Trial Outcomes & Findings for Texting to Improve Adherence in HIV+ With Bipolar Disorder (NCT NCT02090634)
NCT ID: NCT02090634
Last Updated: 2021-08-27
Results Overview
MEMS-derived percent adherence to HIV and psychotropic medications over the study period, i.e., (\[# of bottle openings\]/\[# of prescribed doses\]\*100%).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
4-week
Results posted on
2021-08-27
Participant Flow
HIV+/BD+ participants were recruited from ongoing studies at the UCSD HIV Neurobehavioral Research Program (HNRP).
62 participants were assessed for eligibility, and 4 participants were excluded prior to randomization; 2 did not meet study criteria, 2 withdrew. 58 participants were enrolled and randomized into iTAB (n=30) or control group (n=28). 50 participants completed the study and were included in analyses; excluded from analyses were 5 iTAB participants (3 lost MEMS, 2 had adverse events unrelated to study participation) and 3 control participants (1 lost MEMS, 1 lost contact, 1 was deceased).
Participant milestones
| Measure |
Personalized Reminder Texting + Psychoeducation (iTAB)
Individualized Texting for Adherence Building (iTAB): Participants will receive daily text messaging reminders for antiretroviral and psychotropic medication adherence. These text messages will be targeted to the specific schedule and needs of the individual.
Psychoeducation: Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV and psychotropic medications. Participants will also receive daily text messages to assess mood
|
Psychoeducation (CTRL)
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to antiretroviral and psychotropic medications. Participants will also receive daily text messages to assess mood, but these messages will not receive the medication reminder text messages.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
28
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Personalized Reminder Texting + Psychoeducation (iTAB)
Individualized Texting for Adherence Building (iTAB): Participants will receive daily text messaging reminders for antiretroviral and psychotropic medication adherence. These text messages will be targeted to the specific schedule and needs of the individual.
Psychoeducation: Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV and psychotropic medications. Participants will also receive daily text messages to assess mood
|
Psychoeducation (CTRL)
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to antiretroviral and psychotropic medications. Participants will also receive daily text messages to assess mood, but these messages will not receive the medication reminder text messages.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
58 participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
Baseline characteristics by cohort
| Measure |
Personalized Reminder Texting + Psychoeducation (iTAB)
n=30 Participants
The individualized Texting for Adherence Building (iTAB) intervention is designed to improve adherence to antiretroviral and psychotropic medications for HIV+ persons who have bipolar disorder using automated text message reminders. These text messages will be targeted to the specific medication schedule and needs of the individual. Participants will also receive daily text messages to assesses mood. Additionally, participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to antiretroviral and psychotropic medications.
|
Psychoeducation (CTRL)
n=28 Participants
HIV+ persons who have bipolar disorder will receive a one-time psychoeducational intervention reviewing the importance of adherence to antiretroviral and psychotropic medications. Participants will also receive daily text messages to assess mood, but these participants will not receive the medication reminder text messages.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 9.2 • n=25 Participants • 58 participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
45.9 years
STANDARD_DEVIATION 10.2 • n=25 Participants • 58 participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
47.1 years
STANDARD_DEVIATION 9.7 • n=50 Participants • 58 participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
|
Sex: Female, Male
Female
|
2 Participants
n=25 Participants • 58 participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
4 Participants
n=25 Participants • 58 participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
6 Participants
n=50 Participants • 58 participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
|
Sex: Female, Male
Male
|
23 Participants
n=25 Participants • 58 participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
21 Participants
n=25 Participants • 58 participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
44 Participants
n=50 Participants • 58 participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
16 Participants
n=25 Participants • 62 participants were assessed for eligibility; 2 were ineligible and 2 declined to participate. participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
11 Participants
n=25 Participants • 62 participants were assessed for eligibility; 2 were ineligible and 2 declined to participate. participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
27 Participants
n=50 Participants • 62 participants were assessed for eligibility; 2 were ineligible and 2 declined to participate. participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
7 Participants
n=25 Participants • 62 participants were assessed for eligibility; 2 were ineligible and 2 declined to participate. participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
6 Participants
n=25 Participants • 62 participants were assessed for eligibility; 2 were ineligible and 2 declined to participate. participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
13 Participants
n=50 Participants • 62 participants were assessed for eligibility; 2 were ineligible and 2 declined to participate. participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=25 Participants • 62 participants were assessed for eligibility; 2 were ineligible and 2 declined to participate. participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
5 Participants
n=25 Participants • 62 participants were assessed for eligibility; 2 were ineligible and 2 declined to participate. participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
7 Participants
n=50 Participants • 62 participants were assessed for eligibility; 2 were ineligible and 2 declined to participate. participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
|
Race/Ethnicity, Customized
Hispanic Black
|
0 Participants
n=25 Participants • 62 participants were assessed for eligibility; 2 were ineligible and 2 declined to participate. participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
2 Participants
n=25 Participants • 62 participants were assessed for eligibility; 2 were ineligible and 2 declined to participate. participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
2 Participants
n=50 Participants • 62 participants were assessed for eligibility; 2 were ineligible and 2 declined to participate. participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
|
Race/Ethnicity, Customized
Native American
|
0 Participants
n=25 Participants • 62 participants were assessed for eligibility; 2 were ineligible and 2 declined to participate. participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
1 Participants
n=25 Participants • 62 participants were assessed for eligibility; 2 were ineligible and 2 declined to participate. participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
1 Participants
n=50 Participants • 62 participants were assessed for eligibility; 2 were ineligible and 2 declined to participate. participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants • Participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
25 participants
n=25 Participants • Participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
50 participants
n=50 Participants • Participants were enrolled \& randomized to the CTRL (n=28) or iTAB intervention arm (n=30). Analyses included 25 iTAB participants (excluded: 3 lost MEMS, 1 entered rehab facility, 1 had illness \& went off meds), and 25 CTRL participants (excluded: 1 lost MEMS, 1 lost contact, 1 deceased unrelated to study).
