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

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.
Brief Title
Peer Outreach and Navigation Intervention to Increase 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.
Completion Date
Completion Date Type
Actual
Conditions
Pre-exposure Prophylaxis
HIV-1-infection
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.)
Inclusion 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)

Gender
All
Gender Based
false
Keywords
HIV prevention
PrEP
peer navigation
women
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03226873
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2017-8139
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Obtained from medical and/or pharmacy records
Outcome Measure
PrEP prescription filled
Outcome Time Frame
4-12 weeks
Secondary Ids
Secondary Id
1U01PS005111-01
Secondary Outcomes
Outcome Description
Revised Risk Behavior Assessment (Wechsberg)
Outcome Time Frame
week 0, 4-12
Outcome Measure
HIV risk behaviors
Outcome Description
Perceived HIV Risk Scale (Napper)
Outcome Time Frame
week 0, 4-12
Outcome Measure
HIV risk perception
Outcome Description
PrEP Acceptability Scale (Marcus)
Outcome Time Frame
week 0
Outcome Measure
Interest in PrEP
Outcome Description
PrEP appointment acceptance (yes/ no)
Outcome Time Frame
week 0
Outcome Measure
PrEP appointment acceptance
Outcome Description
Scheduled PrEP appointment (yes/ no)
Outcome Time Frame
week 0-12
Outcome Measure
PrEP appointment scheduled
Outcome Description
PrEP appointment attendance (yes/ no)
Outcome Time Frame
week 0-12
Outcome Measure
PrEP appointment attendance
Outcome Description
PrEP Knowledge Scale (Rucinski) (Kalichman) (Kalichman) (Whiteside)
Outcome Time Frame
week 0, 4-12
Outcome Measure
PrEP-related knowledge
Outcome Description
Attitudes Towards PrEP Measurements (Golub) (Holt) (Mimiaga) (Tobias)
Outcome Time Frame
week 0, 4-12
Outcome Measure
PrEP-related attitudes
Outcome Description
PrEP Self-Efficacy Scale (adapted from HIV-ASES) (Johnson)
Outcome Time Frame
week 0, 4-12
Outcome Measure
PrEP-related self-efficacy
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Brianna Norton
Investigator Email
bnorton@montefiore.org
Investigator Phone