Peer Outreach and Navigation Intervention to Increase PrEP Uptake Among Women at High Risk for HIV

NCT03226873 | Completed

• 2 other identifiers: 2017-81391U01PS005111-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will assess the feasibility and acceptability of a peer outreach and navigation intervention designed to increase access and promote HIV pre-exposure prophylaxis (PrEP) uptake among women at high risk for HIV.

Conditions

Pre-exposure Prophylaxis; HIV-1-infection

Keywords

HIV prevention; PrEP; peer navigation; women

Outcome Measures

Primary Outcomes (1)

• PrEP prescription filled

  Obtained from medical and/or pharmacy records

  4-12 weeks

Secondary Outcomes (9)

• HIV risk behaviors

  week 0, 4-12

• HIV risk perception

  week 0, 4-12

• Interest in PrEP

  week 0

• PrEP appointment acceptance

  week 0

• PrEP appointment scheduled

  week 0-12

Study Arms (1)

Peer Navigation

EXPERIMENTAL

PrEP-UP involves a Peer delivering PrEP education and counseling during street-based outreach followed by offer of a PrEP care appointment along with peer navigation (e.g., appointment accompaniment and reminders, etc.) for the first several PrEP visits.

Behavioral: Peer Navigation

Interventions

Peer Navigation BEHAVIORAL

Peer education, counseling, and facilitation of PrEP care

Peer Navigation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identifying women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• fluent in English
• self-identifies as female or male-to-female transgender (or on the spectrum)

You may not qualify if:

• \) Incapable of providing informed consent (i.e., acutely intoxication, active psychosis, etc.)

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

New York Harm Reduction Educators

New York, New York, 10035, United States

Location

Related Publications (23)

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Study Officials

• Oni J Blackstock, MD, MHS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Brianna Norton, DO, MPH

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (GIM)

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 24, 2017
• Study Start: November 16, 2017
• Primary Completion: March 19, 2018
• Study Completion: March 19, 2018
• Last Updated: July 16, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)