Trial Outcomes & Findings for Personalized Text Messages to Improve Antiretroviral Treatment (ART) Adherence in HIV+ Methamphetamine Users (NCT NCT01317277)
NCT ID: NCT01317277
Last Updated: 2021-08-27
Results Overview
Adherence was defined as the percentage of taken doses using Medication Event Monitoring Systems (MEMS); i.e., \[(# of bottle openings)/(# of prescribed doses)\*100\].
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
6 weeks
Results posted on
2021-08-27
Participant Flow
Participant milestones
| Measure |
iTAB + Psychoeducation
individualized Texting for Adherence Building (iTAB): Participants will receive daily text messaging reminders for antiretroviral medication adherence. These text messages will be targeted to the specific schedule and needs of the individual. Participants will also receive daily text messages to assess mood and methamphetamine use.
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.
|
Psychoeducation
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.
Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
25
|
|
Overall Study
COMPLETED
|
43
|
23
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
iTAB + Psychoeducation
individualized Texting for Adherence Building (iTAB): Participants will receive daily text messaging reminders for antiretroviral medication adherence. These text messages will be targeted to the specific schedule and needs of the individual. Participants will also receive daily text messages to assess mood and methamphetamine use.
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.
|
Psychoeducation
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.
Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Lost MEMS
|
1
|
1
|
|
Overall Study
Unable to comply with intervention
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
Baseline characteristics by cohort
| Measure |
iTAB + Psychoeducation
n=50 Participants
individualized Texting for Adherence Building (iTAB): Participants will receive daily text messaging reminders for antiretroviral medication adherence. These text messages will be targeted to the specific schedule and needs of the individual. Participants will also receive daily text messages to assess mood and methamphetamine use.
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.
|
Psychoeducation
n=25 Participants
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.
Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 7.7 • n=43 Participants • 371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
46.0 years
STANDARD_DEVIATION 8.9 • n=23 Participants • 371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
45.6 years
STANDARD_DEVIATION 8.1 • n=66 Participants • 371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
|
Sex: Female, Male
Female
|
3 Participants
n=43 Participants • 371 participants were assessed for eligibility, of which 50 (iTAB) and 25 (active control) were allocated; 66 participants completed follow-up (42 iTAB, 24 control); 1 participant was excluded from analyses in each group for losing MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
0 Participants
n=23 Participants • 371 participants were assessed for eligibility, of which 50 (iTAB) and 25 (active control) were allocated; 66 participants completed follow-up (42 iTAB, 24 control); 1 participant was excluded from analyses in each group for losing MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
3 Participants
n=66 Participants • 371 participants were assessed for eligibility, of which 50 (iTAB) and 25 (active control) were allocated; 66 participants completed follow-up (42 iTAB, 24 control); 1 participant was excluded from analyses in each group for losing MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
|
Sex: Female, Male
Male
|
40 Participants
n=43 Participants • 371 participants were assessed for eligibility, of which 50 (iTAB) and 25 (active control) were allocated; 66 participants completed follow-up (42 iTAB, 24 control); 1 participant was excluded from analyses in each group for losing MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
23 Participants
n=23 Participants • 371 participants were assessed for eligibility, of which 50 (iTAB) and 25 (active control) were allocated; 66 participants completed follow-up (42 iTAB, 24 control); 1 participant was excluded from analyses in each group for losing MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
63 Participants
n=66 Participants • 371 participants were assessed for eligibility, of which 50 (iTAB) and 25 (active control) were allocated; 66 participants completed follow-up (42 iTAB, 24 control); 1 participant was excluded from analyses in each group for losing MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
23 Participants
n=43 Participants • 371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
7 Participants
n=23 Participants • 371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
30 Participants
n=66 Participants • 371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
15 Participants
n=43 Participants • 371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
7 Participants
n=23 Participants • 371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
22 Participants
n=66 Participants • 371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=43 Participants • 371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
8 Participants
n=23 Participants • 371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
13 Participants
n=66 Participants • 371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=43 Participants • 371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
1 Participants
n=23 Participants • 371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
1 Participants
n=66 Participants • 371 participants were assessed for eligibility. Of the 75 participants allocated to study group (50 in iTAB, 25 in active control), 68 participants completed follow-up visits (44 in iTAB, 24 in active control group); 1 participant in each study arm was excluded from analyses due to loss of MEMS. 66 participants were included in analyses (43 in iTAB group, 23 in active control group)
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
25 participants
n=25 Participants
|
75 participants
n=75 Participants
|
PRIMARY outcome
Timeframe: 6 weeksAdherence was defined as the percentage of taken doses using Medication Event Monitoring Systems (MEMS); i.e., \[(# of bottle openings)/(# of prescribed doses)\*100\].
