Phase 1: Assessment
Who is the new target population, and why are they at risk of HIV/STIs?
In Phase 1, we examined previous research and theory to identify the unique mechanisms linked to HIV/STI-risk behavior for Black girls [33, 54, 73, 74]. Preliminary qualitative data of the first author indicated Black girls as the target population, sociocultural conditions (i.e., early sexual development, adultification, and lack of protection) that place them at disproportionate risk of HIV/STIs, and the need for multilevel interventions to address their risk profiles [16, 20, 50].
A team consisting of graduate students in health-related fields (public health, medicine, and psychology) and experts in family-based HIV/STI prevention intervention, community engagement, and implementation science was created to ensure the intervention was systematically adapted and tailored to address developmental, cultural, and gender needs [16, 21, 75]. Most of our research team identified as Black (NC, AD, DC, WS, BG, RJ, WJ, CC) and had interest and expertise in health disparities and mental and sexual health.
Phase 2: Decision
What EBI will be selected, and will it be adapted or adopted?
HIV/STI prevention EBIs for Black girls and women exist, but the effects are short-lived, and ongoing health disparities for Black girls require innovative approaches to strengthen the long-term effects. Well-known EBIs, such as Sisters Informing Sisters about Topics on AIDS (SISTA), Sisters Informing Healing Living and Empowering (SIHLE), and Women Involved in Life Learning from Other Women (WiLLOW), focus on modifying individual-level risky sexual behaviors, offer information about the cause, treatment, and prevention of HIV/STI, and counsel women about safer sex behavior and all of them were created for Black girls and women [29, 32, 76]. The positive impacts of these programs may be strengthened for Black girls by two factors: tailoring the program for families to address interpersonal and structural drivers to allow for reduction of Black girls’ sexual risk; and including more information for girls to better understand how knowledge, attitudes, messages, and values about sexuality impact the multidimensional process known as adolescence.
One family-based program, Informed, Motivated, Aware, and Responsible about AIDS (IMARA), encompasses both factors . IMARA is an evidence-based psychosocial HIV/STI prevention program designed for Black mothers and daughters to address individual, social, and structural drivers of HIV/STI risk. IMARA leverages the mother-daughter dyad as a structural factor for girls to encourage behavior change by strengthening daughters’ perceptions of mothers as knowledgeable in sexual decision-making and shifting peer norms within the group in favor of prevention. IMARA is one of the only family-based programs focusing on the parent-adolescent relationship related to SRH and empowers parents as role models. It promotes Black values and the importance of family and parents as resources for prevention. Designed for mothers or female caregivers, the curriculum seeks to strengthen mother-daughter relationships and communication, enhance self-efficacy to use condoms, teach assertive communication, increase maternal monitoring, improve emotion regulation, and emphasize the role of social media and stereotype messaging on Black girls, all while creating pride in Black culture and gender empowerment. The IMARA curriculum consists of multiple scripted modules where mother-daughter dyads engage in activities to teach girls how to improve communication styles, engage in safe sex practices, protect themselves against domestic violence situations, and strengthen familial relationships. These highly interactive modules allow mother-daughter dyads to practice newly formed skills  actively. Modules include various activities (e.g., posters, video clips, condoms, social media images of celebrities, worksheets, and role-playing scripts) to allow for visual, auditory, and kinesthetic learning .
In Phase 2, Decision, our research team selected IMARA as the EBI to adapt for Black girls and male caregivers as it was a family-based intervention that was effective for Black girls in urban settings leveraging structural factors. In a 2-arm randomized controlled trial (RCT), girls who received IMARA demonstrated a 43% reduction in HIV/STI incidence at 12-month follow-up compared to girls who received a time-matched health promotion program . IMARA underscores the impact of social and cultural drivers related to HIV/STI risk and can be adapted to include structural factors (i.e., incarceration, police brutality, and lack of protection) limiting Black male caregivers from protecting Black girls. The BSBW framework was selected to guide and address structural factors for this interventional project.
The first author had a pre-existing relationship with the Chicago Lawndale AMACHI Mentoring Program (LAMP), which was selected as our community partner . LAMP provides opportunities for positive youth development for Black youth in the North Lawndale community by providing space to be themselves, learn, grow, and thrive in a community that is affected by disinvestments like poverty and crime . LAMP leaders develop partnerships with organizations in the community such as the University of Illinois of Chicago, to prepare participating youth for opportunities promoting positive youth development. Youth connected with LAMP have been disproportionately impacted by incarceration and generational poverty . LAMP’s innovative design elements include supporting and involving faith-based congregations, promoting strong personal relationships between youth and their mentors, and professional case management .
