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HIV/AIDS
Protocol
PrEP Implementation for Mothers in Antenatal Care (PrIMA): study protocol of a cluster randomised trial
  1. Julia C Dettinger1,
  2. John Kinuthia2,
  3. Jillian Pintye1,
  4. Nancy Mwongeli2,
  5. Laurén Gómez1,
  6. Barbra A Richardson1,3,
  7. Ruanne Barnabas1,4,
  8. Anjuli D Wagner1,
  9. Gabrielle O’Malley1,
  10. Jared M Baeten1,4,5,
  11. Grace John-Stewart1,4,5,6
  1. 1 Department of Global Health, University of Washington, Seattle, Washington, USA
  2. 2 Department of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya
  3. 3 Department of Biostatistics, University of Washington, Seattle, Washington, USA
  4. 4 Department of Medicine, University of Washington, Seattle, Washington, USA
  5. 5 Department of Epidemiology, University of Washington, Seattle, Washington, USA
  6. 6 Department of Pediatrics, University of Washington, Seattle, Washington, USA
  1. Correspondence to Ms Julia C Dettinger; jcdettin{at}uw.edu

Abstract

Introduction Women in regions with high HIV prevalence are at high risk of HIV acquisition during pregnancy and postpartum, and acute maternal HIV contributes a substantial proportion of infant HIV infections. Pre-exposure prophylaxis (PrEP) could prevent HIV during pregnancy/postpartum; however, identifying women who would most benefit from PrEP in this period is challenging. Women may not perceive risk, may not know partner HIV status and partners may have external partners during this period. PrEP offer in pregnancy could be universal or risk guided.

Methods and analysis The PrEP Implementation for Mothers in Antenatal Care (PrIMA) study is a cluster randomised trial that aims to determine the best model for PrEP implementation in pregnancy, among women attending public sector maternal child health clinics in Western Kenya (HIV prevalence >25%). Twenty clinics are randomised to either universal PrEP offer following standardised counselling (‘Universal arm’ 10 clinics) or risk screening with partner self-test option (‘Targeted arm’ 10 clinics). Four thousand women will be enrolled and followed through 9-month postpartum. The primary analysis will be intention to treat. Outcomes reflect the balance between HIV preventive effectiveness and avoiding unnecessary PrEP exposure to women at low risk and include: maternal HIV incidence, PrEP uptake, PrEP adherence, PrEP duration, ‘appropriate’ PrEP use (among women with objective evidence of potential risk), infant birth outcomes, infant growth and partner self-testing uptake. To better understand the feasibility and acceptability of the provision of PrEP in these settings, qualitative interviews and cost-effectiveness analyses will be conducted.

Ethics and dissemination The protocol was approved by the institutional review boards at Kenyatta National Hospital and the University of Washington. An external advisory panel monitors adverse and social harm events. Results will be disseminated through peer-reviewed journals, presentations at local and international conferences to national and global policy makers, community and participants.

Trial registration number NCT03070600.

  • pre-exposure prophylaxis (PrEP)
  • pregnancy
  • postpartum period
  • HIV
  • cluster randomised trial

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-025122

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    Footnotes

    • Contributors GJ-S, JMB, JK and BAR designed the cluster randomised trial. JCD, JK, NM, BAR, RB, ADW, GO, JMB and GJ-S developed the study protocol. GJ-S and JMB are multiple principal investigators. JK is the country principal investigator, JCD is the project director, BAR oversaw development of the statistical analysis plan, GO developed the qualitative methods and RB developed the cost effectiveness analysis plan. JK, JP, BAR, RB, ADW, GO, JMB and GJ-S provided scientific expertise. JCD, JP, NM and LG oversee data collection and data management activities. JCD, JP, NM and LG oversee implementation of the study procedures. JP oversees all laboratory procedures. All authors have contributed to the development of this manuscript, have read and approved the final version for publication.

    • Funding This work was funded by the National Institutes of Allergy and Infectious Disease (NIAID), grant number R01 AI125498.

    • Competing interests None declared.

    • Ethics approval The study protocol was approved by the IRB at the University of Washington (STUDY00000438) and the ERC at Kenyatta National Hospital (P73/02/2017).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Patient consent for publication Not required.