An interventional study of WelTel SMS service in HIV, sponsored by University of British Columbia. Status unknown at 1 site in Kenya. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-18.
Sponsored by University of British Columbia · Not applicable, Interventional, and Supportive care
The purpose of this study is to determine whether weekly text-messages improve retention in care of HIV-infected individuals who are not yet eligible for antiretroviral therapy (ART).
Patient retention in care is critical to the success of programs funded by the President's Emergency Relief Plan for HIV/AIDS (PEPFAR). High levels of patient retention after first clinical contact contribute to the timely initiation of antiretroviral therapy (ART) and better health outcomes for patients. With the dramatic proliferation of cell phone use in Africa, telecommunications technology offers new opportunities to improve retention using a low-cost, culturally appropriate format. In Kenya (WelTel Kenya1), a weekly short message service (SMS) text message led to improved ART adherence and viral load suppression. This study, WelTel Retain, will evaluate the effect of WelTel on retaining pre-ART patients in care and determine the cost-effectiveness of the intervention. Specific objectives include: 1) determining if the WelTel SMS intervention improves patient retention in the first stage of HIV care; 2) determining whether the WelTel SMS intervention improves 12-month retention; and 3) evaluating the cost-effectiveness of the WelTel SMS intervention. We will fulfil these objectives by conducting a randomized controlled trial at the Kibera Community Health Centre in Nairobi, Kenya. Over one year, HIV positive individuals newly enrolling at the clinic will be recruited and randomly allocated to an intervention or control arm at a 1:1 ratio. Intervention arm participants will receive a weekly SMS 'check-in' to which they will be required to respond within 48 hours. An HIV clinician will follow-up and triage any problems that are identified. The control arm will receive standard of care. Patients will be followed for one year. The WelTel Retain study will contribute critical information on the effectiveness of an mHealth program to engage patients in care during the first year of HIV care. This research has the potential to demonstrate that the WelTel SMS intervention is an effective, feasible retention strategy, which can contribute significantly to the long-term success of PEPFAR-funded programs and towards a sustainable global HIV/AIDS response.
University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In addition to standard care, weekly text messages will be delivered to participants randomized to this arm for a one year period. Participants will be requested to respond to the outgoing message "Mambo?" within 48 hours; they may respond that they are doing well (sawa) or that they have a problem (shida). A clinician will call to follow-up with all participants who respond indicating a problem or who do not respond within 48 hours.
Behavioral: WelTel SMS service
This arm will receive standard clinical care.
Weekly text message "Mambo?" ("How are you?") to which participants are required to respond either "Shida" (problem) or "Sawa" (OK) within 48 hours. Shida responses and participants who do not respond are called by a clinician.
Patient retention in care
Time frame: 12 months
First ART eligibility assessment
Proportion of patients completing 1st eligibility assessment within 3 weeks
Time frame: 3 weeks
Enrolment in HIV care and treatment program
Proportion of patients who complete counselling sessions (3) and are eligible to enrol in the HIV care and treatment program
Time frame: 2 months
This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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University of British Columbia