ANCHORS Alcohol & Sexual Health Study: UH3 Project

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Use, Unspecified, Substance Use, Sex Behavior

Intervention / Treatment
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* Drug: PrEP acronym (pre-exposure prophylaxis)
* Behavioral: Initial Web Survey
* Behavioral: Interactive Voice Response (IVR) monitoring
* Behavioral: Educational material on alcohol and sexual health behavior
* Behavioral: Interactive Voice Response (IVR) assessment with personalized information
* Behavioral: Personalized information based on web-based survey responses & standardized information


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized Information<br>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)<br>* A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days.<br>* Other names: emtricitabine/tenofovir disoproxil fumarate;Behavioral: Initial Web Survey<br>* Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors<br>Behavioral: Interactive Voice Response (IVR) assessment with personalized information<br>* 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<br>Behavioral: Personalized information based on web-based survey responses & standardized information<br>* Personalized and information on alcohol use and sexual health behavior based on responses to the web-based survey along with standardized information.<br>|
| Active Comparator: Educational Information<br>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)<br>* A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days.<br>* Other names: emtricitabine/tenofovir disoproxil fumarate;Behavioral: Initial Web Survey<br>* Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors<br>Behavioral: Interactive Voice Response (IVR) monitoring<br>* Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking<br>Behavioral: Educational material on alcohol and sexual health behavior<br>* Educational material to provide information, resources and techniques to enhance awareness regarding alcohol and other substance use, along with sexual health behavior.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |