Developing a Patient Navigation Intervention for PrEP Continuum of Care Among Young Latino MSM (PrEParate)

June 13, 2022 updated by: Aaron Blashill, San Diego State University
This study aims to help young Latino gay and bisexual men access sexual health information, including PrEP. Participants will be randomly assigned to either the patient navigation or the usual care condition and followed for 6 months. The study will recruit self-identified Latino men between the ages of 18 and 29 who also identify as gay, bisexual, and/or have sex with other men, and report CDC defined HIV risk behaviors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Reducing the number of new human immunodeficiency virus (HIV) infections is one of the goals of the National HIV/AIDS Strategy and an objective of Healthy People 2020. Men who have sex with men (MSM) are the most at risk group for contracting HIV in the U.S., comprising 67% of the total new HIV diagnoses in 2014. The HIV epidemic impacts some groups of MSM disproportionately, with Latino MSM comprising 25.1% of new HIV infections among MSM between the ages of 13 and 29 years. Moreover, between 2010 and 2014, incidence of HIV increased 13% among Latino MSM, while all other racial/ethnic MSM groups showed stable or decreasing trends, underscoring the vulnerability of HIV infection among Latino MSM.

Pre-exposure prophylaxis (PrEP), a medication taken daily to reduce risk of becoming infected with HIV, was approved by the Food and Drug Administration (FDA) in 2012, and has demonstrated strong efficacy. When taken consistently, PrEP has been shown to reduce new incidence of HIV by 92%. Despite the promise of PrEP to transform HIV prevention, there remain significant barriers to PrEP use among those who would benefit the most, including low awareness, knowledge, medical mistrust, perceived high costs, lack of access, language barriers, low health literacy, and stigma. In a recent study conducted among 600 MSM between the ages of 18 and 29 years in Southern California, Latino MSM reported the lowest levels of use at 6.6%, compared to 9.8% and 13.9% for Black and White participants, respectively. Although Latino MSM reported the lowest use of PrEP, they also reported the greatest willingness to use PrEP compared to White and Black MSM. This discrepancy in willingness versus actual PrEP use among Latino MSM emphasizes the need to intervene to address barriers among this population.

There are a number of different steps that individuals must take to initiate, regularly adhere to, and persist in taking PrEP, with each step in this cascade associated with its own unique barriers. One approach that has been used to address multiple barriers to adhering to recommended health care is patient navigation (PN). PN has been successfully utilized to facilitate access to healthcare among other Latino populations and peer PN may be an ideal intervention to aid in PrEP uptake among Latino MSM by assisting individuals in overcoming barriers to obtaining and using PrEP. To our knowledge, no known PN programs for PrEP have been developed or pilot tested specifically for Latino MSM.

The proposed study will engage young Latino MSM, a population at substantial risk for HIV infection, to pilot-test a peer PN intervention designed to improve engagement and retention in PrEP care. The peer PN intervention will be pilot-tested by comparing it to receipt of usual medical care (UC) plus written information. Individuals randomized to PN will receive the services of a peer patient navigator who will collaborate with the patient, his partner(s), health care professionals, and support service professionals to improve awareness of PrEP, facilitate engagement and retention in PrEP care, and provide strategies for adherence to PrEP. PN will be compared to UC at a 3 and 6-month follow-ups to evaluate the acceptability and feasibility of the PN intervention, and the preliminary impact of the PN intervention on engagement in PrEP-related care and PrEP adherence. In response to RFA-MH-17-361 "Improving the HIV PrEP Cascade-R34," the investigators propose:

To conduct a pilot randomized controlled trial of the patient navigation intervention by comparing it to usual care to assess feasibility, acceptability, and preliminary impact. The investigators plan to randomize 60 young Latino MSM participants to either the PN or UC condition and follow participants for 6 months. It is expected that the pilot test will provide information about the feasibility and acceptability of the intervention and study methods, in preparation for a future full-scale efficacy trial. In addition, the pilot test will evaluate its preliminary impact on 7 PrEP cascade-related outcomes (i.e., scheduled and attended PrEP consultation; PrEP prescription received; PrEP prescription filled; PrEP initiated; self-reported PrEP adherence; and PrEP follow-up medical appointment attended).