Phase 3: Administration
What is in the original EBI that needs to be adapted, and how should it be adapted?
In the Administration phase, we conducted semi-structured interviews with 30 Black male caregivers (aged 22- 60) to assess how they conceptualize protecting Black girls. Most caregivers (80%) identified as biological fathers, 3.3% as non-biological fathers, 10% as stepfathers, 3.3% as adoptive fathers, and 3.3% as the guardian of their girls. Caregivers (66%) identified residential fathers (e.g., lived in the same residence with girls daily) and primary caretakers (e.g., spending every day with girls), and 33% identified as non-residential fathers (e.g., lived in a separate residence from girls) and secondary caretakers (spending time with girls. bi-weekly, once a month, etc.). Black male caregivers were asked: “What does being a Black male caregiver mean to you? and “What does protection mean? How do you protect Black girls” and “Can you tell me how you might or have engaged in conversations with your girl about sex and puberty?” Additionally, we asked male caregivers, “If you were creating a program for Black girls to protect their bodies better, what would you include?” Male caregivers were compensated $30 for participating in the interview. Findings from our interviews with Black male caregivers indicated they were interested in being involved in protecting Black girls’ sexual development but needed help building skills to comfortably communicate about SRH and to promote safer sex behaviors. Some of the topics Black male caregivers asked to discuss in programming were a lack of knowledge about female bodies and puberty, social media, body image, appropriate communication with girls about their bodies, and a lack of positive Black male role models. Black male caregivers indicated that they would feel safer and more comfortable talking about topics of girls’ sexual and reproductive health with Black female facilitators.
We then constructed a community advisory board (CAB) to help inform how best to create a culturally relevant family intervention. Our CAB was recruited through our partner organization and consisted of Black girls, and male and female caregivers attending LAMP. CAB members were Black girls (n = 10) between the ages of 9–17 years old, Black female caregivers (n = 7) between the ages of 32–45 years old, and male caregivers (n = 8) between the ages of 24–58 years old. We convened 2 CAB meetings with each group (girls, female, and male caregivers). We conducted a total of six focus groups with CAB members to collect initial feedback about the feasibility of engaging Black male caregivers in SRH programming, specifically, how we might make the IMARA curriculum more inclusive and engaging for Black male caregivers. Each focus group ranged from 3–6 members. Two trained Black female facilitators led each group. We provided participants with $50 compensation, dinner, and beverages. CAB focus groups were asked: “How should Black male caregivers be involved in Black girls’ puberty? Questions about their bodies and relationships?” and “Would you feel comfortable with how Black male caregivers would like to be involved?”. We then summarized the modules (topics) covered in IMARA and asked how to engage Black male caregivers in these discussions. We asked about the program’s acceptability, including the language used in modules, activities, program delivery, facilitator identity, and recruitment practices. We also knew the engagement of female caregivers would be critical in this research. Therefore, we asked about their level of comfort with a program for Black girls and their male caregivers, as well as the selection of male caregivers and how to engage them in the process safely. This information helped us to develop recruitment approaches and assent/consent procedures. Interviews and focus groups lasted approximately 60–90 min and were audio-recorded, transcribed, and analyzed for thematic content.
Thematic analysis method developed by Braun and Clarke  was used to analyze interview and focus group data. Thematic analysis was used to guide our analysis of our interviews, as we sought to better understand how Black male caregivers protect Black girls and what they needed to support Black girls’ SRH. Thematic analysis was also used to analyze focus group data, as we wanted to better understand the comfortability and processes around engaging Black male caregivers in SRH topics. We chose thematic analysis to develop more implicit themes and patterns from the data to either adapt or create new modules for the adapted curriculum. Thematic analysis was conducted by the research team of students (WS, AD, and DC) and a faculty expert (NC) in health disparities and qualitative methods. The first phase of this analysis included rereading the interview and focus group transcripts. The data were individually coded by each member of the team to generate initial codes . The team met weekly to discuss discrepancies and reached a consensus on final codes to create themes . Themes represented the experiences of multiple participants. The research team meetings allowed for discussion of analysis, authenticity of coding, and thematic development, to ensure validity of analysis. Once the themes were finalized, they were then reviewed with the IMARA program developer to produce the initial draft of the curriculum.
Phase 4: Production
How are adaptions of the EBI produced, drafted, and documented?
In Phase 4, Production, we utilized feedback from the interviews with 30 Black male caregivers and 25 CAB member focus groups on IMARA, which resulted in the initial draft of the new program IMARA for Black Male Caregivers and Girls Empowerment (IMAGE). Consistent with EBI adaptation literature, core components were preserved to maintain the fidelity of the original intervention while refining the new program to ensure relevancy to the target population . We worked closely with the developer of IMARA to ensure core elements were retained: 1) HIV/STI cognition and skills, 2) mental health/emotion regulation, 3) effective communication, 4) parental monitoring, and 5) partner/relationship characteristics and power dynamics. However, we added content about the impact of structural factors – including stereotype messaging, sexual objectification, and intimate partner violence, adapted the role-plays and scenarios to include Black male caregivers, and integrated the BSBW theoretical underpinnings to highlight key constructs of Black female sexual development (i.e., early sexual development, lack of protection, and stereotype messaging).
Content-related adaptions for IMAGE
After evaluating the IMARA curriculum, a thematic analysis was conducted, and five themes emerged from the interviews and focus groups . These themes included: 1) lack of knowledge about female adolescent development, 2) structural factors (i.e., incarceration, police brutality, and lack of protection) impeding Black men from protecting Black girls, 3) toxic masculinity and lack of positive Black role modeling, 4) body positivity, and 5) challenges of Black male caregiver-girl communication about SRH. The themes, supporting quotes from Black male caregivers, and modifications made to the curriculum are in Table 2. New elements to the program were added that included new materials, activities, and content to enhance IMAGE’s relevance for Black male caregivers. The curriculum refers to the intervention manual, and modules are the topics in the curriculum.
Lack of knowledge about female adolescent development
To address this theme in the curriculum, we begin Day 1 by grounding the IMAGE program with the BSBW framework, which describes Black girls’ sexual developmental process, phases of sexual development, characteristics of early sexual and physical development, and adultification of Black girls’ bodies. Utilizing the BSBW framework provided participants insight into protecting Black girls and why it is necessary. This model also provided a foundation for how stereotyped messaging and protection influence Black girls’ sexual development. More specifically for Black girls, we included new modules that help address concerns about their physical, mental, and emotional development during puberty. In the module “Your Body Your Birth Control,” girls are educated on the different kinds of birth control and practice choosing effective birth control methods for characters in different scenarios to empower them in making their own reproductive decisions. We added interactive activities such as “Adolescent Jeopardy” for both Black male caregivers and girls to teach them about female puberty and menstruation.
The BSBW framework also helps us introduce the impacts of structural factors (i.e., incarceration, police brutality, and lack of protection) on Black girls’ developmental process. We added two modules, the first, “Black male caregivers Challenge Absenteeism and Protection,” speaks explicitly to the topic of incarceration and how that limits the protection of Black girls. In this module, we described protective strategies if Black male caregivers cannot be physically present or live near their girls. For Black male caregivers, we added modules to improve their knowledge about their influence as caretakers, initiating discussions on mental health, and the importance of protecting Black girls. In the second module “Mental Blocks,” we destigmatize conversations around mental health, acknowledge Black male caregivers’ struggles using Jenga blocks, and allow caregivers to have an open discussion about their burdens, along with providing healthy and alternative health strategies. This was crucial to highlight the importance of mental health conversations and allow Black male caregivers to have a safe space to discuss challenges among other Black men.
Toxic masculinity and lack of positive Black male role models
To address transgenerational behaviors and toxic masculinity related to being a Black man, we created a module, “Black Male Caregivers Challenge Toxic Masculinity,” to debunk what it means to be a Black man and to address cultural norms associated with being a Black man. Participants do an activity where Black male caregivers create a gingerbread person and the positive attributes, they associate with being a Black man. In another module, “Your Partner Your Choices,” we discuss how characteristics of partners Black male caregivers have may be reflected in and influence the choices and behaviors their girls exhibit. We also discuss the lack of positive Black male role models in the media associated with the assault of Black girls and women (e.g., Bill Cosby and R. Kelly). Ensuring that Black male caregivers learn protective strategies was critically important to the success of this intervention. Some of these strategies included: calling out creepy or predatory male behavior, having difficult conversations with family members or men in the community, talking to girls about protecting their sexual health, and calling out girls’ ages and labeling them as minors.
To address body positivity, we added the module “Young, Black, and Female” Girls identify positive traits associated with Black females to instill pride in themselves and others within their community. For both Black male caregivers and girls, we added the module “Black female stereotypes,” which included visual activities with images of famous Black women in Black culture historically and currently in the media to promote body positivity. In this module, we do the “What you See vs. What is True” activity and address myths about Black women’s bodies and risks associated with increasingly common surgeries such as Brazilian Butt Lifts. We also discuss what healthy Black female bodies look like and that they come in all different forms, shapes, and sizes. In the module “Guess Who has an STI?”, Black male caregivers and girls, within their groups, had the chance to learn about vaginal discharge, ways to identify and treat sexual and non-sexual (e.g., yeast infections and bacterial vaginosis) infections, the risks of profiling potential partners based on image (i.e., assuming someone has an infection based on how they look rather than through HIV/STI testing), ways to protect themselves from infections (i.e., abstinence or condoms), repercussions of untreated infections (i.e., pelvic inflammatory disease and infertility), and when to seek treatment from a medical professional.
