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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
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Seth Kalichman, University of Connecticut

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Medication Adherence Behavioral: Adherence Counseling Behavioral: General Health Counseling Behavioral: Text Messages Phase 1 Phase 2

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
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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
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 Behavioral: Adherence Counseling
5 Sessions of theory-based medication adherence counseling
Behavioral: Text Messages
Daily medication regimen tailored adherence reminders delivered by cell phone
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
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.
 Behavioral: General Health Counseling
5 sessions of health improvement counseling
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Unannounced Pill Count Adherence [ Time Frame: Monthly ]
    Unannounced phone-based pill counts conducted monthly to obtain an objective measure of medication adherence


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, Connecticut
University of Connecticut
Storrs, Connecticut, United States, 06269
Sponsors and Collaborators
University of Connecticut
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Seth C Kalichman, PhD University of Connecticut
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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