HIV/AIDSNCT03680729
Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM in Alabama
A study testing Adapted Brothers Saving Brothers (aBSB) and Standard Street Outreach in people with HIV/AIDS, run by Florida State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Adapted Brothers Saving Brothers (aBSB) and Standard Street Outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to 11 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35294
About this study
Official title: Adapting and Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM in Alabama
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Adapted Brothers Saving Brothers (aBSB), Standard Street Outreach
- Keywords
- Prevention, HIV/AIDS, MSM, Alabama
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Brothers Saving Brothers (aBSB)Behavioural
This information is listed in the arm description.
Standard Street OutreachBehavioural
This information is listed in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| aBSB | Experimental | 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. Receives: Behavioral: Adapted Brothers Saving Brothers (aBSB) |
| Street Outreach | Active comparator | Standard street outreach was used as the control in the original BSB trial. Receives: Behavioral: Standard Street Outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability as Assessed by Participant Self-rated Satisfaction With the Intervention
Participants rate their satisfaction with the intervention by positive response to "I like this app," scale of 1-4. Scores across participants in each arm were averaged to produce a mean score. Higher scores indicate higher acceptability.
Measured: 36 months
Did the Study Participant Accept a Rapid HIV Test After the Delivery of the Kings or Standard Outreach Intervention?
This information will be assessed by the return of an HIV test result.
Measured: 18 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start24 Feb 2020
- Primary completion11 Jan 2025
- Study completion11 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henna Budhwani, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680729
- Sponsor's protocol ID
- 520558
- Status last verified
- Feb 2026
- First submitted
- 17 Sep 2018
- Last updated
- 9 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35830245
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM in Alabama
- ClinicalTrials.gov ID
- NCT03680729
- Acronym / sponsor ID
- 520558
- Conditions
- HIV/AIDS
- Keywords
- Prevention, HIV/AIDS, MSM, Alabama
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 11 Jan 2025 (actual)
- Study completion
- 11 Jan 2025 (actual)
- First posted
- 21 Sep 2018 (actual)
- Results
- Posted 9 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| aBSB | Experimental | Behavioral: Adapted Brothers Saving Brothers (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. |
| Street Outreach | Active comparator | Behavioral: Standard Street OutreachStandard street outreach was used as the control in the original BSB trial. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Brothers Saving Brothers (aBSB)This information is listed in the arm description. | Behavioural | aBSB |
| Standard Street OutreachThis information is listed in the arm description. | Behavioural | Street Outreach |
Primary outcome
Acceptability as Assessed by Participant Self-rated Satisfaction With the Intervention
Time frame: 36 months
Participants rate their satisfaction with the intervention by positive response to "I like this app," scale of 1-4. Scores across participants in each arm were averaged to produce a mean score. Higher scores indicate higher acceptability.
Did the Study Participant Accept a Rapid HIV Test After the Delivery of the Kings or Standard Outreach Intervention?
Time frame: 18 months
This information will be assessed by the return of an HIV test result.
1 secondary outcome
Did the Study Participant Secure a Prescription for PrEP?
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35830245Budhwani 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Brothers Saving Brothers (aBSB) and Standard Street Outreach in people with HIV/AIDS, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability as Assessed by Participant Self-rated Satisfaction With the Intervention (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03680729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.