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WelTel Retain: Promoting Engagement in Pre-ART HIV Care Through SMS

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of British Columbia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01630304
First received: June 25, 2012
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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 Intervention
HIV
Behavioral: WelTel SMS service

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: WelTel Retain: Promoting Engagement in Pre-ART HIV Care Through SMS

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Patient retention in care [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • First ART eligibility assessment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Proportion of patients completing 1st eligibility assessment within 3 months

  • Enrolment in HIV care and treatment program [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Proportion of patients who complete counselling sessions (3) and are eligible to enrol in the HIV care and treatment program


Estimated Enrollment: 686
Study Start Date: January 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: Standard care
This arm will receive standard clinical care.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630304

Contacts
Contact: Richard T Lester, MD 604.707.5606 rlester.id@gmail.com
Contact: Mia L van der Kop, MSc 604.707.2552 miavanderkop@gmail.com

Locations
Kenya
Kibera Community Health Centre Recruiting
Nairobi, Kenya
Contact: Patrick I Nagide       Patrick.Igunza@amref.org   
Contact: Lilian Mbau       lilian.mbau@googlemail.com   
Principal Investigator: David Ojakaa, PhD         
Kibera Community Health Centre Recruiting
Nairobi, Kenya
Contact: Patrick I Nagide       Patrick.Igunza@amref.org   
Contact: Lilian Mbau       Lilian.Mbau@amref.org   
Principal Investigator: David I Ojakaa, PhD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Richard T Lester, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01630304     History of Changes
Other Study ID Numbers: H12-00563, R01MH097558
Study First Received: June 25, 2012
Last Updated: September 8, 2014
Health Authority: Kenya: Ethical Review Committee
Canada: Ethics Review Committee

Keywords provided by University of British Columbia:
telecommunications
Africa
randomized controlled trial

ClinicalTrials.gov processed this record on November 27, 2014