ANCHORS Alcohol & Sexual Health Study: UH3 Project

Substance Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04331704
• Other study ID #: IRB201902818-N
• Secondary ID: UH3AA026214OCR31
• Status: Recruiting
• Phase: Phase 4
• Start date: January 12, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: University of Florida
• Contact: Robert L. Cook, PhD
• Phone: (352) 273-5869
• Email: cookrl[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use, Unspecified
• Sex Behavior
• Substance Use
• Substance-Related Disorders

Intervention

Drug:
• 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.

Behavioral:
• Initial Web Survey
Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors
• Interactive Voice Response (IVR) monitoring
Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking
• 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.
• 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
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quantity of drinks per week	Change in self-reported number of alcoholic drinks per week	Baseline up to 1 and 6-month follow-up
Primary	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	Baseline up to 1 and 6-month follow-up
Primary	PrEP levels in blood at end of intervention period	Determine whether or not participants have therapeutic levels of PrEP in their blood samples	1-month follow-up
Primary	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	6-month follow-up
Primary	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	during the 1-month intervention period
Primary	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	the 6-month follow-up period
Secondary	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	Baseline up to 1 and 6-month follow-up
Secondary	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	Baseline up to 1 and 6-month follow-up
Secondary	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	Baseline up to 1 and 6-month follow-up
Secondary	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	Baseline up to 1 and 6-month follow-up