Sex WorkEMERALDNCT04413591
A Structural HIV Prevention Intervention Targeting High-risk Women
A study testing Community based combination HIV prevention package in people with Sex Work, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sex Work
- What is being tested?
- Community based combination HIV prevention package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2017to 22 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
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).
Read the detailed description
This study aims:
- To examine the effect of exposure to community intervention components on HIV/STI risk behaviors (e.g., drug use/unprotected sex), and HIV/STI cumulative incidence over time in FSWs in the intervention (n=275) compared to those in the comparison group (N=175);
- to explore the intervention's effects on the risk environment of exotic dance clubs (N=15) over time
- To examine how socio-structural (e.g., social cohesion, stigma) and structural vulnerability (e.g., financial and housing stability) indicators change and are associated with the biological and behavioral outcomes over time in FSWs in the intervention (n=275) compared to those in the comparison (n=175) group
- examine the role of these indicators as mediators of the intervention effect on study outcomes;
- To examine the intervention's implementation through qualitative (e.g., in-depth interviews) and quantitative (e.g., assessment of program fit, reach, facilitators, barriers, program costs) measures.
3.1 To examine participant knowledge of the COVID-19 crisis as well as the impact of the crisis on their mental, and physical well-being.
- Conditions
- Sex Work
- Being tested
- Community based combination HIV prevention package
- Keywords
- Sex work, HIV, STI
- Medical subject headings
- Sex Work, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community based combination HIV prevention packageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Area | Experimental | Participants are assigned to the intervention area or the control area based on the location they were recruited in. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HIV/STI cumulative incidence over time
Participants will be tested for HIV, chlamydia and gonorrhea at each study visit.
Measured: Baseline, 6 month, 12 month, 18 month, 24 month visits.
Secondary outcomes (2)
Sexual Risk Behaviors
Participants will be asked for detailed information about sexual partners in the last 6 months.
For each listed partner, the investigators will ask: gender; age; drug use; incarceration history; type of partner (primary, casual, one-time); frequency of sexual activity and condom use; type of sex (oral, vaginal, anal); and if partner had other sexual partners during the time of their sexual involvement. This data collection method allows for calculation of the number of unprotected sexual acts.
Measured: Baseline, 6 month, 12 month, 18 month visits.
Illicit Drug Use
The investigators will ascertain the initiation and frequency of all illicit drugs through the use of a modified NIDA Risk Assessment Battery that has been used and adapted over the past decade.
Measured: Baseline, 6 month, 12 month, 18 month visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start14 Sep 2017
- Primary completion22 Sep 2020
- Study completion22 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sex WorkStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Susan Sherman, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413591
- Sponsor's protocol ID
- 00007664
- Other IDs
- 1R01DA041243
- Acronym
- EMERALD
- Status last verified
- Oct 2022
- First submitted
- 11 May 2020
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36749851Silberzahn 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.
PubMed 33861210
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Structural HIV Prevention Intervention Targeting High-risk Women
- ClinicalTrials.gov ID
- NCT04413591
- Acronym / sponsor ID
- EMERALD / 00007664
- Conditions
- Sex Work
- Keywords
- Sex work, HIV, STI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study aims:
- To examine the effect of exposure to community intervention components on HIV/STI risk behaviors (e.g., drug use/unprotected sex), and HIV/STI cumulative incidence over time in FSWs in the intervention (n=275) compared to those in the comparison group (N=175);
- to explore the intervention's effects on the risk environment of exotic dance clubs (N=15) over time
- To examine how socio-structural (e.g., social cohesion, stigma) and structural vulnerability (e.g., financial and housing stability) indicators change and are associated with the biological and behavioral outcomes over time in FSWs in the intervention (n=275) compared to those in the comparison (n=175) group
- examine the role of these indicators as mediators of the intervention effect on study outcomes;
- To examine the intervention's implementation through qualitative (e.g., in-depth interviews) and quantitative (e.g., assessment of program fit, reach, facilitators, barriers, program costs) measures.
3.1 To examine participant knowledge of the COVID-19 crisis as well as the impact of the crisis on their mental, and physical well-being.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Area | Experimental | Behavioral: Community based combination HIV prevention packageParticipants are assigned to the intervention area or the control area based on the location they were recruited in. |
| Control Area | No intervention | –Participants are assigned to the intervention area or the control area based on the location they were recruited in. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community based combination HIV prevention packageThe 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. | Behavioural | Intervention Area |
Primary outcome
Change in HIV/STI cumulative incidence over time
Time frame: Baseline, 6 month, 12 month, 18 month, 24 month visits.
Participants will be tested for HIV, chlamydia and gonorrhea at each study visit.
2 secondary outcomes
Sexual Risk Behaviors
Time frame: Baseline, 6 month, 12 month, 18 month visits.
Illicit Drug Use
Time frame: Baseline, 6 month, 12 month, 18 month visits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Derived from this study: PubMed 36749851Sherman 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.
- Derived from this study: PubMed 33861210Silberzahn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Sherman principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community based combination HIV prevention package in people with Sex Work, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HIV/STI cumulative incidence over time (time frame: Baseline, 6 month, 12 month, 18 month, 24 month visits.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04413591, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.