Text messaging for maternal and infant retention in prevention of mother-to-child HIV transmission services: A pragmatic stepped-wedge cluster-randomized trial in Kenya.

Background Timely diagnosis of infant HIV infection is essential for antiretroviral therapy (ART) initiation. In a randomized controlled trial, we found the Texting Improves Testing (TextIT) intervention (a theory-based text messaging system) to be efficacious for improving infant HIV testing rates and maternal retention in prevention of mother-to-child HIV transmission (PMTCT) programs. Using an implementation science approach, we aimed to evaluate real-world effectiveness of the intervention. Methods and findings In a pragmatic, cluster-randomized, stepped-wedge trial with 2 time periods of observation, we randomly allocated 10 clinics to begin implementing the intervention immediately and 10 clinics to begin implementing 6 months later. To approximate real-world conditions, inclusion criteria were broad. Women at clinics implementing the intervention received up to 14 text messages during pregnancy and after delivery and had the option to respond to text messages, call, or send inquiry text messages to a designated clinic phone. The primary outcomes were infant HIV testing and maternal retention in care during the first 8 weeks after delivery. We used modified Poisson regression with robust variance estimation to estimate the relative risk and 95% confidence intervals (CIs). Generalized estimating equations were applied on individual-level data to account for clustering by site. Between February 2015 and December 2016, 4,681 women were assessed for study participation, and 2,515 were included. Participant characteristics at enrollment did not differ by study arm. Overall median age was 27 years (interquartile range [IQR] 23-30), median gestational age was 30 weeks (IQR 28-34), 99% were receiving ART, and 87% who enrolled during intervention phases owned a phone. Of 2,326 infants analyzed, 1,466 of 1,613 (90.9%) in the intervention group and 609 of 713 (85.4%) in the control group met the primary outcome of HIV virologic testing performed before 8 weeks after birth (adjusted relative risk [aRR] 1.03; 95% CI 0.97-1.10; P = 0.3). Of 2,472 women analyzed, 1,548 of 1,725 (90%) in the intervention group and 571 of 747 (76%) in the control group met the primary outcome of retention in care during the first 8 weeks after delivery (aRR 1.12; 95% CI 0.97-1.30; P = 0.1). This study had two main limitations. Staff at all facilities were aware of ongoing observation, which may have contributed to increased rates of infant HIV testing and maternal retention in care at both intervention and control facilities, and programmatic initiatives to improve maternal and infant retention in care were ongoing at all facilities at the time of this study, which likely limited the ability to demonstrate effectiveness of the trial intervention. Conclusions In this study, a larger proportion of infants in the intervention group received HIV testing compared with the control group, but the difference was small and not statistically significant. There was also a nonsignificant increase in maternal postpartum retention in the intervention periods. Despite the lack of a significant effect of the intervention, key lessons emerged, both for strengthening PMTCT and for implementation research in general. Perhaps most important, improving the implementation of usual care may have been sufficient to substantially improve infant HIV testing rates. Author summaryWhy was this study done? Low retention of mother-infant pairs in postpartum HIV care poses a major threat to successful elimination of mother-to-child HIV transmission in sub-Saharan Africa. The increase in the number of mobile phone connections in sub-Saharan Africa has been spectacular, presenting a unique opportunity to add mobile technology for health (mHealth) to the armamentarium for turning the tide of HIV. We developed the Texting Improves Testing (TextIT) intervention to improve uptake of infant HIV testing and maternal retention in postpartum HIV care in a high-HIV-burden setting. Text messages were designed using behavioral theory. Women received up to 14 text messages during pregnancy and after delivery. Messages were tailored based on recipient's gestational age, name, preferred time, desired language (English, Kiswahili, or Dholuo), date of delivery, and infant's name. Participants had the option to respond to text messages, call, or send inquiry text messages. In a randomized controlled efficacy trial, we found that the TextIT intervention significantly improved rates of infant HIV testing and maternal retention in postpartum HIV care. To achieve policy change leading to broader implementation of this evidence-based intervention, we sought to provide evidence of effectiveness under real-world routine care conditions. What did the researchers do and find? Using an implementation science approach, we designed a cluster randomized, stepped-wedge trial with 2 time periods of observation. We randomly allocated 10 health facilities to begin implementing the intervention immediately, while the remaining 10 began implementing approximately 6 months later. Consistent with real-world implementation conditions, inclusion criteria were minimal. Women were offered the opportunity to receive text messages if they were >= 18 years old or emancipated minors and between 28 weeks' gestation and delivery. We found that 1,466 of 1,613 (90.9%) infants in the intervention group underwent HIV testing within 8 weeks after birth compared to 609 of 713 (85.4%) in the control group. We also found that 1,548 of 1,725 (90%) women in the intervention group were retained in care during the first 8 weeks after delivery compared to 571 of 747 (76%) in the control group. What do these findings mean? We observed nonsignificant increases in infant HIV testing and maternal retention in postpartum care associated with short message service (SMS) text messaging. Nevertheless, HIV testing of >90% aligns with the global target of diagnosing >90% of all children living with HIV. Recognizing that strict adherence to statistical thresholds in implementation research may not provide optimal guidance for public health practice, interpretation of estimates of improvement in such studies should be contextualized in terms of the costs and benefits of implementing at scale.