Acceptability of a new 4-in-1 Abacavir/Lamivudine/Lopinavir/Ritonavir paediatric fixed-dose combination: the caregiver–child dyads’ perspective

Author:

Rotsaert Anke1ORCID,Ogara Collin2,Mwanga-Amumpaire Juliet3,Kekitiinwa Adeodata R.4,Musiime Victor25,Najjingo Elizabeth3,Kisitu Grace P.4,Nazzinda Rashidah5,Nambi Esther5,Lee Janice6,Diallo Mariama6,Kyomuhendo Flavia6,Waweru Moses6,Andrieux-Meyer Isabelle6,Nöstlinger Christiana7

Affiliation:

1. Department of Public Health, Institute of Tropical Medicine, Nationalestraat 155, Antwerp 2000, Belgium

2. Makerere University, Kampala, Uganda

3. Epicentre Mbarara Research Centre, Mbarara, Uganda

4. Baylor College of Medicine Children’s Clinical Centre of Excellence, Kampala, Uganda

5. Joint Clinical Research Centre, Kampala, Uganda

6. Drugs for Neglected Diseases initiative (DNDi), Geneva, Switzerland

7. Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

Abstract

Background: Worldwide, 1.7 million children younger than 15 years were living with HIV in 2021. Only 52% of them had access to antiretrovirals (ARVs). Lack of age-appropriate ARV formulations (i.e. easy to swallow for young infants, acceptable taste) remains the main obstacle to the access to ARVs. Therefore, a strawberry-flavoured Abacavir/Lamivudine/Lopinavir/Ritonavir (30/15/40/10 mg) fixed-dose combination of granules in a capsule (4-in-1) for children living with HIV weighing 3–25 kg was developed. Objective: We assessed caregivers’ perceived acceptability of the 4-in-1 compared with previous paediatric ARV formulations and factors influencing acceptability. Methods: This exploratory qualitative case study embedded in a phase I/II, open-label, randomized cross-over pharmacokinetic, safety and acceptability study (LOLIPOP) was conducted in three sites in Uganda (May 2019–October 2020). Thirty-six children weighing between 3 and 19.9 kg participated in the main study. We purposively sampled caregiver–child dyads according to weight bands, and conducted 20 semi-structured interviews with caregivers and 5 with healthcare providers. We triangulated these results with a quantitative acceptability questionnaire. We analysed interviews inductively using NVivo12 adopting a thematic analysis approach and acceptability questionnaires descriptively to assess concordance between them. Results: All caregivers found the 4-in-1 formulation highly acceptable and easier to use than previous formulations (i.e. pellets/tables/syrup). Appealing taste, ease of administration, easy storage and children’s acceptance contributed to acceptability despite structural challenges of food shortage and HIV stigma. Visible improvements in children’s health and comprehensive and tailored healthcare provider support to overcome initial difficulties such as vomiting increased caregivers’ acceptance. Concordant results from questionnaire- and interview-data confirmed high acceptability. Conclusion: Caregivers of children in all weight bands in this sample found the 4-in-1 granules highly acceptable compared with the pellets/tablets combination. Healthcare providers’ support to caregivers allowed for individual tailoring of drug administration despite challenges such as food shortage. This enabled short-term adherence. These findings informed further practical recommendations. Registration: Clinical trial number: NCT03836833

Funder

Drugs for Neglected Diseases initiative

Publisher

SAGE Publications

Subject

Pharmacology (medical),Infectious Diseases

Reference28 articles.

1. WHO, UNAIDS, UNICEF. The global alliance to end aids in children: a global strategic initiative to end AIDS in children by 2030, 2022, https://www.unaids.org/sites/default/files/media_asset/global-alliance-end-AIDS-in-children_en.pdf.

2. Factors influencing adherence to anti-retroviral treatment in children with human immunodeficiency virus in South India – a qualitative study

3. A Systematic Review of Pediatric Adherence to Antiretroviral Therapy in Low- and Middle-Income Countries

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