SavvyHER has been developed based on formative work conducted with Black women living in a high-priority region of the South [19]. We solicited input about the most relevant social inequities hindering or prohibiting HIV prevention through focus groups with Black women. This work gathered Black women’s preferences for the functionality, format, and design of a mobile HIV prevention app tailored for Black women. Black women in our formative work specified the following: (1) lack of access to culturally targeted and gender-considerate health care; (2) gender-based power differentials in couple relationships that limit women’s ability to negotiate HIV-protective actions with their male sex partners (eg, condom use); (3) unreliable HIV prevention education and limited access to HIV prevention resources; and (4) susceptibility to other sexually transmitted infections (STIs) and chronic illnesses. Women desired content pertaining to women’s sexual and reproductive health, including HIV prevention, comprehensive health information relative to the health disparities of the Black community, and linkage to women of color health care providers. Preliminary wireframes were developed using findings from our formative work (Figure 1). In addition, the research team conducted a separate study evaluating perspectives from health care providers regarding challenges and facilitators to PrEP initiation among Black women. This work has helped to guide message framing within the preliminary SavvyHER app [18].

Industrial and technology designers have used human-centered design (HCD) to facilitate innovation [39-41]. Key principles of HCD are the following: (1) the design is driven and refined by user-centered evaluation; (2) the process is iterative; (3) the design addresses the whole user experience; and (4) the design team includes multidisciplinary skills and perspectives. Although not explicitly a research methodology, HCD employs qualitative and quantitative research methods and encourages health innovators to design technology by focusing on how users can, want, and need to use it. This process begins with the identification of health needs, rapid prototyping, and iterative design and development. Once a prototype is created, it is tested and refined based on the user’s experience. The purpose of this approach is to move away from traditional methods of involving users during the latter phases of the prototype and instead regard users as active contributors from the beginning of the design process.

Like other health interventions, mobile health apps face challenges in terms of uptake, engagement, efficiency, and confidentiality. These challenges can be mitigated by ensuring that the intervention content is developmentally appropriate, comprehensible, and comfortable to use. We have chosen an HCD approach to increase the usefulness and use of the app, encourage HIV protective behavior, and promote optimal HIV prevention practices. Additionally, there may be potential risks of abuse during discussions in the app’s virtual peer support communities. The research team will designate chat room moderators to be trained to monitor for abuse. Abuse will be defined in the app-use policies conveyed to participants in the orientation. Examples of these policies might include: no sending of identifying information such as phone numbers or addresses; no posting of links; etc. These policies will be drafted with the CAB. Another potential risk is that women may experience psychological and emotional distress while recounting sexual experiences or discussing sensitive health topics. The research team includes clinicians with experience counseling patients on sensitive health topics. The research team will follow institutional review board (IRB) reporting procedures in the instance that participants experience psychological and emotional distress and will refer participants to local SRH clinicians for support services as needed.

The current version of SavvyHER was derived using recommendations from the CAB and based on our preliminary studies [19,42,43]. The app uses text, video, still frames, and other features to convey tailored health messages. The interactive portions of SavvyHER are primarily click and swipe functions. Our research team ensured the readability of the app content is no higher than sixth grade level, using the Flesch-Kincaid readability score [44]. SavvyHER contains a variety of app features, reflective of the SCT-MC constructs, that were developed based on our formative work with Black women (see Table 1).

My Logger integrates a self-tracking and preventive health messaging feature that incorporates symbolic modeling, behavioral knowledge, behavioral acceptance, and the cultivation of supportive social networks. Participants are encouraged to journal about any sexual or reproductive health encounters, appointments, indicators of social instability associated with HIV risk behaviors (eg, IPV [45,46] and changes in employment and housing), and descriptive anecdotes in the journal section of My Logger [47].

My Test consists of two components: (1) a GPS locator for HIV testing and PrEP clinics; we leveraged the existing application programming interface (API) of the HIV.gov testing locator to provide a centralized place for identifying testing and prevention sites; and (2) to make commodity ordering available to participants. Participants can order condoms and STI testing kits through an in-app widget.

My Resources gives participants access to a multimedia resource kit consisting of videos, current events, news feeds, podcasts, and support groups related to women’s health, reproductive health, and HIV prevention. In addition, the study team has and will continue to generate health messages, like 1- to 2-minute video clips and infographics.

My Circle is a digital environment for women to connect, extending opportunities for peer modeling, learning, and support. In the moderated web-based groups, women share sexual health goals they are pursuing in the app, use messaging features to provide support around these goals and in their lives more broadly, and share insights they have found meaningful through the educational messaging components of the app to support peer learning (eg, through buttons that let them easily share information gained through the My Logger and My Resources features).

The pilot feasibility trial will consist of 3 distinct phases in which data collection, analysis, and interpretation will occur separately for each phase. The procedures were modeled after other successfully implemented HIV app development procedures [48-50]. The first phase included qualitative focus group discussions (FGDs) with participants; the second phase involved a pilot of the SavvyHER app with a select number of participants; and the final phase will consist of a randomized controlled trial in which participants will be randomized to either the SavvyHER intervention arm or the control arm. At the time of this manuscript, phases I and II were complete. Phase III will be initiated during second quarter of 2023. This design approach was deemed appropriate as it allows for further refinement of the SavvyHER app using the data obtained from phase I and phase II before the randomized controlled trial in phase III.

All assessments are taken through REDCap, a secure platform for constructing web-based surveys and databases [54]. Participant data is stored under a unique study ID number to ensure security and privacy. In order to inform intervention testing, we collect data on the number and yield of screened participants enrolled, recruiting sources that generated the largest number of enrolled individuals, effective recruitment used for successful enrollment, elapsed time from first contact to enrollment, amount of app interactions, and technological challenges or glitches. Feedback on content and delivery is elicited through REDCap surveys and focus group sessions or interviews, which both undergo qualitative data analysis, also known as coding. Additionally, we collect data on participants’ ownership of smartphones and preferred app formats. These measures will help determine the time, resources, and workload necessary for implementing the HIV prevention mobile app for Black women. Moreover, with this data, we can assess whether users perceived the app as beneficial and whether alternatives (in app content and delivery) can be determined.

All participants provide demographic information through REDCap surveys. Primary outcome measures focus on the feasibility, usability, and acceptability of the SavvyHER app in addition to the control group procedures. Feasibility metrics will be determined by meeting predefined benchmarks specific to retention, screening, and interaction with app features. Examples include the number of weekly app sign ins, time spent using the app, and its features. Usability and acceptability will be assessed with the system usability scale (SUS) and a 30- to 45-minute exit interview that queries participants’ experience with study procedures [55]. Because this is a feasibility study, we do not propose a statistical analysis of changes in behavior (eg, PrEP initiation, HIV testing) among users of the SavvyHER mobile app. Secondary measures collected in phase III include information on social determinants of health (eg, health care access near her location, employment status, housing status, transportation access, and social support), sexual health history and knowledge, self-perceived discrimination, mental health status, experiences of intimate partner violence, PrEP stigma, racism, and discrimination, personal media and technology use, as well as web-based health information seeking. The completion of the end line survey will also indicate the feasibility of study procedures (eg, retention). A summary of primary and secondary measures is displayed in Table 2.

Ethical approval for this study was obtained through Emory University’s IRB (STUDY00002857). Before enrolling in the study, the research team will discuss the purpose of the study, study procedures, and risks and benefits with participants. Participants who agree to participate in the study will provide informed consent to a member of the research team. For the quantitative portion of the study, written informed consent will be obtained from participants. For the qualitative phase, oral informed consent will be obtained. Participants will be provided a unique study ID upon enrollment, and all data will be deidentified to maintain confidentiality. Survey data is also password protected in REDCap. Focus group transcripts and recordings are password protected in digital files. Only study team members on the IRB will have access to data files. Participants will receive compensation for completion of the baseline assessment (US $50) and for completion of the exit interviews (US $80) for a total of US $130.

Although Black women are a priority population concerning HIV in the southern United States, few public health interventions are curated for prevention and treatment among this group. Black women experience some of the highest rates of HIV acquisition due to broader social forces and systems embedded in discrimination. In order to mitigate the disproportionate impact of HIV among Black women, novel and effective strategies must support Black women’s capacity to protect their own health [92]. We anticipate that the SavvyHER intervention will address barriers in HIV prevention and broader SRH disparities among Black women by providing access to culturally responsive resources, educational materials, and health services that otherwise would be difficult to acquire given the limited awareness and extensive structural barriers that this community faces. Several studies have begun to explore the benefits of digital platforms in addressing HIV burdens at local and global levels. A review conducted by Cao et al [93] indicated that digital health interventions have demonstrated feasibility in increasing PrEP uptake and optimizing clinical interventions for target communities. It is critical, however, for such interventions to be adequately adapted toward demographic profiles including age, gender identity, sexual orientation, race, and ethnicity [94-96]. As reported by Budhwani et al [97], acceptability testing and adaptation that are underpinned by user feedback significantly increase the likelihood of intervention relevance, satisfaction, and acceptability in new populations of interest. As previously described in our methods, our team will be conducting this study in various phases to ensure that SavvyHER is adapted to ensure a strong fit between the intervention and the community being targeted [98,99]. To date, several studies have described the benefits of CBPR in the literature, particularly in creating interventions that reflect community priorities and perceived needs [96-98]. The research teams’ approach of including a diverse array of community stakeholders through CBPR practices, coupled with involving community stakeholders throughout all phases of the research process, can greatly aid in generating awareness and buy-in toward the app on a larger scale [96-98]. Previous literature highlights the need for centering Black voices as a means for discovering knowledge and developing innovative pathways toward advancing health equity [100,101]. The SavvyHER mHealth study is spearheaded by Black women for Black women given that they are underrepresented in public health studies as participants and as researchers [102]. By substantively integrating feedback from Black women at the various phases of this study, our team is continuously refining the SavvyHER app to ensure that the content, design, and navigation are effective for HIV prevention and treatment among Black women.

We have developed a rigorous plan to explore the feasibility, usability, and acceptability of an HIV prevention app for Black women and a strong control comparison. However, potential problems could occur, such as technological glitches, feature imbalances, infirm backend support, irrelevant content, and low engagement, which may be limitations to this study. We have built in questions about all procedures for the focus groups and alternative methods to deal with problems that might arise during the study. This study has low external validity given the randomized controlled trial design and the fact that it is limited to Black cisgender women in the metro-Atlanta area. Therefore, generalization to Black women residing in other areas of Georgia or women of other racial or ethnic identities is limited. This study is strengthened through ensuring that researchers are blinded to which participants are assigned to the intervention and control arms. Thus, observer bias will be mitigated, which will help maximize the validity of the results. Another limitation is the potential for social desirability and recall bias during data collection. Qualitative interviewers will be trained to reduce the likelihood of these biases occurring. While the surveys that will be used contain items from previously validated surveys, the overall survey itself has not been validated, which may contribute to some measurement bias. Measurement bias will be reduced, however, through administering surveys at various time points and coupling Google Analytics data with survey data. Lastly, there may be retention issues with the app; however, we have employed reminders and intrinsic motivation strategies to counter this potential issue.

Future directions for the SavvyHER app involve the integration of mHealth and telemedicine. mHealth solely allows for self-health monitoring, in which app users can take charge of overseeing their health without the guidance of a health care clinician [103,104]. Incorporating telehealth into SavvyHER permits not only patient self-monitoring but also clinician-to-patient and clinician-to-clinician interactions. The telehealth structure authorizes the electronic exchange of personal health information that can be used for full-spectrum remote patient care [105,106]. Previous research notes that clinician-level factors affect uptake, as does the adherence support that patients receive [17,107-109]. In forthcoming iterations of SavvyHER, we will create clinician-specific functions and coaching that address culturally relevant SRH concerns for Black women. Testing would comprise of a 3-arm study that would assess a control group, a mobile app user-only group, and a group where SavvyHER has a health clinician and patient interaction feature.