Black male caregiver-girl communication about SRH
To address the challenges of Black male caregiver-girl communication about SRH, a new module, “The Big Talk: Girls Talking to Black male caregivers about Sex,” was created. The module included important topics to discuss with Black male caregivers (e.g., sex, relationships, bullying, fighting, body image, sexuality); identify reasons why they may avoid these conversations; and identify trusted adults, male or female, they feel comfortable discussing these topics with, to encourage increased communication. The original IMARA curriculum explores different types of communication, including assertive vs. passive and role-playing effective girl-caregiver communication.
Phase 5 & 6: Topic experts and integration
Who can help adapt the EBI, and what additional content should be included?
In Phase 5, content experts (n = 6) were consulted to assist in curriculum development in areas where the adaptation team lacked expertise in Black male health, structural racism, and HIV/STI interventions engaging male caregivers and youth. We invited individuals with expertise on Black men and structural racism to review the adapted curriculum and provide feedback. Experts suggested additional activities to support Black male mental health and address toxic masculiniy and stereotyping. Informed by previously successful interventions with Black men, experts went through draft 1 of the IMAGE curriculum and commented on ideas for activities to better engage Black men. They helped to ensure that critical content and considerations were included in the adapted curriculum. Experts encouraged us to include a module about Black male mental health and resources in the IMAGE curriculum, as discussing structural factors may be challenging. Feedback from the topic experts guided us in improving the IMAGE curriculum, which was better tailored for Black male caregivers and girls. Additionally, experts helped us integrate scales that measure new intervention content in the study survey. These were referred to as baseline measures and were collected during Day 1 of the theater test. In Phase 6, we integrated the input of experts to create the second draft of the IMAGE manual.
Phase 7: Training
Who needs to be trained?
Facilitators (i.e., individuals who deliver the intervention for dyads) were a combination of experienced IMARA group leaders and individuals with training as health educators. Facilitators who previously worked for IMARA brought comfort and familiarity with Black girls and the IMARA curriculum. New facilitators were sought to increase staff availability and allow for additional perspectives when reviewing modules. Staff had different levels of experience working with adolescents, Black men, and group facilitation, and many had previously worked in fields such as medicine, public health, social work, and psychology. To support intervention fidelity, three in-person 8-h training workshops were held to ensure the competency of facilitators. Training sessions included four hours of reviewing modules for Black girls and male caregivers to ensure that all facilitators felt comfortable working with either group. Reviewing modules involved having staff read and act out activities with the corresponding material. After each module, feedback was requested from each staff member to improve content and delivery. The facilitator training also included the practice of utilizing developmentally appropriate for young girls. For example, our newly adapted modules included utilizing the language of participants that we gathered from focus groups and interviews, such as “grown” to describe their developmental phase or “sneaky link” which refers to having a secret affair. Facilitators were also instructed to adjust language based on the comfortability and participation of girls. Additionally, since our population may include individuals who are not cisgender or heterosexual, it was essential to train facilitators on all aspects of gender and sexuality (i.e., gender and sexuality spectrum, appropriate and respectful terminology, and what to do in the event offensive language is used). Facilitators and staff were a trained to intentionally create a safe space when delivering the intervention and challenge participants’ perspectives about what may cause tension within the group. Some of the IMAGE facilitators previously worked as facilitators for the IMARA study, and they provided feedback on new topic integration, the pacing of modules, and flow. This resulted in the third draft of the IMAGE curriculum.
During the training and theater testing facilitators completed evaluations of one another, including each module’s adherence and competence. Facilitators completed fidelity measures, that included observation of IMAGE sessions and feedback for new facilitators. The senior facilitators determined mastery of the material and completed observer ratings of each session to verify that the intervention was delivered as planned and the quality of the delivery was maintained. Questions were focused on if facilitators: followed the script for the session, explained each activity, demonstrated each activity, provided corrective feedback for incorrect responses, maintained quick pacing throughout the lesson, were open and non-judgmental, and the comfortability of facilitators with participants.
Phase 8: Testing
Was the adaptation feasible and acceptable to the target population?
After adequately training the staff, we moved to Phase 8 and conducted a theater test of IMAGE using the new content developed for dyads of Black male caregivers and girls.
