New Advocates’ Primer on HPTN 083 and Webinar

At a time when access, health justice and equity are uppermost for us all, AVAC is pleased to offer a new advocates’ guide to long-acting injectable PrEP, a new prevention strategy that’s shown benefit in some populations and generated a lot of buzz recently.

Want to know what’s known and unknown, who should do what, and what you can do? Click here to read Understanding the Results of HPTN 083.

We’ve also created a webpage of resources for advocates seeking to learn more—click thru to listen to conversations with HPTN 083 and 084 researchers at the AIDS 2020 Research Literacy Networking Zone, learn more about the history of these trials of long-acting cabotegravir (CAB-LA), and more.

Also, save the date for a webinar, this Thursday, July 16, hosted by the HPTN where you can hear the primary results of HPTN 083 and ask all your burning questions! The call is at 10:30am EDT (visit www.worldtimebuddy.com for your local time zone) and dial-in information is here.

In the coming months, we will be convening with prevention research advocates to talk about critical next steps—for CAB-LA and for prevention generally. At AVAC, we will be working to ensure that development and introduction of new PrEP strategies expands equitable access to existing daily oral PrEP, with multi-month prescriptions and self-testing where feasible, to support continued use in COVID-19 contexts. We need your help to advance primary prevention and research agendas that leave no one behind. Join us!

Injectable PrEP is Highly Effective for Some Populations and Must Move Forward as Quickly as Possible

AVAC calls for intensified efforts to increase access to daily oral PrEP

AVAC welcomes new, additional data that shows an injectable antiretroviral for HIV pre-exposure prophylaxis (PrEP) is safe and highly effective in reducing HIV risk cisgender men and transgender women who have sex with men. At the 23rd International AIDS Conference today researchers from the HIV Prevention Trials Network (HPTN) released data comparing rates of HIV among trial participants who received the bi-monthly injection, and those who received daily oral tenofovir/emtricitabine (TDF/FTC). While both strategies reduced HIV risk among participants, the injectable strategy was more effective compared to oral PrEP.

The overall number of infections in both arms of the study was very low, underscoring the high efficacy of both interventions. Importantly, daily oral PrEP is licensed and available now for men, women and adolescents in many communities around the world.

“It’s great to see such a high level of efficacy in a potential additional HIV prevention option and to see the high level of efficacy for an already available option, daily oral PrEP,” said Mitchell Warren, AVAC Executive Director. “As we celebrate this exciting new data, we also must ensure that the companion HPTN 084 study of the same product in cisgender women finishes as quickly as possible and simultaneously work to ensure broader access and support for daily oral PrEP in communities where it is needed now.”

These data add insight to the May 2020 announcement from HPTN 083 that injectable PrEP was highly-effective. Importantly, investigators shared data on adherence among participants taking oral PrEP and found that 76 percent of a random sample had blood levels consistent with daily use. While additional work to understand the results is ongoing, this suggests that the difference in impact might be due to the products. Use of the injection requires an oral “lead-in” phase, and 48 weeks of oral PrEP use after discontinuation. Learning more about preferences and feasibility of both injectable and oral PrEP among people at risk of HIV is a critical next step.

“We need options that will work in people’s lives, we need existing daily PrEP delivered at scale now, and we need multiple additional PrEP options to address diverse needs. CAB-LA, the dapivirine vaginal ring, and future products that show efficacy must be brought to market as quickly as possible,” added Warren.

Given that current data show efficacy in men who have sex with men and transgender women, but not in cisgender women, where rates in adolescent girls and young women are persistently high, messages, licensure and introduction plans need to be swift, clear and strategic with respect to the growing array of PrEP options available for different groups. ViiV, the manufacturer of CAB-LA, must now move quickly to work with regulatory agencies, to share, for community review and input, its plans for seeking review and the timeline for incorporating data from the ongoing HPTN 084 study, while WHO must simultaneously launch a parallel consultative process to support guidance for CAB-LA, so there will be no delay in rolling the drug out.

