Trial Outcomes & Findings for Suppression of HIV 1 RNA in People Living With HIV (NCT NCT02363387)
NCT ID: NCT02363387
Last Updated: 2023-04-24
Results Overview
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).
COMPLETED
NA
102 participants
2 years
2023-04-24
Participant Flow
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.
Participant milestones
| Measure |
Incentive Group
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.
Incentives for Viral Suppression: 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 Care: The best HIV medical care available in each participant's medical clinic.
|
Usual Care Group
Usual Care Control participants will receive the standard HIV medical care offered in their clinic.
Standard HIV Medical Care: The best HIV medical care available in each participant's medical clinic.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
50
|
|
Overall Study
COMPLETED
|
52
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Suppression of HIV 1 RNA in People Living With HIV
Baseline characteristics by cohort
| Measure |
Incentive Group
n=52 Participants
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.
Incentives for Viral Suppression: 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 Care: The best HIV medical care available in each participant's medical clinic.
|
Usual Care Group
n=50 Participants
Usual Care Control participants will receive the standard HIV medical care offered in their clinic.
Standard HIV Medical Care: The best HIV medical care available in each participant's medical clinic.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 10 • n=5 Participants
|
47 years
STANDARD_DEVIATION 9 • n=7 Participants
|
47 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Intent to treat
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).
Outcome measures
| Measure |
Incentive Group
n=461 blood samples
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.
|
Usual Care Group
n=400 blood samples
Usual Care Control participants will receive the standard HIV medical care offered in their clinic.
|
|---|---|---|
|
Undetectable Viral Loads During Treatment
|
70.4 percentage of blood samples undetectable
|
42.5 percentage of blood samples undetectable
|
SECONDARY outcome
Timeframe: 2 yearsWe 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsWe 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsWe 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsWe will assess whether the participant attended at least 2 medical visits per year (Y/N each year based on self-report and medical records).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Year 3We will assess all primary and secondary outcome measures during the third year of the study after the incentive intervention ends
Outcome measures
Outcome data not reported
Adverse Events
Incentive Group
Usual Care Group
Serious adverse events
| Measure |
Incentive Group
n=52 participants at risk
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.
|
Usual Care Group
n=50 participants at risk
Usual Care Control participants will receive the standard HIV medical care offered in their clinic.
|
|---|---|---|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/52 • 2 years
|
2.0%
1/50 • Number of events 1 • 2 years
|
|
Nervous system disorders
Depression
|
1.9%
1/52 • Number of events 1 • 2 years
|
0.00%
0/50 • 2 years
|
|
Nervous system disorders
Hallucinations
|
1.9%
1/52 • Number of events 1 • 2 years
|
0.00%
0/50 • 2 years
|
|
Infections and infestations
Infection
|
1.9%
1/52 • Number of events 1 • 2 years
|
0.00%
0/50 • 2 years
|
|
Gastrointestinal disorders
influenza
|
1.9%
1/52 • Number of events 1 • 2 years
|
0.00%
0/50 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
1.9%
1/52 • Number of events 1 • 2 years
|
0.00%
0/50 • 2 years
|
|
General disorders
Kidney failure
|
1.9%
1/52 • Number of events 1 • 2 years
|
0.00%
0/50 • 2 years
|
|
General disorders
Pneumonia
|
3.8%
2/52 • Number of events 2 • 2 years
|
0.00%
0/50 • 2 years
|
|
Nervous system disorders
Psychiatric treatment
|
3.8%
2/52 • Number of events 2 • 2 years
|
0.00%
0/50 • 2 years
|
|
General disorders
Urinary problems
|
1.9%
1/52 • Number of events 1 • 2 years
|
0.00%
0/50 • 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Kenneth Silverman
Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place