Outcome measures
| Measure |
iTAB + Psychoeducation
n=43 Participants
Participants in the individualized Texting for Adherence Building (iTAB) arm will receive daily text messaging reminders for antiretroviral medication adherence. These text messages will be targeted to the specific schedule and needs of the individual. Participants will also receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.
individualized Texting for Adherence Building (iTAB): Intervention is designed to send automated text messages to HIV+ persons who are current methamphetamine (METH+) users. Text messages are personalized, automated, real-time text messages. The iTAB intervention is designed to improve adherence to ART medications among HIV+/METH+ persons above and beyond an active comparator group.
|
Psychoeducation
n=23 Participants
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications. They will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.
Psychoeducation: Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.
|
|---|---|---|
|
Overall MEMS Adherence to Antiretroviral Medication
|
68.0 percentage of taken doses
Standard Deviation 0.3
|
70.4 percentage of taken doses
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: 6 weeksAdherence using Medication Event Monitoring Systems (MEMS) based on dose timing; i.e., \[(# of bottle openings within a +/- 2-hour time window of the intended dosing time)/(# of prescribed doses)\*100\].
Outcome measures
| Measure |
iTAB + Psychoeducation
n=43 Participants
Participants in the individualized Texting for Adherence Building (iTAB) arm will receive daily text messaging reminders for antiretroviral medication adherence. These text messages will be targeted to the specific schedule and needs of the individual. Participants will also receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.
individualized Texting for Adherence Building (iTAB): Intervention is designed to send automated text messages to HIV+ persons who are current methamphetamine (METH+) users. Text messages are personalized, automated, real-time text messages. The iTAB intervention is designed to improve adherence to ART medications among HIV+/METH+ persons above and beyond an active comparator group.
|
Psychoeducation
n=23 Participants
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications. They will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.
Psychoeducation: Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.
|
|---|---|---|
|
MEMS Adherence to Antiretroviral Medication Based on Dose Timing
|
43.9 percentage of taken doses
Standard Deviation 32.2
|
45.5 percentage of taken doses
Standard Deviation 30.5
|
SECONDARY outcome
Timeframe: Completion of 6-week interventionFor each participant, we calculated the responsiveness to texts assessing METH use \[i.e., (# of texts responded to)/(# of texts received)\], and proportion of days a participants endorsed METH use \[i.e., (# of days endorsing METH use)/(# of texts responded to)\].
Outcome measures
| Measure |
iTAB + Psychoeducation
n=43 Participants
Participants in the individualized Texting for Adherence Building (iTAB) arm will receive daily text messaging reminders for antiretroviral medication adherence. These text messages will be targeted to the specific schedule and needs of the individual. Participants will also receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.
individualized Texting for Adherence Building (iTAB): Intervention is designed to send automated text messages to HIV+ persons who are current methamphetamine (METH+) users. Text messages are personalized, automated, real-time text messages. The iTAB intervention is designed to improve adherence to ART medications among HIV+/METH+ persons above and beyond an active comparator group.
|
Psychoeducation
n=23 Participants
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications. They will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.
Psychoeducation: Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.
|
|---|---|---|
|
Text-reported METH Use
|
14.4 METH use days
Interval 0.0 to 33.6
|
22.0 METH use days
Interval 7.3 to 65.6
|
Adverse Events
iTAB + Psychoeducation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Psychoeducation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
iTAB + Psychoeducation
n=50 participants at risk
Participants in the individualized Texting for Adherence Building (iTAB) arm will receive daily text messaging reminders for antiretroviral medication adherence. These text messages will be targeted to the specific schedule and needs of the individual. Participants will also receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.
individualized Texting for Adherence Building (iTAB): Intervention is designed to send automated text messages to HIV+ persons who are current methamphetamine (METH+) users. Text messages are personalized, automated, real-time text messages. The iTAB intervention is designed to improve adherence to ART medications among HIV+/METH+ persons above and beyond an active comparator group.
|
Psychoeducation
n=25 participants at risk
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications. They will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.
Psychoeducation: Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.
|
|---|---|---|
|
Immune system disorders
Other medical complications
|
2.0%
1/50 • Number of events 1
|
0.00%
0/25
|
Additional Information
Dr. David J Moore, Professor of Psychiatry
UCSD HIV Neurobehavioral Research Program (HNRP)
Phone: 619-543-5093
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place