Developing a PrEP Adherence Intervention Targeting At-Risk and Substance Using Women

Not Applicable

Completed

• Conditions: HIV/AIDS

• Registration Number: NCT04396678
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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.

Study Timeline

• Study Start: 2019-06-12
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-20
• Primary Completion: 2020-07-01
• Study Completion: 2020-12-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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
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
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.

Trial Locations

Locations (1)

SPARC Center; 🇺🇸 Baltimore, Maryland, United States