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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
| California HIV/AIDS Research Program | OTHER |
| Los Angeles County Department of Public Health | OTHER_GOV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AEGIS | Other | All participants will be assigned to this arm of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text Messaging | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
At-Risk Criteria (at least one):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raphael Landovitz, MD | University of California, Los Angeles | Principal Investigator |
| Sheldon Morris, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APLA Health & Wellness' Gleicher / Chen Health Center | Los Angeles | California | 90016 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38822300 | Derived | Anderson KM, Blumenthal J, Jain S, Sun X, Amico KR, Landovitz R, Zachek CM, Morris S, Moore DJ, Stockman JK. The impact of intimate partner violence on PrEP adherence among U.S. Cisgender women at risk for HIV. BMC Public Health. 2024 May 31;24(1):1461. doi: 10.1186/s12889-024-18946-4. | |
| 34851726 | Derived | Blumenthal J, Landovitz R, Jain S, He F, Kofron R, Ellorin E, Ntim GM, Stockman JK, Corado K, Rivet Amico K, Moore DJ, Morris S. Pre-Exposure Prophylaxis Perspectives, Sociodemographic Characteristics, and HIV Risk Profiles of Cisgender Women Seeking and Initiating PrEP in a US Demonstration Project. AIDS Patient Care STDS. 2021 Dec;35(12):481-487. doi: 10.1089/apc.2021.0114. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AEGIS | All participants will be assigned to this arm of the study. Text Messaging: 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. Adherence Counseling: 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. Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 29, 2016 |
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| AIDS Project Los Angeles |
| OTHER |
All enrolled participants will receive daily oral emtricitabine/tenofovir disoproxil fumarate, adherence counseling, and daily text message reminders.
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| Adherence Counseling | Behavioral | 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. |
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| Daily Oral PrEP | Drug | All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis. |
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| 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 |
| Los Angeles Biomedical Research Institute at Harbor-UCLA |
| Los Angeles |
| California |
| 90033 |
| United States |
| USC 5P21 Rand Schrader Clinic | Los Angeles | California | 90033 | United States |
| T.H.E. at Ruth Temple | Los Angeles | California | 90062 | United States |
| UCSD Antiviral Research Center | San Diego | California | 92103 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AEGIS | All participants will be assigned to this arm of the study. Text Messaging: 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. Adherence Counseling: 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. Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Count of Participants | Participants |
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| Monthly Income | Count of Participants | Participants |
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| Relationship | Count of Participants | Participants |
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| Employment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence to PrEP | Adherence is measured by TFV-DP (tenofovir diphosphate) concentrations in Dried Blood Spots (DBS) suggestive of 6-7 doses per week. | Posted | Count of Participants | Participants | Week 4 to Week 48 |
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| |||||||||||||||||||||||||||||||
| Secondary | 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). | Posted | Count of Participants | Participants | Baseline to Week 48 |
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| ||||||||||||||||||||||||||||||||
| Secondary | Number of HIV Infections | Number of new HIV infections observed among participants with at least one follow-up visit. | Participants with one or more follow-up visits were included in this analysis | Posted | Number | infections | Baseline to Week 48 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Correlates of PrEP Adherence | Self-reported adherence by daily texting through iTAB will be correlated with TFV-DP concentrations in DBS | Posted | Count of Participants | Participants | Baseline to Week 48 |
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48 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AEGIS | All participants will be assigned to this arm of the study. Text Messaging: 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. Adherence Counseling: 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. Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis. | 0 | 136 | 0 | 136 | 64 | 136 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Decreased Creatinine Clearance | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jill Blumenthal, MD | UCSD Medical Center, Antiviral Research Center | (619) 471-3913 | jblumenthal@health.ucsd.edu |
| Apr 30, 2020 |
| Prot_SAP_000.pdf |
| Latina |
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| Other |
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| No response |
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| Single/Open |
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| No response |
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| No response |
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| 6-7 doses (≥ 1050 fmol/punch) |
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| Missed Visit, Withdrawal, Off PrEP |
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| Week 12 |
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| Week 24 |
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| Week 36 |
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| Week 48 |
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