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Why did I participate in an HIV vaccine study? Experiences of participation in the first phase II HIV vaccine trial in Mozambique: An ancillary study using a mixed-method approach.

作者信息

Ubisse Capitine Igor P, Manhiça Álvaro Marcela, Tembe Júnior Paulo, Ramgi Patrícia M, Chicumbe Sérgio, Kroidl Arne, Fischer Martin R, De Schacht Caroline

机构信息

Instituto Nacional de Saúde (INS), Maputo Province, Mozambique.

Centre for International Health (CIH), LMU Munich, Munich, Germany.

出版信息

Vaccine X. 2024 Jun 6;19:100510. doi: 10.1016/j.jvacx.2024.100510. eCollection 2024 Aug.


DOI:10.1016/j.jvacx.2024.100510
PMID:39021617
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11254222/
Abstract

INTRODUCTION: This study recognized the lack of information regarding recruitment and retention factors associated with implementing HIV vaccine trials from the perspective of participants. It aimed to describe the motives and experiences of 31 young adults who participated in a phase II HIV vaccine clinical trial conducted in Maputo, Mozambique. METHODS: This was an ancillary study with a mixed-method approach that employed a convergent design, combining both quantitative and qualitative methodologies. Data collection involved questionnaire surveys, in-depth interviews, and focus group discussions. Participants were assessed before and after learning whether they received the experimental vaccine or placebo. Thematic analysis was used for qualitative data, while descriptive analysis and statistical tests such as Fischer's test and McNemar's exact test were applied to quantitative data. The study also utilized the Health Belief Model to understand the decision-making process of participating in an HIV vaccine study. RESULTS: Most of our participants were young females, single, with limited financial resources. Participants joined the trial with the belief that they had a unique opportunity to help the fight against HIV and contribute to the research for the discovery of an HIV vaccine. Positive experiences related to trial participation include gaining knowledge about HIV and personal health and receiving risk reduction counseling. Participants reported blood collection as a negative experience and that they suffered social harm because of trial participation. Participants felt abandoned after the trial ended. CONCLUSION: Preventive HIV vaccine trials should integrate a social-behavioral component to assess reasons for participation and refusal in real-time. Providing ongoing personal attention is crucial for young individuals who have committed 1-2 years to trial participation, extending beyond the trial period. Implementing tailored strategies for HIV risk assessment and reduction during and after the trial is essential. Addressing these factors can enhance preventive HIV vaccine trial implementation.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e82/11254222/5341b775cd13/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e82/11254222/fe5ce278dcdb/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e82/11254222/460fee01fa5f/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e82/11254222/5341b775cd13/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e82/11254222/fe5ce278dcdb/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e82/11254222/460fee01fa5f/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e82/11254222/5341b775cd13/gr3.jpg

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引用本文的文献

[1]
Descriptions of risks and benefits of HIV vaccine trials in low-and middle-income countries (LMICs): an integrative review.

BMC Med Ethics. 2025-7-3

本文引用的文献

[1]
The Validity of the Theory of Planned Behaviour for Understanding People's Beliefs and Intentions toward Reusing Medicines.

Pharmacy (Basel). 2021-3-9

[2]
Unblinding in Randomized Controlled Trials: A Research Ethics Case.

Ethics Hum Res. 2021-3

[3]
Behavioral and social science research to support development of educational materials for clinical trials of broadly neutralizing antibodies for HIV treatment and prevention.

Clin Trials. 2021-2

[4]
Social Impacts Among Participants in HIV Vaccine Trial Network (HVTN) Preventive HIV Vaccine Trials.

J Acquir Immune Defic Syndr. 2020-8-15

[5]
Sexual behaviour, changes in sexual behaviour and associated factors among women at high risk of HIV participating in feasibility studies for prevention trials in Tanzania.

PLoS One. 2020-4-16

[6]
How to … do mixed-methods research.

Clin Teach. 2020-6

[7]
Perception of potential harm and benefits of HIV vaccine trial participation: A qualitative study from urban Tanzania.

PLoS One. 2019-11-8

[8]
Mapping HIV prevalence in sub-Saharan Africa between 2000 and 2017.

Nature. 2019-5-15

[9]
How Biomedical HIV Prevention Trials Incorporate Behavioral and Social Sciences Research: A Typology of Approaches.

AIDS Behav. 2019-8

[10]
Optimizing the immunogenicity of HIV prime-boost DNA-MVA-rgp140/GLA vaccines in a phase II randomized factorial trial design.

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