An interventional study of Incentives for Viral Suppression and Standard HIV Medical Care in HIV, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-24.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Incentives for Viral Suppression · Behavioral: Standard HIV Medical Care
Usual Care Control participants will receive the standard HIV medical care offered in their clinic.
Behavioral: Standard HIV Medical Care
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.
The best HIV medical care available in each participant's medical clinic.
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).
Time frame: 2 years
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: Year 3
We recruited participants between 11/1/2015 and 8/30/2017. Participants were recruited in Baltimore from settings that serve people living with HIV and through compensated referrals by participants. Interested individuals completed a brief phone interview. Potentially eligible participants were invited for a full interview.
| Milestone | Incentive Group | Usual Care Group |
|---|---|---|
| Started | 52 | 50 |
| Completed | 52 | 50 |
| Not completed | 0 | 0 |
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).
| percentage of blood samples undetectable | Incentive Group | Usual Care Group |
|---|---|---|
| Undetectable Viral Loads During Treatment | 70.4 | 42.5 |
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).
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
We will assess all primary and secondary outcome measures during the third year of the study after the incentive intervention ends
Results for this outcome have not been posted.
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Incentive Group | 4/52 (7.7%) | 10/52 (19.2%) | 0/52 (0%) |
| Usual Care Group | 3/50 (6%) | 1/50 (2%) | 0/50 (0%) |
| Event | Incentive Group | Usual Care Group |
|---|---|---|
| PneumoniaGeneral disorders | 2/52 | 0/50 |
| Psychiatric treatmentNervous system disorders | 2/52 | 0/50 |
| Congestive heart failureCardiac disorders | 0/52 | 1/50 |
| DepressionNervous system disorders | 1/52 | 0/50 |
| HallucinationsNervous system disorders | 1/52 | 0/50 |
| InfectionInfections and infestations | 1/52 | 0/50 |
| influenzaGastrointestinal disorders | 1/52 | 0/50 |
| Joint painMusculoskeletal and connective tissue disorders | 1/52 | 0/50 |
| Kidney failureGeneral disorders | 1/52 | 0/50 |
| Urinary problemsGeneral disorders | 1/52 | 0/50 |
| Age, Categorical(Participants) | Incentive Group | Usual Care Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 51 | 50 | 101 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | Incentive Group | Usual Care Group | Total |
|---|---|---|---|
| Mean | 47 ± 10 | 47 ± 9 | 47 ± 10 |
| Sex: Female, Male(Participants) | Incentive Group | Usual Care Group | Total |
|---|---|---|---|
| Female | 24 | 23 | 47 |
| Male | 28 | 27 | 55 |
| Ethnicity (NIH/OMB)(Participants) | Incentive Group | Usual Care Group | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 51 | 49 | 100 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Incentive Group | Usual Care Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 46 | 46 | 92 |
| White | 4 | 4 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Incentive Group | Usual Care Group | Total |
|---|---|---|---|
| United States | 52 | 50 | 102 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — We will publish the results in a peer-reviewed journal.
Ran from Nov 2015 to primary completion in Oct 2019, 47 months.
Results were first posted in Apr 2023, 3 years 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.