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WelTelOAKTREE: Text Messaging to Support Patients With HIV/AIDS in British Columbia (WelTelOAKTREE)

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ClinicalTrials.gov Identifier: NCT02603536
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Melanie C. M. Murray, MD PhD, BC Women's Hospital & Health Centre

Brief Summary:
WelTel Oak Tree is a repeated measures study that enrolled 85 HIV+ individuals from the Oak Tree Clinic at BC Women's Hospital. Participants were be provided with a cell phone and/or unlimited text messaging capability if they do not have it already, and for one year received a weekly text message stating "How are you". Participant problems and non-responses were be followed up by a nurse. Data on demographics, CD4 counts, HIV viral loads, HIV medication adherence and attendance at appointments was collected for the year prior to the intervention and during the intervention for comparison. Data assessing quality of life was also collected at three points during the one year study period. Cost effectiveness and cost benefit of the intervention is being studied to assess feasibility of transferring the intervention to a programmatically funded facet of patient care.

Condition or disease Intervention/treatment Phase
HIV Medication Adherence Other: WelTel Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Repeated measures study. All participants acted as their own controls with data from year prior to intervention serving as control data and data from intervention year as intervention data.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: WelTelOAKTREE: Text Messaging to Support Patients With HIV/AIDS in British Columbia
Actual Study Start Date : April 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Vulnerable or pilot participant
In addition to standard care, WelTel will send a weekly text message to participants in this arm for a one year period. Participants will be requested to respond to the outgoing message "How are you?" within 48 hours; they may respond that they are doing well or that they have a problem. A clinician will call to follow-up with all participants who respond indicating a problem or who do not respond within 48 hours.
Other: WelTel
An evidence-based, text messaging solution for improving patient adherence.




Primary Outcome Measures :
  1. Increased viral load/proportion of HIV viral load tests showing virologic suppression (< 40copies/ml) [ Time Frame: Two years ]
    Measured using lab results available in the patient charts in the intervention year compared to the year prior to enrollment.


Secondary Outcome Measures :
  1. Number of hours spent by health care providers for this intervention [ Time Frame: Two years ]
    To inform future program development

  2. Improved engagement [ Time Frame: Two years ]
    Measured using attendance at outpatient visits in the intervention year compared to the year prior to enrollment.

  3. Increased CD4 counts [ Time Frame: Two years ]
    Measured using lab results available in the patient charts in the intervention year compared to the year prior to enrollment.

  4. Improved antiretroviral medication adherence [ Time Frame: Two years ]
    Measured using patient self-report data available in the patient charts in the intervention year compared to the year prior to enrollment.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • attendance at the Oak Tree Clinic for at least 1 year prior to study entry to permit historical comparison analysis and with at least one clinic visit in the preceding year from date of enrolment
  • age ≥14 years
  • CD4 count ≤500 cells/mm3 or previous prescription for antiretroviral therapy (other than for pregnancy) prior to the control year, (indicating clinical indication for HIV therapy existed during the control year)
  • any detectable viral load (≥200 copies/mL) in the control year OR is one of the 25 participants in the pilot study, WelTelBC1 (H11-03003), and who when approached for consent into the current study, chooses to participate

Exclusion Criteria:

  • attendance at the Oak Tree Clinic for less than one year prior to study entry
  • age <14 years
  • consensus by clinical team that patient does NOT fit high-risk criteria as listed
  • lives in an area where cell phone service is not available
  • unable to communicate via the text-messaging system

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): NCT02603536


Locations
Canada, British Columbia
Oak Tree Clinic
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
BC Women's Hospital & Health Centre
Gilead Sciences
Investigators
Principal Investigator: Melanie Murray, MD,PhD,FRCPC BC Women's Hospital & Health Centre

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Melanie C. M. Murray, MD PhD, Assistant Professor, Div. of Infectious Diseases, Dept. of Medicine, UBC, BC Women's Hospital & Health Centre
ClinicalTrials.gov Identifier: NCT02603536     History of Changes
Other Study ID Numbers: F12-05361
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Melanie C. M. Murray, MD PhD, BC Women's Hospital & Health Centre:
Text Messaging
Harm Reduction