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Project UNITE: a randomized, controlled, open‐label, multicenter trial to evaluate the effect of access to TAMA (Treatment Advice by Mobile Alerts) on treatment effectiveness in HIV‐1 infected individuals initiated on first-line antiretroviral therapy

grid_view HIV

In developing countries, People living with HIV have poor adherence to ART because of costs, running out of pills, symptoms, side effects, lack of a conceptual understanding of HIV, lack of motivation, or because they simply forget. Given the rapid penetration of mobile phones in India, there is lack of information about application of mobile technology in increasing treatment adherence in India.

Objectives:

Primary objective

  • To demonstrate superiority in efficacy of a first‐line NNRTI‐based regimen in the group having access to TAMA (Treatment Advice by Mobile Alerts) versus the control group receiving standard of care, as measured by the proportion of treatment‐naïve HIV‐1 infected subjects with plasma viral load < 50 HIV‐1 RNA copies/mL at Week 48.

Secondary objectives

  • To determine and compare the adherence (for all subjects: subject‐reported adherence via the M‐MASRI questionnaire , and in addition for subjects with access to TAMA: subject‐reported adherence information via the IT system
  • To determine first virologic response defined as drop in viral load to < 400 HIV‐1 RNA copies/mL at Week 24 of ARV treatment
  • To determine final virologic response defined as < 400 HIV‐1 RNA copies/mL at Week 48 of ARV treatment
  • To compare the immunologic response (CD4+ cell counts) over 48 weeks
  • To evaluate and compare safety over 48 weeks
  • To assess and compare the loss to follow‐up (clinical appointments)
  • To evaluate patient satisfaction with the TAMA platform, via usability research

Type of research: Randomized controlled trial

Investigator:

Dr. Vinay Kulkarni (Site Principal investigator)

Funding: Janssen Infectious Diseases – Diagnostics BVBA

Start date – November 2013

End date: May 2015

This trial was terminated early due to very slow recruitment rate than anticipated and due to very little chance to reach at the anticipated difference of 10% in response rate between TAMA and control arm if the study was continued as originally planned. So it was decided by the funders to early terminate the UNITE trial.