Ongoing Research Project UNITE

Project UNITE

Project UNITE

About the research - This is a randomized, controlled, open‐label, multicenter trial to evaluate the effect of access to TAMA (Treatment Advice by Mobile Alerts; an IT system with a cell phone interface) on treatment effectiveness in HIV‐1 infected individuals initiated on first-line antiretroviral therapy

Objectives –

Primary objective:

  • To demonstrate superiority in efficacy of a first‐line NNRTI‐based regimen in the group having access to TAMA versus the control group receiving SoC, 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

Trial Duration: Screening period of 14 days and study period of 48 weeks

Study setting: This is a multi center study with sites from different locations in India.  Prayas Amrita Clinic, Pune with Deenanath Mangeshkar Hospital & Research Center (DMHRC) is one of the sites.

Study participants at Prayas: HIV infected men/women between the age of 18 - 65 years availing care at Prayas clinic or Deenanath Mangeshkar hospital

Site Principal Investigator : Dr. Vinay Kulkarni

Sponsor : Janssen Infectious Diseases – Diagnostics BVBA

Start date – November 2013 to 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. 

 

Prayas-Amrita Clinic, Athawale Corner, Karve Road, Deccan Gymkhana, Pune - 411 004, Maharashtra, India.
Tel.: +91-20-25441230/65615726 Tel./Fax: +91+20-25420337 E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.