The WHO recommends use of mobile phone health technologies (mHealth) to support adherence in HIV. Studies on text messages show promise but with limited rigorous evaluations. The Call for Life UgandaTM (CfLU) study is a randomized controlled trial (RCT) using an interactive voice response (IVR) calls system designed to support PLHIV on ART. The primary study objective was to determine the effect of CfLU on quality of life (QOL) of people living with HIV (PLHIV) in Uganda.
MOTECH software-based Connect for LifeTM (Janssen, Johnson & Johnson) was adapted for Ugandan setting, with the Infectious Diseases Institute. The participants were randomized 1:1 to receive either CfLU or standard of care (SoC-clinic visits only). In English or 2 local languages, the CfLU arm received daily/weekly pill reminder calls or SMS messages, visit reminders, health information advice and symptom reporting. At 6, 12 and 24 months of follow up QOL assessments (HIV Medical Outcomes Survey, MOS-HIV including physical health score [PHS] and mental health score [MHS]) were done using Likert-type scale with difference in differences analysis and analysis of covariance (ANCOVA). Qualitative and tool use data also collected. Data from 6m are presented here.
Between August 2016 and February 2018 across 2 sites, 1031 PLHIV accessing care were screened and 600 enrolled on the study (n=300/site). Sixty-nine percent were female and median age was 32 (IQR25-40). Eight four participants were ART naïve, remaining ART experienced. At baseline, 97% chose IVR over SMS. There was no difference in arms for education level, marital & employment status, previous TB or alcohol use. 277 in each arm attended at 6m. There is no statistical observed difference in mean percentage score of MOS-HIV, MHS and PHS at baseline and 6m between CfLU and SoC arms. In those starting first line ART or switching to second line, there was a significant improvement in PHS (ANCOVA 4.01, p=0.048). There was no significant difference between CfLU versus the SoC in the proportion of patients with viral load <50 copies at 6m (21% vs 18%: p-value=0.372).
This is the first RCT for PLHIV on ART incorporating options for IVR and SMS options; strong preference was shown for IVR over SMS. In this mixed group of patients, there was no statistical effect of CfLU observed on QOL at 6m. Within this study, a higher than expected baseline QOL and virological suppression was encountered for both sites which may have affected results.