Pilot Study of Text Message Reminders to Improve HIV Medication Adherence in Botswana

Tracking Information
First Submitted Date ICMJE	October 23, 2009
First Posted Date ICMJE	October 27, 2009
Last Update Posted Date	September 17, 2015
Study Start Date ICMJE	June 2008
Actual Primary Completion Date	August 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 26, 2009)	HIV medication adherence [ Time Frame: Monthly ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01001741 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Pilot Study of Text Message Reminders to Improve HIV Medication Adherence in Botswana
Official Title ICMJE	A Pilot Study of Cellular Phone Text Message Reminders to Improve HIV Medication Adherence at Independence Surgery Clinic Gaborone, Botswana
Brief Summary	While medication adherence is critical to successful treatment of HIV, there are few studies of interventions demonstrating improvements in adherence. This may be a particular challenge in the developing world, which has a larger burden of HIV but fewer resources than industrialized countries. The investigators propose a randomized controlled trial of cellular phone text message reminders to improve medication adherence. Our pilot study will be set in a large HIV clinic in Gaborone, Botswana, where Penn researchers have collaborated on research projects in the past. The primary study outcome will be antiretroviral medication adherence.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
Condition ICMJE	HIV Infections
Intervention ICMJE	Other: Cell phone text message; We will use cellular text messages to remind patients of impending drug prescription refills and scheduled visits to their healthcare provider.
Study Arms	Not Provided
Publications *	Reid MJ, Dhar SI, Cary M, Liang P, Thompson J, Gabaitiri L, Steele K, Mayisela S, Dickinson D, Friedman H, Linkin DR, Steenhoff AP. Opinions and attitudes of participants in a randomized controlled trial examining the efficacy of SMS reminders to enhance antiretroviral adherence: a cross-sectional survey. J Acquir Immune Defic Syndr. 2014 Feb 1;65(2):e86-8. doi: 10.1097/QAI.0b013e3182a9c72b.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 26, 2009)	128
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	August 2009
Actual Primary Completion Date	August 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: HIV infected; 21 years of age or older Exclusion Criteria: Subjects who do not intend to have continuous follow-up care and monthly medication refills at Independence Surgery for at least the next six months
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Botswana
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01001741
Other Study ID Numbers ICMJE	805891; NIH: P30 AI 045008
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University of Pennsylvania
Study Sponsor ICMJE	University of Pennsylvania
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Darren Linkin, MD University of Pennsylvania Principal Investigator: Harvey Friedman, MD University of Pennsylvania Study Director: James Thompson, MBA Wharton Business School, UPenn Study Director: Andrew Steenhoff University of Pennsylvania
PRS Account	University of Pennsylvania
Verification Date	June 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP