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

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Abstract

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.

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Most cited references 33

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How we design feasibility studies.

Deborah Bowen, Matthew K Kreuter, Bonnie Spring … (2009)

Public health is moving toward the goal of implementing evidence-based interventions. To accomplish this, there is a need to select, adapt, and evaluate intervention studies. Such selection relies, in part, on making judgments about the feasibility of possible interventions and determining whether comprehensive and multilevel evaluations are justified. There exist few published standards and guides to aid these judgments. This article describes the diverse types of feasibility studies conducted in the field of cancer prevention, using a group of recently funded grants from the National Cancer Institute. The grants were submitted in response to a request for applications proposing research to identify feasible interventions for increasing the utilization of the Cancer Information Service among underserved populations.

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Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

Robert M Grant, Javier R Lama, Peter L Anderson … (2010)

Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition. We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57). Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).

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Is Open Access

Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable

Amy Whitehead, Steven A Julious, Cindy L Cooper … (2015)

Sample size justification is an important consideration when planning a clinical trial, not only for the main trial but also for any preliminary pilot trial. When the outcome is a continuous variable, the sample size calculation requires an accurate estimate of the standard deviation of the outcome measure. A pilot trial can be used to get an estimate of the standard deviation, which could then be used to anticipate what may be observed in the main trial. However, an important consideration is that pilot trials often estimate the standard deviation parameter imprecisely. This paper looks at how we can choose an external pilot trial sample size in order to minimise the sample size of the overall clinical trial programme, that is, the pilot and the main trial together. We produce a method of calculating the optimal solution to the required pilot trial sample size when the standardised effect size for the main trial is known. However, as it may not be possible to know the standardised effect size to be used prior to the pilot trial, approximate rules are also presented. For a main trial designed with 90% power and two-sided 5% significance, we recommend pilot trial sample sizes per treatment arm of 75, 25, 15 and 10 for standardised effect sizes that are extra small (≤0.1), small (0.2), medium (0.5) or large (0.8), respectively.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2021

Publication date (Electronic): 26 May 2021

Volume: 11

Issue: 5

Electronic Location Identifier: e040955

Affiliations

[1 ]departmentDepartment of Psychology , San Diego State University , San Diego, California, USA

[2 ]SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology , San Diego, California, USA

[3 ]Family Health Centers of San Diego , San Diego, California, USA

[4 ]San Diego State University Research Foundation , San Diego, California, USA

Author notes

[Correspondence to ] Dr Kristen J Wells; kwells@ 123456mail.sdsu.edu

Author information

Sarah A Rojas http://orcid.org/0000-0003-0268-1682

Nicholas C Lucido http://orcid.org/0000-0002-7426-213X

Article

Publisher ID: bmjopen-2020-040955

DOI: 10.1136/bmjopen-2020-040955

PMC ID: 8160175

PubMed ID: 34039570

SO-VID: 4a96c615-a748-4dfc-ac62-2769f62957ad

License:

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/.

History

Date received : 27 May 2020

Date revision received : 09 January 2021

Date accepted : 16 March 2021

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100000025, National Institute of Mental Health;

Award ID: R34MH114699

Funded by: FundRef http://dx.doi.org/10.13039/100000054, National Cancer Institute;

Award ID: R25CA132699

Award ID: U54CA12384

Award ID: U54CA132379

Funded by: FundRef http://dx.doi.org/10.13039/100000002, National Institutes of Health;

Award ID: 5R25GMO58906

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ScienceOpen disciplines: Medicine

Keywords: preventive medicine,hiv & aids,protocols & guidelines,quality in health care,public health

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ScienceOpen disciplines: Medicine

Keywords: preventive medicine, hiv & aids, protocols & guidelines, quality in health care, public health

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

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

Registration details

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Annual Reviews HIV/AIDS: Public Health and Society

Most cited references 33

How we design feasibility studies.

Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable

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