Text Messaging Intervention to Improve ART Adherence Among HIV-positive Youth
Condition: Patient Adherence; HIV
MeSH terms: HIV Seropositivity
Study type: Interventional

Summary: 
      The purpose of the proposed study is to test SMS (short message service) text messaging
      technology to improve medication adherence among youth living with HIV (YLH). The proposed
      study is a randomized controlled trial of the effect of text message reminders on ART
      (anti-retroviral therapy) adherence among non-adherent YLH. Daily text message reminders will
      be sent to patients randomized to the intervention group according to their medication
      schedule, for 6 months. The investigators will enroll non-adherent YLH, ages 16-29. Half of
      the sample, randomized to the intervention, will receive daily SMS text message medication
      reminders and half will be randomized to the control condition and receive standard of care
      (SOC) only. For the controlled trial, adherence levels and viral load will be collected at
      baseline, 3-month and 6-month follow-up. In addition, at the end of the initial 6-month
      enrollment period, participants in the control condition will cross-over to the SMS
      intervention and participants in the intervention condition will cease to receive the SMS
      intervention. Adherence and viral load data will be collected from each group at 9- and
      12-month follow-up points. The investigators hypothesize that youth in the intervention
      condition will demonstrate a clinically meaningful increase in adherence at 3 and 6 months
      post-baseline, from approximately 70% to 90% adherence to ART.
    

Detailed description: 
      The purpose of the proposed study is to test an intervention using SMS text messaging
      technology to improve medication adherence among YLH. The proposed study is a randomized
      controlled trial of the effect of text message reminders on ART adherence rates among
      non-adherent YLH. Daily text message reminders will be sent to all patients randomized to the
      intervention group according to their medication schedule, for six months. Participants will
      have the option to choose a tailored personalized message that may be changed as requested
      throughout the study period. The investigators will enroll YLH, ages 16-29 (i.e.,
      perinatally, transfusion, or behaviorally acquired -- consistent with our feasibility study
      and the distribution of infection mode in the primary clinic sites) who have demonstrated
      poor adherence to ART. Half of the sample, randomized to the intervention, will receive daily
      short message service (SMS; aka "text message") medication reminders and half will be
      randomized to the control condition and receive standard of care (SOC) only. For the
      controlled trial, adherence levels and viral load will be collected at baseline, 3-month and
      6-month follow-up. In addition, at the end of the initial 6-month enrollment period,
      participants in the control condition will cross-over to the SMS intervention for 6 months
      and participants in the intervention condition will cease to receive the SMS intervention.
      Adherence and viral load data will be collected from each group at the 9-month and 12-month
      follow-up points. The advantages of these additional features are that they allow the
      investigators to offer the intervention to all participants, to evaluate the intervention
      effect in the control group (to confirm the intervention effect) and to assess sustained
      intervention effects in the intervention group (post-intervention). Specific Aims:

        1. To determine the efficacy of an SMS text messaging intervention on our primary outcome:
           adherence to ART among poorly adherent YLH, ages 16-29 (a group shown to be at high risk
           for substance use) over a 6-month intervention period, with effects assessed at 3 and
           6-months post-baseline.

        2. To explore the efficacy of an SMS text messaging intervention on a secondary,
           exploratory outcome: viral load and cluster of differentiation 4 (CD4) counts, over a
           6-month intervention period, with effects assessed at 3 and 6-months post-baseline.

        3. To assess the feasibility, acceptability, and satisfaction of this intervention and
           clinical trial approach by both objective (e.g., automated message delivery and response
           counts) and subjective measures (e.g., reported satisfaction, acceptability).

      Primary Hypotheses:

        1. Youth randomized to the SMS text messaging intervention will show greater improvements
           in levels of adherence to ART and secondary outcomes during the intervention period at 3
           and 6 months post-baseline, in comparison to those receiving standard of care only. The
           investigators hypothesize at least a 10-point difference in adherence level between
           groups at 3 and 6 months for the intervention to be clinically meaningful.

        2. Youth randomized to SMS text messaging intervention will maintain improvements in
           adherence (i.e., > 90% adherence) at 9-month and 12-month follow-ups.
    

Intervention name(s): SMS Text Message Reminder
Intervention type(s): Behavioral
Intervention description(s): Daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Patient Adherence; HIV