Adherence, Medication
Conditions
Keywords
Life-Steps, HIV Prevention
Brief summary
The purpose of this study is to test how different types of interventions may affect how someone takes their pre-exposure prophylaxis (PrEP) medication.
Interventions
BEHAVIORALLifesteps for PrEP
Four weekly nurse delivered counseling sessions plus two optional booster sessions. Sessions last approximately 40-50 minutes each. Sessions employ cognitive behavioral (CBT) techniques, motivational interviewing (MI), and psychoeducation.
BEHAVIORALDaily text message reminders
Participants get daily text messages on their cell phone reminding them to take their PrEP medication.
Sponsors
University of Miami
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age: 18 years or older 2. Male sex at birth or trans man (current gender identity is male) assigned female sex at birth 3. Self-reports as a person who has sex with men 4. PrEP naïve or is currently prescribed PrEP and reports uncertainty about future adherence 5. Medical providers at each site will determine that the participant is indicated for PrEP per Centers for Disease Control (CDC) guidelines 6. Screens in for currently having one or more of the following psychosocial syndemic problems: depression; heavy alcohol use; problematic substance use or polydrug use; history of trauma or abuse; and/or current interpersonal violence 7. Owns a cell phone that has texting and internet / data capacity
Exclusion criteria
1. Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview 2. Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of enrollment (these patients will be referred immediately for treatment, but may join the study when this is resolved) 3. Laboratory or clinical findings that would preclude PrEP initiation (e.g. decreased creatinine clearance)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With TFV-DP Concentrations Consistent With Adherence (≥4 Doses/Week) | 3, 6, 9, 12, 15, and 18 months | Medication adherence as reported by Tenofovir diphosphate (TFV-DP) concentrations measured using dried blood spot (DBS) testing. Measured by the concentration of PrEP medication in dried blood spots (DBS), displaying levels consistent with adherence (4+ pills per week). Outcomes reported categorically as "adherent" vs. "not adherent." Count of participants measures participants with TFV-DP concentrations consistent with adherence (4+ pill per week). |
| Wilson Medication Adherence Self-Report | 3, 6, 9, 12, 15, and 18 months | Medication adherence as reported by the Wilson Medication Adherence self-report. The questionnaire has a score ranging from 0-1, with a higher score indicating greater adherence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention in PrEP Care | 3, 6, 9, 12, 15, and 18 months | The number of participants in attendance at each follow up visit over 18 month study participation |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSteven A Safren, Ph.D.
University of Miami
Participant flow
Recruitment details
Active recruitment was carried out by trained study staff across our two study sites (Miami, FL and Boston, MA). Recruitment opened in 2020 and closed in December 2024. Primary methods used were PrEP clinics, online media platforms, and community outreach. Miami recruitment occurred at the Florida DOH and UM clinics. Boston recruitment occurred via secure report through the Fenway Institute. Online media platforms were utilized to recruit participants across the U.S.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 35.64 Years STANDARD_DEVIATION 11.748 |
| Race/Ethnicity, Customized Ethnicity Haitian/Creole or Afro-Caribbean Black | 4 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic/Latino | 125 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic/Latino, or Haitian/Creole or Afro-Caribbean Black | 77 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants |
| Race (NIH/OMB) More than one race | 27 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 227 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 297 Participants |
| Sex/Gender, Customized Gender Identity Genderqueer/gender non-conforming/non-binary | 9 Participants |
| Sex/Gender, Customized Gender Identity Male | 139 Participants |
| Sex/Gender, Customized Gender Identity Trans man | 2 Participants |
| Sex/Gender, Customized Gender Identity Trans woman | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 151 | 0 / 149 |
| other Total, other adverse events | 1 / 151 | 1 / 149 |
| serious Total, serious adverse events | 1 / 151 | 5 / 149 |
Outcome results
None listed