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通过每周发送短信支持男同性恋者、双性恋者以及其他与男性发生性关系的顺性别男性(MSM)和跨性别女性坚持口服暴露前预防药物(PrEP):嵌套于巴西PrEP研究中的试点随机对照试验

Weekly Text Messages to Support Adherence to Oral Pre-Exposure Prophylaxis (PrEP) Among Gay, Bisexual, and Other Cisgender Men Who Have Sex With Men (MSM) and Transgender Women: Pilot Randomized Controlled Trial Nested in PrEP Brasil Study.

作者信息

Marins Luana Monteiro Spindola, Torres Thiago Silva, Moreira Ronaldo Ismerio, Leite Iuri Costa, Cunha Marcelo, Hoagland Brenda, Freitas Lucilene Araujo, Castanheira Debora, Coutinho Carolina, Jalil Emilia Moreira, Silva Mayara Secco Torres, Madruga Jose Valdez, Grinsztejn Beatriz, Veloso Valdilea Gonçalves

机构信息

Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Av Brasil 4365 Manguinhos, Rio de Janeiro, 21040-360, Brazil, 55 2138659623.

Escola Nacional de Saúde Pública Sérgio Arouca, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.

出版信息

J Med Internet Res. 2025 Jul 18;27:e72360. doi: 10.2196/72360.

DOI:10.2196/72360
PMID:40680163
Abstract

BACKGROUND

Mobile phones have become popular tools to support public health interventions (mobile health [mHealth]). Text messaging, including SMS, is a simple, low-cost approach for health communication to a large population and offers valuable tools in improving health outcomes. Despite the global advances in HIV treatment and prevention, the HIV epidemic continues to disproportionately affect certain populations such as men who have sex with men (MSM) and transgender women, including in Latin America.

OBJECTIVE

This study aimed to evaluate the effectiveness of SMS text messaging in improving adherence after 1-year provision of oral pre-exposure prophylaxis (PrEP) among MSM and transgender women in Brazil.

METHODS

Pilot randomized controlled trial nested in the PrEP Brasil study, a prospective, multicenter, open-label implementation study assessing PrEP delivery in the context of the Brazilian Public Health System. Those who agreed to participate in the pilot trial were randomized 1:1 to standard-of-care (SOC) or intervention (SMS text messaging) arm. SMS text messages were launched fully automated weekly to participants for 48 weeks. Adequate adherence to PrEP has been defined as having (1) tenofovir-diphosphate concentration of ≥700 fmol/punch, (2) medication possession ratio of ≥1.07, (3) pill count of ≥90.1%, and (4) self-report (structured questionnaire) of ≥99.9%. Adequate adherence outcomes at week 48 were compared between arms (SMS text messaging vs SOC) using univariate logistic regression. Comparisons were also performed for young MSM aged 18-24 years and transgender women.

RESULTS

From 450 participants enrolled on PrEP Brasil, 417 (92.7%) were randomized to the pilot trial: 210 to SOC and 207 to SMS arm. Until week 48, participants received a total of 14,099 SMS with the text message: "Are you okay?," and 6959 (49.4%) messages were replied. Of these, the vast majority replied "Yes" (6762/6959, 97.2%). A total of 347 (83.2%) participants completed the study with no difference between arms for the 4 adherence outcomes. Conversely, young MSM who received SMS text messages had 2.50 increased odds of having adequate PrEP adherence measured by medication possession ratio (P=.05). Most participants found SMS text messaging very useful or useful (127/167, 76.0%) and would recommend SMS text messaging as a support strategy for persons using PrEP (134/167, 80.2%). Most participants think that SMS text messaging should be offered to all persons using PrEP (129/167, 77.2%), and 16.2% (27/167) think that SMS text messaging should be offered only to those persons using PrEP with adherence problems. Weekly messages were found adequate by 80.2% (134/167).

CONCLUSIONS

SMS text messaging intervention improved adequate PrEP adherence among young MSM and can be a useful tool for PrEP coverage and persistence. Future interventions using other mHealth tools such as WhatsApp messages and apps tailored to support PrEP adherence should be evaluated among MSM and transgender women in Brazil.

摘要

背景

手机已成为支持公共卫生干预措施(移动健康[mHealth])的流行工具。包括短信服务(SMS)在内的文本消息是一种向大量人群进行健康沟通的简单、低成本方法,并为改善健康结果提供了有价值的工具。尽管全球在艾滋病毒治疗和预防方面取得了进展,但艾滋病毒疫情继续对某些人群产生不成比例的影响,例如男男性行为者(MSM)和跨性别女性,在拉丁美洲也是如此。

目的

本研究旨在评估在巴西为男男性行为者和跨性别女性提供1年口服暴露前预防(PrEP)后,短信文本消息在提高依从性方面的有效性。

方法

在PrEP Brasil研究中进行的试点随机对照试验,PrEP Brasil研究是一项前瞻性、多中心、开放标签的实施研究,评估在巴西公共卫生系统背景下PrEP的提供情况。同意参与试点试验的人被1:1随机分配到标准治疗(SOC)组或干预(短信文本消息)组。每周向参与者自动发送短信,持续48周。对PrEP的充分依从性定义为:(1)二磷酸替诺福韦浓度≥700 fmol/打孔;(2)药物持有率≥1.07;(3)药丸计数≥90.1%;(4)自我报告(结构化问卷)≥99.9%。使用单变量逻辑回归比较两组(短信文本消息组与SOC组)在第48周时的充分依从性结果。还对18 - 24岁的年轻男男性行为者和跨性别女性进行了比较。

结果

在PrEP Brasil研究登记的450名参与者中,417名(92.7%)被随机分配到试点试验:210名分配到SOC组,207名分配到短信组。到第48周时,参与者共收到14099条短信,内容为:“你还好吗?”,其中6959条(49.4%)得到了回复。其中,绝大多数回复为“是”(6762/6959,97.2%)。共有347名(83.2%)参与者完成了研究,两组在4项依从性结果方面没有差异。相反,通过药物持有率衡量,收到短信文本消息的年轻男男性行为者PrEP充分依从的几率增加了2.50倍(P = 0.05)。大多数参与者认为短信文本消息非常有用或有用(127/167,76.0%),并会推荐短信文本消息作为使用PrEP者的一种支持策略(134/167,80.2%)。大多数参与者认为应该向所有使用PrEP的人提供短信文本消息(129/167,77.2%),16.2%(27/167)的人认为应该仅向那些在依从性方面有问题的使用PrEP者提供短信文本消息。80.2%(134/167)的人认为每周的短信是足够的。

结论

短信文本消息干预提高了年轻男男性行为者对PrEP的充分依从性,并且可以成为扩大PrEP覆盖范围和提高持续性的有用工具。未来应在巴西的男男性行为者和跨性别女性中评估使用其他移动健康工具(如WhatsApp消息和为支持PrEP依从性量身定制应用程序)的干预措施。

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