Cell Phone Intervention to Support Antiretroviral Therapy (ART) Adherence in Kenya - Full Text View

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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

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:

Manitoba Resistance and Susceptibility to Infection Group This link exits the ClinicalTrials.gov site

Publications:

Lester R, Karanja S. Mobile phones: exceptional tools for HIV/AIDS, health, and crisis management. Lancet Infect Dis. 2008 Dec;8(12):738-9. No abstract available.

Lester RT, Gelmon L, Plummer FA. Cell phones: tightening the communication gap in resource-limited antiretroviral programmes? AIDS. 2006 Nov 14;20(17):2242-4. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, Jack W, Habyarimana J, Sadatsafavi M, Najafzadeh M, Marra CA, Estambale B, Ngugi E, Ball TB, Thabane L, Gelmon LJ, Kimani J, Ackers M, Plummer FA. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010 Nov 27;376(9755):1838-45. Epub 2010 Nov 9.

Lester RT, Mills EJ, Kariri A, Ritvo P, Chung M, Jack W, Habyarimana J, Karanja S, Barasa S, Nguti R, Estambale B, Ngugi E, Ball TB, Thabane L, Kimani J, Gelmon L, Ackers M, Plummer FA. The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol. Trials. 2009 Sep 22;10:87.

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 October 18, 2012