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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA041243 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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).
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);
a. 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
a. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Area | Experimental | Participants are assigned to the intervention area or the control area based on the location they were recruited in. |
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| Control Area | No Intervention | Participants are assigned to the intervention area or the control area based on the location they were recruited in. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community based combination HIV prevention package | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation evaluation using SPARC Center client satisfaction surveys | SPARC Center client satisfaction surveys will be used to determine the fit, facilitators and barriers, quality, and general experience of women who have used the SPARC Center. | 12-month, 18-month |
| Implementation evaluation using in-depth interviews with SPARC staff and clients |
Inclusion Criteria:
Exclusion Criteria:
Assigned female at birth and identify with female gender
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| Name | Affiliation | Role |
|---|---|---|
| Susan Sherman | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bloomberg School of Public Health | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36749851 | Derived | 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. | |
| 33861210 | Derived | 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. |
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| ID | Term |
|---|---|
| D011477 | Sex Work |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| 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. | Baseline, 6 month, 12 month, 18 month visits. |
An in-depth interview guide will be developed by experienced study staff and used to interview SPARC guests and staff with the goal of examining program reach, fit, facilitators and barriers, and program costs. |
| 18 months |
| Implementation evaluation using cross-sectional surveys | A cross-sectional survey will be developed by study staff and used to determine the reach of the implementation within the FSW community of southwest Baltimore. | 18 months |
| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |