Medication AdherencePhase 1/2PIUNCT01359280
Nurse Delivered Cell Phone Adherence Intervention (Pick It UP)
A Phase 1/2 study testing Adherence Counseling, General Health Counseling and Text Messages in people with Medication Adherence, run by University of Connecticut at 1 site in United States.
Trial summary
Persistent adherence to antiretroviral therapy is necessary for the successful treatment of HIV infection. The proposed research will test a theory-based behavioral intervention that includes objectively monitoring HIV treatment adherence with corrective feedback delivered by cell phone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Adherence Counseling, General Health Counseling and Text Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Aug 2014
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Currently taking HIV treatment medication with non-adherence
Who cannot join
- Under age 18
- Not HIV positive
- Not taking HIV treatment medications
- Adherent to HIV Medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Nurse Delivered Cell Phone Adherence Intervention
Persistent adherence to antiretroviral therapy is necessary for the successful treatment of HIV infection. The proposed research will test a theory-based behavioral intervention that includes objectively monitoring HIV treatment adherence with corrective feedback delivered by cell phone. The study will also test the independent effects of an automated text message reminder system for sustaining adherence improvements. The intervention under study has utility for people living with HIV/AIDS In resource limited rural and urban settings.
Read the detailed description
This study is testing a theory-based HIV treatment adherence intervention delivered by cell phone to patients in urban and rural areas. Adherence to antiretroviral (ART) medications is necessary to achieve HIV suppression and non-adherence can lead to treatment resistant genetic variants of HIV. People living with HIV/AIDS often experience difficulty sustaining high-levels of treatment adherence. Most factors that interfere with adherence are unanticipated and occur between clinical visits, including depression, side effects, substance use, and lapses in pharmacy refill. We will conduct a randomized clinical trial to test a cell phone-delivered theory-based medication adherence counseling intervention. The intervention is grounded in Self-Regulation Model and utilizes unannounced pill counts to monitor adherence and guide corrective feedback within the counseling context. Using pill count adherence information for counseling allows providers to detect and correct patient non-adherence within a time frame that can head off viral resistance. An experimental factorial design will test the effects of counseling and a text message reminder system as well the interaction of counseling and text message components with 600 men and women receiving HIV treatment. Following screening, informed consent and baseline assessments participants will be randomized to one of four intervention conditions:(a) self-regulation counseling + regimen tailored text message reminders; (b) self-regulation counseling only; (c) control counseling + regimen tailored text reminders; or (d) control counseling only. The study will therefore use a 2 (self-regulation counseling) x 2 (text message reminders) full factorial deign with participants followed for 9 months post-intervention. The primary endpoints are medication adherence assessed by unannounced pill counts and HIV RNA (viral load). This newly developed intervention strategy is grounded in Self-Regulation Theory and is designed for use in clinical settings with limited resources.
- Conditions
- Medication Adherence
- Being tested
- Adherence Counseling, General Health Counseling, Text Messages
- Keywords
- HIV, AIDS, Medication, Adherence
- Medical subject headings
- Medication Adherence, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence CounselingBehavioural
5 Sessions of theory-based medication adherence counseling
General Health CounselingBehavioural
5 sessions of health improvement counseling
Text MessagesBehavioural
Daily medication regimen tailored adherence reminders delivered by cell phone
| Study group | Role | What they receive |
|---|---|---|
| Adherence Counseling + Text Messages | Experimental | Participants receive one office-based adherence counseling session and 4 phone-delivered counseling sessions focused on antiretroviral adherence strategies using a model of behavioral self regulation skills building. Participants also receive follow-up medication reminder text messages delivered by cell phone. Receives: Behavioral: Adherence Counseling; Behavioral: Text Messages |
| Adherence Counseling Only | Experimental | Participants receive one office-based adherence counseling session and 4 phone-delivered counseling sessions focused on antiretroviral adherence strategies using a model of behavioral self regulation skills building. Receives: Behavioral: Adherence Counseling |
| General Health Counseling Only | Placebo comparator | Participants receive one office-based counseling session and 4 phone-delivered counseling sessions focused on general health and nutrition strategies using a model of behavioral self regulation skills building. Receives: Behavioral: General Health Counseling |
| General Health Messages + Text Messages | Placebo comparator | Participants receive one office-based counseling session and 4 phone-delivered counseling sessions focused on general health and nutrition strategies using a model of behavioral self regulation skills building. Participants also receive follow-up medication reminder text messages delivered by cell phone. Receives: Behavioral: General Health Counseling; Behavioral: Text Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chart Abstracted Viral Load
Patient HIV viral load is abstracted from medical records at baseline and at 12-month retrospective follow-up.
