HIV/AIDS
Conditions
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.
Detailed description
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.
Interventions
BEHAVIORALPrEP standard of care+behavioral intervention
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.
Sponsors
Baltimore City Health Department
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change over time to adherence to PrEP using plasma | 3 and 6 months | 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. |
| Change over time to adherence to PrEP using dried blood spots | 3 and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Structural vulnerabilities change over time | 3 and 6 months | 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 |
| Behavioral outcomes change over time | 3 and 6 months | 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). |
| Individual PrEP change over time | weekly, from baseline visit to last study visit (six months from baseline) | PrEP adherence, measured by mHealth. Survey question: How many times in the past week have you taken your medication? Please respond with 0-7. |
| Individual health change over time | 3 and 6 months | 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 |
| Social outcomes change over time | 3 and 6 months | 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 |
Countries
United States
Outcome results
None listed