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

Not Applicable

Completed

• Conditions: Pre-exposure Prophylaxis; HIV-1-infection
• Interventions: Behavioral: Peer Navigation

• Registration Number: NCT03226873
• Lead Sponsor: Montefiore Medical Center

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.

Study Timeline

• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-24
• Study Start: 2017-11-16
• Primary Completion: 2018-03-19
• Study Completion: 2018-03-19
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peer Navigation	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.

Primary Outcome Measures

Name	Time	Method
PrEP prescription filled	4-12 weeks	Obtained from medical and/or pharmacy records

Secondary Outcome Measures

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

Trial Locations

Locations (1)

New York Harm Reduction Educators; 🇺🇸 New York, New York, United States