We will assess the percentage of blood samples that have undetectable viral loads (i.e., <200 copies/mL) at the eight 3-month assessments conducted throughout the 2-year intervention evaluation period (Y/N at each assessment).
Measured: 2 years
Secondary outcomes (5)
Biologically-verified Adherence to Antiretroviral Medications
We will assess whether the participant maintained consistent ART adherence by conducting qualitative high-resolution mass spectrometry (HRMS) blood tests of 15 antiretroviral medications. Participants will be considered adherent if they test positive for all of their prescribed medications (Y/N at each 3-month assessment).
Measured: 2 years
Self-reported Adherence to Antiretroviral Medications
We will assess whether the participant reports maintaining consistent ART adherence by reporting taking >90% of all scheduled doses in the past 30 days (Y/N at each 3-month assessment based on responses on a visual analog scale to assess adherence to antiretroviral medications, see below).
Measured: 2 years
Maintaining Prescriptions for Antiretroviral Medications
We will assess the percentage of months that the participant refilled a prescription for antiretroviral medications throughout the 2-year intervention evaluation period (Y/N for each month prior to each 3-month assessment based on timeline follow-back self-report and confirmed by pharmacy records).
Measured: 2 years
Retention in HIV Medical Care
We will assess whether the participant attended at least 2 medical visits per year (Y/N each year based on self-report and medical records).
Measured: 2 years
Post-intervention Effects
We will assess all primary and secondary outcome measures during the third year of the study after the incentive intervention ends
Measured: Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2019
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Silverman, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363387
- Sponsor's protocol ID
- IRB00044740
- Other IDs
- R01AI117065
- Status last verified
- Apr 2023
- First submitted
- 5 Feb 2015
- Last updated
- 24 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: We will publish the results in a peer-reviewed journal.
Publications
Novak MD, Holtyn AF, Toegel F, Rodewald AM, Leoutsakos JM, Fingerhood M, Silverman K. Long-Term Effects of Incentives for HIV Viral Suppression: A Randomized Clinical Trial. AIDS Behav. 2024 Feb;28(2):625-635. doi: 10.1007/s10461-023-04249-z. Epub 2023 Dec 20.
PubMed 38117449
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suppression of HIV 1 RNA in People Living With HIV
- ClinicalTrials.gov ID
- NCT02363387
- Acronym / sponsor ID
- IRB00044740
- Conditions
- HIV
- Keywords
- HIV, antiretroviral medications, incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Nov 2015 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Posted 24 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to evaluate a novel incentive intervention to promote suppression of viral load in people living with HIV that will employ empirically-based parameters that have been proven critical to the effectiveness of incentive interventions. Participants (N = 200) from medical clinics that serve adults living with HIV in Baltimore will be randomly assigned to an Incentive or a Usual Care Control group. Incentive group participants will receive incentives for maintaining suppressed and undetectable viral loads. The incentive program will employ high magnitude incentives, provide incentives for decreases in viral load early in treatment before a patient's viral load has reached undetectable levels, arrange frequent incentives early in treatment and reduce the frequency of incentives as participants achieve progressively longer periods of viral load suppression, arrange a schedule of escalating incentives for sustained suppression of viral load, and the intervention will be maintained for two years. Usual Care Control participants will only receive the standard HIV medical care offered in their clinic. Assessments will be conducted every 3 months throughout the two years of treatment and every 6 months throughout the year following treatment. The primary outcome measure will be the percentage of participants that have undetectable viral loads at the 3-month assessments conducted throughout the 2-year intervention period. Secondary measures will include adherence to HIV care and post-treatment outcomes. The investigators will also assess moderators and mediators of the effects of the incentives on the suppression of viral load, and conduct cost-effectiveness and cost-benefit analyses. If the incentive intervention maintains suppressed viral load and is economically sound, it could be used to improve the health of adults living with HIV, reduce health care costs, and reduce HIV transmission in the community.
Detailed description
Experimental Design. Participants (N = 200) will be randomly assigned to a Usual Care Control group or the Incentive group. A computerized urn randomization procedure (Wei \& Lachin, 1988) will be used to balance groups on five baseline characteristics that may influence outcome: (1) Diagnostic and Statistical Manual (DSM) V dependence on cocaine or opiates assessed on the Composite International Diagnostic Interview (CIDI) (Y/N); (2) DSM V alcohol dependence assessed on the CIDI (Y/N); (3) health literacy as assessed on the Test of Functional Health Literacy in Adults (TOFHLA) (score ≤ the rolling median, Y/N); (4) impulsivity as assessed by delay discounting (k value from the raw discounting data for each participant, which is an index of impulsivity (≤ the rolling median of k, Y/N); and (5) depression as assessed by the Beck Depression Inventory (score ≤ the rolling median, Y/N). Participants will be stratified by DSM V cocaine, opiate and alcohol dependence, health literacy, and depression at intake because drug use, health literacy, and depression has each been associated with poor Anti-Retroviral Therapy (ART) adherence. Participants will be stratified based on measures of impulsivity because high levels of impulsivity have been associated with poor health decision making and adverse health behaviors.
Standard HIV Medical Care.
Upon enrollment, participants will be taught about the benefits of ART adherence and the need to maintain nearly perfect adherence. All participants will receive their HIV medical care in their clinic.
Incentive Group.
The Incentive group will receive the novel empirically-based incentive intervention to promote long term suppression of HIV-1 RNA (viral load) being evaluated in this study. The incentive intervention will employ features and parameters that have been shown critically important to promote therapeutic behavior change in drug users and other populations. participants will be taught the details of the incentive program with written instructions and quizzes.
Usual Care Control Group.
Usual Care Control Only participants will receive the standard HIV medical care described above offered in their medical clinic. Participants in this group will not receive added viral load testing, feedback or incentives, beyond the viral load testing conducted as a routine part of their medical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incentive Group | Experimental | Behavioral: Incentives for Viral Suppression, Behavioral: Standard HIV Medical CareIncentive group participants will receive the standard HIV medical care offered in their clinic. In addition, Incentive group participants will receive incentives for viral suppression. These incentives will be presented if the participants maintain suppressed and undetectable viral loads. The incentive program will employ high magnitude incentives, provide incentives for decreases in viral load early in treatment before a patient's viral load has reached undetectable levels, arrange frequent incentives early in treatment and reduce the frequency of incentives as participants achieve progressively longer periods of viral load suppression, arrange a schedule of escalating incentives for sustained suppression of viral load, and the intervention will be maintained for two years. |
| Usual Care Group | Other | Behavioral: Standard HIV Medical CareUsual Care Control participants will receive the standard HIV medical care offered in their clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- living with HIV
Key exclusion criteria (2 listed)
- report current suicidal or homicidal ideation;
- have a severe psychiatric disorder
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 |
|---|---|---|
| Incentives for Viral SuppressionIncentive group participants will receive incentives for maintaining suppressed and undetectable viral loads. The incentive program will employ high magnitude incentives, provide incentives for decreases in viral load early in treatment before a patient's viral load has reached undetectable levels, arrange frequent incentives early in treatment and reduce the frequency of incentives as participants achieve progressively longer periods of viral load suppression, arrange a schedule of escalating incentives for sustained suppression of viral load, and the intervention will be maintained for two years. | Behavioural | Incentive Group |
| Standard HIV Medical CareThe best HIV medical care available in each participant's medical clinic. | Behavioural | Incentive Group, Usual Care Group |
Primary outcome
Undetectable Viral Loads During Treatment
Time frame: 2 years
We will assess the percentage of blood samples that have undetectable viral loads (i.e., <200 copies/mL) at the eight 3-month assessments conducted throughout the 2-year intervention evaluation period (Y/N at each assessment).
5 secondary outcomes
Biologically-verified Adherence to Antiretroviral Medications
Time frame: 2 years
Self-reported Adherence to Antiretroviral Medications
Time frame: 2 years
Maintaining Prescriptions for Antiretroviral Medications
Time frame: 2 years
Retention in HIV Medical Care
Time frame: 2 years
Post-intervention Effects
Time frame: Year 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38117449Novak MD, Holtyn AF, Toegel F, Rodewald AM, Leoutsakos JM, Fingerhood M, Silverman K. Long-Term Effects of Incentives for HIV Viral Suppression: A Randomized Clinical Trial. AIDS Behav. 2024 Feb;28(2):625-635. doi: 10.1007/s10461-023-04249-z. Epub 2023 Dec 20.
- Individual participant dataSharing planned: No. We will publish the results in a peer-reviewed journal.
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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.
Kenneth Silverman, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentives for Viral Suppression and Standard HIV Medical Care in people with HIV, run by Johns Hopkins University at 1 site 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 1 inclusion and 2 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 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 24 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Undetectable Viral Loads During Treatment (time frame: 2 years). 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 NCT02363387, which also lists 1 linked publication.
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 24 Apr 2023.