We recruited girls and male caregivers attending LAMP into a theater test of IMAGE. Theater testing is a “pretesting methodology” that is commonly used to test interventions with the intended audience and how they respond to the intervention . At the end of the intervention, participants complete a questionnaire to answer questions to gauge their reactions to the intervention. A strength of theater testing is the opportunity to obtain reactions to messages, concepts, and materials in a relatively short period that closely resembles the intervention .
We recruited by placing flyers at LAMP and active recruitment at community-based outreach events. We theater-tested the IMAGE curriculum with six dyads (N = 12). Each dyad consisted of one Black male caregiver to one girl. Black girls were 11–15 years (M = 13), and male caregivers were 25- 65 years old (M = 36). 83% of the male caregivers were < 25 years old, 50% were biological fathers, 33% were primary family members (uncles and grandfathers), and 67% were single or never married.
Consistent with the theater testing approach described by Wingood and DiClemente , newly recruited Black male caregivers and girls participated in each module, administered by trained Black female facilitators. Participants provided feedback on each module via a 4-item evaluation about the acceptability and included the open-ended question “What changes or suggestions do you have to improve the content?” Experienced IMARA facilitators delivered the curriculum, allowing a smoother transition from the IMARA to the IMAGE curriculum. IMAGE was delivered over two consecutive days, Saturday, and Sunday, at LAMP, consistent with IMARAs two-day RCT. The theater test allowed for evaluation of feasibility (i.e., can enough BMCs and girls be recruited and enrolled to participate, and could the intervention be fully delivered within two 6-8 hour days), acceptability (i.e., did Black male caregivers and girls feel they benefited by participating), and tolerability (i.e., could facilitators deliver the necessary content and did Black male caregivers and girls remain engaged). Our community partner, LAMP, selected participants who had never participated in IMARA. The theater test was conducted at the organization (LAMP) because of the proximity to the target population. Participants were compensated a total of $125 for their participation in IMAGE. Both girls and male caregivers received $60 on Day 1 after baseline measures were completed and $65 on Day 2 for the post-evaluation survey. Consistent with IMARA, four facilitators, two with the Black male caregiver group and two with the Black girl group, delivered the intervention. The intervention ran for 6 h each day. After each module, feedback was collected from participants via survey evaluation.
We collected acceptability ratings from evaluation forms each participant completed after each module. Overall, male caregivers and girls rated each module highly, with mean scores ranging from 3.6 to 4.0 (scale: 1 = strongly disagree, 4 = strongly agree). The overall acceptability of IMAGE was 3.8/4.0 for both male caregivers and girls. All acceptability questions scored a 3 (somewhat agree) or higher. Both girls and male caregivers were actively engaged and satisfied with the program. In open-ended responses, girls and male caregivers reported learning new information about HIV/AIDS, how to communicate more effectively with each other and their sexual partners and having greater comfort talking to each other about sex and condoms. We had 100% retention for both days of the IMAGE intervention. Baseline survey measures took about an hour and 15 min to complete.
Additionally, each group (girls and male caregivers) had a program observer to provide feedback on the improvement of content and delivery by facilitators and the program. Assessors were faculty and were selected by the PI. The observer took notes to capture verbal and non-verbal nuance. The two observers rated the following components of the theater testing workshop (5-item scale: 0 = poor, 4 = very well): how smoothly the sessions were administered (mean score = 3.6); how engaged participants were (mean score = 3.8); how comfortable participants were with the material (mean score = 3.4); and how comfortable participants were with the facilitators (mean score = 3.6). Overall, comments from participants indicated that male caregivers and girls found the IMAGE activities informative, effective, and fun.
After the theater test, a rapid content analysis by Hsieh and Shannon  was used to analyze theater testing data. Rapid content analysis was used to interpret the meaning from the qualitative data, with a directed approach starting from prior research findings as guidance for the initial codes (previously identified themes in phase 3) . Rapid qualitative analysis involved eliminating transcription and summarizing data by theme or topic, rather than in-depth manual coding of transcripts . Rapid qualitative analysis was chosen as the results were needed to quickly develop or modify implementation strategies for the IMAGE pilot. The coding team (NC and AD) achieved an inter-rater reliability of 0.90 across all codes. The responses from the observers and participants’ open-ended survey questions were employed to identify additional themes in the dataset to further refine the IMAGE curriculum . This analysis revealed participants wanted more content and resources about birth control, discussion about age and consent, and to make more interactive modules. The participant feedback also revealed the need to reorganize and combine modules for better flow. After modifications, we created a finalized IMAGE curriculum ready to pilot in Table 3.