Evidence map›Paper›PMID 34992111›Full record

ArticleBMJ open2022

CAPRISA 018: a phase I/II clinical trial study protocol to assess the safety, acceptability, tolerability and pharmacokinetics of a sustained-release tenofovir alafenamide subdermal implant for HIV prevention in women.

Tanuja Narayansamy Gengiah, Quarraisha Abdool Karim, Ishana Harkoo, Leila Mansoor, Nonhlanhla Yende Zuma, Precious Radebe, Natasha Samsunder, Cheryl Baxter, B Maharaj, Marc M Baum and 4 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
3.1field-weighted citation impact, top 7% of its field
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

23 citing papers in PubMed, 34 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Observational
  4. Localized inflammasome inhibition mitigates foreign body response to subcutaneous long-acting antiretroviral therapy for HIV.Journal of controlled release : official journal of the Controlled Release Society · 2026
    Article
  5. Article
  6. Review
  7. Article
  8. Antiviral potency of long-acting islatravir subdermal implant in SHIV-infected macaques.Journal of controlled release : official journal of the Controlled Release Society · 2024
    Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Long-Acting Treatments for Hepatitis B.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Article
  15. Review
  16. Review
  17. Article
  18. Article
  19. Article
  20. Article
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

14 authors at 4 institutions in 4 countries.

Tanuja Narayansamy GengiahCentre for the Aids Programme of Research in South Africa, Durban, South Africa tanuja.gengiah@caprisa.org.ORCID 0000-0002-3405-5128
Quarraisha Abdool KarimCentre for the Aids Programme of Research in South Africa, Durban, South Africa.
Ishana HarkooCentre for the Aids Programme of Research in South Africa, Durban, South Africa.
Leila MansoorCentre for the Aids Programme of Research in South Africa, Durban, South Africa.
Nonhlanhla Yende ZumaCentre for the Aids Programme of Research in South Africa, Durban, South Africa.
Precious RadebeCentre for the Aids Programme of Research in South Africa, Durban, South Africa.
Natasha SamsunderCentre for the Aids Programme of Research in South Africa, Durban, South Africa.
Cheryl BaxterCentre for the Aids Programme of Research in South Africa, Durban, South Africa.
B MaharajCentre for the Aids Programme of Research in South Africa, Durban, South Africa.
Marc M BaumOak Crest Institute of Science, Monrovia, California, USA.
John A MossOak Crest Institute of Science, Monrovia, California, USA.
Bruno PozzettoGIMAP(EA3064), Faculty of Medicine Jacques Lisfranc, University Jean Monnet, Saint-Etienne, France.
Catherine HankinsAmsterdam Institute for Global Health and Development, Amsterdam, The Netherlands.
Salim Abdool KarimCentre for the Aids Programme of Research in South Africa, Durban, South Africa.
Centre for the AIDS Programme of Research in South Africa · ZAOak Crest Institute of Science · USAmsterdam Institute for Global Health and Development · NLUniversité Jean Monnet · FR

Funding

European & Developing Countries Clinical Trials Partnership (EDCTP) SRIA2015-1061
6 · The paper itself

Abstract

introductionYoung African women bear a disproportionately high risk for HIV acquisition. HIV technologies that empower women to protect themselves are needed. Safe, potent antiretroviral agents such as tenofovir alafenamide (TAF), formulated as long-acting subdermal implants, offer an innovative solution. METHODS AND ANALYSIS: CAPRISA 018 is a phase I/II trial to evaluate the safety, acceptability, tolerability and pharmacokinetics (PKs) of a TAF ETHICS AND DISSEMINATION: The South African Health Products Regulatory Authority and the University of KwaZulu-Natal's Biomedical Research Ethics Committee have approved the trial. Results will be disseminated through open access peer reviewed publications, conference presentations, public stakeholder engagement and upload of data into the clinical trials registry. TRIAL REGISTRATION NUMBER: PACTR201809520959443.

Indexed as

Anti-HIV AgentsHIV InfectionsAlanineClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicDelayed-Action PreparationsFemaleHumansTenofovirAlanineAnti-HIV AgentsDelayed-Action PreparationsTenofovirtenofovir alafenamideclinical trialsHIV & AIDSpreventive medicinepublic health

Identifiers

PMID34992111
PMCPMC8739430
OpenAlexW4205427740

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.