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Clinical Trials/NCT03226873
NCT03226873
Completed
N/A

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

Montefiore Medical Center1 site in 1 country66 target enrollmentNovember 16, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pre-exposure Prophylaxis
Sponsor
Montefiore Medical Center
Enrollment
66
Locations
1
Primary Endpoint
PrEP prescription filled
Status
Completed
Last Updated
7 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 16, 2017
End Date
March 19, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brianna Norton

Assistant Professor of Medicine (GIM)

Montefiore Medical Center

Eligibility Criteria

Inclusion Criteria

  • ≥18 years old
  • fluent in English
  • self-identifies as female or male-to-female transgender (or on the spectrum)
  • Exclusion Criteria
  • Incapable of providing informed consent (i.e., acutely intoxication, active psychosis, etc.)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

PrEP prescription filled

Time Frame: 4-12 weeks

Obtained from medical and/or pharmacy records

Secondary Outcomes

  • HIV risk behaviors(week 0, 4-12)
  • HIV risk perception(week 0, 4-12)
  • Interest in PrEP(week 0)
  • PrEP appointment scheduled(week 0-12)
  • PrEP appointment acceptance(week 0)
  • PrEP appointment attendance(week 0-12)
  • PrEP-related knowledge(week 0, 4-12)
  • PrEP-related attitudes(week 0, 4-12)
  • PrEP-related self-efficacy(week 0, 4-12)

Study Sites (1)

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