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Improving Outcomes in HIV Patients Using Mobile Phone Based Interactive Software Support (Callforlife)

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ClinicalTrials.gov Identifier: NCT02953080
Recruitment Status : Completed
First Posted : November 2, 2016
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Makerere University

Brief Summary:

Current estimates point towards a huge increase in the number of people that are eligible to start ART in Uganda and globally. As many of the newly eligible patients are largely asymptomatic, there are concerns about adherence and retention of these individuals and especially those starting ART with a higher CD4 counts. Urgent information is required to plan for implementation of most recent WHO and National guidelines in the most cost effective manner as well as maximizing retention of HIV positive individuals in care and achieving virological suppression.

The investigators plan to undertake research designed to see if investigators can optimize adherence, virological outcomes and HIV knowledge, in order to give an overall increased quality of life in vulnerable populations starting or established on ART in Kampala, Uganda. The investigators will test implementation of an open source software-based tool to send text messages and to give access to an interactive voice response system using patients' mobile phones.

The investigators' aim to undertake an open labelled randomised trial at two sites: the IDI which is an urban centre of excellence in HIV care, and Kasangati Health Centre, which is a peri-urban public health care facility. The project aims to enrol HIV positive patients starting ART, already established on first line ART or switching to second line ART, including special populations (pregnant women, discordant couples and young people). The estimated length of the project is 30 months. The technology to be evaluated in this study is based on CONNECT FOR LIFETM m-health technology (CFL2015.01 or higher), which provides text messages or Interactive Voice Response (IVR) functionalities, and allows a computer to interact with humans through the use of voice and tones input via keypad and offers pill reminders, clinic visit reminders, health tips and support symptom reporting.

Primary Objective is to determine the effect of the CFL2015.01 tool on quality of life of HIV patients receiving care at IDI and Kasangati HCIV. At the start of the intervention, all patients will undergo quality of life assessment, which will be repeated at months 6, 12, 18 and 24 months. The scores will be compared to assess the effect of the tool on quality of life. The Secondary Objectives are virological outcomes baseline, 6, 12,18 and 24 months, retention in care, aversion of early treatment failure, disease knowledge, clinic attendance and cost analysis.


Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Other: Call for life mHealth adherence support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Outcomes in HIV Patients Using Mobile Phone Based Interactive Software Support
Actual Study Start Date : August 23, 2016
Actual Primary Completion Date : July 11, 2018
Actual Study Completion Date : December 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Call for Life Mobile phone support
The intervention is "Call for life mHealth adherence support tool " through basic mobile phone-based interactive voice response.
Other: Call for life mHealth adherence support
Daily/ weekly pill reminder support Health Info-tips Appointment visit reminders Self-reported symptom support
Other Name: mHealth system

No Intervention: Standard of Care
No call for life Uganda: Patients are randomized to standard of Care



Primary Outcome Measures :
  1. Determine effect of Call for Life tool on physical quality of life of HIV patients receiving care at the 2 study sites [ Time Frame: Month 06, Month 12, 18 and 24 MONTHS ]
    Change in physical health score by 5-point in those accessing Call for Life Uganda between baseline, 6 , 12, 18 and 24 months of Call for Life Uganda use, and comparison to those with no access to Call for Life UgandaTM at 6 and 12 months


Secondary Outcome Measures :
  1. Determine effect of Call for Life tool on mental quality of life of HIV patients receiving care at the 2 study sites [ Time Frame: Month 06, Month 12 , 18 and month 24 ]
    Change in mental health score by 5-point in those accessing Call for Life Uganda between baseline, 18 and 24 months of Call for Life Uganda use, and comparison to those with no access to Call for Life UgandaTM at 18 and 24 months 2. Proportion of patients with viral load > 50 copies/ml at 18, and 24 months among patients using the Call for Life UgandaTM tool compared to those with no access to Call for Life UgandaTM

  2. Determine effect of Call for Life tool on virological outcome and aversion of early treatment failure [ Time Frame: Baseline, Month 6, 12, 18 and 24 ]
    Viral load measurement at 6,12,18 and 24 months

  3. Determine effect of Call for life Uganda, on retention in care at the 2 sites [ Time Frame: 24 months ]
    Proportions of HIV patients retained in chronic care at the 2 sites

  4. Determine effect of Call for life Uganda on attendance on scheduled appointment days +/- 2 working days [ Time Frame: Month 06, 12, 18 and 24 ]
    Clinic appointment keeping



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Ages Eligible for Study:   18 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

    1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
    2. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3. Patients having the ability to use basic cell phone functions (e.g., being able to make and receive phone calls).
    4. Patients with access to a mobile phone (need to be able to answer the phone at a predetermined time slot and to be able to call the clinic if they are sick)
    5. Patients who are able to understand Luganda or Runyankole or English (as these are the languages of the overwhelming majority of patients at IDI and Kasangati and so will be used for the trial. If any other language has more than 30 patients who require it, the tool will be adapted to include this new language before the roll out of the tool to the entire clinic population

Exclusion Criteria:

  1. Patient whose clinical condition interferes with appropriate use of cell phone (e.g., deafness, severe cognitive impairment)
  2. Patients < 15 years unless emancipated minors as defined by Ugandan National Research Ethics Committee guidelines.
  3. Patients who are enrolled in an interventional study at IDI
  4. Patients who are not receiving standard first and second line treatment
  5. Patients who are critically ill.

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): NCT02953080


Locations
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Uganda
Infectious Diseases Institute,Makerere University College of Health Sciences
Kampala, Uganda
Sponsors and Collaborators
Makerere University
Investigators
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Principal Investigator: Rosalind Parkes-Ratanshi Infectious Diseases Institute, Makerere University College of Health Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT02953080    
Other Study ID Numbers: ST/163/2016
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases