Multimodal Interventions to Improve Adherence to Oral Tenofovir/Emtricitabine as Pre-Exposure Prophylaxis in Women in Southern California
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 136
- Locations
- 5
- Primary Endpoint
- Adherence to PrEP
Study Overview
Brief Summary
The purpose of this study is to test a program that uses drug level monitoring, text messaging ("iTAB") and personalized counseling with HIV prevention services, including PrEP (medicine that can help prevent HIV infection when taken daily).
Detailed Description
This is an open-label single-arm longitudinal clinical trial to estimate medication adherence and retention in a PrEP HIV prevention program that implements a combination intervention strategy that uses text-messages (iTAB) and a staged adherence counseling support strategy titrated from real-time drug levels in women at-risk for HIV acquisition.
A total of 135 participants will receive the combined intervention of text messaging adherence reminders and adherence support. The text messaging system consists of daily, personalized, automated 2-way text messages to maintain adherence and retention. Participants that have a low intracellular tenofovir diphosphate (TFV-DP) concentration will receive escalated, targeted adherence support. All participants will receive access to PrEP in accordance with standardized comprehensive methods of prescribing and clinical assessments that include safety monitoring as well as regular HIV and sexually transmitted infection (STI) screening. All participants will be followed for 48 weeks after enrollment and will receive a post study follow-up at 60 weeks. The primary endpoint will be measured at 48 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female at birth and identifies as female gender
- •Age 18 years or older
- •Able to understand and provide consent in English or Spanish
- •HIV negative by 4th generation test (Ag/Ab test) or combination of enzymeimmunoassay (EIA) and HIV RNA
- •Creatinine clearance ≥ 60 ml/min (via Cockcroft-Gault formula)
- •At-Risk Criteria (at least one):
- •Condomless sex in the last 3 months with one or more male partners of unknown HIV status known to be at substantial risk of HIV infection (IDU, bisexual, sex for goods, recently incarcerated, from a country with HIV prevalence >1%, interpersonal Partner Violence);
- •STI (rectal or vaginal gonorrhea or syphilis) diagnosis during the last 6 months.
- •Previous post-exposure prophylaxis (PEP) use during the last 12 months.
- •Has at least one HIV-infected sexual partner for ≥4 weeks.
- •Sex for exchange of money, goods or services
Exclusion Criteria
- •Pregnancy at enrollment.
- •Any condition, which in the opinion of the provider, will seriously compromise the participant's ability to comply with the protocol, including adherence to PrEP medication dosing, such as active, untreated or unstable major mental illness (i.e. untreated psychotic disorder).
- •Use of prohibited medications, in particular, agents known to be nephrotoxic or drugs slow in renal excretion.
- •Previous participation in an HIV vaccine trial. Participants that were documented to have received only placebo are not excluded.
- •Signs or symptoms suspicious for Primary HIV Infection (PHI).
Arms & Interventions
AEGIS
All participants will be assigned to this arm of the study.
Intervention: Text Messaging (Behavioral)
AEGIS
All participants will be assigned to this arm of the study.
Intervention: Adherence Counseling (Behavioral)
AEGIS
All participants will be assigned to this arm of the study.
Intervention: Daily Oral PrEP (Drug)
Outcomes
Primary Outcomes
Adherence to PrEP
Time Frame: Week 4 to Week 48
Adherence is measured by TFV-DP (tenofovir diphosphate) concentrations in Dried Blood Spots (DBS) suggestive of 6-7 doses per week.
Secondary Outcomes
- Correlates of PrEP Adherence(Baseline to Week 48)
- Number of Participants Experiencing Treatment-Emergent Adverse Events(Baseline to Week 48)
- Number of HIV Infections(Baseline to Week 48)
Investigators
Dr. Raphael Landovitz
Principal Investigator
University of California, Los Angeles