A Randomized Controlled Trial of a Text Messaging Intervention to Promote Virologic Suppression and Retention in Care in an Urban Safety-Net Human Immunodeficiency Virus Clinic: The Connect4Care Trial.

Background: Text messaging is a promising strategy to support human immunodeficiency virus (HIV) care engagement, but little is known about its efficacy in urban safety-net HIV clinics. Methods: We conducted a randomized controlled trial of a supportive and motivational text messaging intervention, Connect4Care (C4C), among viremic patients who had a history of poor retention or were new to the clinic. Participants were randomized (stratified by new or established HIV diagnosis status) to receive either of the following for 12 months: (1) thrice-weekly intervention messages, plus texted primary care appointment reminders and a monthly text message requesting confirmation of study participation or (2) texted reminders and monthly messages alone. Viral load was assessed at 6 and 12 months. The primary outcome was virologic suppression (<200 copies/mL) at 12 months, estimated via repeated-measures log-binomial regression, adjusted for new-diagnosis status. The secondary outcome was retention in clinic care. Results: Between August 2013 and November 2015, a total of 230 participants were randomized. Virologic suppression at 12 months was similar in intervention and control participants (48.8% vs 45.8%, respectively), yielding a rate ratio of 1.07 (95% confidence interval, .82-1.39). Suppression was higher in those with newly diagnosed infection (78.3% vs 45.3%). There were no intervention effects on the secondary outcome. Exploratory analyses suggested that patients with more responses to study text messages had better outcomes, regardless of arm. Conclusions: The C4C text messaging intervention did not significantly increase virologic suppression or retention in care. Response to text messages may be a useful way for providers to gauge risk for poor HIV outcomes. Clinical Trials Registration: NCT01917994.