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

NCT04048382 | Completed Results

• 2 other identifiers: HS-2017-01871R34MH114699-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

HIV Seroprevalence; Pre-Exposure Prophylaxis; Patient Navigation

Outcome Measures

Primary Outcomes (7)

• Percent of Participants That Scheduled an Appointment for PrEP Consultation.

  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.

  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.

  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.

  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.

  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

  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.

  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

Study Arms (2)

Patient Navigation (PN)

EXPERIMENTAL

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

Usual Care (UC)

OTHER

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

Interventions

Patient Navigation BEHAVIORAL

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.

Patient Navigation (PN)

Usual Care OTHER

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.

Usual Care (UC)

Eligibility Criteria

• Age: 18 Years - 29 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity. The relevant eligibility question is, "Do you identify as male?"
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. HIV-infected

Sponsors & Collaborators

• San Diego State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

Related Publications (25)

• Smith DK, Van Handel M, Wolitski RJ, Stryker JE, Hall HI, Prejean J, Koenig LJ, Valleroy LA. Vital Signs: Estimated Percentages and Numbers of Adults with Indications for Preexposure Prophylaxis to Prevent HIV Acquisition--United States, 2015. MMWR Morb Mortal Wkly Rep. 2015 Nov 27;64(46):1291-5. doi: 10.15585/mmwr.mm6446a4.

  PMID: 26606148 BACKGROUND

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  PMID: 22972843 BACKGROUND

• Calhoun EA, Whitley EM, Esparza A, Ness E, Greene A, Garcia R, Valverde PA. A national patient navigator training program. Health Promot Pract. 2010 Mar;11(2):205-15. doi: 10.1177/1524839908323521. Epub 2008 Dec 30.

  PMID: 19116415 BACKGROUND

• Jean-Pierre P, Fiscella K, Winters PC, Post D, Wells KJ, McKoy JM, Battaglia T, Simon MA, Kilbourn K; Patient Navigation Research Program Group. Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. Psychooncology. 2012 Sep;21(9):986-92. doi: 10.1002/pon.2002. Epub 2011 Jun 17.

  PMID: 21681995 BACKGROUND

• Katz ML, Young GS, Reiter PL, Battaglia TA, Wells KJ, Sanders M, Simon M, Dudley DJ, Patierno SR, Paskett ED. Barriers reported among patients with breast and cervical abnormalities in the patient navigation research program: impact on timely care. Womens Health Issues. 2014 Jan-Feb;24(1):e155-62. doi: 10.1016/j.whi.2013.10.010.

  PMID: 24439942 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Golub SA, Gamarel KE, Rendina HJ, Surace A, Lelutiu-Weinberger CL. From efficacy to effectiveness: facilitators and barriers to PrEP acceptability and motivations for adherence among MSM and transgender women in New York City. AIDS Patient Care STDS. 2013 Apr;27(4):248-54. doi: 10.1089/apc.2012.0419.

  PMID: 23565928 BACKGROUND

• Bauermeister JA, Meanley S, Pingel E, Soler JH, Harper GW. PrEP awareness and perceived barriers among single young men who have sex with men. Curr HIV Res. 2013 Oct;11(7):520-7. doi: 10.2174/1570162x12666140129100411.

  PMID: 24476355 BACKGROUND

• Ayala G, Makofane K, Santos GM, Beck J, Do TD, Hebert P, Wilson PA, Pyun T, Arreola S. Access to Basic HIV-Related Services and PrEP Acceptability among Men Who Have sex with Men Worldwide: Barriers, Facilitators, and Implications for Combination Prevention. J Sex Transm Dis. 2013;2013:953123. doi: 10.1155/2013/953123. Epub 2013 Jul 8.

  PMID: 26316968 BACKGROUND

• 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.

  BACKGROUND

• Braschi CD, Sly JR, Singh S, Villagra C, Jandorf L. Increasing colonoscopy screening for Latino Americans through a patient navigation model: a randomized clinical trial. J Immigr Minor Health. 2014 Oct;16(5):934-40. doi: 10.1007/s10903-013-9848-y.

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• Wilson FA, Villarreal R, Stimpson JP, Pagan JA. Cost-effectiveness analysis of a colonoscopy screening navigator program designed for Hispanic men. J Cancer Educ. 2015 Jun;30(2):260-7. doi: 10.1007/s13187-014-0718-7.

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• Medsharing I. Randomizer for Clinical Trial. Fontenay Sous Bois, France: Medsharing, Inc.; 2016.

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• 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

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• 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

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• Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.

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• Blashill AJ, Gordon JR, Rojas SA, Ramers CB, Lin CD, Carrizosa CM, Nogg KA, Lamb KM, Lucido NC, Jones IJ, Rivera D, Cobian Aguilar RA, Brady JP, Fuentes M, Wells KJ. Pilot randomised controlled trial of a patient navigation intervention to enhance engagement in the PrEP continuum among young Latino MSM: a protocol paper. BMJ Open. 2021 May 26;11(5):e040955. doi: 10.1136/bmjopen-2020-040955.

  PMID: 34039570 DERIVED

Related Links

• Family Health Centers of San Diego. LGBT services 2015 \[cited 2019 February 22\].
• United States Census Bureau. QuickFacts: San Diego County, California; California 2019 \[April 13, 2019\].
• Newport F, Gates G. San Francisco Metro Area Ranks Highest in LGBT Percentage 2015 \[cited 2016 June 1\].
• US Public Health Service. Preexposure Prophylaxis for the Prevention of HIV infection in the United States-2014 Clinical Practice Guideline 2014 \[cited 2017 January 5\].
• Family Health Centers of San Diego. Welcome to gay men's health service 2015 \[February 11, 2019\].

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

Due to the COVID-19 pandemic, all participant interactions were required to be virtual. The team was not able to obtain signed releases of information from PN-assigned participants during their final follow up assessment. Thus, it was not feasible to obtain supplementary medical records about PrEP cascade-related health information, as planned. Also, the team was not able to provide electronic MEMS cap devices to PrEP-prescribed participants to track adherence, as planned.

Results Point of Contact

• Title: Dr. Aaron J. Blashill
• Organization: San Diego State University

ajblashill@sdsu.edu

6195942245

Study Officials

• Aaron J Blashill, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Kristen Wells, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 7, 2019
• Study Start: August 5, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: July 8, 2022
• Results First Posted: July 8, 2022

Record last verified: 2022-06

Locations

US (1)