NCT02953080: Callforlife

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

Completed NA Last updated 16 February 2021

What this trial tests

NA trial testing Call for life mHealth adherence support in Human Immunodeficiency Virus in 600 participants. Completed in 14 December 2018.

Timeline

23 August 2016

Primary endpoint
11 July 2018

14 December 2018

Quick facts

Lead sponsor	Makerere University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	600
Start date	23 August 2016
Primary completion	11 July 2018
Estimated completion	14 December 2018
Sites	1 location across Uganda

Drugs / interventions tested

• Call for life mHealth adherence support

Conditions studied

• Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →

Sponsor

Makerere University

Who can join

Adults 18 to 77, any sex, with Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Twimukye A, Bwanika Naggirinya A, Parkes-Ratanshi R, Kasirye R, et al · · 2021 · cited 24× · PMID 34121665 · DOI 10.2196/17418
2. An Interactive Voice Response Software to Improve the Quality of Life of People Living With HIV in Uganda: Randomized Controlled Trial.
   Byonanebye DM, Nabaggala MS, Naggirinya AB, Lamorde M, et al · · 2021 · cited 24× · PMID 33570497 · DOI 10.2196/22229
3. Willingness to pay for an mHealth anti-retroviral therapy adherence and information tool: Transitioning to sustainability, Call for life randomised study experience in Uganda.
   Naggirinya AB, Kyomugisha EL, Nabaggala MS, Nasasira B, et al · · 2022 · cited 2× · PMID 35219309 · DOI 10.1186/s12911-022-01782-0
4. 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.
   Kajubi P, Parkes-Ratanshi R, Twimukye A, Bwanika Naggirinya A, et al · · 2022 · cited 1× · PMID 36472904 · DOI 10.2196/36829