AdherenceNCT01959217
Targeting PM to Improve HIV Adherence in Adolescents at Risk for Substance Abuse
A study testing PM Component Text Reminders in people with Adherence and Substance Abuse, run by Wayne State University at 2 sites in United States.
Trial summary
Medication adherence rates among youth living with HIV are inadequate to effectively manage the disease, and novel interventions grounded in basic behavioral sciences are needed. Read more about this study
- Who is it for?
- Ages 16 to 29 years
- Conditions the study is for
- Adherence, Substance Abuse
- What is being tested?
- PM Component Text Reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Dec 2012to 27 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV-infected
- Ability to speak and understand English
- Prescribed antiretroviral therapy for at least 24 weeks
- Detectable viral load in the last month
- Second detectable viral load in the previous 6 months
- Prescribed a regimen with at least two active drugs at study entry
- Regular access to a cell phone with text messaging.
Who cannot join
- Not fluent in English
- History of severe learning disability, mental retardation, major psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depression with psychotic features, etc.).
- History of a neurological conditions that might influence cognitive functioning (e.g., traumatic brain injury with loss of consciousness > 30 min, central nervous system neoplasms, stroke, seizure disorders, etc.).
- Participation in another adherence intervention trial
- On ART due to pregnancy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wayne State University
Detroit, Michigan, 48201
University of California, San Diego
La Jolla, California, 92093-0553
About this study
Official title: Targeting Prospective Memory to Improve HIV Adherence in Adolescents at Risk for Substance Abuse
Medication adherence rates among youth living with HIV are inadequate to effectively manage the disease, and novel interventions grounded in basic behavioral sciences are needed. This multi-site phased (3 phases) study plans to translate basic cognitive neuroscience regarding prospective memory (PM) into a more potent adherence intervention for youth living with HIV (YLH).
The phases are:
Read more
Phase 1: To improve PM in basic laboratory tasks in YLH with and without substance abuse.
-Hypothesis 1: Manipulations in three theory-based components of PM (strategic encoding, self-monitoring and cue salience) will improve PM within each participant.
Phase 2: To conduct proof of concept studies of a text-delivered PM intervention for taking ART in YLH with suboptimal adherence.
- Hypothesis 2: Using a multiple baseline across subjects design, adherence to antiretroviral therapy (ART) will improve following initiation of the PM adherence intervention and will be maintained for 6 weeks after tapering of the intervention.
- Hypothesis 2a: Similar feasibility, tolerability, and adherence improvement trends will be seen in youth with and without substance problems.
Phase 3: To conduct additional proof of concept studies, based on Phase 2 findings, of a text-delivered PM intervention for taking ART in YLH with suboptimal adherence.
- Hypothesis 3: Using a multiple baseline across subjects design, adherence to ART will improve following initiation of the PM adherence intervention and will be maintained for 6 weeks after tapering of the intervention.
- Hypothesis 3a: Similar feasibility, tolerability, and adherence improvement trends will be seen in youth.
Read the detailed description
Medication adherence rates among youth living with HIV are inadequate to effectively manage the disease, and novel interventions grounded in basic behavioral sciences are needed. Emerging evidence suggests that prospective memory (PM) could represent an important piece of the puzzle. PM is defined as the neurocognitive capacity to successfully form, maintain, and execute an intention at a particular point in the future in response to a specific cue. This study plans to translate basic cognitive neuroscience regarding PM into a more potent adherence intervention for YLH, a population at high risk for poor cognitive function, substance abuse, and poor adherence. While text message reminders are an increasingly popular adherence support, evidence of efficacy is equivocal particularly for the maintenance of adherence after reminders end. By using basic cognitive neuroscience to enhance the potency of technology-based interventions to improve PM for adherence tasks, we hope to achieve both greater initial gains as well as sustained improvements in adherence for youth with and without substance abuse.
This multi-site phased study plans to translate basic cognitive neuroscience regarding PM into a more potent adherence intervention for youth living with HIV (YLH).
- In Phase 1, we conducted theory-driven laboratory studies to improve three components of PM using a within-subjects design and traditional cognitive neuroscience tasks (strategic encoding, monitoring, and cue salience) in 60 youth from clinics where the principal investigators (PIs) are located (Detroit and San Diego).
- In Phase 2, we translated promising Phase 1 PM interventions to the youth's natural context, targeting adherence in combination with text messaging, and test for signals of efficacy using a multiple baseline design for YLH with suboptimal adherence (N=24; 12 with substance abuse and 12 without from Detroit).
- In Phase 3, we repeated the Phase 2 study (targeted adherence in combination with text message reminders and two-way assessment text messages, and tested for signals of efficacy using a multiple baseline design for YLH with suboptimal adherence; N=20; Detroit and national online recruitment).
