- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03680729
Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM in Alabama
Adapting and Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM in Alabama
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Henna Budhwani, PhD
- Phone Number: 2059757613
- Email: hbudhwani@fsu.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Recruiting
- University of Alabama at Birmingham (UAB)
-
Contact:
- Henna Budhwani, PhD, MPH
- Phone Number: 205-975-7613
- Email: budhwani@uab.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
This information is listed in the arm description.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
36 months
|
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.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 520558
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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