Building Trust and Engaging Communities for HIV Prevention Research Globally

Abstract

The HIV Vaccine Trials Network (HVTN) is the largest publicly funded international collaboration facilitating the evaluation of vaccines to prevent HIV and TB. Central to the HVTN’s success is the reliance on robust community engagement methods, ensuring community participation and facilitating community awareness and knowledge of research. Community engagement is a dynamic process that requires active participation from all stakeholders to ensure success. The HVTN and its global Clinical Research Sites (CRSs) located in Africa, Latin America, and North America are known as the Network. We describe relationships across the Network, specific staff roles and responsibilities, and the myriad activities undertaken to ensure optimal community engagement. Key activities include involving active Community Advisory Boards (CABs), using community consultations, and having trained Community Engagement staff at each CRS. Operating with robust community engagement has resulted in rapid enrollment and high retention of diverse participant populations across Network studies.

INTRODUCTION

The HIV Vaccine Trials Network (HVTN), founded in 2000 and funded by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), is the largest publicly funded international collaboration evaluating vaccines to prevent HIV. The HVTN’s mission is to characterize the safety, immunogenicity, and efficacy of HIV vaccine candidates with the goal of developing safe, effective vaccines rapidly for the prevention of HIV globally. The HVTN has conducted the vast majority of the published, presented, and ongoing global clinical trials of preventive HIV vaccines (Kublin et al., 2012). The HVTN operates as a global collaborative network, working in close coordination with approximately 35 global NIAID-funded Clinical Research Sites (CRSs) across Africa, Asia, Latin America, and North America (Figure 1). These sites are led by local investigators and supported by clinical, laboratory, and community teams who are responsible for implementing protocols, engaging communities, and recruiting, enrolling and retaining study participants. Additional CRSs are integrated into the network as needed to meet the capacity demands of individual studies. The HVTN Leadership Operations Center, based in Seattle, Washington, provides coordination and infrastructure support for this global effort.

FIGURE 1.

Locations of HVTN’s current global CRSs and their local CABs as of 7 July 2025.

Community engagement (CE) is central to the success of the HVTN and is the overarching practice used to foster collaboration, education, recruitment, and retention (Abernethy et al., 2024; Andrasik et al., 2021; Dietrich et al., 2023; Hanass-Hancock et al., 2021; Quinn & Andrasik, 2021). The network’s CE has evolved with partnership and insights from the local CRSs conducting clinical trials within their respective social, cultural, and political contexts. The HVTN relies on robust participatory CE methods to inform protocols and educational materials that foster trust in research. This dynamic CE process is data driven and achieves active participation from diverse local and global community partners who have an equal voice in the research process. As such, CE is a shared responsibility among all Network staff and global community partners.

At the foundation of the HVTN’s CE efforts are the Good Participatory Practice (GPP) guidelines (HANC, 2025), to which the HVTN was a contributor, and the Division of AIDS (DAIDS) Recommendations for Community Engagement in HIV/AIDS Research (v3.0) (MacQueen & Auerbach, 2018; UNAIDS/AVAC, 2007, 2011). These guidelines provide tools and strategies on how to effectively engage community partners, and underscore the importance of transparency, accountability, integrity, mutual understanding, respect, and community autonomy. A core standard within the HVTN is that engaging community members from diverse age, racial, ethnic, sexual orientation, and gender identities at each phase of a clinical trial fosters trust, beginning from the earliest point of protocol development through the dissemination of study results. Additionally, all HVTN-affiliated CRS staff are required to complete training before they work with communities, including but not limited to Good Clinical Practice and human subjects protections, thus ensuring ethical protection of community members throughout the clinical trial process. Incorporating varied perspectives increases the acceptability of the HVTN’s research and enhances coownership of the research process. This increases support by the communities where trials are conducted, and ensures that the results are more likely to be relevant to priority populations who are disproportionately impacted and sometimes the focus of recruitment activities for a given study.

