Pre-exposure Prophylaxis (PrEP) Adherence Enhancement Guided by iTAB and Drug Levels for Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multimodal Interventions to Improve Adherence to Oral Tenofovir/Emtricitabine as Pre-Exposure Prophylaxis in Women in Southern California

Conditions
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HIV Prevention

Intervention / Treatment
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* Behavioral: Text Messaging
* Behavioral: Adherence Counseling
* Drug: Daily Oral PrEP


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: All enrolled participants will receive daily oral emtricitabine/tenofovir disoproxil fumarate, adherence counseling, and daily text message reminders.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AEGIS<br>All participants will be assigned to this arm of the study. | Behavioral: Text Messaging<br>* All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.<br>* Other names: iTAB;Behavioral: Adherence Counseling<br>* All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of <1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of <1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.<br>* Other names: PrEP Steps;Drug: Daily Oral PrEP<br>* All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.<br>* Other names: PrEP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to PrEP | Adherence is measured by TFV-DP (tenofovir diphosphate) concentrations in Dried Blood Spots (DBS) suggestive of 6-7 doses per week. | Week 4 to Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Treatment-Emergent Adverse Events | Describe the safety and tolerability of daily emtricitabine/tenofovir disoproxil fumarate TDF/FTC given for PrEP including discontinuation for any adverse event, serious adverse events and adverse events (grade 2 or higher). | Baseline to Week 48 | 
| Number of HIV Infections | Number of new HIV infections observed among participants with at least one follow-up visit. | Baseline to Week 48 | 
| Correlates of PrEP Adherence | Self-reported adherence by daily texting through iTAB will be correlated with TFV-DP concentrations in DBS | Baseline to Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP, Pre-exposure Prophylaxis, HIV Prevention