Substance Use Clinical Trial
Official title:
Advancing New Computer-based Health Outreach Regarding Sexual Behavior (ANCHORS) Study: UH3 Project
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
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 |
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