Trial record 6 of 37 for:    " January 07, 2009":" February 06, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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.


Condition Intervention
HIV
AIDS
HIV Infections
Other: Cell Phone Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Targeted Cell Phone Intervention to Improve Patient Access to Care and Drug Adherence in Patients Taking Antiretroviral (ARV) Medications in Kenya

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 536
Study Start Date: May 2007
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cell Phone Intervention: participant receives weekly SMS text message from the health care worker.
Other: Cell Phone Intervention
Participant receives weekly SMS text messages from the health care provider.
No Intervention: 2
SOC: Participant receives standard of care support but not weekly SMS text messages from the health care worker.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830622

Locations
Kenya
University of Nairobi Clinics
Nairobi, Kenya
Sponsors and Collaborators
University of Manitoba
University of Nairobi
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard T. Lester, MD, FRCPC / Principal Investigator, Dept. of Medical Microbiology and Infectious Diseases, University of Manitoba
ClinicalTrials.gov Identifier: NCT00830622     History of Changes
Other Study ID Numbers: H2007:037, CDC PEPFAR PHE KE.07.0045
Study First Received: January 26, 2009
Last Updated: June 18, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
HIV/AIDS
Adherence
Antiretroviral Therapy, ART, ARV
Mobile phone, cell phone, telephone
Text message, SMS
Telemedicine
Africa
Resource-limited setting
Counseling, support
treatment experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014