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ANCHORS Alcohol & Sexual Health Study: UH3 Project

ConditionsAlcohol Use, UnspecifiedSubstance UseSex Behavior
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-30
SponsorUniversity of Florida

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • PrEP acronym (pre-exposure prophylaxis)

    Drug

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

  • Initial Web Survey

    Behavioral

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

  • Interactive Voice Response (IVR) monitoring

    Behavioral

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

  • Educational material on alcohol and sexual health behavior

    Behavioral

    Educational material to provide information, resources and techniques to enhance awareness regarding alcohol and other substance use, along with sexual health behavior.

  • Interactive Voice Response (IVR) assessment with personalized information

    Behavioral

    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 information

    Behavioral

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

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Personalized InformationExperimental treatment 4 interventions
Group B: Educational InformationActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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