Developing a Patient Navigation Intervention for PrEP Continuum of Care Among Young Latino MSM (PrEParate)
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      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.
    

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).
    

Intervention name(s): Patient Navigation; Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: HIV Seroprevalence; Pre-Exposure Prophylaxis; Patient Navigation