ANCHORS Alcohol & Sexual Health Study: UH3 Project

Phase 4RecruitingNCT04331704

University of Florida88 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Alcohol Use, Unspecified Substance Use Sex Behavior

Interventions

Interactive Voice Response (IVR) assessment with personalized informationBEHAVIORAL

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 information based on web-based survey responses & standardized informationBEHAVIORAL

Personalized and information on alcohol use and sexual health behavior based on responses to the web-based survey along with standardized information.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in quantity of drinks per week

Change in self-reported number of alcoholic drinks per week

Time frame: Baseline up to 1 and 6-month follow-up

Change in peak drinking quantity

Change in self-reported number of alcoholic drinks consumed on one's peak drinking day in the past 30 days

Time frame: Baseline up to 1 and 6-month follow-up

PrEP levels in blood at end of intervention period

Determine whether or not participants have therapeutic levels of PrEP in their blood samples

Time frame: 1-month follow-up

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

Determine whether or not participants have therapeutic levels of PrEP in their blood samples

Time frame: 6-month follow-up

PrEP prescription fill with supporting documentation in the intervention period

Observation of whether or not a participant opts to fill a prescription for PrEP in the intervention period based on pharmacy documentation

Time frame: during the 1-month intervention period

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

Observation of prescription fills for PrEP with documentation during the follow-up period based on pharmacy documentation

Time frame: the 6-month follow-up period

Secondary Outcomes

Reduced alcohol use as a reason for adherence to PrEP

Test reductions in alcohol use following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP

Time frame: Baseline up to 1 and 6-month follow-up

Change in perceived risk of HIV as a reason for adherence to PrEP

Test increase in Perceived Risk of HIV Scale score following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP

Time frame: Baseline up to 1 and 6-month follow-up

Change in sexual risk behavior as a reason for adherence to PrEP

Test reduction in Risk Assessment Battery score following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP

Time frame: Baseline up to 1 and 6-month follow-up

Increased motivation for behavior change as a reason for adherence to PrEP

Test increased score on the Contemplation Ladder for motivation to avoid risky sexual health behavior, to take PrEP and to reduce drinking following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP

Time frame: Baseline up to 1 and 6-month follow-up

ANCHORS Alcohol & Sexual Health Study: UH3 Project

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts