A Targeted Cell Phone Intervention to Improve Patient Access to Care and Drug Adherence in Patients Taking Antiretroviral (ARV) Medications in Kenya
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV
- Sponsor
- University of Manitoba
- Enrollment
- 536
- Locations
- 1
- Primary Endpoint
- Adherence to ART and HIV RNA suppression
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
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.
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Adherence to ART and HIV RNA suppression
Time Frame: 6,12 months
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 Outcomes
- Retention(6, 12 months)
- Quality of Life (SF-12)(3, 6, 9, 12 months)
- Health (CD4, weight, progression to AIDS, all cause mortality)(6, 12 months)