AIDS, HIV, HIV Infections
Conditions
Keywords
HIV/AIDS, Adherence, Antiretroviral Therapy, ART, ARV, Mobile phone, cell phone, telephone, Text message, SMS, Telemedicine, Africa, Resource-limited setting, Counseling, support, treatment experienced
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.
Interventions
Participant receives weekly SMS text messages from the health care provider.
Sponsors
University of Nairobi
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to ART and HIV RNA suppression | 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Kenya
Outcome results
None listed