NCT04396678

Brief Summary

The purpose of this study is to develop and assess the feasibility, acceptability, and preliminary efficacy on adherence of a community-informed intervention for tenofovir/emtricitabine (TDF/FTC) pre-exposure prophylaxis (PrEP) engagement among street-based female sex workers (FSW) in Baltimore, Maryland.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

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

Study Start

First participant enrolled

June 12, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

March 26, 2020

Last Update Submit

August 30, 2021

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (2)

  • Change over time to adherence to PrEP using plasma

    Adherence as the biological outcome, measured by the use of plasma to see concentration of tenofovir (ng/mL), to examine the pilot study's impact on adherence and inform metrics and outcomes of a future R01.

    3 and 6 months

  • Change over time to adherence to PrEP using dried blood spots

    Adherence as the biological outcome, measured by the use of dried blood spots to see concentration of tenofovir (fmol/punch), to examine the pilot study's impact on adherence and inform metrics and outcomes of a future R01.

    3 and 6 months

Secondary Outcomes (5)

  • Behavioral outcomes change over time

    3 and 6 months

  • Social outcomes change over time

    3 and 6 months

  • Structural vulnerabilities change over time

    3 and 6 months

  • Individual health change over time

    3 and 6 months

  • Individual PrEP change over time

    weekly, from baseline visit to last study visit (six months from baseline)

Study Arms (2)

PrEP Standard of Care

NO INTERVENTION

PrEP standard of care, administered through the Baltimore City Health Department

PrEP standard of care+behavioral intervention

EXPERIMENTAL

PrEP standard of care, administered through the Baltimore City Health Department, and the behavioral intervention.

Behavioral: PrEP standard of care+behavioral intervention

Interventions

PrEP standard of care+behavioral interventionBEHAVIORAL

The intervention includes three main components: 1) group PrEP engagement sessions, which include four educational sessions that situate PrEP in a broader framework of access and barriers to care, provider/patient communication, sexual health, HIV/STI education, harm reduction around drug use, stigma, risk compensation and safe sex, and health/science literacy; 2) peer navigation, which aims to help women navigate healthcare engagement with the SPARC nurse practitioner and other providers; and 3) an mHealth component, consisting of a two-way text messaging system through which women will receive automated daily messages and weekly messages requesting adherence reports.

PrEP standard of care+behavioral intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCurrently identify as a woman or female
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Assigned female at birth and identify as a woman
  • Traded sex for money or drugs at least three times in the past three months
  • HIV negative
  • Willing to initiate PrEP
  • Not knowingly pregnant or planning to become pregnant during the following 6 months.

You may not qualify if:

  • Currently taking PrEP for HIV prevention
  • Inability to provide informed consent in English
  • Women who are determined as too high or drunk
  • Women who are cognitively impaired
  • Does not agree to data sharing with the Baltimore City Health Department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPARC Center

Baltimore, Maryland, 21230, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Susan Sherman, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2020

First Posted

May 20, 2020

Study Start

June 12, 2019

Primary Completion

July 1, 2020

Study Completion

December 1, 2020

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

We do not plan to share data outside of the research plan

Locations

US(1)