Wynne Joshua, Muwawu Rosemary, Mubiru Michael C, Kamira Betty, Kemigisha Doreen, Nakyanzi Teopista, Kabwigu Samuel, Nakabiito Clemensia, Kiweewa Matovu Flavia
a Sidney Kimmel Medical College at Thomas Jefferson University , Philadelphia , Pennsylvania , USA.
b Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration , Kampala , Uganda.
HIV Clin Trials. 2018 Oct;19(5):165-171. doi: 10.1080/15284336.2018.1513711. Epub 2018 Oct 27.
The success of longitudinal trials depends greatly on using effective strategies to retain participants and ensure internal validity, maintain sufficient statistical power, and provide for the generalizability of study results.
This paper describes the challenges and specific strategies used to retain participants in a Phase 2B safety and effectiveness study of daily oral and vaginal tenofovir formulations for the prevention of HIV-1 infection in the MTN-003 (VOICE) trial in Kampala, Uganda.
Once enrolled, participants were seen every 28 days at the research site and their study product was re-filled. Challenges to retention included a mobile population, non-disclosure of study participation to spouse/family, and economic constraints. Strategies used to maintain high participation rates included the use of detailed locator information, a participant tracking database, regular HIV/STI testing, and the formation of close bonds between staff and subjects.
We enrolled 322 women out of the 637 screened. The overall retention rate was 95% over a 3 year follow up period. Only 179 (3%) out of the 6124 expected visits were missed throughout study implementation. Reasons for missed visits included: participants thinking that they did not need frequent visits due to their HIV negative status, time constraints due to commercial sex work, and migration for better employment.
With the implementation of multi-faceted comprehensive follow-up and retention strategies, we achieved very high retention rates in the MTN-003 study. This paper provides a blueprint for effective participant retention strategies for other longitudinal HIV prevention studies in resource-limited settings in Sub-Saharan Africa.
纵向试验的成功很大程度上取决于采用有效的策略来留住参与者，并确保内部有效性、维持足够的统计效力以及使研究结果具有可推广性。
本文描述了在乌干达坎帕拉进行的MTN - 003（VOICE）试验中，为在每日口服和阴道用替诺福韦制剂预防HIV - 1感染的2B期安全性和有效性研究中留住参与者所面临的挑战及使用的具体策略。
参与者一旦登记入组，每28天在研究地点接受检查，并重新领取研究产品。留住参与者面临的挑战包括人口流动性大、未向配偶/家人透露参与研究的情况以及经济限制。用于维持高参与率的策略包括使用详细的定位信息、参与者追踪数据库、定期进行HIV/性传播感染检测以及工作人员与受试者之间建立密切关系。
在637名筛查者中，我们招募了322名女性。在3年的随访期内，总体保留率为95%。在整个研究实施过程中，6124次预期访视中只有179次（3%）未进行。未进行访视的原因包括：参与者认为因其HIV阴性状态无需频繁访视、因商业性工作导致时间受限以及为更好的工作而迁移。
通过实施多方面综合的随访和保留策略，我们在MTN - 003研究中实现了非常高的保留率。本文为撒哈拉以南非洲资源有限地区其他纵向HIV预防研究提供了有效的参与者保留策略蓝图。
