Alcohol and sexual health education for young men
Advancing New Computer-based Health Outreach Regarding Sexual Behavior (ANCHORS) Study: UH3 Project
This study is testing whether different types of education on alcohol and sexual health can help young men stay safe from alcohol-related problems and STIs while they use a preventive HIV medication.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 30 Years |
| Sex | Male |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT04331704 on ClinicalTrials.gov |
What this trial studies
This study involves 80 young adult men who will complete an initial survey and receive one of two types of education on alcohol and sexual health to help prevent alcohol-related issues, HIV, and other STIs. Participants will take pre-exposure prophylaxis (PrEP) for HIV prevention and engage in a daily 5-minute telephone-based interactive voice response (IVR) assessment of their alcohol and substance use, sexual behavior, and PrEP adherence for 30 days. Follow-up assessments will occur at 30 days and again at 6 months to evaluate the effectiveness of the interventions.
Who should consider this trial
Good fit: Ideal candidates are young adult men who consume alcohol heavily and engage in unprotected sexual intercourse.
Not a fit: Patients with a history of severe alcohol withdrawal or those with serious psychiatric symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of alcohol-related problems and HIV transmission among young men.
How similar studies have performed: Other studies have shown success with similar educational interventions aimed at reducing alcohol-related risks and improving PrEP adherence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Robert L. Cook, PhD — University of Florida
- Study coordinator: Robert L. Cook, PhD
- Email: cookrl@ufl.edu
- Phone: (352) 273-5869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.