Clinical trial NCT04048382: Developing a Patient Navigation Intervention for PrEP Continuum of Care Among Young Latino MSM (PrEParate)
Official title: Developing a Patient Navigation Intervention for PrEP Continuum of Care Among Young Latino MSM (PrEParate)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV Seroprevalence
Pre-Exposure Prophylaxis
Patient Navigation
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-08-07
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Participants That Scheduled an Appointment for PrEP Consultation.
timeFrame: 3 months
measure: Percent of Participants That Attended an Appointment for PrEP Consultation.
timeFrame: 3 months
measure: Percent of Participants That Received a PrEP Prescription.
timeFrame: 3 months
measure: Percent of Participants That Filled Their PrEP Prescription.
timeFrame: 3 months
measure: Percent of Participants That Initiated PrEP Use.
timeFrame: 3 months
measure: Percent of Participants That Adhered to PrEP Over the Past Seven Days for Participants That Initiated PrEP
timeFrame: 3 months
measure: Percent of Participants That Attended PrEP Follow-up Appointment.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: San Diego State University
name: Aaron J Blashill, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Kristen Wells, PhD
role: PRINCIPAL_INVESTIGATOR
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