NCT02603536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

February 2, 2017

Status Verified

January 1, 2017

Enrollment Period

2.1 years

First QC Date

November 10, 2015

Last Update Submit

January 31, 2017

Conditions

Keywords

Text MessagingHarm Reduction

Outcome Measures

Primary Outcomes (1)

  • Increased viral load/proportion of HIV viral load tests showing virologic suppression (< 40copies/ml)

    Measured using lab results available in the patient charts in the intervention year compared to the year prior to enrollment.

    Two years

Secondary Outcomes (4)

  • Number of hours spent by health care providers for this intervention

    Two years

  • Improved engagement

    Two years

  • Increased CD4 counts

    Two years

  • Improved antiretroviral medication adherence

    Two years

Study Arms (1)

Vulnerable or pilot participant

EXPERIMENTAL

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

Interventions

WelTelOTHER

An evidence-based, text messaging solution for improving patient adherence.

Vulnerable or pilot participant

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oak Tree Clinic

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (3)

  • El Joueidi S, Bardosh K, Musoke R, Tilahun B, Abo Moslim M, Gourlay K, MacMullin A, Cook VJ, Murray M, Mbaraga G, Nsanzimana S, Lester R. Evaluation of the implementation process of the mobile health platform 'WelTel' in six sites in East Africa and Canada using the modified consolidated framework for implementation research (mCFIR). BMC Med Inform Decis Mak. 2021 Oct 26;21(1):293. doi: 10.1186/s12911-021-01644-1.

  • Campbell AR, Kinvig K, Cote HC, Lester RT, Qiu AQ, Maan EJ, Alimenti A, Pick N, Murray MC. Health Care Provider Utilization and Cost of an mHealth Intervention in Vulnerable People Living With HIV in Vancouver, Canada: Prospective Study. JMIR Mhealth Uhealth. 2018 Jul 9;6(7):e152. doi: 10.2196/mhealth.9493.

  • King E, Kinvig K, Steif J, Qiu AQ, Maan EJ, Albert AY, Pick N, Alimenti A, Kestler MH, Money DM, Lester RT, Murray MCM. Mobile Text Messaging to Improve Medication Adherence and Viral Load in a Vulnerable Canadian Population Living With Human Immunodeficiency Virus: A Repeated Measures Study. J Med Internet Res. 2017 Jun 1;19(6):e190. doi: 10.2196/jmir.6631.

Related Links

MeSH Terms

Conditions

Medication AdherenceHarm Reduction

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Melanie Murray, MD,PhD,FRCPC

    BC Women's Hospital & Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Div. of Infectious Diseases, Dept. of Medicine, UBC

Study Record Dates

First Submitted

November 10, 2015

First Posted

November 11, 2015

Study Start

April 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2016

Last Updated

February 2, 2017

Record last verified: 2017-01

Locations