In 2018, AVAC and the Clinton Health Access Initiative (CHAI) established the Biomedical Prevention Implementation Collaborative (BioPIC) to work with a wide range of stakeholders to develop an introduction plan for long-acting injectables and other next-generation HIV prevention options. Today’s announcement makes planning all the more important if promising research results are to be translated into public health impact.

“Planning for health systems to meet future demands for a drug delivered by injection every two months must also be prioritized,” said Jessica Rodrigues, AVAC’s Director of Product Introduction and Access. “Daily oral PrEP was proven effective more than a decade ago, yet people who want and need this vital prevention option are still unable to access it in many communities. We must not repeat that cycle with new prevention options like CAB-LA and the monthly dapivirine vaginal ring for women, which is currently under regulatory review.”

These clinical trials are an important step in the process, but much additional work is needed. Every product has unique attributes and challenges, and there is much more to be understood about CAB-LA and the way in which it might be effectively delivered in communities and among populations where it is most needed. The HPTN 083 team is still analyzing the safety data on the oral lead-in period as well as the potential need for oral PrEP to “cover the tail” of participants who wish to stop receiving CAB-LA. The research to date suggests that stopping CAB-LA and clearing the drug from the body may not be as easy as stopping daily oral PrEP, since traces of CAB-LA can linger in the body well after discontinuing injections. It will be essential to understand how this can be addressed outside of a clinical trial setting.

“Understanding the potential risk of drug resistance, user preferences, health system capacity needs, the price of the product and the programs to deliver it and support use, amongst other issues, are necessary to move forward as quickly as possible if the product is ultimately approved for use,” said Rodrigues. “AVAC and our partners have already begun this work and have valuable insights; it now needs to accelerate with global collaboration so that the delays that have slowed the rollout of daily oral PrEP do not recur again.”

Also at AIDS 2020, the SEARCH study presented additional information on the impact of oral PrEP in the context of a comprehensive “health-fair” based approach. SEARCH previously found that this approach, which provided ‘universal testing’ and same-day antiretroviral treatment, reduced incidence by about 30 percent. In the latest data, the SEARCH team found that once daily-oral PrEP was offered to SEARCH participants, new HIV infections dropped by about 75 percent, compared to the period when PrEP was not yet available. This underscores the feasibility and urgency of making oral PrEP a part of comprehensive programs, anchored in a universal testing approach.

“The UNAIDS report and much of the news at this conference is reminding us that the world was failing at HIV prevention before the COVID-19 pandemic hit. SEARCH shows us the possibilities for PrEP success in some of the hardest hit communities in East Africa,” Warren said. “It’s critical that we find ways to scale up innovative daily oral PrEP programs even as we plan for access to new HIV prevention options. We can’t afford any more delays.”

Press Release

Injectable PrEP is Highly Effective for Some Populations and Must Move Forward as Quickly as Possible

AVAC calls for intensified efforts to increase access to daily oral PrEP

Contact

Mitchell Warren, +1 (914) 661-1536, mitchell@avac.org
Kay Marshall, +1 (347) 249-6375, kay@avac.org

New York City, July 7, 2020 – AVAC welcomes new, additional data that shows an injectable antiretroviral for HIV pre-exposure prophylaxis (PrEP) is safe and highly effective in reducing HIV risk cisgender men and transgender women who have sex with men. At the 23rd International AIDS Conference today researchers from the HIV Prevention Trials Network (HPTN) released data comparing rates of HIV among trial participants who received the bi-monthly injection, and those who received daily oral tenofovir/emtricitabine (TDF/FTC). While both strategies reduced HIV risk among participants, the injectable strategy was more effective compared to oral PrEP.

The overall number of infections in both arms of the study was very low, underscoring the high efficacy of both interventions. Importantly, daily oral PrEP is licensed and available now for men, women and adolescents in many communities around the world.