Working with colleagues at DAIDS, the HVTN’s Ethics Working Group created a participants’ Bill of Rights and Responsibilities for HIV Research (HVTN, 2025) document in 2003 to inform and protect study volunteers. This was the first such document of its kind across the DAIDS research networks, and the process was driven by Community Advisory Board (CAB) members. It has undergone several revisions since, and in 2019 was adopted by all four DAIDS networks (AIDS Clinical Trials Group [ACTG], International Maternal Pediatric Adolescent AIDS Clinical Trials Network[(IMPAACT], HIV Prevention Trials Network [HPTN], and HVTN) under the title Bill of Rights and Responsibilities for HIV Research. In 2004, the HVTN developed the first Community Engagement Training Manual for use by all global CRS staff. The manual, now in version 4 and available in English, Spanish, and Portuguese, is comprised of 18 sections, each containing a full lesson plan with interactive learning activities, a PowerPoint slide deck, and additional resources needed to present the lesson. Additionally, the HVTN’s Manual of Operations contains several sections to guide the implementation of annual CE plans and CABs. Copies of these documents are available upon request.

HVTN ORGANIZATIONAL STRUCTURE

The HVTN’s Social and Behavioral Sciences and Community Engagement Unit (SBS/CEU) leads CE for the HVTN, and the team includes the director, who is a behavioral scientist, a CE associate director, four CE project managers, a social and behavioral sciences project manager, and a graphic designer. Two CE project managers are based in Johannesburg, South Africa, one is based in Lima, Peru, and the fourth is based in the United States. Each project manager is assigned to a subset of CRSs in their region, providing ongoing CE support for their respective CRSs. This support includes provision of staff training, resources, and capacity building for site staff, the local CAB, and local communities. CE project managers ensure that community representatives are equal members on protocol teams and Network committees, working collaboratively to review protocols, informed consent materials, and develop protocol-specific educational community slide sets and other participant-facing materials. The SBS/CEU works collaboratively with the HVTN External Relations team and Communications and Marketing team, which focus on the engagement of communities beyond local site communities, including social media initiatives. Additionally, the SBS/CEU team works closely with CRSs to ensure that staff have the resources needed to conduct local CE efforts and implement their site-developed workplans that document their planned community engagement activities for the coming year (see the section below Annual Community Engagement Work Plans).

The social and behavioral sciences component of the SBS/CEU is responsible for addressing social and behavioral scientific questions that have an impact on the design, implementation, and interpretation of preventive HIV vaccine and monoclonal antibody (mAb) clinical trials. Various behavioral theories, models, and approaches (Bronfenbrenner, 1979; Fisher et al., 2006; Moodley & Beyer, 2019; Prochaska & DiClemente, 1983; Prochaska et al., 2013; Rivet Amico, 2011; Wallerstein et al., 2018) guide the work of the network to ensure that community members are actively engaged at each phase in the clinical trial process. Additionally, social and behavioral science research underpins the HVTN’s CE efforts (Andrasik, Chandler, et al., 2014; Andrasik, Yoon, et al., 2014; Andrasik et al., 2019, 2020; Arnold et al., 2014; Broder et al., 2020; Dietrich et al., 2020, 2021, 2023; Hanass-Hancock et al., 2021; Huamani et al., 2019; Laher et al., 2020; Thiam-Diouf et al., 2018).

A ROBUST COMMUNITY ENGAGEMENT MODEL

The network utilizes a community engagement model that comprises three intersectional concepts: community education, recruitment and retention. These concepts support each other and work together to ensure that communities are informed and aware of research and its potential benefits, risks, and implications for themselves and their communities. The goal is to ensure that studies enroll participants who are well informed and willing to volunteer their time, and that they have the best study experience possible. Over time, this approach (Donnermeyer et al., 1997) also builds community readiness to receive and accept any future HIV vaccines or other biomedical prevention interventions that demonstrate efficacy and become commercially available as a result.

COMMUNITY EDUCATION

Communities are rarely organized around medical research, let alone HIV vaccine or prevention research. Hence, developing a CE infrastructure generally requires engaging with existing community leaders and groups. Moreover, communities generally are not initially seeking or aware of potential advances in the development of preventive HIV vaccines, broadly neutralizing mAbs, or research in general, and they may not prioritize such education as a need. Identifying key opinion leaders and working to build and maintain relationships with them in addition to community partner organizations and the public is imperative for any meaningful community education. These relationships must be sustained to mutually benefit all entities even when the benefit to the trial may not be immediate. Mutual benefits are realized through the development of long-term relationships. This means showing up for and supporting communities when needed (Table 1), and not solely when the community is needed to support recruitment efforts. Ensuring this reciprocity is essential to sustain relationships and to build and maintain the HVTN’s reputation of trustworthiness (Lucero et al., 2017). It is also important to identify and establish viable channels for dissemination of information, utilizing them to ensure transparency and open communication. Viable channels include a range of social media platforms, traditional print and broadcast media in each country where studies are implemented and locally identified key opinion leaders and community partners. Network and site staff also develop mechanisms for the community to provide feedback, guidance, and direction to the research team, and they ensure that community input is sought from study concept development through results dissemination. Mechanisms for community feedback may include having community members from the region where the protocol will be conducted serve on protocol teams, including community members on Network committees, surveys completed by study participants, input from CAB discussions, community forums, and consultations held on specific topics or proposed studies. Additionally, CRSs work to hire staff from priority communities and those who have first-hand knowledge of the communities they seek to engage.

TABLE 1.

Community Engagement Examples

General Community Engagement

Providing staff to do HIV testing at community events Provide licensed vaccinations in partnership with local community-based organizations Seeking membership in local HIV coalitions to provide education and collaborate Serving as community volunteers (e.g., planting trees, providing food, etc.) Creative workshops to make complex scientific research concepts accessible, engaging, and relevant to lived experiences Using social media to engage the community, foster dialogue, share relevant HIV information, and connect peers—an approach that proved essential during COVID-19 restrictions on in-person contact

Correcting misinformation and myths

Facilitation of workshops addressing myths and historical trauma Leading train-the-trainer workshop entitled “Black Community and Medical Research: Reclaiming the Past and Seizing the Future” Serving as a speaker on panels coordinated by community partners Inviting the community into laboratories to observe how samples (particularly blood) are processed and destroyed Demonstrating the amount of blood collected (e.g., teaspoon/tablespoon) during study visits Involving past participants as volunteer peer educators to address myths Demonstrating unfamiliar study procedures like IV infusions and subcutaneous injections

Improving/modifying recruitment strategies to align with local circumstances

Partnering with local drag performance celebrities to connect with nightclub attendees Hosting parents’/caregivers’/guardians’ workshops to discuss adolescent trial participation and safety Assessing clinical site level facilitators and barriers to enrollment for transgender and gender nonconforming individuals, using the data to make site level changes

Improving retention practices that aren’t working with community partner input

Adding WhatsApp or text messages as an option for receiving visit reminders Changing the focus of social events from clinical trials and vaccines to a community identified focus that increased reports of feeling appreciated.

Consideration of community concerns and identifying community assistance needs

Offering anonymous feedback surveys to participants after their screening and study visits Using a brief true/false survey to identify areas of focus for community education Providing a computer for participants to use while waiting at the clinic, enabling them to develop resumes and conduct job searches in response to high unemployment in the local community Hosting fun and factual youth events in partnership with community stakeholders to increase youth awareness of research and participation opportunities

Challenges experienced by research participants and resources provided to address these challenges

Adding early morning, evening, and weekend hour to accommodate schedules – this includes having pharmacy and lab staff available as well Develop methods and tools to educate local clinicians and providers about VISP Providing counseling and referral to support services for participants who reported domestic violence or child abuse Helping with resume writing and job applications in the waiting room

How community input helps to refine a research protocol

Working with protocol teams to have burdensome procedures for only a subset of participants who opt-in, rather than required of all who enroll Revising Informed Consent Language pertaining to blood volume amounts. A CAB member pointed out that men who have sex with men are not allowed to donate blood so comparing volume amount to amounts given during blood donation did not relate. Pregnant women being excluded was raised and more studies now include pregnant women provided it is safe

Community Advisory Board (CAB) Best Practices

Provide stipends for CAB members Invite CAB to co-develop and/or provide input into educational materials and curricula For each protocol team, one CAB member from each region participating in the trial is included on the team CAB members educate CRS staff and investigators o lessons of research impact on their community CAB members addressing journalists with the principal investigator CAB-initiated partnerships with community organizations

Community education involves dissemination of culturally responsive information/materials, outreach, educational presentations, and additional activities. Community partners provide guidance and direction in the planning, development, and implementation of these efforts at each CRS. This information dissemination provides opportunities where misinformation and myths can be corrected and debunked (Table 1).

The HVTN works closely with the Community Educators and Recruiters (CER) staff and CAB members at CRSs globally to conduct activities that increase research literacy within their communities. The development of activities and materials (e.g., website and social media content, educational brochures, etc.) is modeled on community-based participatory research (CBPR) approaches to ensure cultural and contextual appropriateness for the intended audience. CRS staff members are continuously working to establish and maintain an ongoing presence in their communities, positioning themselves as trusted sources of information related to HIV, vaccines, HIV prevention research, and other health concerns as appropriate.

Consideration of community concerns and needed assistance supports community interests and ensures that the research takes into consideration the lived experiences of potential volunteers. This consideration shows the sites’ commitment to community needs beyond just recruiting study volunteers. This underscores the importance of being people-centered and developing community engagement plans that reflect the context of the communities where research is conducted.

RECRUITMENT OF STUDY VOLUNTEERS

Recruitment efforts are the specific activities and processes involved in inviting volunteers to be screened for enrollment into clinical trials. To achieve successful recruitment, researchers must acknowledge that specific communities have been historically excluded from and/or treated unethically in research conducted by medical, public health, and other research institutions. By acknowledging this history and each CRS’s unique relationship with its surrounding communities, research teams can begin to establish common ground. Recruitment strategies may differ based on CRS past experiences and the cultural values and norms of the given population(s) sought for enrollment. Successful recruitment builds upon a solid foundation of community education.

Recruitment strategies may prioritize specific populations because of the disproportionate impact of HIV, the incidence and prevalence of HIV within that community, and/or other medical criteria. In the U.S, the HVTN utilizes tools like adding QR codes to intake forms, using standardized metrics to collect local data that informs regional recruitment best practices (Broder et al., 2020), and the Red Ribbon Registry, a free online self-enrolling registry (www.helpendhiv.org) developed by the HVTN, modeled after the national registry created for U.S. government-funded COVID-19 vaccine clinical trials (Abernethy et al., 2024). The Red Ribbon Registry further enhances recruitment efforts by creating a database of individuals who express interest in participating in HIV research. After providing informed consent, individuals voluntarily share their contact information, demographics, and medical history to demonstrate research interest. This information is securely stored and managed in a password-protected database. CRS staff use the registry to contact individuals in their locale and invite them to screen for an HVTN study for which they may be eligible.

Over the years, the network has found that there is no single standard approach to recruitment for any population, location, or study. CRS staff must be innovative and willing to adapt as they discover what works and what does not in specific circumstances. Through community consultation, monitoring, and evaluation, each local CER team develops their own recruitment practices. Although there may be different approaches to recruitment, there are common factors that promote success. These factors include a strong familiarity with the local community; a willingness to continuously engage the community; an ability to learn from successes and challenges, applying lessons learned to inform future efforts; adjusting strategies for new populations; having established relationships with priority populations; and utilizing recruitment expertise from both inside and outside the network.

Effective recruitment requires tailored approaches for the unique needs of each study protocol, each clinical trial phase, and the needs of each population and locale. Successful enrollment also depends on prior community education that has raised awareness about research. As general awareness rises, the likelihood of encountering people during outreach activities who are interested in knowing more about trial participation increases.

As each CRS plans their recruitment activities for a specific study, they may review their annual community engagement plan in collaboration with their local CAB and determine whether any adaptations are needed. CRS staff are encouraged to consider the broad goals outlined in their annual plan and use them to guide the development of more focused recruitment objectives as appropriate.

RETENTION

Retention of enrolled participants is dynamic and an ongoing process from the inception of study design throughout participation. Retention builds upon community education and recruitment efforts to maintain the scientific integrity of the research, providing a positive experience for study participants who will feel supported, appreciated, compensated, and respected. Successful retention is paramount in research since participants must be retained to successfully meet study aims. It is not typically possible to “replace” a participant if they are lost to follow-up; any loss of an enrolled participant is data lost and a threat to research integrity. As with recruitment, there is no standard approach to retention for any population or study. Retention requires a thorough consent process wherein site staff can learn about the needs and preferences of study volunteers, innovation in engagement approaches to help participants adhere to the study visit schedule, a willingness to adapt practices that aren’t working, and a willingness to learn from feedback.

Successful retention begins before any recruitment activities are undertaken, as the investment in community partnerships, recruitment efforts, CAB membership, and ongoing engagement activities lay the foundation for successful retention. Furthermore, successful retention begins from the first contact CRS staff have with a potential study participant. CRSs collaborate with their local CABs to develop a retention plan (Figure 2) detailing their retention practices and approaches. Retention plans must be considered prior to study implementation, reviewed throughout the study, and evaluated often.

FIGURE 2.

Example elements of a retention plan.

Developing proactive and reactive steps as well as processes to track and evaluate the efforts outlined in the retention plan are important components of successful retention. The ability to recognize a potential retention problem and mitigate it or identify an actual retention problem and respond to it quickly are critically important.

The most important component of retention is the development of a relationship between the CRS staff and volunteers considering screening, who will hopefully become enrolled study participants. During the screening process, CRS staff engage in meaningful discussions to ensure that someone considering joining a study has all of the available information as they make their decision. For example, CRS staff may review known challenges with vaccine induced seropositivity (VISP) (Cooper et al., 2010), including insurance considerations, and how the CRS and sponsor may be able to assist even after the study is completed. The HVTN’s social and behavioral sciences research has informed the creation and maintenance of safe and affirming research sites (Andrasik, Chandler, et al., 2014; Andrasik, Yoon, et al., 2014) through the use of pronoun cards, displaying diverse artwork, hiring people who reflect priority communities, and avoiding labels of “male” and “female” in facilities. CRS staff receive training in cultural responsiveness and work continuously to ensure that their sites provide a welcoming, supportive environment that is physically and psychologically safe.

Participants play a key role in the research and as such are incredibly valuable, and it is critical that their importance is demonstrated to them. The cornerstone of a strong and healthy relationship to support retention is participant satisfaction, which requires genuine efforts to get to know the participant as an individual. CRS staff must consistently demonstrate trustworthy and culturally responsive conduct, maintain positive and unconditional respect for others, and respond to participants’ needs with acceptance while communicating authentic care and concern. In addition to training and workshops offered by the HVTN, CRSs may also turn to local or national agencies for supplementary training for their staff members.

Retention efforts must also validate the participant’s key role and the value of the data they will provide. Across the HVTN, retention is a metric used for the evaluation of site performance and is seen as a solid gauge of a site’s effectiveness in engaging the community. Between December 2000 and November 2023, the network CRSs have retained 82% of participants across all study phases. The ideal participant retention rate is generally considered to be 80% or higher (Abshire et al., 2017). The need for strong retention is shared among all who are involved with a specific clinical trial, including the pharmacy and laboratory personnel who may be in separate locations and invisible to the participant. It is important, however, that these study staff understand that delays in the lab or pharmacy can make it seem like the clinic staff are not being considerate of the participant’s time. Decisions and actions made by anyone on the CRS team may impact retention.

Retention also requires good participant visit management. Each CRS site establishes a uniform system for managing participant appointments. These systems account for scheduling of screening and enrollment appointments, medical procedure appointments, and any appointments that require more than one staff member to be aware of the appointment. CRS staff must ensure that all types of visits occur within the required timeframe, and that there is adequate staff coverage. Using the participant’s time efficiently and minimizing waiting can be key determinants of participant satisfaction with the research experience.

Appointment reminders are another critical component of retention. A best practice is to schedule the participant’s next appointment before they leave the clinic at the conclusion of their current appointment. Many CRSs provide participants with an appointment card or digital alternative such as a text message or email that includes the date and time of the next appointment and the CRS contact information. Other CRSs ask each participant to indicate their preferred appointment reminder method. To allow study volunteers to provide feedback, some sites have developed surveys that give volunteers an opportunity to share their study experiences anonymously. In studies where there is a considerable length of time between appointments or specialized research procedures, it is helpful to remind participants one week prior as well as 1–2 days prior to their appointment, and to consider additional methods of staying in contact between visits. In instances where participants require additional support for meeting the visit schedule, some CRSs have developed strategies such as peer navigation programs (FHI 360/Linkages, 2017) that closely monitor participants experiencing challenges and provide them with additional resources. Peer navigators are trained to identify challenges early and work to address, and ideally prevent, missed study visits.

