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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01001741

First received: October 23, 2009

Last updated: September 16, 2015

Last verified: June 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

October 23, 2009

Last Updated Date

September 16, 2015

Start Date ^ICMJE

June 2008

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HIV medication adherence [ Time Frame: Monthly ] [ Designated as safety issue: No ]

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 Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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

Enrollment ^ICMJE

128

Completion Date

August 2009

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

Gender

Both

Ages

21 Years and older (Adult, Senior)

Accepts Healthy Volunteers

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

Plan to Share Data

Not Provided

IPD Description

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

Information Provided By

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

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