iTAB: Personalized Text Messages to Improve Antiretroviral Treatment (ART) Adherence in HIV+ Methamphetamine Users

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT01317277
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 2
• Duration (Months): 38
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

Methamphetamine (METH) is a debilitating and frequently abused substance that is often comorbid with HIV infection. HIV+ persons with current METH abuse or dependence (HIV+/METH+) have several characteristics, in addition to their substance use, that make them particularly susceptible to nonadherence to antiretroviral treatment (ART) including elevated rates of neurocognitive impairment, co-occurrence of psychiatric disorders, and unstable living situations. The investigators propose an intervention development study designed to address these potential mechanisms of nonadherence with the following Specific Aims: 1) To further develop and refine a personalized, automated, real-time, mobile phone, text messaging intervention (iTAB) designed to improve adherence to ART medications among HIV+/METH+ persons; 2) To evaluate the acceptability and effectiveness of a brief psychoeducation plus text messaging intervention (iTAB) as compared to psychoeducation alone (CTRL) for the improvement of objectively measured medication adherence among HIV+/METH+ persons; and 3) To examine predictors of within-person trajectories of nonadherence using the longitudinal data collected over the study. In order to realize these aims, the investigators will leverage the infrastructure of two unique UCSD resources increasing likelihood of study success, impact, and innovation: 1) the Translational Methamphetamine AIDS Research Center (TMARC), which is a NIDA-funded center that focuses on the combined effects of METH and HIV infection, and 2) the California Institute for Telecommunications and Information Technology (Calit2), which conducts research on state-of-the-art wireless means of health promotion. Initially, the investigators will refine the iTAB intervention to ensure that it is user-centered and tailored to the needs of HIV+/METH+ persons via focus groups and rapid prototyping. Once refined, the proposed iTAB intervention will use text messages that are automated, scalable, personalized, interactive, flexible, and motivating. The investigators will assess the acceptability and effectiveness of iTAB in improving objectively measured adherence (i.e., MEMS caps) over a 6-week period via a pilot RCT with 40 HIV+/METH+ assigned to the iTAB intervention and 20 HIV+/METH+ assigned to a psychoeducational control. Predictors of nonadherence including frequency of METH use, neuropsychological impairment, and mood will be examined to determine whether iTAB is better able to compensate for these factors associated with nonadherence as compared to CTRL. Further refinement to the iTAB intervention will be made in order to pursue a large-scale R01 using our tailored intervention.

Condition or Disease	Intervention/Treatment	Phase
HIV; AIDS	Behavioral: individualized Texting for Adherence Building (iTAB); Behavioral: Psychoeducation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Personalized Text Messages to Improve ART Adherence in HIV+ Methamphetamine Users
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Personalized Reminder Texting (iTAB) + Psychoeducation 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.	Behavioral: individualized Texting for Adherence Building (iTAB); Behavioral: Psychoeducation Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence. Behavioral: 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.
Active Comparator: Psychoeducation (CTRL) 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.	Behavioral: Psychoeducation; Behavioral: Psychoeducation Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.

Outcome Measures

Primary Outcome Measures

1. Overall MEMS Adherence to Antiretroviral Medication [6 weeks]

   Adherence was defined as the percentage of taken doses using Medication Event Monitoring Systems (MEMS); i.e., [(# of bottle openings)/(# of prescribed doses)*100].

2. MEMS Adherence to Antiretroviral Medication Based on Dose Timing [6 weeks]

   Adherence 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].

Secondary Outcome Measures

1. Text-reported METH Use [Completion of 6-week intervention]

   For 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)].

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion/exclusion criteria are generally lenient in order to ensure that our sample is as representative as possible of the overall HIV+/METH+ population.

Inclusion Criteria:

• Ability to provide informed consent

• 18 years or older at the time of enrollment

• HIV-infected

• DSM-IV diagnosis of methamphetamine abuse or dependence in the past 30 days

• Taking at least one medication to treat HIV illness

• Indication of less than 100% adherence to antiretroviral (ART) medication

• Willingness to use electronic monitoring caps to track ART medication

• Willingness to respond to text messages

Exclusion Criteria:

• Axis I psychiatric diagnosis of psychotic disorder or mood disorder with psychotic features

• Presence of a neurological condition (beyond HIV infection) known to impact cognitive functioning (e.g., Huntington's Disease, Stroke)

• Unwillingness or inability to use electronic medication monitoring technology

• Unwillingness or inability to use daily text messaging

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hnrc-Tmarc	San Diego	California	United States	92013

