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ANCHORS Alcohol & Sexual Health Study: UH3 Project

Primary Purpose

Alcohol Use, Unspecified, Substance Use, Sex Behavior

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
PrEP acronym (pre-exposure prophylaxis)
Initial Web Survey
Interactive Voice Response (IVR) monitoring
Educational material on alcohol and sexual health behavior
Interactive Voice Response (IVR) assessment with personalized information
Personalized information based on web-based survey responses & standardized information
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Use, Unspecified

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Ability to read and write English
  • Frequent alcohol consumption
  • Recent sexual intercourse with another man
  • HIV seronegative at medical screening
  • Report taking PrEP a maximum of four times per week in the last month

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

Sites / Locations

  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personalized Information

Educational Information

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in quantity of drinks per week
Change in self-reported number of alcoholic drinks per week
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
PrEP levels in blood at end of intervention period
Determine whether or not participants have therapeutic levels of PrEP in their blood samples
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
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
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

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
March 27, 2020
Last Updated
April 17, 2023
Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04331704
Brief Title
ANCHORS Alcohol & Sexual Health Study: UH3 Project
Official Title
Advancing New Computer-based Health Outreach Regarding Sexual Behavior (ANCHORS) Study: UH3 Project
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, Unspecified, Substance Use, Sex Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized Information
Arm Type
Experimental
Arm 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.
Arm Title
Educational Information
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
PrEP acronym (pre-exposure prophylaxis)
Other Intervention Name(s)
emtricitabine/tenofovir disoproxil fumarate
Intervention Description
A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days.
Intervention Type
Behavioral
Intervention Name(s)
Initial Web Survey
Intervention Description
Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors
Intervention Type
Behavioral
Intervention Name(s)
Interactive Voice Response (IVR) monitoring
Intervention Description
Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking
Intervention Type
Behavioral
Intervention Name(s)
Educational material on alcohol and sexual health behavior
Intervention Description
Educational material to provide information, resources and techniques to enhance awareness regarding alcohol and other substance use, along with sexual health behavior.
Intervention Type
Behavioral
Intervention Name(s)
Interactive Voice Response (IVR) assessment with personalized information
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Personalized information based on web-based survey responses & standardized information
Intervention Description
Personalized and information on alcohol use and sexual health behavior based on responses to the web-based survey along with standardized information.
Primary Outcome Measure Information:
Title
Change in quantity of drinks per week
Description
Change in self-reported number of alcoholic drinks per week
Time Frame
Baseline up to 1 and 6-month follow-up
Title
Change in peak drinking quantity
Description
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
Title
PrEP levels in blood at end of intervention period
Description
Determine whether or not participants have therapeutic levels of PrEP in their blood samples
Time Frame
1-month follow-up
Title
PrEP levels in blood at the end of the follow-up period
Description
Determine whether or not participants have therapeutic levels of PrEP in their blood samples
Time Frame
6-month follow-up
Title
PrEP prescription fill with supporting documentation in the intervention period
Description
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
Title
PrEP prescription fills with supporting documentation during the follow-up period
Description
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 Outcome Measure Information:
Title
Reduced alcohol use as a reason for adherence to PrEP
Description
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
Title
Change in perceived risk of HIV as a reason for adherence to PrEP
Description
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
Title
Change in sexual risk behavior as a reason for adherence to PrEP
Description
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
Title
Increased motivation for behavior change as a reason for adherence to PrEP
Description
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

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
male sex assigned at birth
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert L. Cook, PhD
Phone
(352) 273-5869
Email
cookrl@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. Cook, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert L. Cook, PhD
Phone
352-273-5869
Email
cookrl@ufl.edu
First Name & Middle Initial & Last Name & Degree
Robert L. Cook, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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ANCHORS Alcohol & Sexual Health Study: UH3 Project

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