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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized Reminder Texting (iTAB) + Psychoeducation | Experimental | 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. |
|
| Psychoeducation (CTRL) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| individualized Texting for Adherence Building (iTAB) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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]. | 6 weeks |
| 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]. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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)]. | Completion of 6-week intervention |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J Moore, Ph.D. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hnrc-Tmarc | San Diego | California | 92013 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29958127 | Result | Moore DJ, Pasipanodya EC, Umlauf A, Rooney AS, Gouaux B, Depp CA, Atkinson JH, Montoya JL. Individualized texting for adherence building (iTAB) for methamphetamine users living with HIV: A pilot randomized clinical trial. Drug Alcohol Depend. 2018 Aug 1;189:154-160. doi: 10.1016/j.drugalcdep.2018.05.013. Epub 2018 Jun 21. | |
| 32779730 | Derived | Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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]. | Posted | Mean | Standard Deviation | percentage of taken doses | 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other medical complications | Immune system disorders | Participant developed other medical complications not related to study participation |
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David J Moore, Professor of Psychiatry | UCSD HIV Neurobehavioral Research Program (HNRP) | 619-543-5093 | djmoore@ucsd.edu |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| Psychoeducation | Behavioral | 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. |
|
| 24078868 | Derived | Moore DJ, Montoya JL, Blackstone K, Rooney A, Gouaux B, Georges S, Depp CA, Atkinson JH, Tmarc Group T. Preliminary Evidence for Feasibility, Use, and Acceptability of Individualized Texting for Adherence Building for Antiretroviral Adherence and Substance Use Assessment among HIV-Infected Methamphetamine Users. AIDS Res Treat. 2013;2013:585143. doi: 10.1155/2013/585143. Epub 2013 Sep 3. |
| Unable to comply with intervention |
|
| Withdrawal by Subject |
|
| Adverse Event |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 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) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 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) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Psychoeducation | 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. |
|
|
|
| Primary | 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]. | Posted | Mean | Standard Deviation | percentage of taken doses | 6 weeks |
|
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| Secondary | 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)]. | Posted | Mean | Inter-Quartile Range | METH use days | Completion of 6-week intervention |
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| 0 |
| 50 |
| 0 |
| 50 |
| 1 |
| 50 |
| EG001 | Psychoeducation | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |