Mapetla Katlego, Malahleha Mookho, van Niekerk Nadia, Thindisa Dineo, Mpete Lebogang, Ahmed Khatija, Dilraj Athmanundh
Setshaba Research Centre, Tshwane, South Africa.
Clinical Laboratory Services, Johannesburg, South Africa.
Clin Trials. 2022 Feb;19(1):81-85. doi: 10.1177/17407745211062077. Epub 2021 Dec 7.
Ensuring protocol visit compliance and maintaining high participant retention remain critical elements of clinical trials. In the HVTN 702 HIV vaccine trial, Setshaba Research Centre in Soshanguve, Tshwane, South Africa, experienced challenges in communicating with participants to remind them about their study visits. In order to improve participants adhering to their study visits, and study retention, we aimed to identify challenges in mobile communication, and to establish preferences in communication methods and interest in receiving study information via cellphones.
We conducted a paper-based survey among HVTN 702 HIV vaccine trial participants at Setshaba Research Centre. The survey comprised of dichotomous and scale questions and was completed voluntarily and anonymously. The questions included those on their primary form of communication (calling, SMS and WhatsApp), the best time of day for the site to communicate with them, whether they were interested in receiving regular general study information updates via their cellular phone, how often they changed their cellular phones and/or network, whether they experienced any challenges with their cellular phones and what these challenges were, if any. All participants scheduled to visit the clinic from February to May 2019 were invited to participate. Thus, 90 of 380 (24%) participants enrolled by May 2019 were surveyed.
The majority (68%) of participants were 26-35 years old and almost three-quarters (73%) were female. Almost all participants (99%) had a personal cellphone. Half of the participants experienced some challenge related to cellphones, these being poor network signal at home (12%), battery running flat frequently (11%), sharing their phone (9%), lack of data (9%), challenges with use of applications (6%) and their cellphones being unreliable (3%). Annually, 20% of participants made a single or multiple network changes. Communication preferences were calls by site staff (80%), SMS (16%) and WhatsApp (3%). Most preferred to be contacted in the morning (49%) or afternoon (31%). Site contact was rated as 'very helpful' (87%), and 97% were interested in receiving regular general study information updates via their cellphone.
Despite participants owning cellphones, there are still technical challenges, for example, network signals, battery-charging and applications. The majority of participants preferred being called rather than communicating by text messages or WhatsApp. Future studies need to include addressing participant challenges in maintaining contact and training of participants on use of cellphone applications to optimise communication. Noting the preferred time of day for participants to be called might improve the likelihood of making contact with them. The willingness to receive updates will aid in keeping participant interest high and enhance retention.
确保方案访视的依从性和维持高参与者留存率仍然是临床试验的关键要素。在HVTN 702 HIV疫苗试验中，南非茨瓦内索尚古韦的塞特沙巴研究中心在与参与者沟通以提醒他们进行研究访视方面遇到了挑战。为了提高参与者对研究访视的依从性以及研究留存率，我们旨在确定移动通信方面的挑战，并确定沟通方式的偏好以及通过手机接收研究信息的兴趣。
我们在塞特沙巴研究中心对HVTN 702 HIV疫苗试验的参与者进行了纸质问卷调查。该调查包括二分法和量表问题，由参与者自愿且匿名完成。问题包括他们的主要沟通形式（打电话、短信和WhatsApp）、研究中心与他们沟通的最佳时间、他们是否有兴趣通过手机接收定期的一般研究信息更新、他们更换手机和/或网络的频率、他们的手机是否遇到任何问题以及这些问题是什么（如果有）。邀请了所有计划在2019年2月至5月访问诊所的参与者参加。因此，对2019年5月登记的380名参与者中的90名（24%）进行了调查。
大多数（68%）参与者年龄在26 - 35岁之间，近四分之三（73%）为女性。几乎所有参与者（99%）都有个人手机。一半的参与者在手机方面遇到了一些问题，这些问题包括家中网络信号差（12%）、电池经常没电（11%）、共用手机（9%）、数据不足（9%）、应用程序使用方面的问题（6%）以及手机不可靠（3%）。每年有20%的参与者进行一次或多次网络更换。沟通偏好方面，研究中心工作人员打电话（80%）、短信（16%）和WhatsApp（3%）。大多数人更喜欢在上午（49%）或下午（31%）被联系。研究中心的联系被评为“非常有帮助”（87%），97%的人有兴趣通过手机接收定期的一般研究信息更新。
尽管参与者拥有手机，但仍存在技术挑战，例如网络信号、电池充电和应用程序。大多数参与者更喜欢被打电话而不是通过短信或WhatsApp沟通。未来的研究需要包括解决参与者在保持联系方面的挑战以及对参与者进行手机应用程序使用培训，以优化沟通。注意参与者被打电话的首选时间可能会提高与他们取得联系的可能性。愿意接收更新将有助于保持参与者的高兴趣并提高留存率。
