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

June 18, 2010 updated by: University of Manitoba

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

536

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Nairobi, Kenya
        • University of Nairobi Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Cell Phone Intervention: participant receives weekly SMS text message from the health care worker.
Other: Cell Phone Intervention
Participant receives weekly SMS text messages from the health care provider.
No Intervention: 2
SOC: Participant receives standard of care support but not weekly SMS text messages from the health care worker.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to ART and HIV RNA suppression
Time Frame: 6,12 months
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.
6,12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Retention
Time Frame: 6, 12 months
6, 12 months
Quality of Life (SF-12)
Time Frame: 3, 6, 9, 12 months
3, 6, 9, 12 months
Health (CD4, weight, progression to AIDS, all cause mortality)
Time Frame: 6, 12 months
6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

University of Nairobi

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

January 26, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (Estimate)

January 28, 2009

Study Record Updates

Last Update Posted (Estimate)

June 22, 2010

Last Update Submitted That Met QC Criteria

June 18, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2007:037
  • CDC PEPFAR PHE KE.07.0045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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