- Conditions
- Adherence, Substance Abuse
- Being tested
- PM Component Text Reminders
- Keywords
- HIV, Substance Abuse, Prospective Memory
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM Component Text RemindersBehavioural
The number of PM components (strategic encoding, monitoring, and cue salience) that will comprise the tailored text reminders will be determined by Phase 1.
| Study group | Role | What they receive |
|---|---|---|
| PM Component Text Reminders | Experimental | There will be a a single face-to-face intervention followed by tailored text reminders. The number of PM components (strategic encoding, monitoring, and cue salience) that will comprise the tailored text message reminders will be determined by Phase 1. Receives: Behavioral: PM Component Text Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Medication Adherence
Viral load measurement will be obtained by a blood sample to measure medication adherence
Measured: Change from baseline measurement to 3-months, change from 3-months to 6-months, and change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study start13 Dec 2012
- Primary completion31 May 2018
- Study completion27 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Angulique Outlaw, Wayne State University
- Investigators
- Sylvie Naar-King, Ph.D., Principal investigator, University of FloridaSteven P Woods, Ph.D., Principal investigator, University of HoustonAngulique Y Outlaw, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959217
- Sponsor's protocol ID
- 1R01DA034497
- Status last verified
- Oct 2018
- First submitted
- 30 Aug 2013
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Weber E, Blackstone K, Woods SP. Cognitive neurorehabilitation of HIV-associated neurocognitive disorders: a qualitative review and call to action. Neuropsychol Rev. 2013 Mar;23(1):81-98. doi: 10.1007/s11065-013-9225-6. Epub 2013 Feb 16.
PubMed 23417497Faytell MP, Doyle K, Naar-King S, Outlaw A, Nichols S, Twamley E, Woods SP. Calendaring and alarms can improve naturalistic time-based prospective memory for youth infected with HIV. Neuropsychol Rehabil. 2018 Sep;28(6):1038-1051. doi: 10.1080/09602011.2016.1236733. Epub 2016 Sep 30.
PubMed 27687290Faytell MP, Doyle KL, Naar-King S, Outlaw AY, Nichols SL, Casaletto KB, Woods SP. Visualisation of future task performance improves naturalistic prospective memory for some younger adults living with HIV disease. Neuropsychol Rehabil. 2017 Dec;27(8):1142-1155. doi: 10.1080/09602011.2015.1122636. Epub 2015 Dec 21.
PubMed 26690580Woods SP, Doyle KL, Morgan EE, Naar-King S, Outlaw AY, Nichols SL, Loft S. Task importance affects event-based prospective memory performance in adults with HIV-associated neurocognitive disorders and HIV-infected young adults with problematic substance use. J Int Neuropsychol Soc. 2014 Jul;20(6):652-62. doi: 10.1017/S1355617714000435. Epub 2014 May 16.
PubMed 24834469Loft S, Doyle KL, Naar-King S, Outlaw AY, Nichols SL, Weber E, Casaletto KB, Woods SP. Allowing brief delays in responding improves event-based prospective memory for young adults living with HIV disease. J Clin Exp Neuropsychol. 2014;36(7):761-72. doi: 10.1080/13803395.2014.942255. Epub 2014 Aug 13.
PubMed 25116075
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Prospective Memory to Improve HIV Adherence in Adolescents at Risk for Substance Abuse
- ClinicalTrials.gov ID
- NCT01959217
- Acronym / sponsor ID
- 1R01DA034497
- Conditions
- Adherence, Substance Abuse
- Keywords
- HIV, Substance Abuse, Prospective Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 13 Dec 2012 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medication adherence rates among youth living with HIV are inadequate to effectively manage the disease, and novel interventions grounded in basic behavioral sciences are needed. This multi-site phased (3 phases) study plans to translate basic cognitive neuroscience regarding prospective memory (PM) into a more potent adherence intervention for youth living with HIV (YLH).
The phases are:
Phase 1: To improve PM in basic laboratory tasks in YLH with and without substance abuse.
-Hypothesis 1: Manipulations in three theory-based components of PM (strategic encoding, self-monitoring and cue salience) will improve PM within each participant.
Phase 2: To conduct proof of concept studies of a text-delivered PM intervention for taking ART in YLH with suboptimal adherence.
- Hypothesis 2: Using a multiple baseline across subjects design, adherence to antiretroviral therapy (ART) will improve following initiation of the PM adherence intervention and will be maintained for 6 weeks after tapering of the intervention.
- Hypothesis 2a: Similar feasibility, tolerability, and adherence improvement trends will be seen in youth with and without substance problems.
Phase 3: To conduct additional proof of concept studies, based on Phase 2 findings, of a text-delivered PM intervention for taking ART in YLH with suboptimal adherence.
- Hypothesis 3: Using a multiple baseline across subjects design, adherence to ART will improve following initiation of the PM adherence intervention and will be maintained for 6 weeks after tapering of the intervention.
- Hypothesis 3a: Similar feasibility, tolerability, and adherence improvement trends will be seen in youth.
Detailed description
Medication adherence rates among youth living with HIV are inadequate to effectively manage the disease, and novel interventions grounded in basic behavioral sciences are needed. Emerging evidence suggests that prospective memory (PM) could represent an important piece of the puzzle. PM is defined as the neurocognitive capacity to successfully form, maintain, and execute an intention at a particular point in the future in response to a specific cue. This study plans to translate basic cognitive neuroscience regarding PM into a more potent adherence intervention for YLH, a population at high risk for poor cognitive function, substance abuse, and poor adherence. While text message reminders are an increasingly popular adherence support, evidence of efficacy is equivocal particularly for the maintenance of adherence after reminders end. By using basic cognitive neuroscience to enhance the potency of technology-based interventions to improve PM for adherence tasks, we hope to achieve both greater initial gains as well as sustained improvements in adherence for youth with and without substance abuse.
This multi-site phased study plans to translate basic cognitive neuroscience regarding PM into a more potent adherence intervention for youth living with HIV (YLH).
- In Phase 1, we conducted theory-driven laboratory studies to improve three components of PM using a within-subjects design and traditional cognitive neuroscience tasks (strategic encoding, monitoring, and cue salience) in 60 youth from clinics where the principal investigators (PIs) are located (Detroit and San Diego).
- In Phase 2, we translated promising Phase 1 PM interventions to the youth's natural context, targeting adherence in combination with text messaging, and test for signals of efficacy using a multiple baseline design for YLH with suboptimal adherence (N=24; 12 with substance abuse and 12 without from Detroit).
- In Phase 3, we repeated the Phase 2 study (targeted adherence in combination with text message reminders and two-way assessment text messages, and tested for signals of efficacy using a multiple baseline design for YLH with suboptimal adherence; N=20; Detroit and national online recruitment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PM Component Text Reminders | Experimental | Behavioral: PM Component Text RemindersThere will be a a single face-to-face intervention followed by tailored text reminders. The number of PM components (strategic encoding, monitoring, and cue salience) that will comprise the tailored text message reminders will be determined by Phase 1. |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- HIV-infected
- Ability to speak and understand English
- Prescribed antiretroviral therapy for at least 24 weeks
- Detectable viral load in the last month
- Second detectable viral load in the previous 6 months
Key exclusion criteria (5 listed)
- Not fluent in English
- History of severe learning disability, mental retardation, major psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depression with psychotic features, etc.).
- History of a neurological conditions that might influence cognitive functioning (e.g., traumatic brain injury with loss of consciousness > 30 min, central nervous system neoplasms, stroke, seizure disorders, etc.).
- Participation in another adherence intervention trial
- On ART due to pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PM Component Text RemindersThe number of PM components (strategic encoding, monitoring, and cue salience) that will comprise the tailored text reminders will be determined by Phase 1. | Behavioural | PM Component Text Reminders |
Primary outcome
Change in Medication Adherence
Time frame: Change from baseline measurement to 3-months, change from 3-months to 6-months, and change from baseline to 6 months
Viral load measurement will be obtained by a blood sample to measure medication adherence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Background: PubMed 23417497Weber E, Blackstone K, Woods SP. Cognitive neurorehabilitation of HIV-associated neurocognitive disorders: a qualitative review and call to action. Neuropsychol Rev. 2013 Mar;23(1):81-98. doi: 10.1007/s11065-013-9225-6. Epub 2013 Feb 16.
- Results publication: PubMed 27687290Faytell MP, Doyle K, Naar-King S, Outlaw A, Nichols S, Twamley E, Woods SP. Calendaring and alarms can improve naturalistic time-based prospective memory for youth infected with HIV. Neuropsychol Rehabil. 2018 Sep;28(6):1038-1051. doi: 10.1080/09602011.2016.1236733. Epub 2016 Sep 30.
- Results publication: PubMed 26690580Faytell MP, Doyle KL, Naar-King S, Outlaw AY, Nichols SL, Casaletto KB, Woods SP. Visualisation of future task performance improves naturalistic prospective memory for some younger adults living with HIV disease. Neuropsychol Rehabil. 2017 Dec;27(8):1142-1155. doi: 10.1080/09602011.2015.1122636. Epub 2015 Dec 21.
- Results publication: PubMed 24834469Woods SP, Doyle KL, Morgan EE, Naar-King S, Outlaw AY, Nichols SL, Loft S. Task importance affects event-based prospective memory performance in adults with HIV-associated neurocognitive disorders and HIV-infected young adults with problematic substance use. J Int Neuropsychol Soc. 2014 Jul;20(6):652-62. doi: 10.1017/S1355617714000435. Epub 2014 May 16.
- Results publication: PubMed 25116075Loft S, Doyle KL, Naar-King S, Outlaw AY, Nichols SL, Weber E, Casaletto KB, Woods SP. Allowing brief delays in responding improves event-based prospective memory for young adults living with HIV disease. J Clin Exp Neuropsychol. 2014;36(7):761-72. doi: 10.1080/13803395.2014.942255. Epub 2014 Aug 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Naar-King, Ph.D. principal investigator
University of Florida
Steven P Woods, Ph.D. principal investigator
University of Houston
Angulique Y Outlaw, Ph.D. principal investigator
Wayne State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PM Component Text Reminders in people with Adherence and Substance Abuse, run by Wayne State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Medication Adherence (time frame: Change from baseline measurement to 3-months, change from 3-months to 6-months, and change from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01959217, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.