Sponsors and Collaborators

• University of California, San Diego

Investigators

• Principal Investigator: David J Moore, Ph.D., University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David J. Moore, Ph.D., Associate Professor of Psychiatry, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT01317277
• Other Study ID Numbers: 1R34DA031058-01A1
• First Posted: Mar 17, 2011
• Last Update Posted: Aug 27, 2021
• Last Verified: Aug 1, 2021

• Keywords provided by David J. Moore, Ph.D., Associate Professor of Psychiatry, University of California, San Diego: interventions; technology; drug abuse; methamphetamine

Study Results

Participant Flow

Arm/Group Title	iTAB + Psychoeducation	Psychoeducation
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	50	25
COMPLETED	43	23
NOT COMPLETED	7	2

Baseline Characteristics

Arm/Group Title	iTAB + Psychoeducation	Psychoeducation	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	50	25	75
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.4 (7.7)	46.0 (8.9)	45.6 (8.1)
Sex: Female, Male (Count of Participants)
Female	3 6%	0 0%	3 4%
Male	40 80%	23 92%	63 84%
Race/Ethnicity, Customized (Count of Participants)
Non-Hispanic White	23 46%	7 28%	30 40%
Non-Hispanic Black	15 30%	7 28%	22 29.3%
Hispanic	5 10%	8 32%	13 17.3%
Pacific Islander	0 0%	1 4%	1 1.3%
Region of Enrollment (participants) [Number]
United States	50 100%	25 100%	75 100%

Outcome Measures

1. Primary Outcome

Title	Overall MEMS Adherence to Antiretroviral Medication
Description	Adherence was defined as the percentage of taken doses using Medication Event Monitoring Systems (MEMS); i.e., [(# of bottle openings)/(# of prescribed doses)*100].
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iTAB + Psychoeducation	Psychoeducation
Arm/Group Description	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.	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.
Measure Participants	43	23
Mean (Standard Deviation) [percentage of taken doses]	68.0 (0.3)	70.4 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	iTAB + Psychoeducation, Psychoeducation
	Comments	Randomization strategy for target 75 participants of 2:1 [iTAB(n=50):CTRL(n=25)], resulting in 80% power to detect effect size of .71 for difference of adherence rates between groups (Wilcoxon-Mann-Whitney critical t=1.99, df=69.6). Final # analyzed: iTAB (n=43) & CTRL (n=23).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.68
	Comments	In between-group analyses, overall MEMS adherence was defined as % of doses taken.
	Method	Wilcoxon (Mann-Whitney)
	Comments	Non-parametric methods.

2. Primary Outcome

Title	MEMS Adherence to Antiretroviral Medication Based on Dose Timing
Description	Adherence 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].
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iTAB + Psychoeducation	Psychoeducation
Arm/Group Description	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.	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.
Measure Participants	43	23
Mean (Standard Deviation) [percentage of taken doses]	43.9 (32.2)	45.5 (30.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	iTAB + Psychoeducation, Psychoeducation
	Comments	Randomization strategy for target 75 participants of 2:1 [iTAB(n=50):CTRL(n=25)], resulting in 80% power to detect effect size of .71 for difference of adherence rates between groups (Wilcoxon-Mann-Whitney critical t=1.99, df=69.6). Final # analyzed: iTAB (n=43) & CTRL (n=23).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.95
	Comments	MEMS adherence based on dose timing was examined for between-group differences.
	Method	Wilcoxon (Mann-Whitney)
	Comments	Non-parametric methods

3. Secondary Outcome

Title	Text-reported METH Use
Description	For 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)].
Time Frame	Completion of 6-week intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iTAB + Psychoeducation	Psychoeducation
Arm/Group Description	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.	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.
Measure Participants	43	23
Mean (Inter-Quartile Range) [METH use days]	14.4	22.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	iTAB + Psychoeducation
	Comments	Text-reported METH use days
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments	Z = -1.97
	Method	Wilcoxon (Mann-Whitney)
	Comments	Non-parametric methods; P-Value is calculated.

Adverse Events

Arm/Group Title	iTAB + Psychoeducation		Psychoeducation
Arm/Group Description	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.		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.
All Cause Mortality
	iTAB + Psychoeducation		Psychoeducation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/25 (0%)
Serious Adverse Events
	iTAB + Psychoeducation		Psychoeducation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	iTAB + Psychoeducation		Psychoeducation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/50 (2%)		0/25 (0%)
Immune system disorders
Other medical complications	1/50 (2%)	1	0/25 (0%)	0

Limitations/Caveats

1) Small sample size; 2) Short time period; 3) MEMS adherence data based on # of cap openings, not directly whether the medication was ingested; 4) No group without psychoeducation component

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.