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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||600 participants|
|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|
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
- 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
- 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
- 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
- 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
- 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
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
|Infectious Diseases Institute,Makerere University College of Health Sciences|
|Principal Investigator:||Rosalind Parkes-Ratanshi||Infectious Diseases Institute, Makerere University College of Health Sciences|