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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03680729
• Other study ID #: 520558
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: August 2023
• Source: Florida State University
• Contact: Henna Budhwani, PhD
• Phone: 2059757613
• Email: hbudhwani[@]fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 167
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• Adapted Brothers Saving Brothers (aBSB)
This information is listed in the arm description.
• Standard Street Outreach
This information is listed in the arm description.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham (UAB)	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Dev — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 months
Primary	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.	18 months
Secondary	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.	6 months