In addition to participant retention, CRSs also prioritize retaining their CAB members and sustaining long term partnerships with community groups and individuals. The stability of these relationships, and the continued engagement of these collaborators and CAB volunteers, are key to maintaining trust and ensuring the continuity of meaningful community engagement efforts over time.

POST-STUDY COMMUNITY ENGAGEMENT

Another important aspect of the community engagement continuum is the communication that comes after a study is closed or completed. CRSs may have standard operating procedures for communicating various expected or unplanned outcomes. For example, a site may plan a visit to inform a participant about the specifics of their study participation such as the unblinding of their study group and information about their VISP status. Other end-of-study communications may be to disseminate study results to participants and/or to the wider community, to share unexpected outcomes, and/or to invite study participants to join a CAB. This transparent communication is an impactful component of retention that reinforces trust between the site, study participants, and the larger community.

DESIGNATED CER STAFF AT CLINICAL RESEARCH SITES

Each CRS has a minimum of one staff member designated as a CER to implement local CE efforts. This staff person helps strengthen community relationships, listens to local community input to the research agenda, builds and maintains partnerships within the community, and ensures community participation in the research for the CRS and Network. They are often the primary staff liaison to the CAB, ensuring the routine scheduling of CAB meetings, providing administrative support to CAB volunteers. The CABs also engage with the site’s principal investigator and other key staff. Often, they are responsible for managing the site’s recruitment and retention efforts, working with the principal investigator and other CRS staff to ensure efficient recruitment in accordance with protocol expectations. CER staff focus on establishing partnerships with a range of diverse collaborators in the wider local community, and as such play an important role at the CRS. Together with the principal investigator and other CRS staff members, they work to identify, create, and maintain working relationships with priority populations, community groups, and organizations; conduct education workshops for and with these community partners in appropriate venues; and maintain a presence at community events including those hosted by partners and community members. The engagement and support of the site principal investigator is often instrumental in reinforcing the value of community engagement across the CRS.

Because CER staff are central to CE efforts, it is important to ensure that they have the support needed for successful collaborations and reciprocal community engagement. Ongoing HVTN bimonthly global CER webinars and conference calls allow CERs from different sites and regions to share engagement strategies, successes, challenges, barriers, and facilitators in their efforts to meaningfully engage their local communities. Additionally, global CERs convene annually during the network’s Full Group Meeting to acquire new information and updates, discuss current and upcoming clinical trials, and share best practices across geographic regions. These CER-focused efforts create an ecosystem of peer support beyond the support role that the SBS/CEU project managers play.

ANNUAL COMMUNITY ENGAGEMENT WORK PLANS

Each CRS develops an annual work plan that outlines their objectives for meeting the HVTN’s and the CRSs’ local stated goals for CE. These objectives typically address collaboration with the CRS CAB, recruitment and retention, and the processes for implementing these activities. These plans are developed in partnership with all key site staff, including CERs, investigators, CAB members, and clinicians. A draft is shared with the local CAB for their review and input. After approval by the site’s principal investigator, the plans are uploaded to an online platform for review and approval by the HVTN SBS/CEU. Collaboration with the CAB to develop a strategic and comprehensive annual work plan for CE is key to its successful implementation, and helps to ensure that there is agreement about and community support for how CE work will be carried out locally. The HVTN SBS/CEU works with each CRS to review and revise the plans as needed, ensuring that community engagement efforts are being implemented in accordance with relevant guidelines and HVTN evaluation indicators. Sites are held accountable for the work described in their annual plan by the HVTN Network Evaluation Committee (NEC), which measures the performance of each CRS utilizing metrics from the work plan, as well as data quality trackers and quality assurance metrics. Sites submit progress reports on their CE efforts mid-year, and an annual self-evaluation. These reports ask CRSs to identify any barriers they encountered that can be addressed in the following year’s plan as well as successful efforts to be maintained, and the SBS/CEU ensures that these barriers and facilitators are appropriately incorporated into the subsequent year’s plan.

