Nurse Delivered Cell Phone Adherence Intervention (Pick It UP) (PIU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Connecticut
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Seth Kalichman, University of Connecticut
ClinicalTrials.gov Identifier:
NCT01359280
First received: May 20, 2011
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Medication Adherence
Behavioral: Adherence Counseling
Behavioral: General Health Counseling
Behavioral: Text Messages
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nurse Delivered Cell Phone Adherence Intervention

Resource links provided by NLM:


Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • Chart Abstracted Viral Load [ Time Frame: 12 months retrospective ] [ Designated as safety issue: No ]
    Patient HIV viral load is abstracted from medical records at baseline and at 12-month retrospective follow-up.


Secondary Outcome Measures:
  • Unannounced Pill Count Adherence [ Time Frame: Monthly ] [ Designated as safety issue: No ]
    Unannounced phone-based pill counts conducted monthly to obtain an objective measure of medication adherence


Estimated Enrollment: 600
Study Start Date: July 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359280

Contacts
Contact: Chauncey Cherry, MPH (404) 892-3500 chauncey.cherry@share.uconn.edu
Contact: Seth C Kalichman, PhD (860) 486-3706 seth.k@uconn.edu

Locations
United States, Connecticut
University of Connecticut Recruiting
Storrs, Connecticut, United States, 06269
Contact: Chauncey Cherry, MPH    404-892-3500    chauncey.cherry@share.uconn.edu   
Contact: Seth Kalichman, PhD    (860) 208 3706    seth.k@uconn.edu   
Sponsors and Collaborators
University of Connecticut
Investigators
Principal Investigator: Seth C Kalichman, PhD University of Connecticut
  More Information

No publications provided

Responsible Party: Seth Kalichman, Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT01359280     History of Changes
Other Study ID Numbers: H10-332, 1R01NR012962-01
Study First Received: May 20, 2011
Last Updated: June 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut:
HIV
AIDS
Medication
Adherence

ClinicalTrials.gov processed this record on August 26, 2014