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

• Sponsor: San Diego State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04048382
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 57
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.8
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 57 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: Aug 5, 2019
• Actual Primary Completion Date: Apr 30, 2021
• Actual Study Completion Date: Apr 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Percent of Participants That Scheduled an Appointment for PrEP Consultation. [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. [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. [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. [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. [3 months]

   Participants will be asked to self-report their PrEP initiation on a follow up questionnaire.

6. Percent of Participants That Adhered to PrEP Over the Past Seven Days for Participants That Initiated PrEP [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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 29 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Diego State University	San Diego	California	United States	92182

Sponsors and Collaborators

• San Diego State University
• 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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 2, 2019

More Information

Additional Information:

• Healthy People 2020. 2020 Topics and Objectives: HIV 2016 [updated January 5, 2017January 5, 2017].
• AIDS.gov. National HIV/AIDS Strategy: Overview [January 5, 2017].
• Centers for Disease Control and Prevention. HIV and Gay and Bisexual Men 2018 [February 2, 2019].
• 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].

Publications

• Anderson PL, Glidden DV, Liu A, Buchbinder S, Lama JR, Guanira JV, McMahan V, Bushman LR, Casapía M, Montoya-Herrera O, Veloso VG, Mayer KH, Chariyalertsak S, Schechter M, Bekker LG, Kallás EG, Grant RM; iPrEx Study Team. Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men. Sci Transl Med. 2012 Sep 12;4(151):151ra125.
• 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
• 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.
• 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
• 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.
• Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
• 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.
• 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.
• 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.
• Enard KR, Nevarez L, Hernandez M, Hovick SR, Moguel MR, Hajek RA, Blinka CE, Jones LA, Torres-Vigil I. Patient navigation to increase colorectal cancer screening among Latino Medicare enrollees: a randomized controlled trial. Cancer Causes Control. 2015 Sep;26(9):1351-9. doi: 10.1007/s10552-015-0620-6. Epub 2015 Jun 25.
• Epstein J, Santo RM, Guillemin F. A review of guidelines for cross-cultural adaptation of questionnaires could not bring out a consensus. J Clin Epidemiol. 2015 Apr;68(4):435-41. doi: 10.1016/j.jclinepi.2014.11.021. Epub 2014 Dec 17. Review.
• 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.
• Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapía M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernández T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallás 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.
• Inc. SI. SAS software version 9.4. Cary, NC: SAS Institute; 2013.
• 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.
• 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.
• 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.
• 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.
• McKenna SP, Doward LC. The translation and cultural adaptation of patient-reported outcome measures. Value Health. 2005 Mar-Apr;8(2):89-91.
• Medsharing I. Randomizer for Clinical Trial. Fontenay Sous Bois, France: Medsharing, Inc.; 2016.
• 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.
• 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.
• Swaine-Verdier A, Doward LC, Hagell P, Thorsen H, McKenna SP. Adapting quality of life instruments. Value Health. 2004 Sep-Oct;7 Suppl 1:S27-30.
• Wilson FA, Villarreal R, Stimpson JP, Pagán 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.

• Responsible Party: Aaron Blashill, Associate Professor, San Diego State University
• ClinicalTrials.gov Identifier: NCT04048382
• Other Study ID Numbers: HS-2017-0187; 1R34MH114699-01
• First Posted: Aug 7, 2019
• Last Update Posted: Jul 8, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aaron Blashill, Associate Professor, San Diego State University: HIV Seroprevalence; Pre-Exposure Prophylaxis; Patient Navigation
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections

Study Results

Participant Flow

Arm/Group Title	Patient Navigation (PN)	Usual Care (UC)
Arm/Group Description	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. 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.	Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish). 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.
Period Title: 3-Month Follow Up
STARTED	28	29
COMPLETED	26	28
NOT COMPLETED	2	1
Period Title: 3-Month Follow Up
STARTED	28	28
COMPLETED	26	28
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Patient Navigation (PN)	Usual Care (UC)	Total
Arm/Group Description	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. 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.	Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish). 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.	Total of all reporting groups
Overall Participants	28	29	57
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.07 (2.45)	25.59 (3.01)	25.33 (2.73)
Sex/Gender, Customized (Count of Participants)
Male	24 85.7%	27 93.1%	51 89.5%
Non-binary	3 10.7%	2 6.9%	5 8.8%
Transgender	1 3.6%	0 0%	1 1.8%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	28 100%	29 100%	57 100%
Race/Ethnicity, Customized (Count of Participants)
Hispanic/Latino	28 100%	29 100%	57 100%
Region of Enrollment (Count of Participants)
United States	28 100%	29 100%	57 100%

Outcome Measures

1. Primary Outcome

Title	Percent of Participants That Scheduled an Appointment for PrEP Consultation.
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Number of participants analyzed= 53 due to missing data. This question was displayed contingent on answering "Yes" to "Before this study, had you ever heard of PrEP?"

