Pilot randomised controlled trial of a patient navigation intervention to enhance engagement in the PrEP continuum among young Latino MSM: a protocol paper

BMJ Open. 2021 May 26;11(5):e040955. doi: 10.1136/bmjopen-2020-040955.


Introduction: Men who have sex with men (MSM) are one of the most at-risk group for contracting HIV in the USA. However, the HIV epidemic impacts some groups of MSM disproportionately. Latino MSM comprise 25.1% of new HIV infections among MSM between the ages of 13 and 29 years. The daily medication tenofovir/emtricitabine was approved by the Food and Drug Administration for pre-exposure prophylaxis (PrEP) in 2012 and has demonstrated strong efficacy in reducing HIV acquisition.

Methods and analysis: Through extensive formative research, this study uses a pilot randomised controlled trial design and will examine the feasibility and acceptability of a patient navigation intervention designed to address multiple barriers to improve engagement in the PrEP continuum among 60 Latino MSM between the ages of 18 and 29 years. The patient navigation intervention will be compared with usual care plus written information to evaluate the feasibility and acceptability of the intervention and study methods and the intervention's potential in improving PrEP continuum behaviours. The results will be reviewed for preparation for a future full-scale efficacy trial.

Ethics and dissemination: This study was approved by the institutional review board at San Diego State University and is registered at ClinicalTrials.gov. The intervention development process, plan and the results of this study will be shared through peer-reviewed journal publications, conference presentations and healthcare system and community presentations.

Registration details: Registered under the National Institutes of Health's ClinicalTrials.gov (NCT04048382) on 7 August 2019 and approved by the San Diego State University (HS-2017-0187) institutional review board. This study began on 5 August 2019 and is estimated to continue through 31 March 2021. The clinical trial is in the pre-results stage.

Keywords: HIV & AIDS; preventive medicine; protocols & guidelines; public health; quality in health care.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Adult
  • Anti-HIV Agents* / therapeutic use
  • HIV Infections* / drug therapy
  • HIV Infections* / prevention & control
  • Hispanic or Latino
  • Homosexuality, Male
  • Humans
  • Male
  • Patient Navigation*
  • Pilot Projects
  • Pre-Exposure Prophylaxis*
  • Randomized Controlled Trials as Topic
  • Sexual and Gender Minorities*
  • Young Adult


  • Anti-HIV Agents

Associated data

  • ClinicalTrials.gov/NCT04048382