HIV Prevention
Conditions
Keywords
PrEP, Pre-exposure Prophylaxis, HIV Prevention
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.
Interventions
BEHAVIORALText 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.
BEHAVIORALAdherence 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.
DRUGDaily Oral PrEP
All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.
Sponsors
University of California, San Diego
California HIV/AIDS Research Program
Los Angeles County Department of Public Health
AIDS Project Los Angeles
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
All enrolled participants will receive daily oral emtricitabine/tenofovir disoproxil fumarate, adherence counseling, and daily text message reminders.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to PrEP | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Treatment-Emergent Adverse Events | Baseline to Week 48 | 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). |
| Number of HIV Infections | Baseline to Week 48 | Number of new HIV infections observed among participants with at least one follow-up visit. |
| Correlates of PrEP Adherence | Baseline to Week 48 | Self-reported adherence by daily texting through iTAB will be correlated with TFV-DP concentrations in DBS |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 136 |
| Total | 136 |
Baseline characteristics
| Characteristic | AEGIS |
|---|---|
| Age, Continuous | 39.16 years STANDARD_DEVIATION 9.98 |
| Education High school or less | 61 Participants |
| Education Some college or more | 75 Participants |
| Employment Full/Part time/Retired | 68 Participants |
| Employment No response | 8 Participants |
| Employment Unemployed/Unable to work | 60 Participants |
| Monthly Income $2,000 or less | 74 Participants |
| Monthly Income More than $2,000 | 35 Participants |
| Monthly Income No response | 27 Participants |
| Race/Ethnicity, Customized Latina | 26 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 52 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 30 Participants |
| Race/Ethnicity, Customized Other | 28 Participants |
| Region of Enrollment United States | 136 participants |
| Relationship Divorced/Widowed/Separated | 17 Participants |
| Relationship Married/Monogamous | 53 Participants |
| Relationship No response | 3 Participants |
| Relationship Single/Open | 63 Participants |
| Sex: Female, Male Female | 136 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 136 |
| other Total, other adverse events | 64 / 136 |
| serious Total, serious adverse events | 0 / 136 |
Outcome results
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.
Time frame: Week 4 to Week 48
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| AEGIS | Adherence to PrEP | Week 24 | <2 doses (BLQ - 349 fmol/punch) | 15 Participants |
| AEGIS | Adherence to PrEP | Week 4 | <2 doses (BLQ - 349 fmol/punch) | 22 Participants |
| AEGIS | Adherence to PrEP | Week 12 | <2 doses (BLQ - 349 fmol/punch) | 21 Participants |
| AEGIS | Adherence to PrEP | Week 12 | 2-3 doses (350 - 699 fmol/punch) | 19 Participants |
| AEGIS | Adherence to PrEP | Week 12 | 4-5 doses (700 - 1049 fmol/punch) | 17 Participants |
| AEGIS | Adherence to PrEP | Week 12 | 6-7 doses (≥ 1050 fmol/punch) | 45 Participants |
| AEGIS | Adherence to PrEP | Week 12 | Missed Visit, Withdrawal, Off PrEP | 34 Participants |
| AEGIS | Adherence to PrEP | Week 36 | 2-3 doses (350 - 699 fmol/punch) | 8 Participants |
| AEGIS | Adherence to PrEP | Week 36 | 4-5 doses (700 - 1049 fmol/punch) | 17 Participants |
| AEGIS | Adherence to PrEP | Week 36 | 6-7 doses (≥ 1050 fmol/punch) | 28 Participants |
| AEGIS | Adherence to PrEP | Week 24 | 4-5 doses (700 - 1049 fmol/punch) | 25 Participants |
| AEGIS | Adherence to PrEP | Week 24 | 6-7 doses (≥ 1050 fmol/punch) | 29 Participants |
| AEGIS | Adherence to PrEP | Week 24 | Missed Visit, Withdrawal, Off PrEP | 56 Participants |
| AEGIS | Adherence to PrEP | Week 36 | <2 doses (BLQ - 349 fmol/punch) | 16 Participants |
| AEGIS | Adherence to PrEP | Week 36 | Missed Visit, Withdrawal, Off PrEP | 67 Participants |
| AEGIS | Adherence to PrEP | Week 48 | <2 doses (BLQ - 349 fmol/punch) | 16 Participants |
| AEGIS | Adherence to PrEP | Week 48 | 2-3 doses (350 - 699 fmol/punch) | 8 Participants |
| AEGIS | Adherence to PrEP | Week 48 | 4-5 doses (700 - 1049 fmol/punch) | 17 Participants |
| AEGIS | Adherence to PrEP | Week 48 | 6-7 doses (≥ 1050 fmol/punch) | 25 Participants |
| AEGIS | Adherence to PrEP | Week 48 | Missed Visit, Withdrawal, Off PrEP | 70 Participants |
| AEGIS | Adherence to PrEP | Week 4 | 2-3 doses (350 - 699 fmol/punch) | 11 Participants |
| AEGIS | Adherence to PrEP | Week 4 | 4-5 doses (700 - 1049 fmol/punch) | 30 Participants |
| AEGIS | Adherence to PrEP | Week 4 | 6-7 doses (≥ 1050 fmol/punch) | 54 Participants |
| AEGIS | Adherence to PrEP | Week 4 | Missed Visit, Withdrawal, Off PrEP | 19 Participants |
| AEGIS | Adherence to PrEP | Week 24 | 2-3 doses (350 - 699 fmol/punch) | 11 Participants |
Secondary
Correlates of PrEP Adherence
Self-reported adherence by daily texting through iTAB will be correlated with TFV-DP concentrations in DBS
Time frame: Baseline to Week 48
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| AEGIS | Correlates of PrEP Adherence | Week 4 | TFV-DP <1050 fmol/punch (0-5 doses weekly) | 58 Participants |
| AEGIS | Correlates of PrEP Adherence | Week 4 | TFV-DP ≥1050 fmol/punch (6-7 doses weekly) | 50 Participants |
| AEGIS | Correlates of PrEP Adherence | Week 4 | Missing/Withdrawn/On study, off medication | 28 Participants |
| AEGIS | Correlates of PrEP Adherence | Week 12 | TFV-DP ≥1050 fmol/punch (6-7 doses weekly) | 44 Participants |
| AEGIS | Correlates of PrEP Adherence | Week 12 | Missing/Withdrawn/On study, off medication | 37 Participants |
| AEGIS | Correlates of PrEP Adherence | Week 24 | TFV-DP <1050 fmol/punch (0-5 doses weekly) | 48 Participants |
| AEGIS | Correlates of PrEP Adherence | Week 24 | TFV-DP ≥1050 fmol/punch (6-7 doses weekly) | 28 Participants |
| AEGIS | Correlates of PrEP Adherence | Week 12 | TFV-DP <1050 fmol/punch (0-5 doses weekly) | 55 Participants |
| AEGIS | Correlates of PrEP Adherence | Week 24 | Missing/Withdrawn/On study, off medication | 60 Participants |
| AEGIS | Correlates of PrEP Adherence | Week 36 | TFV-DP <1050 fmol/punch (0-5 doses weekly) | 39 Participants |
| AEGIS | Correlates of PrEP Adherence | Week 36 | TFV-DP ≥1050 fmol/punch (6-7 doses weekly) | 26 Participants |
| AEGIS | Correlates of PrEP Adherence | Week 36 | Missing/Withdrawn/On study, off medication | 71 Participants |
| AEGIS | Correlates of PrEP Adherence | Week 48 | TFV-DP <1050 fmol/punch (0-5 doses weekly) | 38 Participants |
| AEGIS | Correlates of PrEP Adherence | Week 48 | TFV-DP ≥1050 fmol/punch (6-7 doses weekly) | 23 Participants |
| AEGIS | Correlates of PrEP Adherence | Week 48 | Missing/Withdrawn/On study, off medication | 75 Participants |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Number of HIV Infections
Number of new HIV infections observed among participants with at least one follow-up visit.
Time frame: Baseline to Week 48
Population: Participants with one or more follow-up visits were included in this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AEGIS | Number of HIV Infections | 0 infections |
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).
Time frame: Baseline to Week 48
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AEGIS | Number of Participants Experiencing Treatment-Emergent Adverse Events | One of more grade 2+ AEs | 72 Participants |
| AEGIS | Number of Participants Experiencing Treatment-Emergent Adverse Events | No grade 2+ AEs reported | 64 Participants |