A Stepped-Wedge, Cluster-Randomized, Multisite Study of Text Messaging Plus Peer Navigation to Improve Adherence and Viral Suppression Among Youth on Antiretroviral Therapy.

BACKGROUND

To address the need for improved virologic suppression among youth living with HIV (YLH) on antiretroviral treatment (ART), we evaluated peer navigation plus TXTXT daily text message ART reminders.

SETTING

YLH aged 15-24 years on ART for at least 3 months at 6 research sites in 4 Nigerian cities.

METHODS

Using a stepped-wedge design, cluster 1 was nonrandomized, whereas clusters 2 and 3 were randomized to sequences of routine care (control period) and 48 weeks of the combination intervention (intervention period). The primary end point was viral suppression (HIV-1 RNA <200 copies/mL) at week 48 of the intervention. Secondary end points included adherence measured by self-report ( 90% considered adherent). Post hoc analysis assessed virologic control at <50 copies per milliliter and <1000 copies per milliliter. Generalized estimating equations determined the difference between intervention and control periods in the intention-to-treat population.

RESULTS

We enrolled 558 YLH and followed 541 over time, mean age 18 years, 53.8% female, 71.7% perinatally infected, and 38.6% virologically nonsuppressed at enrollment. For the primary end point, the intervention periods displayed a small, nonsignificant increase in viral suppression < 200 copies per milliliter [odds ratio (OR) = 1.16 (0.88-1.54), P = 0.297]. There was a significant effect of the combination intervention on virologic control <1000 copies per milliliter (OR = 1.42 [1.03-1.94], P = 0.030). Self-reported adherence also improved (OR = 2.07 [1.46-2.95], P < 0.001).

CONCLUSIONS

Peer navigation plus daily text message ART reminders demonstrated limited benefit among ART-experienced, predominantly perinatally infected YLH, with no significant effect on viral suppression below 200 copies per milliliter despite improvement in self-reported adherence.