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

July 12, 2018 updated by: Brianna Norton, Montefiore Medical Center

Assessing the Feasibility and Acceptability of a Peer Outreach and Navigation Intervention to Increase Pre-exposure Prophylaxis Uptake Among Women at High Risk for HIV

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women who engage in exchange sex (i.e., sex in exchange for money, drugs, or other services) remain are at substantial risk for HIV infection. (1-6) Due to a confluence of social and structural factors, exchange sex is relatively prevalent among women from socially and economically marginalized groups, such as women who are transgender, unstably housed/homeless and/or those who use and/or inject drugs. (1-3, 19-23) The overarching goal of this research is to decrease new HIV infections among women who engage in exchange sex. Daily oral HIV pre-exposure prophylaxis (PrEP) is an innovative method of HIV prevention that women, themselves, can control; as such, PrEP has the potential to reduce the risk of HIV acquisition among women who engage in exchange sex. Therefore, the investigators developed a theory-guided behavioral intervention (PrEP-UP) which utilizes street-based peer outreach and navigation to increase access to PrEP and promote PrEP uptake among women involved in exchange sex. Specifically, 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 care visits. The objective of this study is to assess the feasibility and acceptability of PrEP-UP. To implement PrEP-UP, the investigators will collaborate with an established community-based organization (CBO) in East Harlem, NY, which uses street-based peer outreach and navigation to connect individuals to needed health and social services. Medical and pharmacy records will be reviewed to assess PrEP initiation. The investigators will conduct self-report surveys at baseline and at a week 4-12 follow-up visit that will collect data about sexual and drug use risk behaviors, perceived HIV risk, and PrEP-related knowledge, attitudes, and self-efficacy to assess for temporal changes in these variables. Additionally, individual interviews will be conducted post-intervention with a subset of the women as well as the CBO staff and leadership to access acceptability of the intervention.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10035
        • New York Harm Reduction Educators

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ≥18 years old
  2. fluent in English
  3. self-identifies as female or male-to-female transgender (or on the spectrum)

Exclusion Criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer Navigation
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
Peer education, counseling, and facilitation of PrEP care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP prescription filled
Time Frame: 4-12 weeks
Obtained from medical and/or pharmacy records
4-12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV risk behaviors
Time Frame: week 0, 4-12
Revised Risk Behavior Assessment (Wechsberg)
week 0, 4-12
HIV risk perception
Time Frame: week 0, 4-12
Perceived HIV Risk Scale (Napper)
week 0, 4-12
Interest in PrEP
Time Frame: week 0
PrEP Acceptability Scale (Marcus)
week 0
PrEP appointment acceptance
Time Frame: week 0
PrEP appointment acceptance (yes/ no)
week 0
PrEP appointment scheduled
Time Frame: week 0-12
Scheduled PrEP appointment (yes/ no)
week 0-12
PrEP appointment attendance
Time Frame: week 0-12
PrEP appointment attendance (yes/ no)
week 0-12
PrEP-related knowledge
Time Frame: week 0, 4-12
PrEP Knowledge Scale (Rucinski) (Kalichman) (Kalichman) (Whiteside)
week 0, 4-12
PrEP-related attitudes
Time Frame: week 0, 4-12
Attitudes Towards PrEP Measurements (Golub) (Holt) (Mimiaga) (Tobias)
week 0, 4-12
PrEP-related self-efficacy
Time Frame: week 0, 4-12
PrEP Self-Efficacy Scale (adapted from HIV-ASES) (Johnson)
week 0, 4-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Oni J Blackstock, MD, MHS, Albert Einstein College Of Medicine
  • Principal Investigator: Brianna Norton, DO, MPH, Albert Einstein College Of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2017

Primary Completion (Actual)

March 19, 2018

Study Completion (Actual)

March 19, 2018

Study Registration Dates

First Submitted

July 19, 2017

First Submitted That Met QC Criteria

July 20, 2017

First Posted (Actual)

July 24, 2017

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 12, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-8139
  • 1U01PS005111-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV-1-infection

Clinical Trials on Peer Navigation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe