Recruitment staff.

Informants described the skills and experience they looked for when selecting recruitment staff. They felt prior experience working in the community was important, as this gave staff credibility and an understanding of the community. Recruitment staff were also expected to speak the same language as the community and to understand local culture and dialect, affording them the communication skills needed to actively engage with potential participants. Informants felt that strategies that gave potential participants a chance to interact one-on-one with a recruiter were the most effective. They stressed the importance of hiring people to whom potential participants could relate.

"So if you want to recruit young women, you should have somebody who can speak their language, and know what their needs are, and understand their lifestyle."

When asked whether recruitment staff were all female, many study teams said it was important to have male staff as well, as some women would be interested in talking with men. Male recruitment staff also helped encourage male partner engagement in the studies and provide an extra level of security for female staff while they were out in the community.

Informants offered advice about who should be involved in outreach activities in real-world PrEP delivery settings and agreed that the traits important for recruitment staff were relevant outside the clinical trial context. Some suggested that community health workers or other trusted community-based workers could support community outreach and education.

Community engagement.

All trials employed one or more community engagement approaches that involved educating individuals known as “gatekeepers” about PrEP and the trial. These were people within the targeted community regarded as having influence over both the study team’s access to prospective participants and women’s interest in joining the trial. Gatekeepers included community leaders such as chiefs, religious leaders, ward counselors, and non-governmental organization (NGO) representatives. Separately, studies often convened community advisory boards (CABs) consisting of community representatives who were charged with helping design and implement research being conducted in their community. Engagement with both gatekeepers and CABs sought to foster a collaborative atmosphere in which they could understand the trial and study product(s) and guide researchers in study promotion and recruitment. Often, they also provided approval for researchers to conduct community education and recruitment.

Informants found that engaging with community gatekeepers and CABs helped to create an enabling environment for the trial to take place and added legitimacy to the work. When gatekeepers spoke publicly in support of the research, it helped build trust in both the researchers and the study. While discussing the importance of community engagement, one informant said:

"When you just walk up to somebody and tell them about a study […] people often think you're coming with an agenda. If you get trusted community members who can speak about studies, its kind of takes some of the agenda away."

Since community gatekeepers and CAB members had access to different populations, engaging a wide range of people helped researchers to increase their reach.

“I think that it’s difficult for us to reach everybody […] and each of these NGOs and different people reach different groups. So these help us to engage widely and get messages out.”

When asked about real-world application, informants felt that engaging gatekeepers—including leaders, traditional healers, and senior people in the community—was essential. While CABs are not traditionally employed outside of the research context, they felt bringing together an advisory board around PrEP rollout in the community could be productive. Informants suggested stakeholders should have the chance to provide input to the rollout strategy to promote their ownership over the process. This information exchange should happen before PrEP promotion activities starts in the community.

Information dissemination.

All study sites disseminated information to educate the community and potential study participants about clinical trial research generally, PrEP, and the study. Potential participants were not targeted with these approaches; rather, information was shared widely with the aim of creating a supportive environment for PrEP use and trial participation, thereby encouraging potential participants to self-identify and to seek out the study. Common channels for information dissemination included: speaking and handing out pamphlets at community events, distributing printed materials, and using mass media.

Our informants viewed information dissemination as essential as it allowed recruitment staff to reach many people simultaneously, raise awareness, and legitimize the study. Informants felt that hearing about the trial in the community before talking about it with a healthcare provider at the study clinic was helpful.

"We learned that it is important to give information, especially way before you can introduce a product to the people, so that they know it exists.”

Materials like posters and pamphlets posted in clinic waiting rooms and in the community were useful to allow participants time to educate themselves about PrEP, to learn about the study, and to consider participating.

“By us giving them the pamphlets …it gave them some time to read through it, think about it, consider if they wanted to be part of such a program."

Media was a popular form of information dissemination, with radio being the most popular, followed by television. Participants said these were good ways of reaching large groups of people at once, as they would both raise awareness and legitimize the study. However, informants warned that wide-reaching information dissemination strategies lack personal interaction between potential participants and recruitment staff, and as such can lead to misconceptions or stigma. To avoid stigma, informants encouraged use of key messages rather than giving many details about target population or risk status.

"On radio, we really don’t talk about “high risk.” We don't want to add stigma. . . . Instead of actively looking for a group, the group comes to us, and now we can prescreen one-on-one."

