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

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ClinicalTrials.gov Identifier: NCT04048382
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : December 18, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Aaron Blashill, San Diego State University

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Patient Navigation Other: Usual Care Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Developing a Patient Navigation Intervention for PrEP Continuum of Care Among Young Latino MSM (PrEParate)
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.

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.




Primary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. PrEP adherence rates 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is based on self-representation of gender identity. The relevant eligibility question is, "Do you identify as male?"
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048382


Contacts
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Contact: Aaron J Blashill, PhD 619-594-2245 ajblashill@mail.sdsu.edu
Contact: Kristen Wells, PhD 619-594-1919 kwells@sdsu.edu

Locations
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United States, California
San Diego State University Recruiting
San Diego, California, United States, 92182
Contact: Aaron J Blashill, Ph.D.    619-594-2245    ablashill@mail.sdsu.edu   
Sponsors and Collaborators
San Diego State University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Aaron J Blashill, PhD San Diego State University
Principal Investigator: Kristen Wells, PhD San Diego State University

Additional Information:
Publications:
Centers for Disease Control and Prevention. Diagnoses of HIV infection in the United States and dependent areas, 2014. HIV Surveillance Report. 2015;26:1-123.
Pulsipher CA MJ, Plant A, Curtis P, Holloway IW, Leibowitz AA. Addressing PrEP Dispartities Among Young Gay and Bisexual Men in California. California HIV/AIDS Research Program, 2016 September. Report No.
Lui A, Colfax G, Cohen S, Bacon O, Kolber M, Amico K, et al., editors. The spectrum of engagement in HIV prevention: Proposal for a PrEP cascade. 7th International conference on HIV treatment and prevention adherence; 2012; Miami Beach, Florida.
Medsharing I. Randomizer for Clinical Trial. Fontenay Sous Bois, France: Medsharing, Inc.; 2016.
Bartholomew LK, Parcel GS, Kok G, Gottlieb NH, Fernandez ME. Planning health promotion programs: An intervention mapping approach. Third ed. San Francisco, California: Jossey-Bass; 2011
Attkisson CC, Greenfield TK. The UCSF Client Satisfaction Scales: I. The Client Satisfaction Questionnaire-8. In: Maruish ME, editor. The use of psychological testing for treatment planning and outcomes assessment. 3. 3rd ed. Mahwah, New Jersey: Lawrence Erlbaum Associates; 2004
Knodel J. The design and analysis of focus group studies: A practical approach. Successful focus groups: Advancing the state of the art. 1. London: Sage Publications; 1993. p. 35-50.
Inc. SI. SAS software version 9.4. Cary, NC: SAS Institute; 2013.

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Responsible Party: Aaron Blashill, Associate Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT04048382    
Other Study ID Numbers: HS-2017-0187
1R34MH114699-01 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aaron Blashill, San Diego State University:
HIV Seroprevalence
Pre-Exposure Prophylaxis
Patient Navigation