“It’s great to see such a high level of efficacy in a potential additional HIV prevention option and to see the high level of efficacy for an already available option, daily oral PrEP,” said Mitchell Warren, AVAC Executive Director. “As we celebrate this exciting new data, we also must ensure that the companion HPTN 084 study of the same product in cisgender women finishes as quickly as possible and simultaneously work to ensure broader access and support for daily oral PrEP in communities where it is needed now.”

These data add insight to the May 2020 announcement from HPTN 083 that injectable PrEP was highly-effective. Importantly, investigators shared data on adherence among participants taking oral PrEP and found that 76 percent of a random sample had blood levels consistent with daily use. While additional work to understand the results is ongoing, this suggests that the difference in impact might be due to the products. Use of the injection requires an oral “lead-in” phase, and 48 weeks of oral PrEP use after discontinuation. Learning more about preferences and feasibility of both injectable and oral PrEP among people at risk of HIV is a critical next step.

“We need options that will work in people’s lives, we need existing daily PrEP delivered at scale now, and we need multiple additional PrEP options to address diverse needs. CAB-LA, the dapivirine vaginal ring, and future products that show efficacy must be brought to market as quickly as possible,” added Warren.

Given that current data show efficacy in men who have sex with men and transgender women, but not in cisgender women, where rates in adolescent girls and young women are persistently high, messages, licensure and introduction plans need to be swift, clear and strategic with respect to the growing array of PrEP options available for different groups. ViiV, the manufacturer of CAB-LA, must now move quickly to work with regulatory agencies, to share, for community review and input, its plans for seeking review and the timeline for incorporating data from the ongoing HPTN 084 study, while WHO must simultaneously launch a parallel consultative process to support guidance for CAB-LA, so there will be no delay in rolling the drug out.

In 2018, AVAC and the Clinton Health Access Initiative (CHAI) established the Biomedical Prevention Implementation Collaborative (BioPIC) to work with a wide range of stakeholders to develop an introduction plan for long-acting injectables and other next-generation HIV prevention options. Today’s announcement makes planning all the more important if promising research results are to be translated into public health impact.

“Planning for health systems to meet future demands for a drug delivered by injection every two months must also be prioritized,” said Jessica Rodrigues, AVAC’s Director of Product Introduction and Access. “Daily oral PrEP was proven effective more than a decade ago, yet people who want and need this vital prevention option are still unable to access it in many communities. We must not repeat that cycle with new prevention options like CAB-LA and the monthly dapivirine vaginal ring for women, which is currently under regulatory review.”

These clinical trials are an important step in the process, but much additional work is needed. Every product has unique attributes and challenges, and there is much more to be understood about CAB-LA and the way in which it might be effectively delivered in communities and among populations where it is most needed. The HPTN 083 team is still analyzing the safety data on the oral lead-in period as well as the potential need for oral PrEP to “cover the tail” of participants who wish to stop receiving CAB-LA. The research to date suggests that stopping CAB-LA and clearing the drug from the body may not be as easy as stopping daily oral PrEP, since traces of CAB-LA can linger in the body well after discontinuing injections. It will be essential to understand how this can be addressed outside of a clinical trial setting.

“Understanding the potential risk of drug resistance, user preferences, health system capacity needs, the price of the product and the programs to deliver it and support use, amongst other issues, are necessary to move forward as quickly as possible if the product is ultimately approved for use,” said Rodrigues. “AVAC and our partners have already begun this work and have valuable insights; it now needs to accelerate with global collaboration so that the delays that have slowed the rollout of daily oral PrEP do not recur again.”

Also at AIDS 2020, the SEARCH study presented additional information on the impact of oral PrEP in the context of a comprehensive “health-fair” based approach. SEARCH previously found that this approach, which provided ‘universal testing’ and same-day antiretroviral treatment, reduced incidence by about 30 percent. In the latest data, the SEARCH team found that once daily-oral PrEP was offered to SEARCH participants, new HIV infections dropped by about 75 percent, compared to the period when PrEP was not yet available. This underscores the feasibility and urgency of making oral PrEP a part of comprehensive programs, anchored in a universal testing approach.

“The UNAIDS report and much of the news at this conference is reminding us that the world was failing at HIV prevention before the COVID-19 pandemic hit. SEARCH shows us the possibilities for PrEP success in some of the hardest hit communities in East Africa,” Warren said. “It’s critical that we find ways to scale up innovative daily oral PrEP programs even as we plan for access to new HIV prevention options. We can’t afford any more delays.”

###

About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of HIV prevention options as part of a comprehensive response to the pandemic.

Injectable PrEP Effective in MSM and Transgender Women

We are writing with breaking PrEP news—data now show that bi-monthly injections of long-acting cabotegravir (CAB-LA) appears to be safe and effective in preventing HIV in cisgender men and transgender women who have sex with men.

The data come from a large-scale efficacy trial, HPTN 083, which is ongoing in 4,500 participants at sites in the Americas, Asia and South Africa. These data were announced after a regularly scheduled review by its data and safety monitoring board (DSMB) found that CAB-LA provided significant protection against HIV. As reported, the DSMB recommended that all HPTN 083 trial participants be told which active drug (CAB-LA or oral TDF/FTC) they were receiving and that placebos be dropped from the study. The study will continue to completion with all participants receiving one of the two active products.

Importantly, these data only apply to the population in HPTN 083—and there is an ongoing “sister” study, HPTN 084, which is evaluating CAB-LA for prevention in cisgender women. This trial began after HPTN 083 and is still enrolling participants. The DSMB recommended that HPTN 084 continue per protocol with both the active and placebo products.

The data announced today by the HPTN and partners show the promise of CAB-LA as a prevention option for some people. This is an exciting development and welcome news for HIV prevention but questions remain, including whether it’s safe and effective in cisgender women, how a bi-monthly injection might be delivered if licensed, how these findings will affect ongoing HIV prevention trials and more.

The HIV Prevention Trials Network (HPTN) held a community webinar on May 22 to discuss the preliminary results of HPTN 083 and the importance of its sister study, HPTN 084, as HIV prevention for cisgender women. Click here to watch the recording.

Press Release

Trial Finds Long-Acting Injectable Antiviral Safe and Effective HIV Prevention for Some Populations

AVAC calls for trial among women to continue with urgency and to accelerate planning for possible introduction of new option to prevent HIV

Contact

Mitchell Warren, +1 (914) 661-1536, mitchell@avac.org
Kay Marshall, +1 (347) 249-6375, kay@avac.org

New York City, May 18, 2020 – AVAC welcomes the news that an injectable antiretroviral for HIV pre-exposure prophylaxis (PrEP) has demonstrated initial safety and efficacy in cisgender men and transgender women who have sex with men. The US National Institute of Allergy and Infectious Diseases (NIAID), the HIV Prevention Trials Network (HPTN) and ViiV announced today that a bi-monthly injection of cabotegravir (CAB-LA) appears to be at least as effective as daily oral TDF/FTC (brand-name Truvada) at preventing HIV acquisition in HIV-uninfected cisgender men and transgender women who have sex with men. The data come from HPTN 083, one of two ongoing HIV prevention safety and efficacy trials of CAB-LA. The announcement was based on a scheduled review by an independent data and safety monitoring board (DSMB) that found that CAB-LA was providing significant protection.

“This is encouraging news for the HIV prevention field. We need additional prevention options to help people protect themselves from HIV,” said Mitchell Warren, AVAC executive director. “We now know that for men and transgender women who have sex with men, CAB-LA appears safe and effective. We look forward to the peer review publication of these data, as well as the results from the ongoing, companion trial in cisgender women, HPTN 084, in hopes that this might be a safe and effective option for all people at risk of HIV infection.”

As reported today, the DSMB recommended that all HPTN 083 trial participants be told which active drug (CAB-LA or oral TDF/FTC) they were receiving and that placebos be dropped from the study. The study will continue to completion with all participants receiving their preferred product. The DSMB also recommended that the HPTN 084 companion study continue with both active and placebo products. Both HPTN 083 and HPTN 084 are designed as double dummy, double blind studies with participants receiving both an active product and a placebo.