|
PRIMARY outcome
Timeframe: 4-weekPopulation: Of the 30 participants in iTAB intervention group, 25 were analyzed; 3 lost MEMS cap, 1 in rehabilitation facility, 1 too sick.Of the 28 participants in CTRL group, 25 were analyzed; 1 lost MEMS cap, 1 lost to follow up, 1 deceased.
MEMS-derived percent adherence to HIV and psychotropic medications over the study period, i.e., (\[# of bottle openings\]/\[# of prescribed doses\]\*100%).
Outcome measures
| Measure |
Personalized Reminder Texting + Psychoeducation (iTAB)
n=25 Participants
Individualized Texting for Adherence Building (iTAB): Participants will receive daily text messaging reminders for antiretroviral and psychotropic medication adherence. These text messages will be targeted to the specific schedule and needs of the individual.
Psychoeducation: Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV and psychotropic medications. Participants will also receive daily text messages to assess mood.
|
Psychoeducation (CTRL)
n=25 Participants
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV and psychotropic medications. Participants will also receive daily text messages to assess mood, but these messages will not receive the medication reminder text messages.
|
|---|---|---|
|
Proportion Adherent to ARV and Psychotropic Medication by Electronic Monitoring System (MEMS)
PSY adherence
|
83.9 percentage of taken doses
Interval 70.2 to 95.1
|
90.0 percentage of taken doses
Interval 74.5 to 96.7
|
|
Proportion Adherent to ARV and Psychotropic Medication by Electronic Monitoring System (MEMS)
ARV adherence
|
90.3 percentage of taken doses
Interval 75.8 to 96.5
|
90.0 percentage of taken doses
Interval 77.6 to 93.3
|
PRIMARY outcome
Timeframe: 4-weekPopulation: Of the 30 participants in iTAB intervention group, 25 were analyzed; 3 lost MEMS cap, 1 in rehabilitation facility, 1 too sick.Of the 28 participants in CTRL group, 25 were analyzed; 1 lost MEMS cap, 1 lost to follow up, 1 deceased.
Medication "dose timing window" for participants was calculated by subtracting the time at which the MEMS cap was opened (i.e., dose taken) from the previously indicated targeted time for dosing (i.e., the time at which participants received adherence text messages for the iTAB intervention group, or time at which participants indicated they would take their medication for the control group). Dose timing windows were used in analyses to indicate the discrepancy between intended dosing time and actual dosing time (in minutes) such that higher values indicate more variable dosing (i.e., decreased therapeutic coverage).
Outcome measures
| Measure |
Personalized Reminder Texting + Psychoeducation (iTAB)
n=25 Participants
Individualized Texting for Adherence Building (iTAB): Participants will receive daily text messaging reminders for antiretroviral and psychotropic medication adherence. These text messages will be targeted to the specific schedule and needs of the individual.
Psychoeducation: Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV and psychotropic medications. Participants will also receive daily text messages to assess mood.
|
Psychoeducation (CTRL)
n=25 Participants
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV and psychotropic medications. Participants will also receive daily text messages to assess mood, but these messages will not receive the medication reminder text messages.
|
|---|---|---|
|
Dose Timing for ARV and Psychotropic Medications as Determined by Electronic Medication Monitoring System (MEMS).
Dose timing window for ART
|
27.8 minutes from dosing target time
Interval 15.0 to 105.5
|
77.0 minutes from dosing target time
Interval 36.3 to 137.8
|
|
Dose Timing for ARV and Psychotropic Medications as Determined by Electronic Medication Monitoring System (MEMS).
Dose timing window for PST
|
46.8 minutes from dosing target time
Interval 18.7 to 121.3
|
66.5 minutes from dosing target time
Interval 24.0 to 135.0
|
Adverse Events
Personalized Reminder Texting + Psychoeducation (iTAB)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Psychoeducation (CTRL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Personalized Reminder Texting + Psychoeducation (iTAB)
n=30 participants at risk
Individualized Texting for Adherence Building (iTAB): Participants will receive daily text messaging reminders for antiretroviral and psychotropic medication adherence. These text messages will be targeted to the specific schedule and needs of the individual.
Psychoeducation: Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV and psychotropic medications. Participants will also receive daily text messages to assess mood.
|
Psychoeducation (CTRL)
n=28 participants at risk
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV and psychotropic medications. Participants will also receive daily text messages to assess mood, but these messages will not receive the medication reminder text messages.
|
|---|---|---|
|
Social circumstances
Rehabilitation Facility
|
3.3%
1/30 • Number of events 1
|
0.00%
0/28
|
|
Immune system disorders
Participant sickness
|
3.3%
1/30 • Number of events 1
|
0.00%
0/28
|
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