The Impact of Short Message Services (SMS) on ARV Adherence in Western Kenya (CAPS)
This study has been completed.
Sponsor:
Georgetown University
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
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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
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 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 May 23, 2013