Trial Outcomes & Findings for Adherence Interventions for HIV Youth Via Text & Cell Phone - Sequential Multiple Assignment Randomized Trial (SMART) (NCT NCT03535337)
NCT ID: NCT03535337
Last Updated: 2024-12-13
Results Overview
Percent of participants that have an undetectable HIV Viral Load.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
baseline, month 3, month 6, month 9, and month 12
Results posted on
2024-12-13
Participant Flow
Participant milestones
| Measure |
Stage 1 Cell Phone Support
CPS: Assessment of participant's medication adherence and barrier problem solving via phone conversation
|
Stage 1 Short Message Service (SMS)
SMS: Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.
|
Stage 2 Cell Phone Support CPS-I
Cell Phone Support Non-responder re-randomized to cell phone support incentivized
|
Stage 2 Cell Phone Support SMS-I
Cell phone support non-responder, re-randomized to SMS incentivized
|
Stage 2 Cell Phone Support CPS-T
Cell phone support responder, re-randomized to cell phone support tapered
|
Stage 2 Cell Phone Support SC
Cell phone support responder, re-randomized to standard of care
|
Stage 2 Short Message Service SMS-T
Short message service (SMS) responder, re-randomized to SMS tapered
|
Stage 2 Short Message Service SC
Short message service responder, re-randomized to standard of care
|
Stage 2 Short Message Service CPS-I
Short message service non-responder, re-randomized to cell phone support incentivized
|
Stage 2 Short Message Service SMS-I
Short message service non-responder, re-randomized to SMS incentivized
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1 Randomization
STARTED
|
40
|
43
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1 Randomization
COMPLETED
|
40
|
43
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1 Randomization
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2 Randomization
STARTED
|
0
|
0
|
2
|
4
|
11
|
16
|
14
|
14
|
3
|
5
|
|
Stage 2 Randomization
COMPLETED
|
0
|
0
|
0
|
3
|
6
|
12
|
11
|
8
|
3
|
3
|
|
Stage 2 Randomization
NOT COMPLETED
|
0
|
0
|
2
|
1
|
5
|
4
|
3
|
6
|
0
|
2
|
Reasons for withdrawal
| Measure |
Stage 1 Cell Phone Support
CPS: Assessment of participant's medication adherence and barrier problem solving via phone conversation
|
Stage 1 Short Message Service (SMS)
SMS: Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.
|
Stage 2 Cell Phone Support CPS-I
Cell Phone Support Non-responder re-randomized to cell phone support incentivized
|
Stage 2 Cell Phone Support SMS-I
Cell phone support non-responder, re-randomized to SMS incentivized
|
Stage 2 Cell Phone Support CPS-T
Cell phone support responder, re-randomized to cell phone support tapered
|
Stage 2 Cell Phone Support SC
Cell phone support responder, re-randomized to standard of care
|
Stage 2 Short Message Service SMS-T
Short message service (SMS) responder, re-randomized to SMS tapered
|
Stage 2 Short Message Service SC
Short message service responder, re-randomized to standard of care
|
Stage 2 Short Message Service CPS-I
Short message service non-responder, re-randomized to cell phone support incentivized
|
Stage 2 Short Message Service SMS-I
Short message service non-responder, re-randomized to SMS incentivized
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2 Randomization
Lost to Follow-up
|
0
|
0
|
2
|
1
|
5
|
4
|
3
|
6
|
0
|
2
|
Baseline Characteristics
Adherence Interventions for HIV Youth Via Text & Cell Phone - Sequential Multiple Assignment Randomized Trial (SMART)
Baseline characteristics by cohort
| Measure |
Stage 1 Cell Phone Support
n=40 Participants
CPS: Assessment of participant's medication adherence and barrier problem solving via phone conversation
|
Stage 1 Short Message Service (SMS)
n=43 Participants
SMS: Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Education
High School or Equivalent
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Continuous
|
22.58 Years
STANDARD_DEVIATION 1.63 • n=5 Participants
|
21.9 Years
STANDARD_DEVIATION 1.80 • n=7 Participants
|
22.27 Years
STANDARD_DEVIATION 1.78 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial/Other
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region
Northeast United States
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region
Midwest United Stated
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region
Southeastern United States
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region
Western United States
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Employed
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Education
Less than High School
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Education
Some College or Above
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sexual Identity
Gay
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sexual Identity
Heterosexual or Other
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, month 3, month 6, month 9, and month 12Population: Significant attrition at follow-ups for viral load testing. Therefore the overall model would not converge.
Percent of participants that have an undetectable HIV Viral Load.
Outcome measures
| Measure |
Stage 1 Cell Phone Support
n=34 Participants
CPS: Assessment of participant's medication adherence and barrier problem solving via phone conversation
|
Stage 1 Short Message Service (SMS)
n=35 Participants
SMS: Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.
|
Stage 2 Cell Phone Support CPS-I
n=1 Participants
Cell phone support non-responder re-randomized to cell phone support incentivized
|
Stage 2 Cell Phone Support SMS-I
n=1 Participants
Cell Phone Support non-responder, re-randomized to SMS Incentivized
|
Stage 2 Cell Phone Support CPS-T
n=7 Participants
Cell phone support responder, re-randomized to cell phone support tapered
|
Stage 2 Cell Phone Support SC
n=8 Participants
Cell phone support responder, re-randomized to standard of care
|
Stage 2 Short Message Service SMS-T
n=9 Participants
Short message service (SMS) responder, re-randomized to SMS tapered
|
Stage 2 Short Message Service SC
n=12 Participants
Short message service responder, re-randomized to standard of care
|
Stage 2 Short Message Service CPS-I
n=1 Participants
Short message service non-responder, re-randomized to cell phone support incentivized
|
Stage 2 Short Message Service SMS-I
n=2 Participants
Short message service non-responder, re-randomized to SMS incentivized
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Undetectable Viral Load
12 Month
|
80.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
100 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
|
Undetectable Viral Load
Baseline
|
58.8 percentage of participants
|
62.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Undetectable Viral Load
3 Month
|
89.5 percentage of participants
|
87.5 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
90.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Undetectable Viral Load
6 Month
|
93.8 percentage of participants
|
89.5 percentage of participants
|
100 percentage of participants
|
—
|
85.7 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
85.7 percentage of participants
|
—
|
100 percentage of participants
|
|
Undetectable Viral Load
9 Month
|
83.3 percentage of participants
|
83.3 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
80.0 percentage of participants
|
80.0 percentage of participants
|
100 percentage of participants
|
83 percentage of participants
|
—
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: baseline, month 3, month 6, month 9, and month 12Population: Numbers are different due to attrition.
Self reported percentage of medication taken in the past 7 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups.
Outcome measures
| Measure |
Stage 1 Cell Phone Support
n=40 Participants
CPS: Assessment of participant's medication adherence and barrier problem solving via phone conversation
|
Stage 1 Short Message Service (SMS)
n=43 Participants
SMS: Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.