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92182
        • San Diego State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 to 29 years
  2. Identifies as male
  3. Identifies as gay/bisexual or reports having sex with men in past 12 months
  4. Identifies as Latino/Hispanic
  5. Self-reports being HIV-uninfected
  6. Resides in San Diego County, California
  7. Speaks English or Spanish
  8. Willing and able to provide informed consent
  9. Willing to receive PrEP-related health care at FHCSD
  10. Reports at least one HIV risk factor as informed by CDC guidelines

10a. MSM are at elevated risk for HIV (as per CDC) if they report one of the following:

  • an HIV-infected sexual partner
  • diagnosis of a bacterial STI within the past 12 months
  • engaging in condomless anal sex with a non-monogamous partner in the past 12 months
  • engaging in commercial sex work in the past 12 months
  • injection of illicit drugs and sharing of injection equipment in the past 12 months
  • engaging in drug treatment for injection drug use in the past 12 months.

Exclusion criteria:

1. HIV-infected

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient Navigation (PN)
This intervention consists of standardized health educational materials and manualized sessions that can be implemented based on a participant's stage in the PrEP continuum. The intervention will utilize bilingual peer lay navigators and also consist of barrier reduction strategies to assist individuals with implementing HIV prevention, including the use of PrEP.
Behavioral: Patient Navigation
Spanish-English bilingual peer lay navigators hired by Family Health Centers of San Diego will provide the PN intervention during the study, trained using manuals developed in formative research and via the Patient Navigation Research Program training approach. Services will generally focus on: 1) overcoming community, health system, interpersonal, and individual barriers to accessing PrEP-related healthcare; 2) increasing each patient's knowledge, attitudes, and self-efficacy for initiating and adhering to PrEP; 3) improving communication between the patient and healthcare team through appointment scheduling and reminders; and 4) sexual risk reduction counseling.
Other: Usual Care (UC)
Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish).
Other: Usual Care
The booklet given is a 2-page booklet including the following information: 1) overview of PrEP; 2) eligibility for PrEP; 3) efficacy of PrEP; 4) safety of PrEP; and 5) obtaining, initiating, and adhering to PrEP. Participants will also be provided with both verbal and written information regarding available sexual health and HIV prevention services, including PrEP, at Family Health Centers of San Diego (FHCSD). Comprehensive HIV-prevention healthcare, including PrEP, is available to study participants at FHCSD at no or minimal cost. If a UC participant is diagnosed with a sexually transmitted infection, including HIV, treatment and follow-up will be coordinated by FHCSD staff as per usual care procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Participants That Scheduled an Appointment for PrEP Consultation.
Time Frame: 3 months
Participants will be asked if they have scheduled an appointment for PrEP consultation on a follow up questionnaire. It will be confirmed by reviewing their medical records.
3 months
Percent of Participants That Attended an Appointment for PrEP Consultation.
Time Frame: 3 months
Participants will be asked if they have attended an appointment for PrEP consultation on a follow up questionnaire. It will be confirmed by reviewing their medical records.
3 months
Percent of Participants That Received a PrEP Prescription.
Time Frame: 3 months
Participants will be asked if they have received a PrEP prescription on a follow up questionnaire. It will be confirmed by reviewing their medical records.
3 months
Percent of Participants That Filled Their PrEP Prescription.
Time Frame: 3 months
Participants will be asked if they have filled their PrEP prescription on a follow up questionnaire. It will be confirmed by reviewing their medical records.
3 months
Percent of Participants That Initiated PrEP Use.
Time Frame: 3 months
Participants will be asked to self-report their PrEP initiation on a follow up questionnaire.
3 months
Percent of Participants That Adhered to PrEP Over the Past Seven Days for Participants That Initiated PrEP
Time Frame: 3 months
Participants will be asked to self-report their PrEP use over the past seven days on a follow up questionnaire.
3 months
Percent of Participants That Attended PrEP Follow-up Appointment.
Time Frame: 3 months
Participants will be asked if they have attended a PrEP follow-up appointment on a follow up questionnaire. It will be confirmed by reviewing their medical records.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego State University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Aaron J Blashill, PhD, San Diego State University
  • Principal Investigator: Kristen Wells, PhD, San Diego State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2019

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

August 2, 2019

First Submitted That Met QC Criteria

August 5, 2019

First Posted (Actual)

August 7, 2019

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-2017-0187
  • 1R34MH114699-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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