Clinical trial

Advancing New Computer-based Health Outreach Regarding Sexual Behavior (ANCHORS) Study: UH3 Project

Name

IRB201902818-N

Description

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.

Trial arms

Trial start

2021-01-12

Estimated PCD

2024-08-31

Trial end

2024-08-31

Status

Recruiting

Phase

Early phase I

Treatment

PrEP acronym (pre-exposure prophylaxis)

A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days.

Arms:

Educational Information, Personalized Information

Other names:

emtricitabine/tenofovir disoproxil fumarate

Initial Web Survey

Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors

Arms:

Educational Information, Personalized Information

Interactive Voice Response (IVR) monitoring

Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking

Arms:

Educational Information

Educational 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.

Arms:

Educational Information

Interactive 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

Arms:

Personalized Information

Personalized 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.

Arms:

Personalized Information

Size

Primary endpoint

Change in quantity of drinks per week

Baseline up to 1 and 6-month follow-up

Change in peak drinking quantity

Baseline up to 1 and 6-month follow-up

PrEP levels in blood at end of intervention period

1-month follow-up

PrEP levels in blood at the end of the follow-up period

6-month follow-up

PrEP prescription fill with supporting documentation in the intervention period

during the 1-month intervention period

PrEP prescription fills with supporting documentation during the follow-up period

the 6-month follow-up period

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 88, 'type': 'ESTIMATED'}}

Updated at

2023-11-30

1 organization

1 product

4 indications

Organization

University of Florida

Product

Indication

Indication

Indication

Indication