Cell Phone Intervention to Support Antiretroviral Therapy (ART) Adherence in Kenya

This study has been completed.
Sponsor:
Collaborator:
University of Nairobi
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00830622
First received: January 26, 2009
Last updated: June 18, 2010
Last verified: January 2009

January 26, 2009
June 18, 2010
May 2007
December 2009   (final data collection date for primary outcome measure)
Adherence to ART and HIV RNA suppression [ Time Frame: 6,12 months ] [ Designated as safety issue: No ]
Although many patients are seen every 3 months, study visits with questionnaires and viral load are completed at 0, 6, and 12 month scheduled follow-up visits.
Adherence to ART and HIV RNA suppression [ Time Frame: 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00830622 on ClinicalTrials.gov Archive Site
  • Retention [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]
  • Quality of Life (SF-12) [ Time Frame: 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Health (CD4, weight, progression to AIDS, all cause mortality) [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]
Retention [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cell Phone Intervention to Support Antiretroviral Therapy (ART) Adherence in Kenya
A Targeted Cell Phone Intervention to Improve Patient Access to Care and Drug Adherence in Patients Taking Antiretroviral (ARV) Medications in Kenya

A clinical study to evaluate the use of cell phones to support drug adherence and follow-up of patients taking antiretroviral therapy (ART) for treatment of HIV. The intervention involves health-care providers sending regular short-message-service (SMS) text messages to patients and following up their responses. The hypothesis is that the cell phone intervention will improve ART adherence and health outcomes compared with the current standard of care.

This RCT study focuses on enrolling and following patients initiating ART. Note, a second parallel prospective cohort study enrolls and follows ART experienced patients who have already been taking ART for at least one year before and after the same intervention.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • HIV
  • AIDS
  • HIV Infections
Other: Cell Phone Intervention
Participant receives weekly SMS text messages from the health care provider.
  • Experimental: 1
    Cell Phone Intervention: participant receives weekly SMS text message from the health care worker.
    Intervention: Other: Cell Phone Intervention
  • No Intervention: 2
    SOC: Participant receives standard of care support but not weekly SMS text messages from the health care worker.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
536
March 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infected and starting antiretroviral therapy
  • Adequate (daily) access to a cell phone
  • Intending to attend the enrollment clinic for 2 years
  • Consent to participate

Exclusion Criteria:

  • Not meeting inclusion criteria
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT00830622
H2007:037, CDC PEPFAR PHE KE.07.0045
No
Richard T. Lester, MD, FRCPC / Principal Investigator, Dept. of Medical Microbiology and Infectious Diseases, University of Manitoba
University of Manitoba
University of Nairobi
Principal Investigator: Richard T Lester, MD, FRCPC University of Manitoba
Study Chair: Joshua Kimani, MBChB University of Manitoba / University of Nairobi
Study Director: Francis A Plummer, MD, FRCPC University of Manitoba
University of Manitoba
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP