The study will use intersectionality theory as a theoretical framework to guide the formative phase and overall development of the intervention [31-33]. Our usage of intersectionality theory will incorporate a culturally relevant perspective that includes the voices of Black girls, allowing them to redefine themselves, include discussions around protective factors that they themselves perceive as beneficial in their lives, and celebrate supportive structures that nurture their ability to be resilient. An intersectional perspective, therefore, provides a unified lens through which to view health disparities and develop interventions that are more responsive to race, ethnicity, gender, age, and class [28]. Intersectionality functions as a framework in this study to understand the experiences of Black girls, who possess a different social location than Black women based on their age and cognitive and psychological development. In addition, because an intersectional perspective can be strengths based, it moves the blame away from individual behaviors to systemic and contextual factors that have historically placed Black girls at risk. The framework considers the cultural and historical context of Black girls that influences their susceptibility and exposure to drug use and sexual risk behaviors, as well as highlights the significance of systemic racism, classism, and misogyny within the United States as contributing factors to their exposure. Such a framework has been useful not only in designing and guiding social programs but also in developing ethnic, racial, gender, and class-responsive research for girls. It is to be acknowledged that Black girls are not a homogenous group, which means that significant within-group differences will exist. Therefore, the use of intersectionality theory as a framework allows for our study team to account for those differences in order to make interventions more appropriate to the experiences of Black girls [31].

We will conduct an exploratory, sequential mixed methods study. The protocol is registered on ClinicalTrials.gov (NCT05014074) and was approved by Yale University Institutional Review Board.

Adolescent girls who identify as (1) Black, (2) identify as female, (3) are between the ages of 13 and 18 years, (4) can speak and understand English, and (5) live in the United States will be allowed to participate in this study.

All procedures performed in studies involving human participants are in accordance with the ethical standards of the institutional and national research committee, the 1964 Helsinki Declaration and its later amendments, or comparable ethical standards. The study was funded by the National Institute of Mental Health (R25MH087217) and approved by the Yale University Institutional Review Board in 2020 (IRB-2000026660). Due to the sensitivity of the research questions, we requested that written parental consent be waived for the young participants. All youth who participate in the study (including focus groups and completing surveys) will receive a youth information sheet and parents and guardians will receive a parent information sheet. Youth must give verbal consent in order to participate in the study. We will obtain informed consent from all girls who meet the eligibility criteria and want to participate before they are enrolled in study activities.

Purposive sampling for focus group recruitment will be used to ensure a representation of different subgroups of Black girls. The research team has relationships with community-based organizations in New Jersey and organizations that serve Black girls across the nation. Flyers will be given to program administrators at these organizations to disseminate to interested participants. Flyers for the recruitment of focus groups will also be posted on social media sites such as Facebook, Instagram, and Twitter. All girls who are interested in being a part of the focus groups will have to complete an eligibility form on Qualtrics (Qualtrics International Inc), which will ask for demographic information and contact information. Only girls who identify as Black and female, are between the ages of 13 and 18 years, and live in the United States will be allowed to participate. Research staff will contact eligible participants and will inform them of the purpose of the study and will screen them to confirm that they are eligible to participate based on inclusion criteria. Potential participants will be told that all data will be kept anonymous and confidential and that a monetary incentive of US $30 will be provided for participants who complete the focus group. Potential participants for the qualitative component of this study will also be informed that their responses to questions will be recorded. Upon confirmation of their desire to participate, they will be given a date, time, and Zoom (Zoom Corp) link if web-based or a physical location if appearing in person. The institutional review board has approved this study and agreed to waive parental consent due to the sensitivity of the topic. Youth assent will be obtained verbally. All youth and parents and guardians will be provided an information sheet regarding their daughter’s participation in the study. All participants and parents and guardians of participants younger than 18 years will be told that they can opt out at any time during the study. Community organizations who are able to provide us with space for in-person focus groups will receive honorariums. Recruitment for survey data collection will involve sharing the survey link on various social media platforms and community organizations that serve Black girls. Only girls who identify as Black and female, are between the ages of 13 and 18 years, and live in the United States will be allowed to complete the survey. All participants who completed the survey were compensated with a US $10 gift card.

