ANCHORS Alcohol & Sexual Health Study: UH3 Project
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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.
Other Names:
Behavioral: Initial Web Survey
Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors
Behavioral: 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
Behavioral: 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.
|
| Active Comparator: Educational Information 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. |
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.
Other Names:
Behavioral: Initial Web Survey
Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors
Behavioral: Interactive Voice Response (IVR) monitoring
Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ability to read and write English
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Frequent alcohol consumption
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Recent sexual intercourse with another man
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HIV seronegative at medical screening
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Report taking PrEP a maximum of four times per week in the last month
Exclusion Criteria:
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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.
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Self report injection drug use
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DSM-5 criteria for moderate or severe current substance use disorder besides alcohol and nicotine.
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Serious psychiatric symptoms
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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
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Active hepatitis B infection
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The following medical exclusions: serious or life-threatening conditions; inadequate biochemical, hepatic, hematologic, or pancreatic function according to laboratory testing
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Florida | Gainesville | Florida | United States | 32611 |
Sponsors and Collaborators
- University of Florida
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: Robert Leeman, PhD, University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB201902818-N
- UH3AA026214
- OCR31862
- F31AA028751