“Data on safety and efficacy among women, expected from HPTN 084, remain an urgent priority,” Warren added. “In many communities, women are at very high risk for HIV and have few options for HIV prevention. We cannot allow women to be left behind in the search for safe, effective and licensed HIV prevention options.”

“In addition, there is urgent work to be done to understand what HIV prevention programs and health systems need to do now in order to meet future demands of delivering a drug by injection every two months,” Warren added. “In 2018, AVAC and the Clinton Health Access Initiative (CHAI) established the Biomedical Prevention Implementation Collaborative (BioPIC) to work with a wide range of stakeholders to develop an introduction plan for long-acting injectables and other next-generation HIV prevention options. Today’s announcement makes planning all the more important if promising research results are to be translated into public health impact.”

These clinical trials are an important step in the process, but much additional work is needed. Every product has unique attributes and challenges, and there is much more to be understood about CAB-LA and the way in which it might be effectively delivered in communities and among populations where it is most needed. Understanding user preferences, health system capacity needs, the price of the product and the programs to deliver it, and the potential risk of drug resistance, amongst other issues, is necessary to move forward as quickly as possible.

“Operational research to find out how communities and individuals can best be supported to access the drug and how health systems can be strengthened to deliver it, should it be approved for use, is a critical next step while we await complete data from all populations that would inform a regulatory submission,” said Warren. “This is essential work that can and must begin now so that we don’t repeat the same kind of delays that have slowed daily oral PrEP rollout over the past eight years.”

###

About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of HIV prevention options as part of a comprehensive response to the pandemic.

New Resources on AVAC.org and PrEPWatch.org

On the heels of our spotlight last week looking at the intersection of COVID-19 and HIV, this edition of the Advocates Network features new resources for HIV prevention research and advocacy, work that’s as important today as ever before. Both HIV and COVID-19 are urgent matters of public health, demanding a sustained commitment. Use these tools to stay informed and connected, and scroll down for COVID-19 materials.

PrEP Use Today

  • Our infographic, PrEP Initiations By Country World Wide, updates the global number of people initiating PrEP to date. We are monitoring this data particularly closely to see the impact of COVID-19 on PrEP use, so stay tuned for next quarter’s update and all things PrEP at PrEPWatch.org.

Three Weeks of Activism in Action: PEPFAR COPs 2020

Every year, country teams from more than 50 countries work with the US Government’s President’s Emergency Plan for AIDS Relief (PEPFAR) to make plans and set targets for the year ahead. Over three weeks, civil society and advocates are in meeting rooms fighting for better policies and winning important gains. Check out this year’s wins:

Px Pulse: Understanding HVTN 702

The latest installment of AVAC’s podcast, Px Pulse, talks about what’s next for HVTN 702 (also known as Uhambo). Data show the vaccine tested is safe, but offers no protection against HIV.

COVID-19 & HIV

AVAC.org’s dedicated page to COVID-19 and HIV provides essential resources to support an advocacy agenda on the combined impact of COVID-19 and HIV.

Telling the PrEP Story through Pictures: The Untapped Potential of the PhotoVoice Project

Qualitative research on PrEP often hinges on interviews with study participants. The 3Ps for Prevention (Partners, Perceptions and Pills) study (3P), which evaluates PrEP use and adherence in adolescent girls and young women in Cape Town, South Africa, decided to also try an alternative methodology: incorporate photography as a way for the young women to document their experience with PrEP. Their photographs added a visual component to the research, enhanced their agency as participants in the study, and helped them to shape the conversation about PrEP. The images they created gave researchers a unique view into participants’ perspectives on PrEP, revealing new dimensions to their experience and the factors that encourage or discourage PrEP use.

