The Impact of Short Message Services (SMS) on ARV Adherence in Western Kenya (CAPS)
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| First Received Date ICMJE | January 27, 2010 | ||||||||||||||||||||||||||||||||
| Last Updated Date | January 28, 2010 | ||||||||||||||||||||||||||||||||
| Start Date ICMJE | June 2007 | ||||||||||||||||||||||||||||||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
MEMS Adherence [ Time Frame: 12 months follow up ] [ Designated as safety issue: No ] | ||||||||||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01058694 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
Frequency/incidence of ARV treatment interruptions [ Time Frame: 12 months follow up ] [ Designated as safety issue: No ] | ||||||||||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||||||||||
| Brief Title ICMJE | The Impact of Short Message Services (SMS) on ARV Adherence in Western Kenya | ||||||||||||||||||||||||||||||||
| Official Title ICMJE | Adherence to ARV Treatment and Its Effects on Medium Run Socio-Economic Outcomes: Evidence From Western Kenya | ||||||||||||||||||||||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Pop-Eleches C, Thirumurthy H, Habyarimana JP, Zivin JG, Goldstein MP, de Walque D, Mackeen L, Haberer J, Kimaiyo S, Sidle J, Ngare D, Bangsberg DR. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS. 2011 Mar 27;25(6):825-34. | ||||||||||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||||||||||
| Enrollment ICMJE | 720 | ||||||||||||||||||||||||||||||||
| Completion Date | July 2009 | ||||||||||||||||||||||||||||||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||
| Location Countries ICMJE | Kenya | ||||||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT01058694 | ||||||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 2008-005 | ||||||||||||||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||||||||||||||
| Responsible Party | James Habyarimana, PhD/Assistant Professor, Georgetown Public Policy Institute | ||||||||||||||||||||||||||||||||
| Study Sponsor ICMJE | Georgetown University | ||||||||||||||||||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Georgetown University | ||||||||||||||||||||||||||||||||
| Verification Date | January 2010 | ||||||||||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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