Clinical trial NCT03226873: Peer Outreach and Navigation Intervention to Increase PrEP Uptake Among Women at High Risk for HIV
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-exposure Prophylaxis
HIV-1-infection
Keywords: HIV prevention
PrEP
peer navigation
women
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2017-07-24
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: PrEP prescription filled
timeFrame: 4-12 weeks
Secondary outcomes:
measure: HIV risk behaviors
timeFrame: week 0, 4-12
measure: HIV risk perception
timeFrame: week 0, 4-12
measure: Interest in PrEP
timeFrame: week 0
measure: PrEP appointment acceptance
timeFrame: week 0
measure: PrEP appointment scheduled
timeFrame: week 0-12
measure: PrEP appointment attendance
timeFrame: week 0-12
measure: PrEP-related knowledge
timeFrame: week 0, 4-12
measure: PrEP-related attitudes
timeFrame: week 0, 4-12
measure: PrEP-related self-efficacy
timeFrame: week 0, 4-12
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Harm Reduction Educators
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Oni J Blackstock, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Brianna Norton, DO, MPH
role: PRINCIPAL_INVESTIGATOR
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