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| ID | Type | Description | Link |
|---|---|---|---|
| UH3AA026214 | U.S. NIH Grant/Contract | View source | |
| OCR31862 | Other Identifier | OnCore University of Florida | |
| F31AA028751 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized Information | Experimental | 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 | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP acronym (pre-exposure prophylaxis) | Drug | A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
male sex assigned at birth
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert L. Cook, PhD | Contact | (352) 273-5869 | cookrl@ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert L. Cook, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32611 | United States |
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| Initial Web Survey | Behavioral | Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors |
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| Interactive Voice Response (IVR) monitoring | Behavioral | Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking |
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| Educational material on alcohol and sexual health behavior | Behavioral | Educational material to provide information, resources and techniques to enhance awareness regarding alcohol and other substance use, along with sexual health behavior. |
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| Interactive Voice Response (IVR) assessment with personalized information | Behavioral | 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 |
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| Personalized information based on web-based survey responses & standardized information | Behavioral | Personalized and information on alcohol use and sexual health behavior based on responses to the web-based survey along with standardized information. |
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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 |
| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D019966 | Substance-Related Disorders |
| D012725 | Sexual Behavior |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065129 | Pre-Exposure Prophylaxis |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000431 | Ethanol |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D000438 | Alcohols |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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