When considering translation to real-world PrEP delivery, informants felt information dissemination was equally important and strategies could easily be translated. They stressed that since young women are less likely to reach out and get information actively, rollout strategies to reach young women should employ multiple passive communication channels. Use of mass media in trials was limited, often due to the small scope of trials or ethical concerns, but informants expressed that outreach via media (including social media and nationally endorsed media channels) could build trust and combat stigma during PrEP rollout.

Targeted recruitment.

Targeted recruitment of known or perceived at-risk groups-such as sex workers-within geographic areas of high prevalence was one of the most consistently employed and effective strategies mentioned by informants. Targeted recruitment allowed recruitment staff to have one-on-one or small group conversations with potential participants, allowing women who were contemplating joining the study to ask questions specific to their own situations, often privately. Informants agreed that these activities were crucial for reaching participants at-risk for HIV, as they increased interpersonal contact: by moving beyond the clinic, researchers could access people who do not normally seek health services.

Targeted recruitment was often guided by community mapping, which involved talking to gatekeepers, CABs, and other community members to understand areas where potential trial participants gather and which influential people to collaborate with. Informants stated that each community is different, and it is important to understand the community fully prior to recruitment.

“First we did the community mapping and talked to community members to understand where the study could get a good number of women…. We visited the areas before the study, talked with the community members to know which areas to reach women, and got a sense of hotspots.”

Some informants used existing data or conducted primary data collection as part of their community mapping. One team conducted in-depth interviews with gatekeepers and community members to understand the community and determine which places to target with recruitment efforts. Another team mapped recruitment areas of participants who became HIV-positive during the trial to identify areas with high risk; these areas were used for further recruitment.

"In terms of statistics, we did map…. What we did is we said, ‘Where are our sero-converters coming from? Which local districts?’ Then from there we gather these places are where we got our seroconverters…. And to date, those places still remain high risk."

Other study teams reported using existing information from other stakeholders. For example, one team partnered with NGOs who were conducting HIV testing in communities and asked them where most of their HIV-positive clients were coming from to determine hot spots. Another team worked with community members that were identified by community leaders to understand areas of high risk and provide door-to-door counseling in those neighborhoods.

Others found that existing data were not as helpful, because either they were not detailed enough, or prevalence was high enough that they felt the entire community was at risk. When discussing the use of statistics to find women most at-risk, one informant said:

“The assumption is that everyone is at high risk. We have a prevalence of about 25% …so generally we think that if you are a woman and you live (here) you are high risk.”

Using community mapping results, informants were able to target establishments where they were likely to find at-risk women, such as bars, brothels, youth clubs, and universities. Informants said this approach worked well when recruitment staff understood the community and were supported by community leaders, and could be employed in PrEP rollout if the same level of support was given. Other informants expressed concerns around privacy and safety, explaining that some potential trial participants were not comfortable talking to researchers while they were out with their friends. Further, sending recruiters out at night could be dangerous, and some teams had to hire secure vehicles for their recruiters to travel safely.

Another common approach was door-to-door recruitment. Research teams noted the importance of applying this method only in communities with high HIV prevalence or-in the absence of prevalence data-in communities perceived to be at-risk by community stakeholders. Going door-to-door in low prevalence areas was perceived to be neither time- nor cost-effective. Informants felt door-to-door was successful because it allowed recruiters to give each potential participant one-on-one attention and gave them time to answer questions.

“With door-to-door you spend time with the person. You don't leave there until that person is clear about what you're talking about […] unlike a group setting where you have limited time to explain and they may be afraid to ask personal questions.”

Reflecting on translation to real-world delivery of PrEP, informants acknowledged that door-to-door recruitment is time-intensive. They stressed that every house must be visited to ensure PrEP use is not stigmatized by being associated with the visits made to the homes of people living with HIV. Some study teams reduced cost by partnering with other groups who were already providing door-to-door education or HIV testing services. Informants suggested this could be a strategy when applying this approach in non-trial contexts.

Informants also attempted to target known or perceived at-risk groups by encouraging recruitment among friends, spreading information about PrEP by word-of-mouth by enrolled trial participants. Several informants emphasized that this was particularly effective for recruiting high-risk participants, specifically participants who were similar to those already enrolled.

“That works kind of both ways. If you find a high-risk participant, they are likely to have a high-risk friend. But also if you find a participant who is going to be poor with retention then their friend is also likely poor at retention.”

Some informants reported experiencing challenges with trial participants giving their acquaintances the wrong information. To combat this, informants suggested giving out pamphlets or information sheets to share with people they tell about trial participation.

Clinician referrals.

Most informants described recruiting participants from clinical settings, including family planning clinics, and sexually transmitted infection service settings. Study teams trained health care providers to support recruitment by giving them information about the trial, contraception (since using an effective contraceptive method was often required for participation), and PrEP. They reasoned that providers offering these services would have a good sense of a client’s trial eligibility.

“The low-hanging fruits would be the place where people seek HIV testing-both facility and NGOs- HIV testing, STI, and cervical cancer.”

While most respondents regarded this as an important approach for identifying prospective PrEP users in clinical trials as well as real world PrEP delivery, several informants highlighted challenges associated with relying on clinicians to promote PrEP trial participation among their clients. Some mentioned that this strategy may not work if at-risk women are not utilizing health services. Some study teams encountered challenges with provider workload, which led to fewer referrals than expected.

“As the study went on, the clinics were too busy so that the referral became fewer and fewer. This was a challenge throughout.”

Some study teams had problems with provider turnover and regularly went back to the clinics to review and train new clinical staff.

“Health provider turnover was a challenge, because new health providers did not know about the study. So sometimes we went back to the facility for trainings, reviewing with health providers as well as giving training to new health providers.”

Positive messaging.

Discussing PrEP as a tool to empower women, rather than using fear-based messages about disease and risk, was described as an effective way of motivating study participation and PrEP uptake. Informants mentioned that many women were motivated to use PrEP to empower them to prevent HIV without permission from their partners. Informants commented that women often do not know their partners’ HIV status and lack the ability to insist on condom use. As a result, using messages about empowerment was successful in supporting recruitment. Informants also discussed messages that suggested altruistic motivations for trial participation:

"Women knew that participating in a study that was […] for women, it gave power to negotiate safer sex if it worked. So the key statement would be, 'We are looking for something for us, for women. We want to be the heroes of women, heroes for our children, heroes for our sisters,' like that. Because with condoms they know, 'It is not always in my power.’”

Messages should be grounded in the local context.

Informants felt that people would be more likely to listen to messages about PrEP if the messages were grounded in the reality of the community. They stressed that PrEP promotional materials should be locally made and reflect local, easy to understand language. Often, sites were given posters or materials that were made at the national level, or even above national level. These materials did not resonate with the local audience. One informant described an experience of materials they were given with un-relatable stock photos that resulted in backlash at the community level.

Similarly, some informants felt national statistics were not compelling, but local statistics about HIV incidence and prevalence, that women can directly translate to the risk they face, were helpful.

"I think it is important for people to get information and relate them to their situation or what is happening in the real world. Like being able to understand there is HIV, especially in their communities. And to understand that there is need for something to be done. By giving them this information, it will be important."

Use of multi-faceted communication channels.

Informants stressed the importance of using multiple channels to deliver messages about PrEP, as hearing about PrEP via many sources can add legitimacy to the product. Informants encountered challenges during trials associated with insufficient publicity:

"You find that when speaking to people … who have never ever heard of PrEP… they don’t believe that the PrEP is really available because they haven't heard about it on radio, they haven't seen it in the newspaper, it’s just us coming to them with pamphlets giving them information about PrEP. So I think that we should involve the media as much as we can."

As discussed above, informants used communication channels like radio, television, and public forums to disseminate information about PrEP and their trials. Informants suggested that using communication channels that focus not only on those who might participate in the study, but also on their partners and others in the community. Messages that inform partners and community leaders can help educate and create a supportive environment.

Avoiding stigmatization of PrEP.

Many informants expressed concerns about framing messages about PrEP to focus on stigmatized populations, like sex workers or men who have sex with men. If messaging was designed to target specific populations, they warned, other populations might not feel comfortable taking it. Some researchers stated that they did target mainly sex workers but made sure not to frame their messages to indicate such.

Informants also expressed concerns with the term, “high risk.” There was a consensus that “risk” and “high risk” should never be used in PrEP messaging.

"In the community, using ‘high risk’ words is stigmatizing. The challenge is finding the alternative to this word. Finding ‘high-risk women’ is finding [the] right language to speak with them without stigmatizing.”