Pre-exposure Prophylaxis
Conditions
Keywords
PrEP, MSM, HIV, telemedicine, randomized controlled trial
Brief summary
The premise for the study is that a tailored approach for rural young men who have sex with men (YMSM), addressing known barriers of transportation, access to providers, and privacy, is most likely to yield high levels of Pre-exposure Prophylaxis (PrEP) initiation and persistence in care.
Detailed description
The premise for the study is that a tailored approach for YMSM from rural and small town areas, addressing known barriers of transportation, access to providers, and privacy, is most likely to yield high levels of PrEP initiation and persistence in care. The study sites are Alabama, Georgia, North Carolina, and Mississippi. Using a smartphone application (app), participants assigned to the intervention will receive and maintain a PrEP prescription without needing to leave their home (excepting pharmacy pick-up in some cases) - achieved through app-based surveys/screenings, telemedicine consultations, and home specimen self-collection.
Interventions
OTHERePrEP
Participants will have a baseline teleconsultation with a site study clinician who will be responsible for prescribing PrEP as indicated. They will be offered a 1-month check-in and telemedicine consultations at 3, 6, 9 and 12 months. Participants will complete home specimen collection for laboratory tests for each consultation. The virtual study visit consists of surveys, specimen collection, and a telemedicine consultation.
Sponsors
National Institutes of Health (NIH)
University of North Carolina, Chapel Hill
University of Mississippi Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
* Assigned male at birth * Age 18-29 (inclusive) * Live in a study state (Georgia, Mississippi, North Carolina, Alabama) * Able to provide informed consent and complete survey instruments in English * Willing to provide complete contact information (including 2 alternate contacts) * Able and willing to provide identification verification for viewing confirmation only * Laboratory confirmed HIV negative * Owns a smartphone capable of running the study app * Male sex partners in past 6 months or clinician discretion of epidemiologic context of HIV risk * Behavioral/epidemiological indication for PrEP : * History of inconsistent or no condom use with more than one partner * History of inconsistent or no condom use with one partner who is not mutually monogamous * HIV-positive sexual partner * Any sexually transmitted infection (STI) diagnosed in past 6 months * Commercial sex work * African American MSM reporting anal sex in the past 6 months * Clinician discretion based on epidemiologic context of HIV risk * Willing to take FDA-approved daily oral PrEP * Willing to use study-provided PrEP navigation services * Willing to self-collect specimens
Exclusion criteria
* HIV positive (self-report or laboratory confirmed) * Chronic Hepatitis B or no verification of hepatitis B vaccination * Currently enrolled in any HIV prevention trial (biomedical) * Currently taking oral PrEP based on self-report * Creatinine clearance \<60 ml/min based on the Cockcroft-Gault equation * Symptoms of acute HIV infection within the prior 30 days * Contraindications to oral PrEP * Personal diagnosis or family history of hemophilia * Health insurance with Kaiser Permanente (unable to prescribe PrEP through the study) * Investigator discretion to exclude anyone whose best interest is not to participate * Evidence of fraudulent participation, such as duplicate Internet Protocol (IP) address, multiple screening attempts, duplicate emails, etc
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 6 Months Follow-up | 6-month follow up | Measurements TFV-DP levels will be conducted for participants in both arms using liquid chromatography/tandem mass spectrometry methods on self-collected DBS samples. TFV-DP level can be translated to an interpretation that indicates the mean number of days per week PrEP is ingested over approximately 1 month preceding specimen collection. The cutpoint used for the primary outcome measure will be medication levels indicating \>4 doses/wk. For participants taking emtricitabine/tenofovir disoproxil fumarate, this will be TFV-DP levels: \>1000 femtomole per blood spot (fmol/punch). For participants taking emtricitabine/tenofovir alafenamide this will be TFV-DP levels: \>140 femtomole per blood spot (fmol/punch). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 12 Months Follow-up | 12-month follow up | Measurement of TFV-DP levels will be conducted for participants in both arms using liquid chromatography/tandem mass spectrometry methods on self-collected DBS samples. TFV-DP level can be translated to an interpretation that indicates the mean number of days per week PrEP is ingested over approximately 1 month preceding specimen collection. The cutpoint used for the primary outcome measure will be medication levels indicating \>4 doses/wk. For participants taking emtricitabine/tenofovir disoproxil fumarate, this will be TFV-DP levels: \>1000 femtomole per blood spot (fmol/punch). For participants taking emtricitabine/tenofovir alafenamide this will be TFV-DP levels: \>140 femtomole per blood spot (fmol/punch). |
Countries
United States
Participant flow
Recruitment details
Participants recruited online in Georgia, North Carolina, Alabama, and Mississippi. Participating universities: Rollins School of Public Health in Atlanta, Georgia; University of North Carolina in Chapel Hill, North Carolina; University of Alabama in Birmingham, Alabama; and University of Mississippi Medical Center in Jackson, Mississippi. Enrollment began on May 28, 2019, and follow-up was complete by May 31, 2022. Study completion is defined as enrolled persons completing their 6-month survey.
