Evidence map›Paper›PMID 39441777›Full record

ArticlePloS one2024

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

Elizabeth E Tolley, Agatha Bula, Miria Chitukuta, Nomhle Ndimande-Khoza, Juliane Etima, Emily Namey, Doreen Kemigisha, Lerato Makhale, Mercy Tsidya, Marie Shoen and 3 more

Abstract read
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

13 authors.

Elizabeth E TolleyFHI 360, Durham, North Carolina, United States of America.ORCID https://orcid.org/0000-0002-9823-3675
Agatha BulaUNC-Project Malawi, Malawi Clinical Research Site, Lilongwe, Malawi.
Miria ChitukutaUniversity of Zimbabwe Clinical Trials Research Centre (UZCTRC) - Spilhaus Clinical Research Site, Harare, Zimbabwe.
Nomhle Ndimande-KhozaWits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Juliane EtimaMakarere-Johns Hopkin University Clinical Research Site, Kampala, Uganda.
Emily NameyFHI 360, Durham, North Carolina, United States of America.
Doreen KemigishaMakarere-Johns Hopkin University Clinical Research Site, Kampala, Uganda.
Lerato MakhaleWits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Mercy TsidyaUNC-Project Malawi, Malawi Clinical Research Site, Lilongwe, Malawi.
Marie ShoenFHI 360, Durham, North Carolina, United States of America.ORCID https://orcid.org/0000-0002-3627-7613
Mina C HosseinipourUNC-Project Malawi, Malawi Clinical Research Site, Lilongwe, Malawi.ORCID https://orcid.org/0000-0003-2174-313X
Sinead Delany-MoretlweWits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
HPTN 084 study team

Funding

LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI Sinead Delany-Moretlwe, RAPHAEL J LANDOVITZ · 2011 to 2026
$779.5M
SDMC: HPTN 084 Pregnancy SupplementUM1AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Elizabeth Renata Brown, Deborah J Donnell · 2011 to 2026
$204.9M
LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
HIV Prevention trials Network (HPTN) Coordinating and Operations CenterU01AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI VERMUND, STEN H. · 2006 to 2010
$72.7M
The Johns Hopkins University - Uganda Clinical Trials UnitUM1AI069530 · NIAID · JOHNS HOPKINS UNIVERSITY · PI MARY Glenn Fowler, Philippa Musoke · 2012 to 2026
$34.8M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
Units for HIV/AIDS Clinical Trials NetworksU01AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI SANNE, IAN MATTHIAS · 2007 to 2011
$24.2M
Stellenbosch University Clinical Trial Unit, Cape Town, South AfricaUM1AI069521 · NIAID · STELLENBOSCH UNIVERSITY · PI Shaun Barnabas, Anneke Catharina Hesseling · 2012 to 2026
$21.5M
NIAID NIH HHS U01 AI068619NIAID NIH HHS U01 AI069463NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069521NIAID NIH HHS UM1 AI069530
6 · The paper itself

Abstract

backgroundHPTN 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.

methodsParticipants 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.

findingsParticipants 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.

conclusionWomen'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.

Indexed as

Anti-HIV AgentsHIV InfectionsPre-Exposure ProphylaxisAdministration, OralAdultDiketopiperazinesFemaleHumansInjectionsPatient PreferencePyridonesSexual BehaviorYoung AdultAnti-HIV AgentscabotegravirDiketopiperazinesPyridones

Identifiers

PMID39441777
PMCPMC11498703

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.