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HIV/AIDSNCT04048382

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

A study testing Patient Navigation in people with HIV/AIDS, run by San Diego State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 29 yearsHealthy volunteers can take part
Conditions the study is for
HIV/AIDS
What is being tested?
Patient Navigation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteUnited States
Study dates
5 Aug 2019to 30 Apr 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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
  • 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.

Who cannot join

  • 1. HIV-infected

Trial locations and contacts

1 site in 1 country.

United States1 site

  • San Diego State University

    San Diego, California, 92182

Other trials in United States

About this study

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.

Read the 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).

Conditions
HIV/AIDS
Being tested
Patient Navigation, Usual Care
Keywords
HIV Seroprevalence, Pre-Exposure Prophylaxis, Patient Navigation
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient NavigationBehavioural

    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 CareOther

    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.

Study groups in NCT04048382
Study groupRoleWhat they receive
Patient Navigation (PN)ExperimentalThis 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.
Receives: Behavioral: Patient Navigation
Usual Care (UC)OtherParticipants in this condition will receive the CDC's 2-page PrEP Information Sheet in the participant's preferred language (either English or Spanish).
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

  3. 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.

    Measured: 3 months

  4. 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.

    Measured: 3 months

  5. Percent of Participants That Initiated PrEP Use.

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

    Measured: 3 months

  6. 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.

    Measured: 3 months

  7. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2019
  2. Study start5 Aug 2019
  3. Primary completion30 Apr 2021
  4. Study completion30 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04048382
Sponsor's protocol ID
HS-2017-0187
Other IDs
1R34MH114699-01
Status last verified
Jun 2022
First submitted
2 Aug 2019
Last updated
8 Jul 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26606148

  • Anderson PL, Glidden DV, Liu A, Buchbinder S, Lama JR, Guanira JV, McMahan V, Bushman LR, Casapia M, Montoya-Herrera O, Veloso VG, Mayer KH, Chariyalertsak S, Schechter M, Bekker LG, Kallas 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. doi: 10.1126/scitranslmed.3004006.

    PubMed 22972843

  • 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.

    PubMed 19116415

  • 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.

    PubMed 21681995

  • 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.

    PubMed 24439942

  • 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.

  • 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.

    PubMed 23565928

  • 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.

    PubMed 24476355

  • 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.

    PubMed 26316968

  • 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.

  • 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.

    PubMed 23736964

  • 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.

    PubMed 26109462

  • 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.

    PubMed 25168070

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

Questions about this trial

What is this clinical trial studying?

A study testing Patient Navigation in people with HIV/AIDS, run by San Diego State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Participants That Scheduled an Appointment for PrEP Consultation. (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04048382, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.

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Clinical Trial NCT04048382 | AzTrials