PhotoVoice is a participatory research methodology that depicts personal narratives through photography. Researchers at the Women’s Global Health Imperative program (WGHI) at RTI International conducted the PhotoVoice project in partnership with the Desmond Tutu HIV Foundation (DTHF). Six young women from adherence clubs in the 3P study volunteered to participate in the project over a two-week period in July 2018. Researchers presented PhotoVoice as a tool participants could use to reflect on what motivates or deters PrEP use and adherence. At the time of the project, they had been taking PrEP for up to one year as participants in the 3P study.

By relying on visuals with brief captions as the primary mode of communication, PhotoVoice brought to light particular aspects to their experience that may not have emerged in interviews or surveys. In research studies with young people, sustaining participant interest and motivation can be difficult. This project is “a fun way to get participants more engaged,” says Shannon O’Rourke of WGHI at RTI International. “PhotoVoice taps into a different part of young women’s brain as they try to explain their experience through this PrEP journey,” says Ariane van der Straten, Senior Fellow and Director, WGHI at RTI International. “We tend to be verbal when we are conducting research – we primarily ask questions and ask participants to answer. PhotoVoice a very different process to produce images of that experience.”

The project kicked off with an initial focus group discussion and a training session by a local photographer on the PhotoVoice method and basic elements of photography. The young women participated in a series of follow up meetings where they shared their photography and discussed what they were hoping to capture about their experiences with PrEP. While the project facilitators provided some guidance, feedback and suggestions were largely offered by the participants themselves.

The project was structured around three topics – relationships, risk perception, messaging – which came through as major themes in interviews with 3P participants. Using these same themes as a guide for the photography allowed researchers to compare the images with the interviews. Participants were also encouraged to go beyond these themes and photograph anything related to their journey with PrEP, and in so doing, they drove the direction of the research. The project culminated in an exhibition at the DTHF Youth Centre in Masiphumelele, Cape Town (where the 3P study is located).

A rich array of photos were produced, highlighting how young women saw themselves in their communities and the lives they were aspiring to lead. The images explore what empowered them, what gave them a sense of belonging, and what they found challenging. In addition to taking photographs, participants wrote captions for each image, describing its significance or symbolic meaning.

Through this process, participants created their own representations of PrEP in their lives. For instance, a photo of women dancing signified how PrEP is empowering to one PhotoVoice participant. Photos depicting a partner’s distrust, worries about sexual violence, and alcohol abuse in their communities were uniquely vivid compared to verbal accounts of these situations, filtered through researchers’ written words. “I don’t think we realize the level of stress and trauma that these young women have to navigate on a daily basis – and what that translates to in terms of creating a commitment and a habit of taking pills,” explains van der Straten. “It was important to ground the words they’re saying into something that is more visually real.”

“When your partner is with you but still looks at other girls, he can put you in danger.”

These photographs enabled young women to express feelings metaphorically, expanding the range and depth of experiences they explored with researchers. A picture of plants deteriorating represents how PrEP prevents HIV in the body; another of children running along the beach shows how PrEP can help foster a fulfilling life. While talking can draw out the rationalized reasons behind the decision to take PrEP, “there is an emotional component to taking PrEP and sticking with PrEP. These pictures render better the emotional dimension that is sometimes hard to capture when we just ask questions,” says van der Straten.

“CD4 is losing power. Taking 3P (PrEP) to avoid HIV and make my CD4 strong.”

The photos and captions revealed the shifting factors that encourage or discourage PrEP use and how they change over time, depending on how long the women had been taking PrEP. Social support was fundamental for new users, with many depicting who they could count on. Family members, particularly mothers whom participants lived with, served as both strong sources of support and in some cases opposition. Those with longer term PrEP use portrayed self-motivation to take PrEP, saying it empowered them and made them feel safer in their communities. Some explored images showing the importance they attach to acting as advocates in their community.

“Support: my mom supports me all the time.”

