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| Name | Class |
|---|---|
| Baltimore City Health Department | OTHER |
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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.
This study is a prospective two-group trial comparing the efficacy of a comprehensive PrEP adherence program compared to PrEP standard of care among FSW. Outcomes will be assessed through self-reported PrEP adherence as well as biological adherence indicators.
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/sexually transmitted infection (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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP standard of care+behavioral intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral outcomes change over time | unsafe syringe use, unsafe sex, measured by survey. No scales for these, just individual questions about behavior. Syringe use are binary yes/no questions, condom use is frequency of condom use during vaginal, oral, and anal sex (separately). | 3 and 6 months |
| Social outcomes change over time |
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Inclusion Criteria:
Exclusion Criteria:
Currently identify as a woman or female
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| Name | Affiliation | Role |
|---|---|---|
| Susan Sherman, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPARC Center | Baltimore | Maryland | 21230 | United States |
We do not plan to share data outside of the research plan
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Social support, measured by survey. Social support: Moser, A., Stuck, A. E., Silliman, R. A., Ganz, P. A., & Clough-Gorr, K. M. (2012). The eight-item modified Medical Outcomes Study Social Support Survey: psychometric evaluation showed excellent performance. Journal of clinical epidemiology, 65(10), 1107-1116. Possible range is 0-32, higher score indicates better outcome |
| 3 and 6 months |
| Structural vulnerabilities change over time | housing, access to healthcare, measured by survey. Access to healthcare partially measured by: modified Kalichman, S. C., Catz, S., and Ramachandran, B. (1999). Barriers to HIV/AIDS treatment and adherence among African-American adults with disadvantaged education. Journal of the National Medical Association, 91, 439-446. Higher # endorsed means greater barriers to care | 3 and 6 months |
| Individual health change over time | PrEP uptake, awareness and knowledge, measured by survey. Adapted from the ACTG Adherence Questionnaire The AIDS Clinical Trials Group (ACTG) (2009). ACTG Adherence Questionnaires. Retrieved at: https://prevention.ucsf.edu/sites/prevention.ucsf.edu/files/uploads/tools/surveys/pdf/2098.4188.pdf Independently developed self-report questions to measure PrEP uptake, knowledge, and perceived barriers and facilitators | 3 and 6 months |
| Individual PrEP change over time | PrEP adherence, measured by mHealth. Survey question: How many times in the past week have you taken your medication? Please respond with 0-7. | weekly, from baseline visit to last study visit (six months from baseline) |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |