ANCHORS Alcohol & Sexual Health Study: UH3 Project

Phase 4

Recruiting

• Conditions: Alcohol Use, Unspecified; Sex Behavior; Substance Use
• Interventions: Drug: PrEP acronym (pre-exposure prophylaxis); Behavioral: Initial Web Survey; Behavioral: Interactive Voice Response (IVR) assessment with personalized information; Behavioral: Interactive Voice Response (IVR) monitoring; Behavioral: Personalized information based on web-based survey responses & standardized information; Behavioral: Educational material on alcohol and sexual health behavior

• Registration Number: NCT04331704
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-03-27
• Study First Submitted QC: 2020-03-31
• Study First Posted: 2020-04-02
• Study Start: 2021-01-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 88

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized Information	PrEP acronym (pre-exposure prophylaxis)	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.
Personalized Information	Initial Web Survey	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.
Personalized Information	Interactive Voice Response (IVR) assessment with personalized information	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.
Personalized Information	Personalized information based on web-based survey responses & standardized information	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.
Educational Information	PrEP acronym (pre-exposure prophylaxis)	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.
Educational Information	Initial Web Survey	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.
Educational Information	Interactive Voice Response (IVR) monitoring	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.
Educational Information	Educational material on alcohol and sexual health behavior	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.

Primary Outcome Measures

Name	Time	Method
Change in quantity of drinks per week	Baseline up to 1 and 6-month follow-up	Change in self-reported number of alcoholic drinks per week
Change in peak drinking quantity	Baseline up to 1 and 6-month follow-up	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	1-month follow-up	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	6-month follow-up	Determine whether or not participants have therapeutic levels of PrEP in their blood samples
PrEP prescription fill with supporting documentation in the intervention period	during the 1-month 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	the 6-month follow-up period	Observation of prescription fills for PrEP with documentation during the follow-up period based on pharmacy documentation

Secondary Outcome Measures

Name	Time	Method
Reduced alcohol use as a reason for adherence to PrEP	Baseline up to 1 and 6-month follow-up	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	Baseline up to 1 and 6-month follow-up	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	Baseline up to 1 and 6-month follow-up	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	Baseline up to 1 and 6-month follow-up	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

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States