Nurse Delivered Cell Phone Adherence Intervention (Pick It UP)

Medication Adherence Clinical Trial

— PIU  

Official title:

Nurse Delivered Cell Phone Adherence Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359280
• Other study ID #: H10-332
• Secondary ID: 1R01NR012962-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 20, 2011
• Last updated: December 2, 2014
• Start date: July 2011
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Medication Adherence

Intervention

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

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Unannounced Pill Count Adherence	Unannounced phone-based pill counts conducted monthly to obtain an objective measure of medication adherence	Monthly	No