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

NCT02953080 | Completed DMC

• 1 other identifier: ST/163/2016
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Determine effect of Call for Life tool on physical quality of life of HIV patients receiving care at the 2 study sites

  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

  Month 06, Month 12, 18 and 24 MONTHS

Secondary Outcomes (4)

• Determine effect of Call for Life tool on mental quality of life of HIV patients receiving care at the 2 study sites

  Month 06, Month 12 , 18 and month 24

• Determine effect of Call for Life tool on virological outcome and aversion of early treatment failure

  Baseline, Month 6, 12, 18 and 24

• Determine effect of Call for life Uganda, on retention in care at the 2 sites

  24 months

• Determine effect of Call for life Uganda on attendance on scheduled appointment days +/- 2 working days

  Month 06, 12, 18 and 24

Study Arms (2)

Call for Life Mobile phone support

ACTIVE COMPARATOR

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

Standard of Care

NO INTERVENTION

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

Interventions

Call for life mHealth adherence support OTHER

Daily/ weekly pill reminder support Health Info-tips Appointment visit reminders Self-reported symptom support

Also known as: mHealth system

Call for Life Mobile phone support

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Patients having the ability to use basic cell phone functions (e.g., being able to make and receive phone calls).
• 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)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Infectious Diseases Institute,Makerere University College of Health Sciences

Kampala, Uganda

Location

Related Publications (4)

• Kajubi P, Parkes-Ratanshi R, Twimukye A, Bwanika Naggirinya A, Nabaggala MS, Kiragga A, Castelnuovo B, King R. Perceptions and Attitudes Toward an Interactive Voice Response Tool (Call for Life Uganda) Providing Adherence Support and Health Information to HIV-Positive Ugandans: Qualitative Study. JMIR Form Res. 2022 Dec 6;6(12):e36829. doi: 10.2196/36829.

  PMID: 36472904 DERIVED

• Naggirinya AB, Kyomugisha EL, Nabaggala MS, Nasasira B, Akirana J, Oseku E, Kiragga A, Castelnuovo B, King RL, Katabira E, Byonanebye DM, Lamorde M, Parkes-Ratanshi R. Willingness to pay for an mHealth anti-retroviral therapy adherence and information tool: Transitioning to sustainability, Call for life randomised study experience in Uganda. BMC Med Inform Decis Mak. 2022 Feb 26;22(1):52. doi: 10.1186/s12911-022-01782-0.

  PMID: 35219309 DERIVED

• Twimukye A, Bwanika Naggirinya A, Parkes-Ratanshi R, Kasirye R, Kiragga A, Castelnuovo B, Wasswa J, Nabaggala MS, Katabira E, Lamorde M, King RL. Acceptability of a Mobile Phone Support Tool (Call for Life Uganda) for Promoting Adherence to Antiretroviral Therapy Among Young Adults in a Randomized Controlled Trial: Exploratory Qualitative Study. JMIR Mhealth Uhealth. 2021 Jun 14;9(6):e17418. doi: 10.2196/17418.

  PMID: 34121665 DERIVED

• Byonanebye DM, Nabaggala MS, Naggirinya AB, Lamorde M, Oseku E, King R, Owarwo N, Laker E, Orama R, Castelnuovo B, Kiragga A, Parkes-Ratanshi R. An Interactive Voice Response Software to Improve the Quality of Life of People Living With HIV in Uganda: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Feb 11;9(2):e22229. doi: 10.2196/22229.

  PMID: 33570497 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

CD56 Antigen

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Neural Cell Adhesion Molecules; Cell Adhesion Molecules, Neuronal; Cell Adhesion Molecules; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Antigens, Differentiation, T-Lymphocyte; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Biomarkers

Study Officials

• Rosalind Parkes-Ratanshi

  Makerere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 2, 2016
• Study Start: August 23, 2016
• Primary Completion: July 11, 2018
• Study Completion: December 14, 2018
• Last Updated: February 16, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)