Comparing Self-Report Pre-Exposure Prophylaxis Adherence Questions to Pharmacologic Measures of Recent and Cumulative Pre-Exposure Prophylaxis Exposure.
Jill Blumenthal, Elizabeth C Pasipanodya, Sonia Jain...
https://pubmed.ncbi.nlm.nih.gov/31333454Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
All Genders
Healthy Volunteers
ID06005298
Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum Application and Efficacy of SBIRT Intervention
Led by Shirish S Barve · Updated on 2024-07-22
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Shirish S Barve
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a randomized control trial to study the effects of Screening, Brief Intervention, and Referral to Treatment (SBIRT) on reducing alcohol use among people who use pre-exposure prophylaxis (PrEP). The study aims to understand how alcohol affects PrEP adherence, the effectiveness of SBIRT in preventing hazardous drinking, and its impact on gut microbiome changes, intestinal balance, inflammation, and liver disease markers in this population. Participants are assigned to different groups based on their Alcohol Use Disorders Identification Test (AUDIT) scores, with one group receiving the SBIRT behavioral intervention if their score indicates hazardous drinking. The study compares these participants to those with non-hazardous alcohol use and those with hazardous use not receiving the intervention. Visits occur at 3, 6, and 12 months, during which participants may complete surveys, interviews, and provide various biological samples including blood, urine, stool, saliva, and oral and vaginal samples if applicable. Throughout the study, participants will be monitored for changes in alcohol use, gut microbial diversity, PrEP adherence measured by urine tests, and self-reported factors such as confidence in PrEP use, stigma, substance use, mood symptoms, and hopefulness. The study involves repeated assessments at baseline, 3, 6, and 12 months, including several standardized tools and biological markers. The total duration of participation is about one year with visits lasting 60 to 90 minutes each.
CONDITIONS
Brief Title
Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention
Who Can Participate
Age: 18Years - 85Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- Confirmed negative status for HIV, Hepatitis B, and Hepatitis C
- Current use of pre-exposure prophylaxis (PrEP)
- Able to speak English or Spanish
- Cognitively able to provide informed consent
- Attending a participating healthcare facility
You will not qualify if you...
- Unable to provide informed consent
- Diagnosed with major psychiatric illness
- Having unstable medical conditions such as cancer
- Currently taking immunosuppressants or chemotherapy
- Taking daily antibiotics or probiotics
- Severe gastrointestinal or liver disease
- Diagnosed with autoimmune disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Outpatient Treatment
Duration - 12 months
Participants receive the SBIRT intervention or usual care to reduce risky alcohol use and support PrEP adherence. This includes meetings with an interventionist, surveys, interviews, and biological sample collection.
Visits at 3 months, 6 months, and 12 months, each lasting about 60 to 90 minutes
Trial Site Locations
Total: 1 location
1
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
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Research Team
A
Andrea Reyes Vega, MD, MSc
V
Vania Remenik, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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Published Research Related To This Trial
A review of the Alcohol Use Disorders Identification Test (AUDIT), AUDIT-C, and USAUDIT for screening in the United States: Past issues and future directions.
John C Higgins-Biddle, Thomas F Babor
https://pubmed.ncbi.nlm.nih.gov/29723083The AUDIT questionnaire: choosing a cut-off score. Alcohol Use Disorder Identification Test.
K M Conigrave, W D Hall, J B Saunders
https://pubmed.ncbi.nlm.nih.gov/8616463Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II.
J B Saunders, O G Aasland, T F Babor...
https://pubmed.ncbi.nlm.nih.gov/8329970Validating a shortened depression scale (10 item CES-D) among HIV-positive people in British Columbia, Canada.
Wendy Zhang, Nadia O'Brien, Jamie I Forrest...
https://pubmed.ncbi.nlm.nih.gov/22829885Age-Associated Gut Dysbiosis, Marked by Loss of Butyrogenic Potential, Correlates With Altered Plasma Tryptophan Metabolites in Older People Living With HIV.
Smita Ghare, Richa Singhal, Vaughn Bryant...
https://pubmed.ncbi.nlm.nih.gov/35015746Rectal Microbiome Alterations Associated With Oral Human Immunodeficiency Virus Pre-Exposure Prophylaxis.
Jennifer A Fulcher, Fan Li, Ryan R Cook...
https://pubmed.ncbi.nlm.nih.gov/32258202Daily HIV pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate-emtricitabine reduced Streptococcus and increased Erysipelotrichaceae in rectal microbiota.
Michael P Dubé, Sung Yong Park, Heather Ross...
https://pubmed.ncbi.nlm.nih.gov/30315206Evaluation of the Microbiome in Men Taking Pre-exposure Prophylaxis for HIV Prevention.
Bryce K Perler, Elizabeth M Reinhart, Madeline Montgomery...
https://pubmed.ncbi.nlm.nih.gov/33394167