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

Primary Purpose

HIV/AIDS

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adapted Brothers Saving Brothers (aBSB)
Standard Street Outreach
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring Prevention, HIV/AIDS, MSM, Alabama

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at Birmingham (UAB)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

aBSB

Street Outreach

Arm 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.

Standard street outreach was used as the control in the original BSB trial.

Outcomes

Primary Outcome Measures

Acceptability as assessed by participant self-rated satisfaction with the intervention
Participants rate their satisfaction with the intervention on a 5-point Likert-type scale where 1 = not at all satisfied and 5 = very satisfied.
Did the study participant accept a community-based rapid HIV test after the delivery of the aBSB or standard outreach intervention?
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

Did the study participant secure a prescription for PrEP?
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.

Full Information

First Posted
September 17, 2018
Last Updated
August 21, 2023
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT03680729
Brief Title
Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM in Alabama
Official Title
Adapting and Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM in Alabama
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study was developed in the spirit of the K01 mechanism, thoughtfully linking training to research. The research study proposed in this K01-application includes the conduct of three specific aims that are aligned with four training objectives. Objective 1 outlines an intensive training and mentoring plan on social theory including theories of intersectionality and emerging masculinities. Objective 2 provides in-depth training on qualitative research methods including how to conduct focus groups, in-depth interviews, and qualitative data analysis. Aim 1, which will be conducted after Objective 2, is to elucidate experiences, beliefs, and predictors related to delivery and utilization of HIV testing and prevention services for black YMSM using qualitative research methods, namely in-depth interviews with HIV prevention and outreach staff, focus groups with black YMSM, and in-depth interviews with other members of key population sub-groups such as transgender women and black YMSM who are no longer on PrEP, to inform the adaptation of BSB. Aim 1 will include 6 focus groups with black YMSM to explore perceptions and experiences with testing, prevention services, and PrEP as these relate to the adaptation of the intervention (estimated N=36-48). Aim 1 will include in-depth interviews with transgender women, black YMSM who have not taken an HIV-test in the past 6-months, black YMSM who are on PrEP, and black YMSM who were on PrEP but are no longer on PrEP (estimated N=16-24). This first aim will also include in-depth interviews with HIV prevention and outreach staff to document inner and outer contexts of community-based testing and clinical settings (estimated N=10). Thematic coding and analysis methods will be used to elucidate ways in which the intervention will need to be modernized and revised to be culturally acceptable to the target population and to address locally relevant structural barriers. Objective 3 provides robust training on how to scientifically and iteratively adapt HIV behavioral interventions using validated frameworks, such as intervention mapping. Aim 2 is to adapt the Brothers Saving Brothers (BSB) intervention to include two HIV prevention tools (rapid testing and PrEP), to address structural barriers, and to be acceptable to black YMSM in Alabama. In Aim 2, I will use intervention mapping, informed by Aim 1 data, to iteratively adapt BSB to include the aforementioned updates. Since BSB will require extensive revisions, I have selected an intervention development framework (rather than an adaptation model) to guide the scientific adaptation process. After each cycle, the adapted intervention will be shared with CBO outreach staff and black YMSM to solicit their feedback. I anticipate 2-4 iterations (adaptations). Objective 4 offers methodical training and mentoring in the field of implementation science. Aim 3, which concludes the proposed research study and K01 project, is to conduct a hybrid type 1 effectiveness-implementation pilot study of the adapted intervention in which the investigators will a) assess acceptability and feasibility of the adapted BSB (aBSB); b) preliminarily estimate effects on HIV prevention outcomes; and c) collect data on real-world implementation. I will pilot-test aBSB with black YMSM in Alabama (N=60); half will be randomized to the control condition; half will receive aBSB. I will collect effectiveness data (including acceptability and feasibility) pre-intervention/control, immediately post-intervention/control, 3-months after initial contact, and 6-months after initial contact. Toward the end of the study-period, I will collect implementation data from staff interviewed in Aim 1 (N=10) and from study participants to assess how aBSB was experienced and internalized (N=12). This rigorous project includes intensive training at UAB and from other prominent institutions that offer very specific training not found at UAB; comprehensive mentoring from senior HIV researchers with expertise in minority, youth, and MSM health; and a thoughtful research strategy that addresses a significant threat -- high rates of undiagnosed HIV and the lack of HIV prevention, including PrEP uptake -- in black YMSM in Alabama. The combination of the proposed mentoring and training with study findings will culminate in the candidates attainment of independence and the development of a full-scale R01 implementation science proposal to test the adapted intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
Prevention, HIV/AIDS, MSM, Alabama

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
167 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aBSB
Arm Type
Experimental
Arm 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.
Arm Title
Street Outreach
Arm Type
Active Comparator
Arm Description
Standard street outreach was used as the control in the original BSB trial.
Intervention Type
Behavioral
Intervention Name(s)
Adapted Brothers Saving Brothers (aBSB)
Intervention Description
This information is listed in the arm description.
Intervention Type
Behavioral
Intervention Name(s)
Standard Street Outreach
Intervention Description
This information is listed in the arm description.
Primary Outcome Measure Information:
Title
Acceptability as assessed by participant self-rated satisfaction with the intervention
Description
Participants rate their satisfaction with the intervention on a 5-point Likert-type scale where 1 = not at all satisfied and 5 = very satisfied.
Time Frame
36 months
Title
Did the study participant accept a community-based rapid HIV test after the delivery of the aBSB or standard outreach intervention?
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Did the study participant secure a prescription for PrEP?
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
For part of the study, tentatively, only males will be eligible.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henna Budhwani, PhD
Phone
2059757613
Email
hbudhwani@fsu.edu
Facility Information:
Facility Name
University of Alabama at Birmingham (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henna Budhwani, PhD, MPH
Phone
205-975-7613
Email
budhwani@uab.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
35830245
Citation
Budhwani H, Kiszla BM, Outlaw AY, Oster RA, Mugavero MJ, Johnson MO, Hightow-Weidman LB, Naar S, Turan JM. Adapting a Motivational Interviewing Intervention to Improve HIV Prevention Among Young, Black, Sexual Minority Men in Alabama: Protocol for the Development of the Kings Digital Health Intervention. JMIR Res Protoc. 2022 Jul 13;11(7):e36655. doi: 10.2196/36655.
Results Reference
result

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

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