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In 1995, the Advisory Committee on Immunization Practices (ACIP) recommended universal hepatitis B (HepB) vaccine for all 11- and 12-year-old children and all children < 11 years old who are […]

Background: 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. Methods: 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. Results: 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. Conclusion: 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. [ABSTRACT FROM AUTHOR]

In clinical trials, a vital protocol requirement for participants is adherence to scheduled visits. A substantial number of missed visits and the resultant missing data could affect generalisability of the findings and undermine the scientific conclusions. We aimed to investigate the extent of and reasons for missed visits in the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial in order to optimise recruitment and retention practices. Despite being a multi-country study, we investigated missed visits only at Setshaba Research Centre in Soshanguve, Tshwane, South Africa. Of 810 participants enrolled at Setshaba Research Centre, 94 (11.6%) participants missed visits and 231 missed visits were recorded. Of the 94 participants who missed visits, 53 (56.4%) missed at least two visits; 37 (39.4%) missed three or more visits, and of these, 32 (86.5%) missed at least two visits for the same reason. Overall, the main reasons for missed visits were: participant had to work (60; 26.0%), unable to contact participant (60; 26.0%), participant relocated (32; 13.9%), and participant travelled out of area (23; 10%). The large proportion of participants who missed two or more visits indicates that participants who miss a single visit are likely to miss even more, often for the same reason. Site staff need to be vigilant to detect any trends in missed visits early and innovative in developing personalised strategies to minimise missed visits and retain participants until completion of their scheduled visits. [ABSTRACT FROM AUTHOR]