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

Sponsor

Georgetown University (Other)

Overall Status

Completed

CT.gov ID

NCT01058694

Collaborator

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

720

Enrollment

Location

Arms

Duration (Months)

28.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
AIDS Antiretroviral Therapy Medication Adherence HIV Infections	Behavioral: Short Message Services to Support ARV therapy adherence	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

720 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (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

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

MEMS Adherence [12 months follow up]

Secondary Outcome Measures

Frequency/incidence of ARV treatment interruptions [12 months follow up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Chulaimbo Rural Health Center	Kisumu	Maseno District	Kenya

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 (HMS and HSDM)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01058694

Other Study ID Numbers:

2008-005

First Posted:

Jan 29, 2010

Last Update Posted:

Jan 29, 2010

Last Verified:

Jan 1, 2010

Keywords provided by , ,

Mobile phones,

Medication Adherence

Micro-Electrical-Mechanical Systems

HIV Infections

Additional relevant MeSH terms: