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

This study has been completed.
Sponsor:
Collaborators:
Moi Univeristy
World Bank
Indiana University
Harvard University
Columbia University
University of California, San Diego
University of North Carolina
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT01058694
First received: January 27, 2010
Last updated: January 28, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
AIDS
Antiretroviral Therapy
Medication Adherence
HIV Infections
Behavioral: Short Message Services to Support ARV therapy adherence

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Adherence to ARV Treatment and Its Effects on Medium Run Socio-Economic Outcomes: Evidence From Western Kenya

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • MEMS Adherence [ Time Frame: 12 months follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency/incidence of ARV treatment interruptions [ Time Frame: 12 months follow up ] [ Designated as safety issue: No ]

Enrollment: 720
Study Start Date: June 2007
Study Completion Date: July 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058694

Locations
Kenya
Chulaimbo Rural Health Center
Kisumu, Maseno District, Kenya
Sponsors and Collaborators
Georgetown University
Moi Univeristy
World Bank
Indiana University
Harvard University
Columbia University
University of California, San Diego
University of North Carolina
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: Damien de Walque, Phd World Bank
Principal Investigator: Cristian Pop-Eleches, Phd Columbia University
Principal Investigator: David Bangsberg, MD Harvard Medical School
  More Information

No publications provided by Georgetown University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James Habyarimana, PhD/Assistant Professor, Georgetown Public Policy Institute
ClinicalTrials.gov Identifier: NCT01058694     History of Changes
Other Study ID Numbers: 2008-005
Study First Received: January 27, 2010
Last Updated: January 28, 2010
Health Authority: United States: Institutional Review Board
Kenya: Institutional Review Board

Keywords provided by Georgetown University:
Mobile phones,
Medication Adherence
Micro-Electrical-Mechanical Systems
HIV Infections

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014