ANCHORS Alcohol & Sexual Health Study: UH3 Project
Advancing New Computer-based Health Outreach Regarding Sexual Behavior (ANCHORS) Study: UH3 Project
University of Florida
88 participants
Jan 12, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria8
- 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
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Interventions
A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days.
Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors
Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking
Educational material to provide information, resources and techniques to enhance awareness regarding alcohol and other substance use, along with sexual health behavior.
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
Personalized and information on alcohol use and sexual health behavior based on responses to the web-based survey along with standardized information.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04331704