COMMUNITY ADVISORY BOARDS (CABS)

As a condition of receiving NIAID funding, all HVTN CRSs are required to “maintain a productive partnership in the communities in which clinical research will be conducted. This partnership may be facilitated through a Community Advisory Board (CAB)” (National Institutes of Health, 2012). As CRSs build a trusting, open and transparent relationship with their CAB, its members are able to go back into their respective communities to discuss important issues, spread messages about the work of the site with their social and professional networks, bring community concerns to the sites, and ultimately help to build a trusting bond between the CRS and the wider community. The HVTN CAB members are trained and take on roles as community representatives on protocol teams and Network committees, and can serve as spokespersons at local, national, and international events. CAB members provide valuable input on simplifying language within consent forms and educational material, which has also led to the HVTN allocating resources for the development of videos, print materials, websites, slide decks and flipcharts to meaningfully communicate about the research studies.

To ensure continuous improvement in the relationship between CABs and CRS staff, the HVTN NEC administers an annual Community Indicators Survey. This survey assesses the effectiveness of the site/CAB collaboration, tracks changes over time, and identifies areas for growth. Each site submits two surveys annually: one representing the collective responses of the CAB and another from the CRS staff. To ensure unbiased feedback, these surveys are completed independently and then compared by the NEC to identify points of harmonization or disagreement. The results are reported back to each site, and insights gathered from the survey are used to strengthen CE practices, enhance collaboration, and align efforts. Survey items with answers that differ by two or more points on the scale require follow-up, and CRSs submit an “action plan” indicating how these issues identified in the survey will be addressed with their CAB.

As CRSs develop their local CABs, HVTN recommends that a minimum of 40% of CAB members represent populations that are prioritized for enrollment, including but not limited to people who have been or are currently study participants. The CRSs should ideally have guidelines describing CAB membership eligibility criteria, duration of participation, and a description of the expected CAB role(s) in the local research endeavors. Community representatives serving on the CAB should ideally reflect populations with varied likelihood for HIV acquisition and can include people with and without HIV.

Since CAB members are engaged throughout the research process, a frequent activity is to review new protocols and informed consent materials for studies to be implemented locally. CAB members also advise on education and recruitment strategies, suggest events and locations where recruitment efforts should be conducted, participate in community forums, assist in the development and coordination of training on complex concepts and new scientific breakthroughs, and are instrumental in providing research updates and disseminating results in their communities. In addition to these local efforts, CAB members are selected on a rotating basis by the network from sites in different regions to participate as the community representatives on each protocol team that develops and writes a new protocol. CAB members also serve as members of Network committees and working groups, including the HVTN’s Scientific Governance Committee (Figure 3). To facilitate participation, real-time language interpretation is provided for these meetings as needed.

FIGURE 3.

HVTN organizational structure, with community involvement throughout.

CAB members assist in the development of new educational and recruitment materials and messages and assist with efforts to dispel myths and provide accurate information to their social and professional networks. For most HVTN efficacy trials, Community Working Groups are convened by the SBS/CEU comprised of CAB members and CER staff from the sites that will implement the study, consulting on the development of materials to support the specific study. Through these activities, CAB members undergo personal growth and professional development, building their skills, research literacy, and confidence in being liaisons between communities and researchers.

CRSs ensure that CAB meetings are held in a comfortable space that is easily accessible, and work to ensure that any identified barriers are eliminated. To reduce challenges to CAB participation, CRS staff provide food, virtual/hybrid meeting options, reimbursement for travel or parking and, when possible, honorariums and childcare during meetings. For CAB members who will be involved in online meetings, CRSs may provide access to a computer at the research site, as well as financial support for Wi-Fi and data plans to ensure that CAB members can participate effectively. Principal investigators and/or co-investigators are required to attend a minimum of 80% of CAB meetings each year. This level of participation is viewed as the minimum needed to foster a more egalitarian relationship between scientists and community members, ensuring that a trusting relationship can form among researchers and community members who know one another and feel comfortable to speak openly with each other (Switzer et al., 2019).

