Skip to main content
OpenTrials
Completed

NCT Number: NCT03226873

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Harm Reduction Educators

New York, 10035, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Peer navigation

Behavioral

Peer education, counseling, and facilitation of PrEP care

Primary outcomes

  1. PrEP prescription filled

    Time frame: 4-12 weeks

    Obtained from medical and/or pharmacy records

Secondary outcomes

  1. HIV risk behaviors

    Time frame: week 0, 4-12

    Revised Risk Behavior Assessment (Wechsberg)

  2. HIV risk perception

    Time frame: week 0, 4-12

    Perceived HIV Risk Scale (Napper)

  3. Interest in PrEP

    Time frame: week 0

    PrEP Acceptability Scale (Marcus)

  4. PrEP appointment acceptance

    Time frame: week 0

    PrEP appointment acceptance (yes/ no)

  5. PrEP appointment scheduled

    Time frame: week 0-12

    Scheduled PrEP appointment (yes/ no)

  6. PrEP appointment attendance

    Time frame: week 0-12

    PrEP appointment attendance (yes/ no)

  7. PrEP-related knowledge

    Time frame: week 0, 4-12

    PrEP Knowledge Scale (Rucinski) (Kalichman) (Kalichman) (Whiteside)

  8. PrEP-related attitudes

    Time frame: week 0, 4-12

    Attitudes Towards PrEP Measurements (Golub) (Holt) (Mimiaga) (Tobias)

  9. PrEP-related self-efficacy

    Time frame: week 0, 4-12

    PrEP Self-Efficacy Scale (adapted from HIV-ASES) (Johnson)

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2017
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.