NCT03293290

Brief Summary

This study has two components. The first component is designed to assess and compare the awareness, attitudes and clinical eligibility of Pre-exposure Prophylaxis (PrEP) in criminal justice (CJ) involved women. The second component is designed to evaluate the acceptability and feasibility of strategically delivering PrEP to CJ involved women and their risk network members.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Dec 2017

Typical duration for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

December 11, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

2.4 years

First QC Date

September 20, 2017

Last Update Submit

July 27, 2021

Conditions

HIV Infections

Keywords

HIV pre-exposure prophylaxiscriminal justicewomenrisk networks

Outcome Measures

Primary Outcomes (2)

  • % PrEP uptake

    \# starting PrEP/ # enrolled subjects

    Month 1

  • % eligible PrEP uptake

    \# starting PrEP/ # eligible subjects

    Month 1

Secondary Outcomes (3)

  • Mean % PrEP adherence

    12 months

  • Mean TDF level

    12 months

  • HIV incidence

    12 months

Study Arms (1)

PrEP

EXPERIMENTAL

For participants who are eligible for PrEP and willing to participate, subjects on PrEP will be followed for 1 year with quarterly assessments.

Drug: PrEP

Interventions

PrEPDRUG

Subjects on PrEP will be followed for 1 year with quarterly assessments by trained research assistants. Study visits will take place at in New Haven and Hartford. At every scheduled visit, participants will receive a comprehensive package of preventive services, including a prescription for the next 30-day supply of TDF/FTC (with 2 refills), a symptom screen for acute HIV, risk-reduction counseling, PrEP adherence support, bleach for cleaning injection equipment, and condoms. HIV rapid testing with Orasure® will be performed quarterly; participants testing newly positive for HIV (representing seroconversions) will be followed with confirmatory testing and referred to care as needed.

Also known as: TDF/FTC
PrEP

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCis- or trans- female participants are eligible.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Index participants reside in, or planning to reside in New Haven or Hartford, Connecticut,.
  • Criminal justice-involved (anticipate release or have been released from prison or jail within 6 months, and/or are under or anticipating transfer to correctional community supervision (i.e. probation or parole)).
  • Self-reported HIV negative.
  • Eligible and enrolled women will then recruit risk network members through respondent driven sampling, using vouchers.
  • Risk network members must:
  • have a unique and valid referral coupon (from Index participant).
  • Reside or planning to reside in New Haven or Hartford, Connecticut.
  • Self-reported HIV negative
  • years of age or older

You may not qualify if:

  • They are unable or unwilling to provide informed consent.
  • Are threatening to staff.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Clinical and Community Research, 270 Congress Ave

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • Meyer JP, Price CR, Ye Y, Qin Y, Tracey D, Demidont AC, Melbourne K, Altice FL. A PrEP Demonstration Project Using eHealth and Community Outreach to Justice-Involved Cisgender Women and Their Risk Networks. AIDS Behav. 2022 Dec;26(12):3807-3817. doi: 10.1007/s10461-022-03709-2. Epub 2022 Jun 7.

    PMID: 35672552DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jaimie Meyer, MD, MS, FACP

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 26, 2017

Study Start

December 11, 2017

Primary Completion

May 15, 2020

Study Completion

May 15, 2020

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

US(1)