A semistructured interview guide using intersectionality theory will be developed to explore drivers of substance use, social supports necessary to promote the prevention of substance use and supports necessary to reduce HIV risk behaviors. The study principal investigator (PI) and first author of the protocol (IO) is an expert in using intersectionality theory as a framework for studies involving Black girls. More specifically, the study PI has published studies that used intersectionality theory as a framework in analyzing quantitative and qualitative data [10,34,35] and teaching courses using an intersectionality framework [36]. After the interview guide was developed, another expert who serves as a coauthor of this protocol (KB) will review and revise the guide to ensure that questions use an intersectionality framework. KB is an expert on intersectionality theory and qualitative methodology with Black cisgender and transgender girls and women. Collectively, the study team including the study PI, who has several years of experience in designing studies for Black girls, will develop questions to ensure that girls across the development age span of 13 to 18 years would be able to understand the questions.

Data collection will involve in-depth focus groups to be conducted in a group setting at a community partner’s location sites (mainly in New Jersey due to the study team’s relationships with New Jersey–based community organizations) and web-based groups will be conducted on Zoom. Research in web-based settings has been increasing due to the COVID-19 pandemic and may continue to be a major platform to connect with participants. Research conducted in web-based settings has been established as effective venue for research on multiple content areas [37]. Efforts will be made to place participants into groups that are separated by demographic variables such as age or religion (ie, aged 13-15 and 16-18 years) as it is recommended to group individuals with similar life experiences for optimal focus group dynamics. Each focus group will be audio recorded, transcribed by trained research assistants, and entered into NVivo 11 (QSR International), a qualitative data analysis software package. Focus groups will aim to uncover how Black girls view substance use and sexual risk behavior in their community. Questions that will be discussed in the focus groups are (1) How do race, gender, and class impact views on drug use and sexual risk behavior among Black girls? (2) How do Black girls view their identity and expectations that they perceive from society? (3) What are the risk factors of engaging in drug use and sexual risk behavior that are specific to Black girls? (4) What are protective factors and what do they look like? and (5) What would a successful prevention intervention look like for Black girls in various communities? While 3 or 4 focus groups are recommended for saturation [38], we aim to conduct at least 10 focus groups or until no new data emerge from focus group discussions.

Interviewers will be research staff who identify as Black women, trained by a qualitative methodology expert (KB) on how to engage and conduct focus group interviews with Black girls. The training will involve discussions around being aware of power dynamics that may emerge during the interview in order to facilitate the focus groups effectively. In addition, interviewers will be challenged on assumptions and biases that they may have of Black girls in order to assure that data collection is conducted in an objective and respectful manner that honors Black girls. All facilitators and cofacilitators must identify as Black women, as there is evidence of the importance of racial and gender matching when conducting research with vulnerable and marginalized groups such as Black girls [39].

The goal of this study is to understand the lived experiences of Black girls and obtain information that can be used to develop and pilot a race-specific intervention for this group. We anticipate that having Black girls co-design this intervention with the research team will have great potential to facilitate healthy behaviors and challenge negative stereotypes that impact Black girls’ decision-making over the course of the study and thereafter. This study has the potential to transform the way researchers work with Black girls and cocreate in order to develop sustainable solutions toward ending the HIV epidemic and addiction. The development of racial- and gender-specific intervention specifically for Black girls is essential, and developing interventions specific to a certain demographic has proven to produce successful results in health-promoting behaviors. For instance, one HIV prevention intervention tailored to the experiences and needs of Black women in Atlanta, Georgia was assessed for efficacy at improving condom use after 1 session. The authors found that at the 6-month follow-up women who participated in the session reported more frequent condom use and recent HIV screening [49]. Gender- and racial-specific interventions often move beyond individual risk behaviors and focus on social, environmental, and political influences on the well-being of women and girls. Specific focus on racial and gender pride, healthy relationships and healthy sexuality, reproductive justice, sexual communication, and empowerment around sexual refusal are just a few key aspects of effective interventions for Black women that may be tailored to Black girls [50]. The findings of this study will assist with identifying the elements of HIV prevention interventions specific to Black girls that can be applied broadly in the area to improve sexual health and HIV and STI prevention broadly. Given the current climate, interventions that address key factors such as racism, ethnic identity, and gendered racism must be integrated with intervention efforts for adolescent girls.

This is a formative sequential exploratory study design using mixed methods (qualitative data, cross-sectional survey data). A limitation of this study is that data will be collected via self-report and subject to response bias.

The Dreamer Girls Project lessons learned will aim to provide real-world contributions to implementation science regarding the uptake of a combination of evidence-based prevention interventions guided by Black girls. The evidence from this study will be used for the preparation of a feasibility trial and a more robust and larger HIV, STI, and drug use prevention clinical trial specifically for Black girls.