The Impact of Short Message Services (SMS) on ARV Adherence in Western Kenya (CAPS)

January 28, 2010 updated by: Georgetown University

Adherence to ARV Treatment and Its Effects on Medium Run Socio-Economic Outcomes: Evidence From Western Kenya

The purpose of proposed research is to implement a randomized study that will allow us to understand and address a number of key barriers to patient adherence as well as study the effects of better adherence on health and socio-economic outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Several studies have shown that proper adherence to treatment regimens is essential for the effectiveness of ARV therapy (e.g Wools-Kaloustian et al. 2006). There is also evidence in that in some treatment programs in Africa, adherence rates are not always high (Gill et al. 2005). Even in settings where adherence levels are found to be high, numerous factors have been identified as being relevant, although the causal effects are unknown (Castro, 2006). As ARV treatment programs are scaled up in Africa, it is essential to understand the socio-economic determinants of adherence to ARV treatment, as well as the impact of interventions to support high levels of adherence. A secondary objective of this study is to understand the socio-economic impacts of higher adherence.

Study Type

Interventional

Enrollment (Actual)

720

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
    • Maseno District
      • Kisumu, Maseno District, Kenya
        • Chulaimbo Rural Health Center

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:

  • Patients who had been on ARV therapy at the Chulaimbo Rural Health Center for a maximum of three months and providing consent to participate in the study.

Exclusion Criteria:

  • Patients who had been on ARV therapy for more than 3 months.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Weekly SMS, brief message
Weekly SMS received on Monday at 12 noon
Behavioral: Short Message Services to Support ARV therapy adherence
Short message services were sent to randomly selected consenting subjects on ARV therapy. The frequency and content of the message is varied in a factorial design.
Active Comparator: Control Group
Receives a phone, but no messages.
Behavioral: Short Message Services to Support ARV therapy adherence
Short message services were sent to randomly selected consenting subjects on ARV therapy. The frequency and content of the message is varied in a factorial design.
Experimental: Daily SMS, Brief message
Receive daily brief message at 12 noon: "This is your reminder"
Behavioral: Short Message Services to Support ARV therapy adherence
Short message services were sent to randomly selected consenting subjects on ARV therapy. The frequency and content of the message is varied in a factorial design.
Experimental: Daily SMS, Long Message
Receive a daily long message at 12 noon: "This is your reminder + encouragement"
Behavioral: Short Message Services to Support ARV therapy adherence
Short message services were sent to randomly selected consenting subjects on ARV therapy. The frequency and content of the message is varied in a factorial design.
Experimental: Weekly SMS, Long Message
Weekly message sent at 12 noon on Mondays: "This is your reminder + encouragement"
Behavioral: Short Message Services to Support ARV therapy adherence
Short message services were sent to randomly selected consenting subjects on ARV therapy. The frequency and content of the message is varied in a factorial design.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MEMS Adherence
Time Frame: 12 months follow up
12 months follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency/incidence of ARV treatment interruptions
Time Frame: 12 months follow up
12 months follow up

Collaborators and Investigators

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

Sponsor

Georgetown University

Collaborators

University of California, San Diego
Columbia University
Indiana University
Harvard University
World Bank
University of North Carolina
Moi Univeristy

Investigators

  • Principal Investigator: John Sidle, MD, Indiana University
  • Principal Investigator: Duncan Ngare, Phd, Moi University
  • Principal Investigator: Harsha Thirumurthy, Phd, University of North Carolina
  • Principal Investigator: Markus Goldstein, Phd, World Bank
  • Principal Investigator: Joshua Graff-Zivin, Phd, University of California, San Diego
  • Principal Investigator: Cristian Pop-Eleches, Phd, Columbia University
  • Principal Investigator: David Bangsberg, MD, Harvard Medical School (HMS and HSDM)

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

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

June 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

January 29, 2010

Study Record Updates

Last Update Posted (Estimate)

January 29, 2010

Last Update Submitted That Met QC Criteria

January 28, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-005

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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