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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03226873
Enrollment
66
Registered
2017-07-24
Start date
2017-11-16
Completion date
2018-03-19
Last updated
2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-exposure Prophylaxis, HIV-1-infection

Keywords

HIV prevention, PrEP, peer navigation, women

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.

Interventions

BEHAVIORALPeer Navigation

Peer education, counseling, and facilitation of PrEP care

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Montefiore Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.)

Design outcomes

Primary

MeasureTime frameDescription
PrEP prescription filled4-12 weeksObtained from medical and/or pharmacy records

Secondary

MeasureTime frameDescription
HIV risk behaviorsweek 0, 4-12Revised Risk Behavior Assessment (Wechsberg)
HIV risk perceptionweek 0, 4-12Perceived HIV Risk Scale (Napper)
Interest in PrEPweek 0PrEP Acceptability Scale (Marcus)
PrEP appointment acceptanceweek 0PrEP appointment acceptance (yes/ no)
PrEP-related self-efficacyweek 0, 4-12PrEP Self-Efficacy Scale (adapted from HIV-ASES) (Johnson)
PrEP appointment attendanceweek 0-12PrEP appointment attendance (yes/ no)
PrEP-related knowledgeweek 0, 4-12PrEP Knowledge Scale (Rucinski) (Kalichman) (Kalichman) (Whiteside)
PrEP-related attitudesweek 0, 4-12Attitudes Towards PrEP Measurements (Golub) (Holt) (Mimiaga) (Tobias)
PrEP appointment scheduledweek 0-12Scheduled PrEP appointment (yes/ no)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026