ArticleTrials2026
Nurse counselors' experiences of recruitment and retention of female sex workers in a HIV vaccine trial: a qualitative study from urban Tanzania.
Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04066881 (A Phase IIb Three-arm, Two-stage HIV Prophylactic Vaccine Trial With a Second Randomisation to Compare TAF/FTC to TDF/FTC as Pre-exposure Prophylaxis), which is not on this map. Not yet cited in PubMed.
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A Phase IIb Three-arm, Two-stage HIV Prophylactic Vaccine Trial With a Second Randomisation to Compare TAF/FTC to TDF/FTC as Pre-exposure Prophylaxis
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9 authors.
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Abstract
backgroundNurse counselors play a pivotal role in recruiting and facilitating the retention of volunteers in HIV vaccine trials. They act as the primary interface between the research team and volunteers, typically tasked with educating, supporting, and guiding participants through the trial process, including adherence to the study protocol for care and safety. There is limited research on the series of experiences and challenges faced by nurse counselors during the recruitment and retention of volunteers in HIV vaccine trials. This study aimed to describe the experiences of nurse counselors in recruiting and retaining female sex workers in the HIV PrEP and Vaccine (PrEPVacc) trial.
methodsThis employed a descriptive qualitative study design nested within the larger phase IIb three-arm, two-stage HIV prophylactic vaccine trial conducted in Dar es Salaam, Tanzania. The qualitative data were collected among three nurse counselors and one field worker who participated in 16 debrief sessions. The participants were purposefully selected due to their roles and responsibilities in the recruitment and retention of volunteers. The audio-recorded sessions were transcribed verbatim, and the content analysis approach was applied.
findingsThe study revealed that nurse counselors felt responsible and honored through enhancing volunteers' recruitment and enrollment, ensuring retention, and facilitating trial interventions. The availability of a supportive trial environment, engagement meetings, collaboration among staff and volunteers, good staff performance, and volunteers' positive attitude were the qualities for effective management of volunteers in the trial. However, the participants described encountering barriers to trial recruitment and retention, such as volunteers' noncompliance with trial requirements, perceived lack of honesty, personal life and family resistance, stigma, and social perception.
conclusionThe nurse counselors can encounter great turmoil while ensuring recruitment and retention in an HIV vaccine trial. Despite the challenges, volunteer engagement and adherence to study protocol are important for maintaining the continuity of trial procedures over time. Collaboration among staff and engagement of volunteers are essential to enhancing retention until the end of the study.
trial registrationThe trial was registered with the US clinicaltrials.gov on 29 September 2021 and can be found at https://clinicaltrials.gov/study/NCT04066881 . REGISTRATION NUMBER: NCT04066881.
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