NCT03019770

Brief Summary

The purpose of this study is to test a clinical Decision Aid that will help patients and providers determine if pre-exposure prophylaxis (PrEP) is the right decision. The Decision Aid will be tested in both clinical and non-clinical settings with 80 patient-provider dyads. The investigators hypothesize that the use of the Decision Aid will reduce patient decisional conflict. The investigators predict that it will increase patient and provider knowledge of and intent to initiate PrEP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

February 24, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2018

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

November 28, 2016

Last Update Submit

August 23, 2019

Conditions

Pre-Exposure Prophylaxis

Keywords

Pre-Exposure ProphylaxisHIVDecision AidShared Decision Making

Outcome Measures

Primary Outcomes (1)

  • Change in Decisional Conflict Scale

    Decisional conflict will be measured for patients before and immediately after reviewing the Decision Aid, as well as 3 months later.

    30 minutes prior to intervention, 5 minutes after intervention, 3 months after intervention

Secondary Outcomes (1)

  • Change in Knowledge

    30 minutes prior to intervention, 5 minutes after intervention, 3 months after intervention

Other Outcomes (5)

  • Acceptability of Decision Aid

    5 minutes after intervention

  • Shared Decision Making Questionnaire

    5 minutes after intervention

  • Use of PrEP since intervention

    3 months after intervention

  • +2 more other outcomes

Study Arms (1)

PrEP Decision Aid

EXPERIMENTAL

All participants in the study will go through the Decision Aid with a provider.

Behavioral: PrEP Decision Aid

Interventions

PrEP Decision AidBEHAVIORAL

All participants will participate in a simulated or actual clinical visit with a healthcare provider. During this visit, they will review the Decision Aid which will give them an HIV risk score and ask questions about their values. The goal of these visits will be to make an informed decision about whether or not to begin using PrEP.

PrEP Decision Aid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • English speaking
  • Male at birth
  • HIV-uninfected
  • Have sex with men
  • Have never been prescribed HIV pre-exposure prophylaxis
  • years or older
  • English speaking
  • Healthcare clinicians who provide clinical care to any HIV-uninfected MSM at BIDMC, Fenway Health, or other practices
  • Licensed to prescribe medications (Medical Doctor, Doctor of Osteopathy, Physician Assistant, or Nurse Practitioner).

You may not qualify if:

  • Patients or providers who are unable to provide informed consent due to severe mental or physical illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

The Fenway Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (4)

  • Legare F, O'Connor AM, Graham ID, Wells GA, Tremblay S. Impact of the Ottawa Decision Support Framework on the agreement and the difference between patients' and physicians' decisional conflict. Med Decis Making. 2006 Jul-Aug;26(4):373-90. doi: 10.1177/0272989X06290492.

    PMID: 16855126BACKGROUND

  • Menza TW, Hughes JP, Celum CL, Golden MR. Prediction of HIV acquisition among men who have sex with men. Sex Transm Dis. 2009 Sep;36(9):547-55. doi: 10.1097/OLQ.0b013e3181a9cc41.

    PMID: 19707108BACKGROUND

  • Smith DK, Pals SL, Herbst JH, Shinde S, Carey JW. Development of a clinical screening index predictive of incident HIV infection among men who have sex with men in the United States. J Acquir Immune Defic Syndr. 2012 Aug 1;60(4):421-7. doi: 10.1097/QAI.0b013e318256b2f6.

    PMID: 22487585BACKGROUND

  • Schneider J, Kaplan SH, Greenfield S, Li W, Wilson IB. Better physician-patient relationships are associated with higher reported adherence to antiretroviral therapy in patients with HIV infection. J Gen Intern Med. 2004 Nov;19(11):1096-103. doi: 10.1111/j.1525-1497.2004.30418.x.

    PMID: 15566438BACKGROUND

Related Links

Study Officials

  • Douglas Krakower, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician, Division of Infectious Diseases

Study Record Dates

First Submitted

November 28, 2016

First Posted

January 13, 2017

Study Start

February 24, 2017

Primary Completion

May 24, 2018

Study Completion

May 24, 2018

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)