ANCHORS Alcohol & Sexual Health Study: UH3 Project

University of Florida

Status and phase: Enrolling; Phase 4

Conditions: Substance Use; Alcohol Use, Unspecified; Sex Behavior

Treatments: Behavioral: Interactive Voice Response (IVR) assessment with personalized information; Behavioral: Personalized information based on web-based survey responses & standardized information; Behavioral: Initial Web Survey; Behavioral: Interactive Voice Response (IVR) monitoring; Drug: PrEP acronym (pre-exposure prophylaxis); Behavioral: Educational material on alcohol and sexual health behavior

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04331704

UH3AA026214 (U.S. NIH Grant/Contract)

OCR31862 (Other Identifier)

F31AA028751 (U.S. NIH Grant/Contract)

IRB201902818-N

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

88 participants in 2 patient groups

Personalized Information

Experimental group

Description:

Participants randomized to this condition will complete a web-based questionnaire and then receive personalized information regarding their alcohol use and sexual health behavior. They will complete daily, phone-based IVR monitoring for assessment purposes and receive further personalized information based on their responses.

Treatment:

Drug: PrEP acronym (pre-exposure prophylaxis)

Behavioral: Initial Web Survey

Behavioral: Personalized information based on web-based survey responses & standardized information

Behavioral: Interactive Voice Response (IVR) assessment with personalized information

Educational Information

Active Comparator group

Description:

Participants randomized to this condition will complete a web-based questionnaire and then receive educational material regarding their alcohol use and sexual health behavior. They will complete daily phone-based IVR monitoring for assessment purposes.

Treatment:

Behavioral: Educational material on alcohol and sexual health behavior

Drug: PrEP acronym (pre-exposure prophylaxis)

Behavioral: Interactive Voice Response (IVR) monitoring

Behavioral: Initial Web Survey