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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Montefiore Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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