Preferences for oral and injectable PrEP among qualitative sub-study participants in HPTN 084.


Journal

PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081

Informations de publication

Date de publication:
2024
Historique:
received: 26 01 2024
accepted: 20 08 2024
medline: 24 10 2024
pubmed: 23 10 2024
entrez: 23 10 2024
Statut: epublish

Résumé

HPTN 084 compared the safety and efficacy of long-acting injectable cabotegravir (CAB) to daily oral TDF/FTC for prevention of HIV-1 in uninfected African women. Like a similar trial in MSM/TGW (HPTN 083), the trial was stopped early for efficacy, expediting the need to consider introduction strategies for different populations. We examine survey and qualitative data from a four-country sub-study to examine oral and injectable PrEP acceptability and considerations for CAB access among African women. Participants completed baseline and follow-up surveys on HIV risk perception, sexual behavior. product acceptability and adherence during the blinded trial. Additionally, up to two in-depth interviews each with 73 sub-study participants explored product use and trial-related experiences, during the blinded and unblinded study periods. Using survey data, we classified participants as: engaged in female sex work (FSW), having multiple non-transactional partners, or monogamous. A study statistician identified participants' assigned study arm. We followed a thematic analysis process to read transcripts, develop a codebook and apply codes in NVivo to transcripts with intermittent intercoder reliability checks; using Excel matrices to explore differences across risk categories and study arms. Participants overwhelmingly preferred injections to pills, appreciating the ease, convenience, and privacy of a long-acting formulation. Many participants described challenges with contraceptive and/or study pill adherence, impeded by late night work, unexpected travel, or heavy drinking. Women in the TDF/FTC arm were more likely to describe side effects, compared to those in the CAB arm. Pain also varied widely by study arm. When considering post-trial access to CAB, limited PrEP knowledge, cost and concerns around stigma and poor service quality were potential access barriers. Women's desire for privacy and ease of use outweighed injectable concerns, resulting in a strong preference for CAB. Cost and accessibility will need to be addressed by implementation programs.

Sections du résumé

BACKGROUND BACKGROUND
HPTN 084 compared the safety and efficacy of long-acting injectable cabotegravir (CAB) to daily oral TDF/FTC for prevention of HIV-1 in uninfected African women. Like a similar trial in MSM/TGW (HPTN 083), the trial was stopped early for efficacy, expediting the need to consider introduction strategies for different populations. We examine survey and qualitative data from a four-country sub-study to examine oral and injectable PrEP acceptability and considerations for CAB access among African women.
METHODS METHODS
Participants completed baseline and follow-up surveys on HIV risk perception, sexual behavior. product acceptability and adherence during the blinded trial. Additionally, up to two in-depth interviews each with 73 sub-study participants explored product use and trial-related experiences, during the blinded and unblinded study periods. Using survey data, we classified participants as: engaged in female sex work (FSW), having multiple non-transactional partners, or monogamous. A study statistician identified participants' assigned study arm. We followed a thematic analysis process to read transcripts, develop a codebook and apply codes in NVivo to transcripts with intermittent intercoder reliability checks; using Excel matrices to explore differences across risk categories and study arms.
FINDINGS RESULTS
Participants overwhelmingly preferred injections to pills, appreciating the ease, convenience, and privacy of a long-acting formulation. Many participants described challenges with contraceptive and/or study pill adherence, impeded by late night work, unexpected travel, or heavy drinking. Women in the TDF/FTC arm were more likely to describe side effects, compared to those in the CAB arm. Pain also varied widely by study arm. When considering post-trial access to CAB, limited PrEP knowledge, cost and concerns around stigma and poor service quality were potential access barriers.
CONCLUSION CONCLUSIONS
Women's desire for privacy and ease of use outweighed injectable concerns, resulting in a strong preference for CAB. Cost and accessibility will need to be addressed by implementation programs.

Identifiants

pubmed: 39441777
doi: 10.1371/journal.pone.0309811
pii: PONE-D-23-42740
doi:

Substances chimiques

Anti-HIV Agents 0
cabotegravir HMH0132Z1Q
Pyridones 0
Diketopiperazines 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e0309811

Informations de copyright

Copyright: © 2024 Tolley et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Déclaration de conflit d'intérêts

The authors have declared that no competing interests exist.

Auteurs

Elizabeth E Tolley (EE)

FHI 360, Durham, North Carolina, United States of America.

Agatha Bula (A)

UNC-Project Malawi, Malawi Clinical Research Site, Lilongwe, Malawi.

Miria Chitukuta (M)

University of Zimbabwe Clinical Trials Research Centre (UZCTRC) - Spilhaus Clinical Research Site, Harare, Zimbabwe.

Nomhle Ndimande-Khoza (N)

Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

Juliane Etima (J)

Makarere-Johns Hopkin University Clinical Research Site, Kampala, Uganda.

Emily Namey (E)

FHI 360, Durham, North Carolina, United States of America.

Doreen Kemigisha (D)

Makarere-Johns Hopkin University Clinical Research Site, Kampala, Uganda.

Lerato Makhale (L)

Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

Mercy Tsidya (M)

UNC-Project Malawi, Malawi Clinical Research Site, Lilongwe, Malawi.

Marie Shoen (M)

FHI 360, Durham, North Carolina, United States of America.

Mina C Hosseinipour (MC)

UNC-Project Malawi, Malawi Clinical Research Site, Lilongwe, Malawi.
University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, United States of America.

Sinead Delany-Moretlwe (S)

Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

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Classifications MeSH