Participants by arm
| Arm | Count |
|---|---|
| ePrEP Participants will receive the ePrEP home care system for telemedicine PrEP, permitting initiation and persistence in PrEP care. The ePrEP home care system consists of: a smartphone application (app) for video-based telemedicine PrEP consultations with a clinician; secure messaging; a system to track shipments to & from participants; and behavioral risk surveys that are complemented by home specimen kits. Self-collected specimens will be mailed to laboratories for routine, guideline-based testing for PrEP care. Home specimen collection will be used to determine the primary study outcome of tenofovir-diphosphate levels.
ePrEP: Participants will have a baseline teleconsultation with a site study clinician who will be responsible for prescribing PrEP as indicated. They will be offered a 1-month check-in and telemedicine consultations at 3, 6, 9 and 12 months. Participants will complete home specimen collection for laboratory tests for each consultation. The virtual study visit consists of surveys, specimen collection, and a telemedicine consultation. | 108 |
| Standard of Care Participants will be referred to a publicly available website that geolocates the nearest PrEP provider. They will receive standard of care, defined as what a member of the general public would be able to access for PrEP services. Home specimen self-collection will be used to determine the primary study outcome of tenofovir-diphosphate levels. Additional research assessments will include quarterly surveys. | 109 |
| Total | 217 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Bad Experience | 0 | 1 |
| Overall Study | Did not enjoy being in the control group | 0 | 1 |
| Overall Study | Did not want to continue taking medications | 0 | 1 |
| Overall Study | Family Conflict | 0 | 1 |
| Overall Study | Found another PrEP provider | 1 | 0 |
| Overall Study | Lost to Follow-up | 16 | 20 |
| Overall Study | Moved out of the city | 1 | 0 |
| Overall Study | No reason provided | 2 | 1 |
| Overall Study | Seroconversion | 5 | 0 |
| Overall Study | Time Commitment | 2 | 0 |
| Overall Study | Time Conflict | 1 | 0 |
Baseline characteristics
| Characteristic | ePrEP | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 23.29 years STANDARD_DEVIATION 3.11 | 23.49 years STANDARD_DEVIATION 3.24 | 23.39 years STANDARD_DEVIATION 3.17 |
| Age, Customized 18 to 21 YO | 36 Participants | 34 Participants | 70 Participants |
| Age, Customized 22 to 25 YO | 42 Participants | 43 Participants | 85 Participants |
| Age, Customized 26 to 29 YO | 30 Participants | 32 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 12 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants | 97 Participants | 197 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 46 Participants | 49 Participants | 95 Participants |
| Race/Ethnicity, Customized More than one race | 10 Participants | 7 Participants | 17 Participants |
| Race/Ethnicity, Customized Native American/Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 50 Participants | 49 Participants | 99 Participants |
| Region of Enrollment United States | 108 Participants | 109 Participants | 217 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 108 Participants | 109 Participants | 217 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 0 / 109 |
| other Total, other adverse events | 1 / 108 | 0 / 109 |
| serious Total, serious adverse events | 0 / 108 | 0 / 109 |
Outcome results
Primary
Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 6 Months Follow-up
Measurements TFV-DP levels will be conducted for participants in both arms using liquid chromatography/tandem mass spectrometry methods on self-collected DBS samples. TFV-DP level can be translated to an interpretation that indicates the mean number of days per week PrEP is ingested over approximately 1 month preceding specimen collection. The cutpoint used for the primary outcome measure will be medication levels indicating \>4 doses/wk. For participants taking emtricitabine/tenofovir disoproxil fumarate, this will be TFV-DP levels: \>1000 femtomole per blood spot (fmol/punch). For participants taking emtricitabine/tenofovir alafenamide this will be TFV-DP levels: \>140 femtomole per blood spot (fmol/punch).
Time frame: 6-month follow up
Population: Participants with biomarker data indicating adherent daily PrEP dosing. For participants either reporting the use of both medications in the period or not reporting which medication they used during this period, investigators used decision rules to determine adherence. For instance, if a participant had a TFV-DP level above both cutpoints, they were classified as adherent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ePrEP | Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 6 Months Follow-up | 17 Participants |
| Standard of Care | Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 6 Months Follow-up | 7 Participants |
Secondary
Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 12 Months Follow-up
Measurement of TFV-DP levels will be conducted for participants in both arms using liquid chromatography/tandem mass spectrometry methods on self-collected DBS samples. TFV-DP level can be translated to an interpretation that indicates the mean number of days per week PrEP is ingested over approximately 1 month preceding specimen collection. The cutpoint used for the primary outcome measure will be medication levels indicating \>4 doses/wk. For participants taking emtricitabine/tenofovir disoproxil fumarate, this will be TFV-DP levels: \>1000 femtomole per blood spot (fmol/punch). For participants taking emtricitabine/tenofovir alafenamide this will be TFV-DP levels: \>140 femtomole per blood spot (fmol/punch).
Time frame: 12-month follow up
Population: Participants with biomarker data indicating adherent daily PrEP dosing. For participants either reporting the use of both medications in the period or not reporting which medication they used during this time, investigators used decision rules to determine adherence. For instance, if a participant had a TFV-DP level above both cutpoints, they would be classified as adherent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ePrEP | Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 12 Months Follow-up | 15 Participants |
| Standard of Care | Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 12 Months Follow-up | 20 Participants |