Freidenson-Bejar Jeffrey, Espinoza Dianne, Calderon-Flores Rodrigo, Mejia Fernando, González-Lagos Elsa
School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.
Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.
JMIR Res Protoc. 2025 May 22;14:e66941. doi: 10.2196/66941.
Young people living with HIV face challenges in consistently adhering to antiretroviral therapy (ART). Although mobile health interventions, particularly those using SMS text messaging, have been implemented to improve ART adherence, many lack a focus on specific behavioral mechanisms. Interventions incorporating behavioral change techniques (BCTs), especially those emphasizing customization, may enhance effectiveness. WhatsApp offers potential for delivering tailored, behaviorally grounded interventions with diverse communication features. We hypothesize that WhatsApp messages self-designed by participants, with spontaneous targeting of BCTs, could be more effective than standard WhatsApp messages designed by the researchers to improve ART adherence.
The objective of this study is to evaluate the effectiveness of WhatsApp messages created by participants (self-designed) compared to WhatsApp messages designed by the researchers (standardized) over adherence to ART at 16 weeks of intervention in young people living with HIV who receive HIV care under routine conditions at a public hospital in Lima, Peru.
A 2-arm randomized controlled trial with a parallel assignment of 1:1, with no blinding of study intervention, was performed. Eligible participants are consenting people living with HIV aged 18-29 years who receive HIV care at the study center and whose mobile phones support WhatsApp. Following informed consent and a baseline survey on clinical and personal preferences (eg, timing and frequency of messages), participants are randomized to the control group (messages designed by the research team) or to the experimental group (messages designed by participants), stratified by sex, educational level, current ART intake, and history of ART abandonment. Participants in both groups receive up to 3 WhatsApp messages per week for 16 weeks. ART adherence, the primary outcome, is measured using the Simplified Medication Adherence Questionnaire (SMAQ) at 4, 8, 12, and 16 weeks. Monthly feedback questionnaires on user experience are also administered. The WhatsApp chat format allows two-way communication between participants and the research team throughout the study. We will compare ART adherence between 2 groups at 16 weeks under the intention-to-treat principle, with no interim analysis planned. Based on an estimated 10% difference in adherence, 78.9% power, and a 2-sided α of .05, the target sample size was set at 120, later increased to 131 to include a 2-week pilot phase.
In March 2024, we started enrolling and randomizing participants. The study follow-up will continue until the last participant completes 16 weeks of intervention (November 2024). As of February 2025, we are in the process of data curation.
This trial will compare the effectiveness of standardized vs self-designed WhatsApp messages on ART adherence measured at 16 weeks among young people living with HIV receiving routine care in a low-resource setting in Lima.
ClinicalTrials.gov NCT06500013; https://clinicaltrials.gov/ct2/show/NCT06500013.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/66941.
感染艾滋病毒的年轻人在持续坚持抗逆转录病毒疗法（ART）方面面临挑战。尽管已经实施了移动健康干预措施，特别是那些使用短信的措施来提高ART依从性，但许多措施缺乏对特定行为机制的关注。纳入行为改变技术（BCTs）的干预措施，尤其是那些强调个性化的措施，可能会提高有效性。WhatsApp具有通过多种通信功能提供量身定制的、基于行为的干预措施的潜力。我们假设，参与者自行设计的、自发针对BCTs的WhatsApp消息可能比研究人员设计的标准WhatsApp消息在提高ART依从性方面更有效。
本研究的目的是评估在秘鲁利马一家公立医院接受常规艾滋病毒护理的感染艾滋病毒的年轻人中，在干预16周时，参与者创建的WhatsApp消息（自行设计）与研究人员设计的WhatsApp消息（标准化）相比，对ART依从性的有效性。
进行了一项双臂随机对照试验，平行分配比例为1:1，不设研究干预盲法。符合条件的参与者是年龄在18 - 29岁之间、在研究中心接受艾滋病毒护理且手机支持WhatsApp的同意参与的艾滋病毒感染者。在获得知情同意并进行关于临床和个人偏好（如消息发送时间和频率）的基线调查后，参与者按性别、教育水平、当前ART摄入量和ART中断史分层，随机分为对照组（研究团队设计的消息）或实验组（参与者设计的消息）。两组参与者在16周内每周最多接收3条WhatsApp消息。主要结局指标ART依从性在第4、8、12和16周使用简化药物依从性问卷（SMAQ）进行测量。还每月发放关于用户体验的反馈问卷。WhatsApp聊天格式允许参与者和研究团队在整个研究过程中进行双向沟通。我们将根据意向性分析原则比较两组在16周时的ART依从性，不计划进行中期分析。基于估计的10%的依从性差异、78.9%的检验效能和双侧α为0.05，目标样本量设定为120，后来增加到131以纳入为期2周的试点阶段。
2024年3月，我们开始招募和随机分配参与者。研究随访将持续到最后一名参与者完成16周的干预（2024年11月）。截至2025年2月，我们正在进行数据整理。
本试验将比较标准化与自行设计的WhatsApp消息在利马低资源环境中接受常规护理的感染艾滋病毒的年轻人中16周时测量的ART依从性方面的有效性。
ClinicalTrials.gov NCT06500013；https://clinicaltrials.gov/ct2/show/NCT06500013。
国际注册报告识别码（IRRID）：DERR1 - 10.2196/66941。