|
Stage 2 Cell Phone Support CPS-I
n=2 Participants
Cell phone support non-responder re-randomized to cell phone support incentivized
|
Stage 2 Cell Phone Support SMS-I
n=4 Participants
Cell Phone Support non-responder, re-randomized to SMS Incentivized
|
Stage 2 Cell Phone Support CPS-T
n=11 Participants
Cell phone support responder, re-randomized to cell phone support tapered
|
Stage 2 Cell Phone Support SC
n=15 Participants
Cell phone support responder, re-randomized to standard of care
|
Stage 2 Short Message Service SMS-T
n=14 Participants
Short message service (SMS) responder, re-randomized to SMS tapered
|
Stage 2 Short Message Service SC
n=14 Participants
Short message service responder, re-randomized to standard of care
|
Stage 2 Short Message Service CPS-I
n=3 Participants
Short message service non-responder, re-randomized to cell phone support incentivized
|
Stage 2 Short Message Service SMS-I
n=5 Participants
Short message service non-responder, re-randomized to SMS incentivized
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Medication Adherence Rate - 7 Day
3 month
|
90.69 percentage of medication adherence
Standard Deviation 15.57
|
76.18 percentage of medication adherence
Standard Deviation 34.20
|
70.00 percentage of medication adherence
Standard Deviation 0.00
|
100 percentage of medication adherence
Standard Deviation 0.00
|
94.60 percentage of medication adherence
Standard Deviation 8.20
|
88.00 percentage of medication adherence
Standard Deviation 19.30
|
95.40 percentage of medication adherence
Standard Deviation 8.80
|
79.30 percentage of medication adherence
Standard Deviation 32.50
|
15.00 percentage of medication adherence
Standard Deviation 21.20
|
42.00 percentage of medication adherence
Standard Deviation 35.60
|
|
Medication Adherence Rate - 7 Day
9 month
|
79.17 percentage of medication adherence
Standard Deviation 29.18
|
82.76 percentage of medication adherence
Standard Deviation 23.89
|
100 percentage of medication adherence
Standard Deviation 0.00
|
76.70 percentage of medication adherence
Standard Deviation 40.40
|
85.70 percentage of medication adherence
Standard Deviation 21.50
|
72.00 percentage of medication adherence
Standard Deviation 35.50
|
94.60 percentage of medication adherence
Standard Deviation 5.20
|
92.50 percentage of medication adherence
Standard Deviation 7.10
|
56.70 percentage of medication adherence
Standard Deviation 40.40
|
54.00 percentage of medication adherence
Standard Deviation 28.80
|
|
Medication Adherence Rate - 7 Day
12 month
|
73.33 percentage of medication adherence
Standard Deviation 38.12
|
79.63 percentage of medication adherence
Standard Deviation 30.19
|
—
|
33.30 percentage of medication adherence
Standard Deviation 57.70
|
98.00 percentage of medication adherence
Standard Deviation 4.50
|
79.10 percentage of medication adherence
Standard Deviation 29.50
|
97.00 percentage of medication adherence
Standard Deviation 6.70
|
70.00 percentage of medication adherence
Standard Deviation 36.30
|
66.70 percentage of medication adherence
Standard Deviation 25.20
|
46.70 percentage of medication adherence
Standard Deviation 47.30
|
|
Medication Adherence Rate - 7 Day
Baseline
|
63.68 percentage of medication adherence
Standard Deviation 34.91
|
74.52 percentage of medication adherence
Standard Deviation 29.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Medication Adherence Rate - 7 Day
6 month
|
80.00 percentage of medication adherence
Standard Deviation 31.93
|
84.55 percentage of medication adherence
Standard Deviation 20.09
|
100 percentage of medication adherence
Standard Deviation 0.00
|
40 percentage of medication adherence
Standard Deviation 45.80
|
96.30 percentage of medication adherence
Standard Deviation 7.40
|
74.40 percentage of medication adherence
Standard Deviation 33.20
|
94.60 percentage of medication adherence
Standard Deviation 8.80
|
76.70 percentage of medication adherence
Standard Deviation 28.10
|
95.00 percentage of medication adherence
Standard Deviation 7.10
|
70.00 percentage of medication adherence
Standard Deviation 24.50
|
PRIMARY outcome
Timeframe: baseline, month 3, month 6, month 9, and month 12Population: Numbers are different due to attrition.
Self reported percentage of medication taken in the past 30 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups.
Outcome measures
| Measure |
Stage 1 Cell Phone Support
n=31 Participants
CPS: Assessment of participant's medication adherence and barrier problem solving via phone conversation
|
Stage 1 Short Message Service (SMS)
n=36 Participants
SMS: Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.
