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

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.

Study Overview

• Status: Completed
• Conditions: Medication Adherence
• Intervention / Treatment: Behavioral: Adherence Counseling; Behavioral: Text Messages; Behavioral: General Health Counseling

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 Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Storrs, Connecticut, United States, 06269
      • University of Connecticut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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: Text Messages; Daily medication regimen tailored adherence reminders delivered by cell phone; Behavioral: General Health Counseling; 5 sessions of health improvement counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chart Abstracted Viral Load	Patient HIV viral load is abstracted from medical records at baseline and at 12-month retrospective follow-up.	12 months retrospective

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unannounced Pill Count Adherence	Unannounced phone-based pill counts conducted monthly to obtain an objective measure of medication adherence	Monthly

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Seth C Kalichman, PhD, University of Connecticut

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: May 20, 2011
• First Submitted That Met QC Criteria: May 20, 2011
• First Posted (Estimate): May 24, 2011

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Adherence; HIV; AIDS; Medication
• Other Study ID Numbers: H10-332; 1R01NR012962-01 (U.S. NIH Grant/Contract)