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

This study is currently recruiting participants.
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

May 20, 2011
June 14, 2013
July 2011
July 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01359280 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Nurse Delivered Cell Phone Adherence Intervention (Pick It UP)
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Medication Adherence
  • Behavioral: Adherence Counseling
    5 Sessions of theory-based medication adherence counseling
  • Behavioral: General Health Counseling
    5 sessions of health improvement counseling
  • Behavioral: Text Messages
    Daily medication regimen tailored adherence reminders delivered by cell phone
  • 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.
    Interventions:
    • Behavioral: Adherence Counseling
    • Behavioral: Text Messages
  • 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.
    Intervention: Behavioral: 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.
    Intervention: Behavioral: General Health 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.
    Interventions:
    • Behavioral: General Health Counseling
    • Behavioral: Text Messages
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Chauncey Cherry, MPH (404) 892-3500 chauncey.cherry@share.uconn.edu
Contact: Seth C Kalichman, PhD (860) 486-3706 seth.k@uconn.edu
United States
 
NCT01359280
H10-332, 1R01NR012962-01
No
Seth Kalichman, University of Connecticut
University of Connecticut
National Institute of Nursing Research (NINR)
Principal Investigator: Seth C Kalichman, PhD University of Connecticut
University of Connecticut
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP