Alcohol Use, Unspecified, Sex Behavior, Substance Use
Conditions
Brief summary
80 young adult men will complete an initial survey and receive 1 of 2 types of alcohol and sexual health education and information to encourage prevention of alcohol-related problems, HIV and other sexually transmitted infections (STIs). Participants will then take pre-exposure prophylaxis (PrEP) for HIV prevention and complete a daily 5-minute, telephone-based interactive voice response (IVR) assessment of alcohol/substance use, sexual behavior and PrEP taking for 30 days. Medication will all be active PrEP. There is no placebo control in this study. Follow-up will occur after 30-days and 6-months later.
Interventions
A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days.
BEHAVIORALInitial Web Survey
Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors
BEHAVIORALInteractive Voice Response (IVR) monitoring
Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking
BEHAVIORALEducational material on alcohol and sexual health behavior
Educational material to provide information, resources and techniques to enhance awareness regarding alcohol and other substance use, along with sexual health behavior.
BEHAVIORALInteractive Voice Response (IVR) assessment with personalized information
Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking with personalized and information based on daily IVR responses
BEHAVIORALPersonalized information based on web-based survey responses & standardized information
Personalized and information on alcohol use and sexual health behavior based on responses to the web-based survey along with standardized information.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Ability to read and write English * Consumption of 5 or more drinks per drinks in a day at least once in the past 30-days * Sexual intercourse with another man without condom use at least once in the past 30 days * HIV seronegative at medical screening * Report currently taking PrEP willingness to take PrEP
Exclusion criteria
* History of clinically significant withdrawal from alcohol, defined as any one of the following: a) a lifetime history of seizures, delirium, or hallucinations during alcohol withdrawal; b) a Clinical Institute Withdrawal Assessment scale score \> 8; c) a report of drinking to avoid withdrawal symptoms in the past 12 months; or d) a lifetime history of medical treatment for withdrawal. * Self report injection drug use * DSM-5 criteria for moderate or severe current substance use disorder besides alcohol and nicotine. * Serious psychiatric symptoms * Use of medications that interfere with PrEP including diuretics, nephrotoxic drugs, non-steroidal anti-inflammatory drugs, antiretroviral drugs or other drugs that may interfere with tenofovir excretion * Active hepatitis B infection * The following medical exclusions: serious or life-threatening conditions; inadequate biochemical, hepatic, hematologic, or pancreatic function according to laboratory testing * Participant reports currently taking injectable PrEP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP prescription fills with supporting documentation during the follow-up period | the 6-month follow-up period | Observation of prescription fills for PrEP with documentation during the follow-up period based on pharmacy documentation |
| Change in peak drinking quantity | Baseline up to 1 and 6-month follow-up | Change in self-reported number of alcoholic drinks consumed on one's peak drinking day in the past 30 days |
| PrEP levels in blood at end of intervention period | 1-month follow-up | Determine whether or not participants have therapeutic levels of PrEP in their blood samples |
| PrEP levels in blood at the end of the follow-up period | 6-month follow-up | Determine whether or not participants have therapeutic levels of PrEP in their blood samples |
| PrEP prescription fill with supporting documentation in the intervention period | during the 1-month intervention period | Observation of whether or not a participant opts to fill a prescription for PrEP in the intervention period based on pharmacy documentation |
| Change in quantity of drinks per week | Baseline up to 1 and 6-month follow-up | Change in self-reported number of alcoholic drinks per week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in perceived risk of HIV as a reason for adherence to PrEP | Baseline up to 1 and 6-month follow-up | Test increase in Perceived Risk of HIV Scale score following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP |
| Change in sexual risk behavior as a reason for adherence to PrEP | Baseline up to 1 and 6-month follow-up | Test reduction in Risk Assessment Battery score following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP |
| Increased motivation for behavior change as a reason for adherence to PrEP | Baseline up to 1 and 6-month follow-up | Test increased score on the Contemplation Ladder for motivation to avoid risky sexual health behavior, to take PrEP and to reduce drinking following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP |
| Reduced alcohol use as a reason for adherence to PrEP | Baseline up to 1 and 6-month follow-up | Test reductions in alcohol use following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP |
Countries
United States
Contacts
Primary ContactRobert L. Cook, PhD
Outcome results
None listed