Human Immunodeficiency Virus
Conditions
Keywords
PrEP, HIV, MSM, Men Having Sex With Men, Episodic PrEP, Adherence, Episodic HIV Risk
Brief summary
This study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis (PrEP) for HIV prevention among men who have sex with men (MSM). The overall objective is to determine the feasibility of a clinic-based Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report occasional condomless sex and who anticipate a period of high-risk while away from home (e.g. vacation) during the study period.
Detailed description
This proposed study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis for HIV prevention among men who have sex with men (MSM). Long-term PrEP may be unnecessary for the many HIV-uninfected men who have episodic contextually defined high-risk periods, particularly when away from their home setting. Alternative dosing strategies, such as short-term fixed-interval episodic PrEP (Epi-PrEP), may be a more realistic, feasible, acceptable, and useful option with high public health impact for the majority of MSM. The overall objective is to determine the feasibility of a clinic-based Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report occasional condomless sex and who anticipate a period of high-risk while away from home (e.g. vacation) during the study period.
Interventions
Short-term episodic use for 2-3 weeks.
BEHAVIORALCBT-based counseling
Brief CBT-based counseling to promote adherence
Sponsors
Fenway Community Health
National Institute of Mental Health (NIMH)
James Egan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Self-identify as MSM: (1) born male who (2) has sex with men * Age: 18 or older * Sexual Risk: has had condomless anal sex with 2 or more men or any transactional sex with a man within the past 12-months. * Vacation: identified an upcoming period of episodic risk away (i.e. vacation) from their home city that will last at least 7 but not more than 14 days during which they anticipate having at least one high-risk sexual event. * Able and willing to provide informed consent
Exclusion criteria
* HIV positive * Glomerular filtration rate \< 60 mL/min (calculated using the Cockcroft-Gault formula) * Hepatitis B surface antigen positive * Symptoms suggestive of acute HIV seroconversion at screening or enrollment * Have used PrEP or PEP within the previous 3 months * Currently enrolled in another study involving medications, investigational drug, or medical device * Has other conditions (based on opinion of investigator or designee) that would preclude informed consent, make the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With PrEP Adherence | Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP) | Biological measure of medication in the blood. Adherence will be measured using plasma analyses. We used the cut off of 4 doses/week to determine protective levels of adherence. The determination of this was drug levels equal to TFV 4.2 ng/mL FTC 4.6 ng/mL. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence
emtricitabine/tenofovir: Short-term episodic use for 2-3 weeks.
CBT-based counseling: Brief CBT-based counseling to promote adherence | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 39 years STANDARD_DEVIATION 11.85 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 7 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 | 39 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 0 / 48 |
| serious Total, serious adverse events | 1 / 48 |
Outcome results
Primary
Number of Participants With PrEP Adherence
Biological measure of medication in the blood. Adherence will be measured using plasma analyses. We used the cut off of 4 doses/week to determine protective levels of adherence. The determination of this was drug levels equal to TFV 4.2 ng/mL FTC 4.6 ng/mL.
Time frame: Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With PrEP Adherence | 45 Participants |