Participation in a clinical trial of a text messaging intervention is associated with increased infant HIV testing: A parallel-cohort randomized controlled trial

Objective
Text messages significantly improve uptake of infant HIV testing in clinical trial contexts. Women who were excluded from a randomized trial in Kenya were followed to create a comparison between women who were enrolled and did not receive the study SMS intervention and women who were screened but not enrolled.
Design
Parallel-cohort randomized controlled trial analysis.
Methods
We compared time to infant HIV testing between women in three groups: the Trial SMS group, the Trial Control group, and the Comparison Cohort comprised of women who were screened but not enrolled.
Results
Of the 1,115 women screened, 388 (35%) were eligible for trial enrollment, and were randomized to receive either intervention text messages (Trial SMS; N = 195) or continue usual care (Trial Control; N = 193). Among 727 women not enrolled in the study (Comparison Cohort), we obtained infant HIV testing data from clinic records for 510 (70%). The cumulative probability of infant HIV testing was highest in the Trial SMS group (92.0%; 95% CI 87.5–95.3), followed by the Trial Control group (85.1%; 95% CI 79.5–89.8), and lowest among women in the Comparison Cohort (43.4%; 95% CI 39.2–47.8).
Conclusions
Both the Trial SMS group and the Trial Control group were significantly more likely to have their infants tested for HIV compared to the Comparison Cohort, providing evidence of a “clinical trial effect.” This analysis suggests that SMS interventions should be implemented as an adjunct to consistent and engaged delivery of basic health services.

研究目标：短信干预可显著提升临床试验场景下婴儿HIV检测的参与率。本研究对肯尼亚某随机对照试验中被排除的女性开展随访，以构建三类人群的对比队列：入组且接受研究短信干预的女性、入组且未接受研究短信干预的女性，以及筛查后未入组的女性。
研究设计：平行队列随机对照试验分析。
研究方法：本研究对比了三组女性的婴儿HIV检测时间，分别为试验短信干预组、试验对照组，以及由筛查后未入组女性组成的比较队列。
研究结果：1115名接受筛查的女性中，388名（35%）符合试验入组标准，随后被随机分配至干预短信组（试验短信组；N = 195）或常规护理组（试验对照组；N = 193）。在未入组本研究的727名女性（比较队列）中，我们从临床记录中获取了510名（70%）女性的婴儿HIV检测数据。婴儿HIV检测的累积概率以试验短信干预组最高（92.0%；95%置信区间（Confidence Interval, CI）87.5–95.3），其次为试验对照组（85.1%；95%CI 79.5–89.8），比较队列女性的累积概率最低（43.4%；95%CI 39.2–47.8）。
研究结论：与比较队列相比，试验短信干预组与试验对照组的婴儿HIV检测率均显著更高，这为"临床试验效应"提供了实证依据。本分析表明，短信干预应作为基础医疗服务持续规范开展的辅助手段加以推广应用。