AIDS, HIV
Conditions
Keywords
interventions, technology, drug abuse, methamphetamine
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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., \[(# of bottle openings)/(# of prescribed doses)\*100\]. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 \[i.e., (# of days endorsing METH use)/(# of texts responded to)\]. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 25 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost MEMS | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Unable to comply with intervention | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | iTAB + Psychoeducation | Psychoeducation | Total |
|---|---|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 7.7 | 46.0 years STANDARD_DEVIATION 8.9 | 45.6 years STANDARD_DEVIATION 8.1 |
| Race/Ethnicity, Customized Hispanic | 5 Participants | 8 Participants | 13 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 15 Participants | 7 Participants | 22 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 23 Participants | 7 Participants | 30 Participants |
| Race/Ethnicity, Customized Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 50 participants | 25 participants | 75 participants |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 40 Participants | 23 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 25 |
| other Total, other adverse events | 1 / 50 | 0 / 25 |
| serious Total, serious adverse events | 0 / 50 | 0 / 25 |
Outcome results
MEMS Adherence to Antiretroviral Medication Based on Dose Timing
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iTAB + Psychoeducation | MEMS Adherence to Antiretroviral Medication Based on Dose Timing | 43.9 percentage of taken doses | Standard Deviation 32.2 |
| Psychoeducation | MEMS Adherence to Antiretroviral Medication Based on Dose Timing | 45.5 percentage of taken doses | Standard Deviation 30.5 |
Overall MEMS Adherence to Antiretroviral Medication
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iTAB + Psychoeducation | Overall MEMS Adherence to Antiretroviral Medication | 68.0 percentage of taken doses | Standard Deviation 0.3 |
| Psychoeducation | Overall MEMS Adherence to Antiretroviral Medication | 70.4 percentage of taken doses | Standard Deviation 0.3 |
Text-reported METH Use
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| iTAB + Psychoeducation | Text-reported METH Use | 14.4 METH use days |
| Psychoeducation | Text-reported METH Use | 22.0 METH use days |