Improving Outcomes in HIV Patients Using Mobile Phone Based Interactive Software Support
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      CALL FOR LIFE UGANDATM Janssen Global Public Health Research and Development, in close
      collaboration with the Infectious Disease Institute Kampala (IDI), has developed Call for
      Life Uganda tailored to the needs of PLHIV in Uganda. Call for Life UgandaTM is based on the
      CONNECT FOR LIFETM technology (CFL2015.01 or higher version) and the MOTECH platform, an open
      source platform developed by Grameen Foundation and the University of Southern Maine with
      financial support from the Bill and Melinda Gates Foundation, and was released under the
      terms of the MOTECH open source license agreement.

      All patients consenting will; At enrolment receive detailed information from a
      nurse/counsellor on the Call for Life UgandaTM system and how it operates Receive calls or
      text messages from Call for Life UgandaTM will include recording of self-reported adherence
      (soliciting active feedback via keypad) and symptom management triggering alerts for the
      clinic.

      STUDY PROCEDURES Screening The subjects will be screened and enrolled over a period of 6
      months These are the screening procedures oAll consecutive eligible patients will be
      approached for participation in the study.

      oFor patients interested in participating the inclusion and exclusion criteria will be
      ascertained.

      oThe patients will receive information about the study by the study nurse or counselor
      Patients who agree to participate in the study will sign the informed Follow-up Visit The
      participants will come to the clinic monthly or 2 monthly to pick up their ART and
      concomitant medications (non-study visits).

      The participants will come for their study follow up visits every 6 months Every 6 months The
      patients will be assessed by the study staff.

        -  The study doctor will collect General Medical History and perform Physical Examination
           and enter it in an electronic CRF.

        -  The counsellor will collect the Quality of life and Knowledge questionnaires and enter
           them in an electronic CRF.

      At baseline, 6, 12,18 and 24 months the following samples will be collected;

        -  Viral load

        -  Storage plasma (1 aliquot) serum (3 aliquots)

      Additional procedures Resistance testing: It will be done on stored samples

        -  Baseline Resistance testing will be carried out if subsequent viral failure in order to
           investigate transmitted resistant virus

        -  Biological samples will also be stored at 6, 12,18 and 24 months and resistance testing
           carried out in case of viral load >1,000 copies/ml

      Subject Withdrawal Subjects may withdraw from the study at any time at their own request, or
      they may be withdrawn at any time at the discretion of the investigator for safety or
      behavioral reasons, or the inability of the subject to comply with the protocol required
      schedule of study visits or procedures.

      SAFETY ASSESSMENT Safety monitoring for this study will focus on unanticipated problems
      involving risks to participants, including unanticipated problems that meet the definition of
      a serious adverse event.

      DATA ANALYSIS/STATISTICAL METHODS Based on a pre and post ART assessment in Burkino Faso and
      Uganda, it is anticipated that the quality of life score (MOS-HIV) in ART naïve patients will
      increase at least by 15 points for physical health summary (PHS) between baseline and 12
      months ART use. We estimate there will be an additional 5 points improvement in those
      receiving C4LTM which would give 20-point improvement for those on C4LTM and 15 points for
      those not on call for Life. In those already on ART, investigators estimate an improvement
      for those established on ART with a 5-point improvement for those on C4LTM and nil for those
      not accessing C4LTM. We also estimate a 5-point increase in mental health score in those
      receiving C4LTM compared to no change in those without C4LTM starting ART, and a lower
      improvement of 2 points in mental health score in those already on ART. The study is powered
      on the PHS for QOL. For a power of 0.9 and precision of 0.05 we would need a minimum of 273
      in each arm (overall 546) patients, if the mean PHS among patients with C4L was 58.2 compared
      to 55.2 among patients without C4L. The investigators will include a 10% LTFUP/mortality rate
      to give a sample size of 600.

      The composition of the study participants is estimated as 300 patients at Kasangati and 300
      patients at IDI. With the proposed sample size, the numbers above depict over 90% power to
      test even the smallest differences in mean PHS at 12 months in the group of patients with and
      without C4L. The investigators also anticipate that it is possible to detect changes in MHS
      QOL with this sample Analysis of Primary Endpoint Scales to measure quality of life For this
      study we have chosen to use the Medical Outcomes Study (MOS-HIV) Health Survey which is the
      most widely used health related HRQoL measure in PLHIV.

      The MOS-HIV scale was chosen because it has been validated in various settings including
      Uganda, has a Luganda language version, and was found to be useful in assessing HRQoL in
      PLHIV.

      The MOS-HIV measures HRQoL in 11 areas: health perceptions, bodily pain, physical function,
      role function, social function, mental function, vitality, health distress, cognitive
      function, QoL, and health transition. One scores scale in a range from 0-100 with a higher
      score implying better health (41). In addition to these subscales, a Physical Health Summary
      score (PHS) and Mental Health Summary score (MHS) can be calculated.

      Intra patient in QoL scores will be compared using Paired T-tests and overall change will be
      investigated. The effect of calendar time on QoL life scores will be accounted for during
      analysis. Furthermore, the changes and or effect of the intervention on different sub-groups
      of HIV positives patients will be carried. The effect of the intervention will also be
      compared between IDI and Kasangati sites. All analysis will be conducted using STATA, USA.

        -  Investigators will assess perceptions and attitudes to the Call for Life UgandaTM tool
           thorough focus group discussions and Key informant interviews, targeting each special
           population. We will use purposeful sampling and will continue until no new themes
           emerge. We will use NVIVO software for coding of themes.

        -  Cost analysis along with the study evaluation; appropriate and detailed cost evaluation
           will also be performed. It is anticipated that if the intervention is proved effective,
           a cost effective analysis would contribute to developing a sustainable scale up strategy
           for similar service across Uganda.

      RADOMISATION Patients will randomly be assigned to either one of the two arms, that is, with
      and without CFL. To ensure that all patients in each of the arms are represented and equally
      balanced out in both arms, the study will use stratified randomization where each of the
      categories of patients at the start of the study will form the strata on interest. Within
      each stratum, the patients will be randomly assigned to C4L or no C4L. Randomization lists
      will be generated by an independent statistician and kept under lock and key in the two
      sites.

      DATA PRIVACY Any and all data generated in IDI's use of Call for Life UgandaTM shall be owned
      solely by IDI. Therefore, IDI will take all reasonable steps to restrict disclosure of
      personal data including patient-identifiable to third parties.

      In addition, the following Security Measures are in place to protect Patient's privacy when
      using Call for Life UgandaTM
    

Intervention name(s): Call for life mHealth adherence support
Intervention type(s): Other
Intervention description(s): Daily/ weekly pill reminder support Health Info-tips Appointment visit reminders Self-reported symptom support
Other intervention name(s): mHealth system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care