Some of the most significant relationships a CRS has are those established with CAB members. It is critical that each CRS maintains a strong local CAB to provide a local perspective at all stages of the research. CABs that are representative of the community serve as a bridge between the CRS and the local community and help to build trust. CER staff are important ambassadors for the research in their respective local communities, and their efforts are enhanced by CAB members who can provide introductions to key community members and help to keep staff informed about local events.

THE GLOBAL CAB

Since the HVTN was founded, it has expanded the CAB model through the development and convening of a Global CAB (GCAB) comprised of one member from each CRS’s local CAB. This group meets by conference calls or webinars quarterly and in regional subgroups every other month. Just as local CABs provide guidance to their sites on all aspects of CE, the HVTN SBS/CEU facilitates the work of the GCAB and seeks its input on a range of initiatives in support of advancing the network’s mission and about global research and community engagement efforts. Simultaneous language interpretation is provided for all GCAB meetings, including webinars, to ensure inclusion and to facilitate the meaningful and active participation of all global members regardless of their primary spoken language.

DISCUSSION AND CONCLUSION

Community engagement efforts within the HVTN are dedicated to building and maintaining trust, scientific integrity, and ensuring research is conducted ethically with global communities to achieve the network’s mission. Through effective community engagement, communities provide HVTN researchers with critical social and cultural context, thus enabling researchers to better understand the values, beliefs, and norms of local communities. HVTN Community Engagement efforts contribute to broad and efficient participant enrollment, facilitate community awareness and knowledge, generate insight about the local contexts surrounding HIV prevention research, mitigate social harms, enhance the benefits of trial participation, and support high participant retention. Community engagement ensures inclusive participation throughout the research process, fosters trust, respects regional differences, and ensures that all populations that need an HIV vaccine are included (Network HVT, 2024).

This approach contributes to increased diversity and inclusion across HVTN clinical trials (Huamani et al., 2019). For example, in the U.S., where new HIV diagnoses are highest among communities of color, the percentage of Black, Indigenous, and people of color (BIPOC) individuals in HVTN trials (32.7%) is notably larger when compared to U.S.-based clinical trials of other vaccines (22.1%) (Flores et al., 2021). The network continues to strive for enrollment in all regions in proportion to the number of new HIV diagnoses among priority populations. It is noteworthy that, in the absence of strong community engagement and diverse population enrollment, clinical trials yield results that may be implementable only for limited groups of people, rather than globally. Regulators typically only license products for those populations who were included in the clinical trials, necessitating additional trials and causing implementation delays—the cost of this is therefore measured not only monetarily, but also in human lives (Landovitz et al., 2021).

The HVTN and its affiliated CRSs establish community trust by actively seeking community input, being responsive to suggested changes, and ensuring that spaces are respectful, welcoming, affirming and participant centered. This has resulted in most participants (81%) reporting at least one beneficial social impact as a result of their participation in an HVTN study (Andrasik et al., 2020).

Community engagement plays a critical role in shaping the development of clinical trials, bringing added value to the science, thus ensuring that knowledge gained by both scientists and communities can benefit all parties who stand to benefit most. The network is forever indebted to the participants and community partners who continue to be the best ambassadors for the HVTN’s research.

LESSONS LEARNED AND OPPORTUNITIES FOR THE FUTURE

In our CE efforts, strong relationships with and continuous collaboration with CAB members has been critical. It is important to involve CAB members in all aspects of the research. They should be included as part of the CRS team, during site visits when a CRS is being considered for a study, in community events, and as educators for the researchers and the larger community. The use of peer navigators and community education staff is also an important strategy and should be included in the budgets for all clinical trials.

As we continuously work to improve our CE efforts, we have identified the need for greater inclusion of community members as educators and trainers in HVTN programs. A recent initiative has focused on active involvement of CAB and CER members as coauthors on abstracts and manuscripts emanating from HVTN research. Finally, we hope to identify indicators to assess the extent, quality, and impact of community involvement in clinical trials, creating practical tools to assist in reinforcing community engagement.

Data availability.

Appendices can be provided upon request.