NCT04413591

Brief Summary

The purpose of this study is to assess the effectiveness of a community based combination HIV prevention package, including biomedical, behavioral, and structural services for female sex workers (FSW) in Baltimore, Maryland. This study is a prospective two-group trial comparing the efficacy of a community-based comprehensive HIV/STI prevention package compared to standard of care (HIV testing, counseling, and referrals) among FSWs. Outcomes will be assessed through self-reported illicit drug use and sexual risk behaviors (behavioral) as well as HIV/STI testing (biological).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
385

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

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

September 14, 2017

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2020

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

3 years

First QC Date

May 11, 2020

Last Update Submit

October 4, 2022

Conditions

Sex Work

Keywords

Sex workHIVSTI

Outcome Measures

Primary Outcomes (1)

  • Change in HIV/STI cumulative incidence over time

    Participants will be tested for HIV, chlamydia and gonorrhea at each study visit.

    Baseline, 6 month, 12 month, 18 month, 24 month visits.

Secondary Outcomes (2)

  • Sexual Risk Behaviors

    Baseline, 6 month, 12 month, 18 month visits.

  • Illicit Drug Use

    Baseline, 6 month, 12 month, 18 month visits.

Other Outcomes (3)

  • Implementation evaluation using SPARC Center client satisfaction surveys

    12-month, 18-month

  • Implementation evaluation using in-depth interviews with SPARC staff and clients

    18 months

  • Implementation evaluation using cross-sectional surveys

    18 months

Study Arms (2)

Intervention Area

EXPERIMENTAL

Participants are assigned to the intervention area or the control area based on the location they were recruited in.

Behavioral: Community based combination HIV prevention package

Control Area

NO INTERVENTION

Participants are assigned to the intervention area or the control area based on the location they were recruited in.

Interventions

Community based combination HIV prevention packageBEHAVIORAL

The intervention compares the efficacy of a community-based comprehensive HIV/STI prevention package compared to standard of care (HIV testing, counseling, and referrals) among Female Sex Workers.

Intervention Area

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAssigned female at birth and identify with female gender
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older;
  • Assigned female at birth and identify with female gender
  • Have exchanged sex in Baltimore City at least 3 times in the past 3 months;
  • Willing to undergo testing for HIV, gonorrhea, and chlamydia
  • Willing to provide locator information.

You may not qualify if:

  • Inability to provide informed consent in English;
  • Women who are determined as too high or drunk;
  • Women who are cognitively impaired.
  • Currently enrolled in the SAPPHIRE study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

  • Sherman SG, Tomko C, Nestadt DF, Silberzahn BE, Clouse E, Haney K, Allen ST, Galai N. Impact of a Community Empowerment Intervention on Sexually Transmitted Infections Among Female Sex Workers in Baltimore, Maryland. Sex Transm Dis. 2023 Jun 1;50(6):374-380. doi: 10.1097/OLQ.0000000000001781. Epub 2023 Feb 8.

    PMID: 36749851DERIVED

  • Silberzahn BE, Tomko CA, Clouse E, Haney K, Allen ST, Galai N, Footer KHA, Sherman SG. The EMERALD (Enabling Mobilization, Empowerment, Risk Reduction, and Lasting Dignity) Study: Protocol for the Design, Implementation, and Evaluation of a Community-Based Combination HIV Prevention Intervention for Female Sex Workers in Baltimore, Maryland. JMIR Res Protoc. 2021 Apr 16;10(4):e23412. doi: 10.2196/23412.

    PMID: 33861210DERIVED

MeSH Terms

Conditions

Sex WorkSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Susan Sherman

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2020

First Posted

June 4, 2020

Study Start

September 14, 2017

Primary Completion

September 22, 2020

Study Completion

September 22, 2020

Last Updated

October 5, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)