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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pre-exposure Prophylaxis, HIV-1-infection

Intervention / Treatment
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* Behavioral: Peer Navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old fluent in English 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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer Navigation<br>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<br>* Peer education, counseling, and facilitation of PrEP care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP prescription filled | Obtained from medical and/or pharmacy records | 4-12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV prevention, PrEP, peer navigation, women