Clinical trial NCT04331704: ANCHORS Alcohol & Sexual Health Study: UH3 Project
Official title: Advancing New Computer-based Health Outreach Regarding Sexual Behavior (ANCHORS) Study: UH3 Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Alcohol Use, Unspecified
Substance Use
Sex Behavior
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-04-02
Enrollment: 88
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Change in quantity of drinks per week
timeFrame: Baseline up to 1 and 6-month follow-up
measure: Change in peak drinking quantity
timeFrame: Baseline up to 1 and 6-month follow-up
measure: PrEP levels in blood at end of intervention period
timeFrame: 1-month follow-up
measure: PrEP levels in blood at the end of the follow-up period
timeFrame: 6-month follow-up
measure: PrEP prescription fill with supporting documentation in the intervention period
timeFrame: during the 1-month intervention period
measure: PrEP prescription fills with supporting documentation during the follow-up period
timeFrame: the 6-month follow-up period
Secondary outcomes:
measure: Reduced alcohol use as a reason for adherence to PrEP
timeFrame: Baseline up to 1 and 6-month follow-up
measure: Change in perceived risk of HIV as a reason for adherence to PrEP
timeFrame: Baseline up to 1 and 6-month follow-up
measure: Change in sexual risk behavior as a reason for adherence to PrEP
timeFrame: Baseline up to 1 and 6-month follow-up
measure: Increased motivation for behavior change as a reason for adherence to PrEP
timeFrame: Baseline up to 1 and 6-month follow-up
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Robert L. Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References: