WelTel Retain: Promoting Engagement in Pre-ART HIV Care Through SMS
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| ClinicalTrials.gov Identifier: NCT01630304 |
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Recruitment Status
: Unknown
Verified December 2015 by University of British Columbia.
Recruitment status was: Active, not recruiting
First Posted
: June 28, 2012
Last Update Posted
: December 18, 2015
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Sponsor:
University of British Columbia
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of British Columbia
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Brief Summary:
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV | Behavioral: WelTel SMS service | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 700 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | WelTel Retain: Promoting Engagement in Pre-ART HIV Care Through SMS |
| Study Start Date : | January 2013 |
| Estimated Primary Completion Date : | September 2016 |
| Estimated Study Completion Date : | September 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Experimental: WelTel SMS service
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.
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Behavioral: WelTel SMS service
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.
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No Intervention: Standard care
This arm will receive standard clinical care.
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Primary Outcome Measures
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- Patient retention in care [ Time Frame: 12 months ]
Secondary Outcome Measures
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- First ART eligibility assessment [ Time Frame: 3 weeks ]Proportion of patients completing 1st eligibility assessment within 3 weeks
- Enrolment in HIV care and treatment program [ Time Frame: 2 months ]Proportion of patients who complete counselling sessions (3) and are eligible to enrol in the HIV care and treatment program
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- evidence of HIV infection
- newly enrolling at the Kibera Community Health Centre
- own or have sufficient access to a cell phone; able to operate a cell phone using simple text-messaging*
- able and willing to provide informed assent/consent to participate *If a participant does not own a phone but has sufficient access to a cell phone (through a partner, relative, etc.), the participant would be able to either 1) use the accessed phone to respond to the text messages themselves; or, if they are unable to text themselves 2) have their partner, relative etc. respond on their behalf.
Exclusion Criteria:
- individuals will be excluded if they do not meet all of the inclusion criteria.
- individuals transferring from other clinics who are already taking ART will also be excluded.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630304
Locations
| Kenya | |
| Kibera Community Health Centre | |
| Nairobi, Kenya | |
Sponsors and Collaborators
University of British Columbia
National Institute of Mental Health (NIMH)
Investigators
| Principal Investigator: | Richard T Lester, MD | University of British Columbia |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01630304 History of Changes |
| Other Study ID Numbers: |
H12-00563 R01MH097558 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 28, 2012 Key Record Dates |
| Last Update Posted: | December 18, 2015 |
| Last Verified: | December 2015 |
Keywords provided by University of British Columbia:
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telecommunications Africa randomized controlled trial |