Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM in Alabama

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03680729
Recruitment Status : Not yet recruiting
First Posted : September 21, 2018
Last Update Posted : March 15, 2019
Sponsor:
Collaborators:
Florida State University
University of California, San Francisco
Information provided by (Responsible Party):
Henna Budhwani, University of Alabama at Birmingham

Brief Summary:
The overall goal of this 5-year Mentored Research Scientist Development K01-Award is to support Henna Budhwani, PhD, MPH to become an independent implementation science investigator in the field of HIV prevention. The proposed project seeks to address the HIV crisis in Alabama, where rates of undiagnosed HIV in black young men who have sex with men (YMSM, 18-29 years) exceed 20%. This project will adapt and test a behavioral intervention to promote HIV rapid testing in the community, deliver culturally appropriate prevention education, offer sociostructural support, and refer eligible participants for pre-exposure prophylaxis (PrEP). Four training objectives are proposed that are in lockstep with three specific aims.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Adapted Brothers Saving Brothers (aBSB) Behavioral: Standard Street Outreach Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: aBSB is the adaptation of BSB. BSB a two part intervention to improve rates of community-based HIV testing and prevention education in black young MSM (YMSM). BSB was developed on Information Motivation Behavioral Skills (IMB) theory. The first part of BSB uses Motivational Interviewing in a culturally appropriate way to encourage participants to accept testing and return for test results. The second part is conducted after the participant has received his result, assuming it was not reactive and offers prevention education.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adapting and Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM in Alabama
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: aBSB
aBSB is the adaptation of BSB. BSB a two part intervention to improve rates of community-based HIV testing and prevention education in black young MSM (YMSM). BSB was developed on Information Motivation Behavioral Skills (IMB) theory. The first part of BSB uses Motivational Interviewing in a culturally appropriate way to encourage participants to accept testing and return for test results. The second part is conducted after the participant has received his result, assuming it was not reactive and offers prevention education.
Behavioral: Adapted Brothers Saving Brothers (aBSB)
This information is listed in the arm description.

Active Comparator: Street Outreach
Standard street outreach was used as the control in the original BSB trial.
Behavioral: Standard Street Outreach
This information is listed in the arm description.




Primary Outcome Measures :
  1. Acceptability as assessed by participant self-rated satisfaction with the intervention [ Time Frame: 36 months ]
    Participants rate their satisfaction with the intervention on a 5-point Likert-type scale where 1 = not at all satisfied and 5 = very satisfied.

  2. Did the study participant accept a community-based rapid HIV test after the delivery of the aBSB or standard outreach intervention? [ Time Frame: 18 months ]
    This information will be assessed by the interventionist. If the participant accepts a community-based rapid HIV test, the response is yes. Otherwise it is no.


Secondary Outcome Measures :
  1. Did the study participant secure a prescription for PrEP? [ Time Frame: 6 months ]
    This information will be assessed through clinical records. If the clinic reports that a script was issued, the measure will be marked as yes. If the clinic reports that a script was not issued, this measure will be marked as no.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   For part of the study, tentatively, only males will be eligible.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Staff:

  • Minimally 18 years and 0 months of age
  • Interacts with youth routinely
  • Conducts or supervises community outreach and community-based HIV testing
  • English speaking
  • Can read English text
  • Able and willing to provide informed consent

Inclusion Criteria for youth participants:

  • Youth aged 18 years, 0 months to 29 years, 11 months
  • Identifies as Black (or African American)
  • Identifies as biologically male
  • Is sexually active with male partners (MSM)
  • Hasn't taken an HIV test in 6-months
  • Is not currently on PrEP
  • English speaking
  • Able and willing to provide informed consent

Exclusion Criteria:

• Does not meet inclusion criteria


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680729


Contacts
Layout table for location contacts
Contact: Henna Budhwani, PhD 2059757613 budhwani@uab.edu

Sponsors and Collaborators
University of Alabama at Birmingham
Florida State University
University of California, San Francisco

Layout table for additonal information
Responsible Party: Henna Budhwani, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03680729     History of Changes
Other Study ID Numbers: 520558
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data gathered during the proposed study will be available to all participating mentors, advisors, and institutions. This includes the University of Alabama at Birmingham (UAB), University of California, San Francisco (UCSF), Florida State University College of Medicine, Wayne State University, Birmingham AIDS Outreach, and Selma AIR. All participating mentors and advisors will be included as authors in the dissemination of study findings through peer-review journals, conferences, and other presentations. Since the study will not develop model organisms or genome data, no sharing plan has been included for these contingencies.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Henna Budhwani, University of Alabama at Birmingham:
Prevention
HIV/AIDS
MSM
Alabama