HIV PreventionPhase 4AEGiSNCT02584140
Pre-exposure Prophylaxis (PrEP) Adherence Enhancement Guided by iTAB and Drug Levels for Women
A Phase 4 study testing Text Messaging, Adherence Counseling and Daily Oral PrEP in people with HIV Prevention, run by University of California, Los Angeles at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Text Messaging, Adherence Counseling and Daily Oral PrEP
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2016to 14 Jun 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
Show all 11Show fewer
- 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
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
APLA Health & Wellness' Gleicher / Chen Health Center
Los Angeles, California, 90016
Los Angeles Biomedical Research Institute at Harbor-UCLA
Los Angeles, California, 90033
USC 5P21 Rand Schrader Clinic
Los Angeles, California, 90033
T.H.E. at Ruth Temple
Los Angeles, California, 90062
UCSD Antiviral Research Center
San Diego, California, 92103
About this study
Official title: Multimodal Interventions to Improve Adherence to Oral Tenofovir/Emtricitabine as Pre-Exposure Prophylaxis in Women in Southern California
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).
Read the 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.
- Conditions
- HIV Prevention
- Being tested
- Text Messaging, Adherence Counseling, Daily Oral PrEP
- Keywords
- PrEP, Pre-exposure Prophylaxis, HIV Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessagingBehavioural
Also called iTAB
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 CounselingBehavioural
Also called Integrate Next Step Counseling (iNSC), Targeted iNSC, PrEP Steps
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 PrEPDrug
Also called PrEP
All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| AEGIS | Other | All participants will be assigned to this arm of the study. Receives: Behavioral: Text Messaging; Behavioral: Adherence Counseling; Drug: Daily Oral PrEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to PrEP
Adherence is measured by TFV-DP (tenofovir diphosphate) concentrations in Dried Blood Spots (DBS) suggestive of 6-7 doses per week.
Measured: Week 4 to Week 48
Secondary outcomes (3)
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).
Measured: Baseline to Week 48
Number of HIV Infections
Number of new HIV infections observed among participants with at least one follow-up visit.
Measured: 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
Measured: Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startMay 2016
- Primary completion15 May 2019
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive daily oral emtricitabine/tenofovir disoproxil fumarate, adherence counseling, and daily text message reminders.
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, California HIV/AIDS Research Program, Los Angeles County Department of Public Health, AIDS Project Los Angeles
- Responsible party
- Principal investigator, Dr. Raphael Landovitz, University of California, Los Angeles
- Investigators
- Raphael Landovitz, MD, Principal investigator, University of California, Los AngelesSheldon Morris, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584140
- Sponsor's protocol ID
- 15-001583
- Acronym
- AEGiS
- Status last verified
- Jun 2021
- First submitted
- 15 Oct 2015
- Last updated
- 8 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 38822300Blumenthal 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.
PubMed 34851726
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Interventions to Improve Adherence to Oral Tenofovir/Emtricitabine as Pre-Exposure Prophylaxis in Women in Southern California
- ClinicalTrials.gov ID
- NCT02584140
- Acronym / sponsor ID
- AEGiS / 15-001583
- Conditions
- HIV Prevention
- Keywords
- PrEP, Pre-exposure Prophylaxis, HIV Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of California, San Diego, California HIV/AIDS Research Program, Los Angeles County Department of Public Health, AIDS Project Los Angeles
- Study start
- May 2016 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Posted 27 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive daily oral emtricitabine/tenofovir disoproxil fumarate, adherence counseling, and daily text message reminders.
| Arm | Type | Receives |
|---|---|---|
| AEGIS | Other | Behavioral: Text Messaging, Behavioral: Adherence Counseling, Drug: Daily Oral PrEPAll participants will be assigned to this arm of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text MessagingAlso: iTABAll 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. | Behavioural | AEGIS |
| Adherence CounselingAlso: Integrate Next Step Counseling (iNSC), Targeted iNSC, PrEP StepsAll 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. | Behavioural | AEGIS |
| Daily Oral PrEPAlso: PrEPAll participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis. | Drug | AEGIS |
Primary outcome
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.
3 secondary outcomes
Number of Participants Experiencing Treatment-Emergent Adverse Events
Time frame: Baseline to Week 48
Number of HIV Infections
Time frame: Baseline to Week 48
Correlates of PrEP Adherence
Time frame: Baseline to Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38822300Anderson 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.
- Derived from this study: PubMed 34851726Blumenthal 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael Landovitz, MD principal investigator
University of California, Los Angeles
Sheldon Morris, MD principal investigator
UCSD
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Text Messaging, Adherence Counseling and Daily Oral PrEP in people with HIV Prevention, run by University of California, Los Angeles at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to PrEP (time frame: Week 4 to Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02584140, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.