|
Stage 2 Cell Phone Support CPS-I
n=2 Participants
Cell phone support non-responder re-randomized to cell phone support incentivized
|
Stage 2 Cell Phone Support SMS-I
n=2 Participants
Cell Phone Support non-responder, re-randomized to SMS Incentivized
|
Stage 2 Cell Phone Support CPS-T
n=10 Participants
Cell phone support responder, re-randomized to cell phone support tapered
|
Stage 2 Cell Phone Support SC
n=14 Participants
Cell phone support responder, re-randomized to standard of care
|
Stage 2 Short Message Service SMS-T
n=13 Participants
Short message service (SMS) responder, re-randomized to SMS tapered
|
Stage 2 Short Message Service SC
n=13 Participants
Short message service responder, re-randomized to standard of care
|
Stage 2 Short Message Service CPS-I
n=3 Participants
Short message service non-responder, re-randomized to cell phone support incentivized
|
Stage 2 Short Message Service SMS-I
n=4 Participants
Short message service non-responder, re-randomized to SMS incentivized
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Medication Adherence - 30 Days
9 Month
|
78.34 percentage of medication adherence
Standard Deviation 27.92
|
83.74 percentage of medication adherence
Standard Deviation 21.33
|
93.00 percentage of medication adherence
Standard Deviation 1.40
|
90.50 percentage of medication adherence
Standard Deviation 13.40
|
87.40 percentage of medication adherence
Standard Deviation 21.70
|
67.90 percentage of medication adherence
Standard Deviation 35.50
|
94.60 percentage of medication adherence
Standard Deviation 6.00
|
91.10 percentage of medication adherence
Standard Deviation 8.70
|
56.00 percentage of medication adherence
Standard Deviation 39.30
|
58.00 percentage of medication adherence
Standard Deviation 19.60
|
|
Medication Adherence - 30 Days
12 Month
|
83.94 percentage of medication adherence
Standard Deviation 22.73
|
80.60 percentage of medication adherence
Standard Deviation 28.73
|
—
|
52.00 percentage of medication adherence
Standard Deviation 67.90
|
94.00 percentage of medication adherence
Standard Deviation 5.50
|
85.60 percentage of medication adherence
Standard Deviation 12.80
|
97.10 percentage of medication adherence
Standard Deviation 6.30
|
75.40 percentage of medication adherence
Standard Deviation 29.80
|
69.00 percentage of medication adherence
Standard Deviation 28.60
|
17.00 percentage of medication adherence
Standard Deviation 24.00
|
|
Medication Adherence - 30 Days
Baseline
|
68.55 percentage of medication adherence
Standard Deviation 27.18
|
74.33 percentage of medication adherence
Standard Deviation 23.60
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Medication Adherence - 30 Days
3 Month
|
87.56 percentage of medication adherence
Standard Deviation 20.35
|
84.87 percentage of medication adherence
Standard Deviation 22.73
|
75.00 percentage of medication adherence
Standard Deviation 0.00
|
53.00 percentage of medication adherence
Standard Deviation 32.50
|
95.10 percentage of medication adherence
Standard Deviation 6.00
|
88.00 percentage of medication adherence
Standard Deviation 22.00
|
96.20 percentage of medication adherence
Standard Deviation 4.60
|
83.90 percentage of medication adherence
Standard Deviation 24.50
|
70.00 percentage of medication adherence
Standard Deviation 0.00
|
58.00 percentage of medication adherence
Standard Deviation 31.10
|
|
Medication Adherence - 30 Days
6 Month
|
85.48 percentage of medication adherence
Standard Deviation 21.14
|
82.13 percentage of medication adherence
Standard Deviation 20.08
|
77.50 percentage of medication adherence
Standard Deviation 23.30
|
88.50 percentage of medication adherence
Standard Deviation 16.30
|
96.00 percentage of medication adherence
Standard Deviation 9.80
|
77.20 percentage of medication adherence
Standard Deviation 27.00
|
94.30 percentage of medication adherence
Standard Deviation 8.40
|
73.50 percentage of medication adherence
Standard Deviation 28.30
|
95.00 percentage of medication adherence
Standard Deviation 7.10
|
55.00 percentage of medication adherence
Standard Deviation 35.20
|
Adverse Events
Stage 1 Cell Phone Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 1 Short Message Service (SMS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2 Cell Phone Support CPS-I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2 Cell Phone Support SMS-I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2 Cell Phone Support CPS-T
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2 Cell Phone Support SC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2 Short Message Service SMS-T
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2 Short Message Service SC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2 Short Message Service CPS-I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2 Short Message Service SMS-I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sylvie Naar, PhD; Distinguished Endowed Professor
Florida State University
Phone: 18506442334
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place