Nurse Delivered Cell Phone Adherence Intervention (Pick It UP) (PIU)
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ClinicalTrials.gov Identifier: NCT01359280 |
Recruitment Status
:
Completed
First Posted
: May 24, 2011
Last Update Posted
: December 3, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Medication Adherence | Behavioral: Adherence Counseling Behavioral: General Health Counseling Behavioral: Text Messages | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Nurse Delivered Cell Phone Adherence Intervention |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | August 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Adherence Counseling + Text Messages
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.
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Behavioral: Adherence Counseling
5 Sessions of theory-based medication adherence counseling
Behavioral: Text Messages
Daily medication regimen tailored adherence reminders delivered by cell phone
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Experimental: Adherence Counseling Only
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.
|
Behavioral: Adherence Counseling
5 Sessions of theory-based medication adherence counseling
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Placebo Comparator: General Health Counseling Only
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.
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Behavioral: General Health Counseling
5 sessions of health improvement counseling
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Placebo Comparator: General Health Messages + Text Messages
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.
|
Behavioral: General Health Counseling
5 sessions of health improvement counseling
Behavioral: Text Messages
Daily medication regimen tailored adherence reminders delivered by cell phone
|
- 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.
- Unannounced Pill Count Adherence [ Time Frame: Monthly ]Unannounced phone-based pill counts conducted monthly to obtain an objective measure of medication adherence

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 or older
- Currently taking HIV treatment medication with non-adherence
Exclusion Criteria:
- Under age 18
- Not HIV positive
- Not taking HIV treatment medications
- Adherent to HIV Medications

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359280
United States, Connecticut | |
University of Connecticut | |
Storrs, Connecticut, United States, 06269 |
Principal Investigator: | Seth C Kalichman, PhD | University of Connecticut |
Responsible Party: | Seth Kalichman, Professor, University of Connecticut |
ClinicalTrials.gov Identifier: | NCT01359280 History of Changes |
Other Study ID Numbers: |
H10-332 1R01NR012962-01 ( U.S. NIH Grant/Contract ) |
First Posted: | May 24, 2011 Key Record Dates |
Last Update Posted: | December 3, 2014 |
Last Verified: | December 2014 |
Keywords provided by Seth Kalichman, University of Connecticut:
HIV AIDS Medication Adherence |