Evidence map›Paper›PMID 42410635›Full record

ArticleTrials2026

Nurse counselors' experiences of recruitment and retention of female sex workers in a HIV vaccine trial: a qualitative study from urban Tanzania.

Masunga K Iseselo, Edith A M Tarimo, Joel S Ambikile, Gift G Lukumay, Patricia Munseri, Mohamed Bakari, Eligius Lyamuya, Said Aboud, PrEPVacc Trial Team

Registry-linked trialAbstract read
In one paragraph

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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0citing papers in PubMed
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04066881 phase2completednot on this map

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

TypeinterventionalSponsorMRC/UVRI and LSHTM Uganda Research UnitRan2020 to 2024Enrolled1,512ConditionsHIV InfectionsArmsVaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48), Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48), Vaccine Group C: Saline placebo (weeks 0,4,24,48), Control PrEP:TDF/FTC once daily (weeks 0-26), Experimental PrEP:TAF/FTC once daily (weeks 0-26)
3 · Its place in the literature

Who cites it

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No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Masunga K IseseloDepartment of Clinical Nursing, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania. masungaiseselo@yahoo.com.
Edith A M TarimoDepartment of Nursing Management, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Joel S AmbikileDepartment of Clinical Nursing, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Gift G LukumayDepartment of Community Health Nursing, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Patricia MunseriDepartment of Internal Medicine, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Mohamed BakariDepartment of Internal Medicine, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Eligius LyamuyaDepartment of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Said AboudDepartment of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
PrEPVacc Trial Team

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AIDS VaccinesCounselingCounselorsHIV InfectionsNursesNurse's RolePatient SelectionSex WorkersAdultAttitude of Health PersonnelClinical Trials, Phase II as TopicFemaleHumansMulticenter Studies as TopicQualitative ResearchTanzaniaAIDS VaccinesDar es SalaamExperiencesFemale sex workersHIV vaccine trialNurse counselorsQualitative researchRecruitment of volunteersTanzaniaTrial retention

Identifiers

PMID42410635
PMCPMC13617680

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.