Cell Phone Intervention to Support Antiretroviral Therapy (ART) Adherence in Kenya

This study has been completed.

Sponsor:

Collaborator:

University of Nairobi

Information provided by:

University of Manitoba

ClinicalTrials.gov Identifier:

NCT00830622

First received: January 26, 2009

Last updated: June 18, 2010

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

January 26, 2009

Last Updated Date

June 18, 2010

Start Date ^ICMJE

May 2007

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adherence to ART and HIV RNA suppression [ Time Frame: 6,12 months ] [ Designated as safety issue: No ]

Although many patients are seen every 3 months, study visits with questionnaires and viral load are completed at 0, 6, and 12 month scheduled follow-up visits.

Original Primary Outcome Measures ^ICMJE

Adherence to ART and HIV RNA suppression [ Time Frame: 3, 6, 9, 12 months ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00830622 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Retention [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]
Quality of Life (SF-12) [ Time Frame: 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
Health (CD4, weight, progression to AIDS, all cause mortality) [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Retention [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cell Phone Intervention to Support Antiretroviral Therapy (ART) Adherence in Kenya

Official Title ^ICMJE

A Targeted Cell Phone Intervention to Improve Patient Access to Care and Drug Adherence in Patients Taking Antiretroviral (ARV) Medications in Kenya

Brief Summary

A clinical study to evaluate the use of cell phones to support drug adherence and follow-up of patients taking antiretroviral therapy (ART) for treatment of HIV. The intervention involves health-care providers sending regular short-message-service (SMS) text messages to patients and following up their responses. The hypothesis is that the cell phone intervention will improve ART adherence and health outcomes compared with the current standard of care.

Detailed Description

This RCT study focuses on enrolling and following patients initiating ART. Note, a second parallel prospective cohort study enrolls and follows ART experienced patients who have already been taking ART for at least one year before and after the same intervention.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Condition ^ICMJE

HIV
AIDS
HIV Infections

Intervention ^ICMJE

Other: Cell Phone Intervention

Participant receives weekly SMS text messages from the health care provider.

Study Arm (s)

Experimental: 1
Cell Phone Intervention: participant receives weekly SMS text message from the health care worker.

Intervention: Other: Cell Phone Intervention
No Intervention: 2
SOC: Participant receives standard of care support but not weekly SMS text messages from the health care worker.

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

536

Completion Date

March 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

HIV infected and starting antiretroviral therapy
Adequate (daily) access to a cell phone
Intending to attend the enrollment clinic for 2 years
Consent to participate

Exclusion Criteria:

Not meeting inclusion criteria

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Kenya

Administrative Information

NCT Number ^ICMJE

NCT00830622

Other Study ID Numbers ^ICMJE

H2007:037, CDC PEPFAR PHE KE.07.0045

Has Data Monitoring Committee

Responsible Party

Richard T. Lester, MD, FRCPC / Principal Investigator, Dept. of Medical Microbiology and Infectious Diseases, University of Manitoba

Study Sponsor ^ICMJE

University of Manitoba

Collaborators ^ICMJE

University of Nairobi

Investigators ^ICMJE

Principal Investigator:	Richard T Lester, MD, FRCPC	University of Manitoba
Study Chair:	Joshua Kimani, MBChB	University of Manitoba / University of Nairobi
Study Director:	Francis A Plummer, MD, FRCPC	University of Manitoba

Information Provided By

University of Manitoba

Verification Date

January 2009

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

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