Arm/Group Title	Patient Navigation (PN)	Usual Care (UC)
Arm/Group Description	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. 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.	Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish). 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.
Measure Participants	26	27
Count of Participants [Participants]	10 35.7%	11 37.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient Navigation (PN), Usual Care (UC)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.88
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percent of Participants That Attended an Appointment for PrEP Consultation.
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Number of participants analyzed= 53 due to missing data. This question was displayed contingent on answering "Yes" to "Before this study, had you ever heard of PrEP?"

Arm/Group Title	Patient Navigation (PN)	Usual Care (UC)
Arm/Group Description	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. 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.	Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish). 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.
Measure Participants	26	27
Count of Participants [Participants]	10 35.7%	11 37.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient Navigation (PN), Usual Care (UC)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.49
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.7
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Percent of Participants That Received a PrEP Prescription.
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Number of participants analyzed= 53 due to missing data. This question was displayed contingent on answering "Yes" to "Before this study, had you ever heard of PrEP?"

Arm/Group Title	Patient Navigation (PN)	Usual Care (UC)
Arm/Group Description	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. 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.	Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish). 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.
Measure Participants	26	27
Count of Participants [Participants]	12 42.9%	12 41.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient Navigation (PN), Usual Care (UC)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.91
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	Percent of Participants That Filled Their PrEP Prescription.
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Number of participants analyzed= 54 due to missing data. This question was displayed if answer to "Before this study, had you ever heard of PrEP?" was "Yes." Some participants obtained a PrEP prescription outside of the 3-month follow up timeframe (i.e., prior to their previous assessment), but did not fill their prescription at that time. These participants responded "No" to obtaining a PrEP prescription in the last 3-months, but "Yes" to filling their prescription in the last 3 months.

Arm/Group Title	Patient Navigation (PN)	Usual Care (UC)
Arm/Group Description	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. 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.	Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish). 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.
Measure Participants	26	28
Count of Participants [Participants]	11 39.3%	10 34.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient Navigation (PN), Usual Care (UC)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.65
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.4
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Primary Outcome

Title	Percent of Participants That Initiated PrEP Use.
Description	Participants will be asked to self-report their PrEP initiation on a follow up questionnaire.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

This question was displayed contingent on answering "Yes" to "Before this study, had you ever heard of PrEP?" Number of participants analyzed= 35. Some participants obtained and/or filled a PrEP prescription outside of the 3-month follow up timeframe (i.e., prior to their previous assessment), but did not initiate PrEP use at that time. These participants responded "No" to obtaining or filling a PrEP prescription in the last 3-months, but "Yes" to initiating PrEP in the last 3 months.

Arm/Group Title	Patient Navigation (PN)	Usual Care (UC)
Arm/Group Description	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. 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.	Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish). 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.
Measure Participants	18	17
Count of Participants [Participants]	11 39.3%	12 41.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient Navigation (PN), Usual Care (UC)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.17
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	.29
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Primary Outcome

Title	Percent of Participants That Adhered to PrEP Over the Past Seven Days for Participants That Initiated PrEP
Description	Participants will be asked to self-report their PrEP use over the past seven days on a follow up questionnaire.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

This question was displayed if "Before this study, had you ever heard of PrEP?" was "Yes." Number of participants analyzed= 34. Some participants obtained and/or filled a PrEP prescription outside of the 3-month follow up timeframe (i.e., prior to their previous assessment), but did not initiate PrEP use at that time. These participants responded "No" to obtaining/filling a PrEP prescription in the last 3-months, but "Yes" to initiating PrEP in the last 3 months, and had adherence to report.

Arm/Group Title	Patient Navigation (PN)	Usual Care (UC)
Arm/Group Description	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. 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.	Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish). 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.
Measure Participants	18	16
Count of Participants [Participants]	8 28.6%	10 34.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient Navigation (PN), Usual Care (UC)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.19
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	.29
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Primary Outcome

Title	Percent of Participants That Attended PrEP Follow-up Appointment.
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Data was not collected due to a coding error, thus the number of participants analyzed was zero.

Arm/Group Title	Patient Navigation (PN)	Usual Care (UC)
Arm/Group Description	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. 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.	Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish). 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.
Measure Participants	0	0

Adverse Events

Time Frame	March 12, 2020 through study completion, an average of 2 months
Adverse Event Reporting Description	A participant notified the study team that he was diagnosed with HIV and would like to discontinue participation in the study. The study team is uncertain of the exposure or diagnosis date. This information is Protected Health Information and the participant does not wish to continue participating, thus we will not have access to medical records for the exact date of the adverse event. All-cause mortality and other (not including serious) adverse events were not monitored/assessed.
Arm/Group Title	Patient Navigation (PN)		Usual Care (UC)
Arm/Group Description	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. 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.		Participants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish). 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.
All Cause Mortality
	Patient Navigation (PN)		Usual Care (UC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Patient Navigation (PN)		Usual Care (UC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		1/29 (3.4%)
Immune system disorders
Serious Adverse Event	0/28 (0%)	0	1/29 (3.4%)	1
Other (Not Including Serious) Adverse Events
	Patient Navigation (PN)		Usual Care (UC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.