Cell Phone Intervention to Support Antiretroviral Therapy (ART) Adherence 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.
|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|
- 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.
- 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 ]
|Study Start Date:||May 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
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.
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.
|University of Nairobi Clinics|
|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|