Measured: 12 months retrospective
Secondary outcomes (1)
Unannounced Pill Count Adherence
Unannounced phone-based pill counts conducted monthly to obtain an objective measure of medication adherence
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Seth Kalichman, University of Connecticut
- Investigators
- Seth C Kalichman, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359280
- Sponsor's protocol ID
- H10-332
- Other IDs
- 1R01NR012962-01
- Acronym
- PIU
- Status last verified
- Dec 2014
- First submitted
- 20 May 2011
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Delivered Cell Phone Adherence Intervention
- ClinicalTrials.gov ID
- NCT01359280
- Acronym / sponsor ID
- PIU / H10-332
- Conditions
- Medication Adherence
- Keywords
- HIV, AIDS, Medication, Adherence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jul 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 May 2011 (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.
Persistent adherence to antiretroviral therapy is necessary for the successful treatment of HIV infection. The proposed research will test a theory-based behavioral intervention that includes objectively monitoring HIV treatment adherence with corrective feedback delivered by cell phone. The study will also test the independent effects of an automated text message reminder system for sustaining adherence improvements. The intervention under study has utility for people living with HIV/AIDS In resource limited rural and urban settings.
Detailed description
This study is testing a theory-based HIV treatment adherence intervention delivered by cell phone to patients in urban and rural areas. Adherence to antiretroviral (ART) medications is necessary to achieve HIV suppression and non-adherence can lead to treatment resistant genetic variants of HIV. People living with HIV/AIDS often experience difficulty sustaining high-levels of treatment adherence. Most factors that interfere with adherence are unanticipated and occur between clinical visits, including depression, side effects, substance use, and lapses in pharmacy refill. We will conduct a randomized clinical trial to test a cell phone-delivered theory-based medication adherence counseling intervention. The intervention is grounded in Self-Regulation Model and utilizes unannounced pill counts to monitor adherence and guide corrective feedback within the counseling context. Using pill count adherence information for counseling allows providers to detect and correct patient non-adherence within a time frame that can head off viral resistance. An experimental factorial design will test the effects of counseling and a text message reminder system as well the interaction of counseling and text message components with 600 men and women receiving HIV treatment. Following screening, informed consent and baseline assessments participants will be randomized to one of four intervention conditions:(a) self-regulation counseling + regimen tailored text message reminders; (b) self-regulation counseling only; (c) control counseling + regimen tailored text reminders; or (d) control counseling only. The study will therefore use a 2 (self-regulation counseling) x 2 (text message reminders) full factorial deign with participants followed for 9 months post-intervention. The primary endpoints are medication adherence assessed by unannounced pill counts and HIV RNA (viral load). This newly developed intervention strategy is grounded in Self-Regulation Theory and is designed for use in clinical settings with limited resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adherence Counseling + Text Messages | Experimental | Behavioral: Adherence Counseling, Behavioral: Text MessagesParticipants receive one office-based adherence counseling session and 4 phone-delivered counseling sessions focused on antiretroviral adherence strategies using a model of behavioral self regulation skills building. Participants also receive follow-up medication reminder text messages delivered by cell phone. |
| Adherence Counseling Only | Experimental | Behavioral: Adherence CounselingParticipants receive one office-based adherence counseling session and 4 phone-delivered counseling sessions focused on antiretroviral adherence strategies using a model of behavioral self regulation skills building. |
| General Health Counseling Only | Placebo comparator | Behavioral: General Health CounselingParticipants receive one office-based counseling session and 4 phone-delivered counseling sessions focused on general health and nutrition strategies using a model of behavioral self regulation skills building. |
| General Health Messages + Text Messages | Placebo comparator | Behavioral: General Health Counseling, Behavioral: Text MessagesParticipants receive one office-based counseling session and 4 phone-delivered counseling sessions focused on general health and nutrition strategies using a model of behavioral self regulation skills building. Participants also receive follow-up medication reminder text messages delivered by cell phone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older
- Currently taking HIV treatment medication with non-adherence
Key exclusion criteria (4 listed)
- Under age 18
- Not HIV positive
- Not taking HIV treatment medications
- Adherent to HIV Medications
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 |
|---|---|---|
| Adherence Counseling5 Sessions of theory-based medication adherence counseling | Behavioural | Adherence Counseling + Text Messages, Adherence Counseling Only |
| General Health Counseling5 sessions of health improvement counseling | Behavioural | General Health Counseling Only, General Health Messages + Text Messages |
| Text MessagesDaily medication regimen tailored adherence reminders delivered by cell phone | Behavioural | Adherence Counseling + Text Messages, General Health Messages + Text Messages |
Primary outcome
Chart Abstracted Viral Load
Time frame: 12 months retrospective
Patient HIV viral load is abstracted from medical records at baseline and at 12-month retrospective follow-up.
1 secondary outcome
Unannounced Pill Count Adherence
Time frame: Monthly
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 3 Dec 2014.
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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.
Seth C Kalichman, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adherence Counseling, General Health Counseling and Text Messages in people with Medication Adherence, run by University of Connecticut at 1 site 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 2 inclusion and 4 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Chart Abstracted Viral Load (time frame: 12 months retrospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2014.