Qualitative study exploring reintegration of clinical trial participants with HIV to public health services in Johannesburg, South Africa

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Authors

Nxumalo, Sibongiseni T.
Harris, Bernice Nerine
Napoles, Lizeka
Oladimeji, Kelechi E.
Lalla-Edward, Samanta T.

Journal Title

Journal ISSN

Volume Title

Publisher

BMJ Publishing Group

Abstract

OBJECTIVE: People living with HIV (PLHIV) are often recruited from primary healthcare clinics (PHC) into clinical trials. On trial completion, they are transferred back to the facility for continued care and support in managing their condition, potentially leading to better health outcomes. Because transferring PLHIV back to PHCs post-clinical trials may result in decreased access to specialised care or resources that were available during the trial, this study explored insights into challenges faced during reintegration from clinical trial settings into PHCs and antiretroviral therapy (ART) adherence post-clinical trials. DESIGN: This cross-sectional study was conducted using a qualitative research approach. Participants were recruited using purposive sampling. SETTING: The study was conducted at the Ezintsha Research Centre in Johannesburg, South Africa, between November 2022 and February 2023. PARTICIPANTS: The study population consisted of PLHIV who had participated in two clinical trials (DORA and ADVANCE) at the Ezintsha Research Centre in Johannesburg, South Africa. METHODS: Using a semistructured guide, 12 in-depth interviews were conducted with PLHIV until data saturation was reached. Data were then transcribed verbatim and analysed thematically with MAXQDA software. RESULTS: The majority (n=8, 67%) of participants were female, and the average age of all participants was 40 (SD 7.2) years. Two main themes emerged: reintegration from clinical trials to public healthcare and barriers to ART adherence. These themes were further separated into seven subthemes, namely, negative attitude of healthcare workers, poor healthcare service delivery, poor communication to patients, waiting time at healthcare facilities, lack of privacy and confidentiality, mistakes in ART dispensing and bad reception at facilities post-clinical trials. CONCLUSION: Clinical trial sites should cultivate better stakeholder engagement with PHCs to facilitate a smoother transition of research participants, especially PLHIV, back into public healthcare for continued care.

Description

DATA AVAILABITY STATEMENT: Data are available upon reasonable request.

Keywords

Clinical trials, Antiretroviral therapy (ART), Primary healthcare (PHC), Reintegration, SDG-03: Good health and well-being, SDG-10: Reduced inequalities, Human immunodeficiency virus (HIV), People living with HIV (PLHIV)

Sustainable Development Goals

SDG-03:Good heatlh and well-being
SDG-10:Reduces inequalities

Citation

Nxumalo, S.T., Harris, B., Napoles, L., et al. Qualitative study exploring reintegration of clinical trial participants with HIV to public health services in Johannesburg, South Africa. BMJ Open 2024;14:e084947. doi:10.1136/bmjopen-2024-084947.