The photos also illuminated reasons and patterns related to PrEP discontinuation. Most of the young women who stopped PrEP pointed to external circumstances that made PrEP use less feasible, rather than questioning its value. One stopped because she went through the process of becoming a traditional healer but intended to restart after her initiation in the role. Some experienced a death in the family; others had to move out of their communities. The project also highlighted the need to better understand women’s desire to stop and restart, and how to support changes in PrEP use. Those who stopped expressed that, “this is something I will look forward to do later on – just not right now,” says van der Straten.

In fact, most PhotoVoice participants reported positive experiences taking PrEP. It gave them an avenue to communicate with their partners about sexual health that they didn’t previously have. One said the PhotoVoice process allowed her to think more about why she was taking PrEP, and as a result now feels more motivated to adhere to her pills. Another felt it was important to depict her struggle with side effects in the beginning and overcoming these barriers.

“Be who you are.”

The issue of stigma was underrepresented in photos, not because it did not play a role in young women’s lives, but because it was harder for participants to take pictures of those who reject them. One, whose mother disapproved of PrEP, took a photo with her peer’s mother to illustrate a parent’s opposition to preventive pill-taking. Whereas PhotoVoice found that supportive relationships proved central to adherence and a positive experience of PrEP use; how young women internalize stigma and social opposition merits further research exploration.

The exhibition of participants’ photos at the Desmond Tutu HIV Foundation Youth Centre in Masiphumelele created a dialogue among other young women in the 3P study who came to the exhibition, as they compared their own PrEP experiences to what was depicted in the photos.

PhotoVoice proved instrumental for the 3P study and has the potential to enrich research studies more broadly. In the 3P study, PhotoVoice cued researchers early to the need to know much more about the emotional journey young PrEP users experienced. Subsequent qualitative analysis was structured to continue to explore these questions, yielding valuable insights around different types of motivations and the process of forming an identity as a PrEP user. Other studies could similarly benefit from giving participants this alternative, expressive form of self-exploration, and a participatory process to feel more engaged in co-creating the research.

Beyond research, PhotoVoice projects could be built into the design of PrEP programs to understand how PrEP users define their emotional journey and the significance of PrEP. It would allow programs to better align with what’s happening in participants’ lives and offer tailored support. And while many researchers and implementers grapple with the question of how to improve PrEP persistence rates, PhotoVoice could unearth potential solutions. “It’s a powerful tool that is not used enough,” says van der Straten. Making research more visual offers a new window into the lives of young women and, in turn, allow programs to better serve them.

For more information on the work of the Desmond Tutu HIV Foundation and RTI International’s work, see:

Diversifying PrEP delivery models—what about DSD for PrEP?

Help us collect examples and evidence that supports differentiated service delivery (DSD) models for PrEP—fill out this survey!

As part of an effort by The Differentiated Service Delivery Initiative of the International AIDS Society (IAS), AVAC and CHAI’s HIV Prevention Market Manager project and PATH are reaching out with a survey to better understand DSD models currently being piloted and implemented for oral PrEP. The survey should take approximately 10 minutes to complete.

Responses will help inform guidance and development of DSD models, which we hope will ultimately help improve access to oral PrEP and new interventions on the horizon. All data will be kept confidential and will be aggregated to inform a planned satellite session at AIDS2020.

This effort will collect and share what countries are doing to diversify PrEP service delivery models, what models are moving beyond the clinic to reach PrEP users, and what DSD models can be borrowed from treatment and family planning programs to significantly increase oral PrEP use now and for next-generation HIV prevention options as they become available.

Thanks in advance for your time and please send on to relevant networks and colleagues!

Designing PrEP Messages That Work for Young Women: Learning from the Jilinde PrEP project in Kenya

One of the most ambitious programs to roll out oral pre-exposure prophylaxis (PrEP) to populations at risk of HIV so far is Kenya’s Bridge to Scale project, also known as Jilinde, and run by Jhpiego (a Johns Hopkins University affiliate). Jilinde has built in a robust evaluation process that continuously tests and changes its messages and outreach aimed at adolescent girls and young women (AGYW), among other populations. This process was based on an iterative strategy using human-centered design and broad stakeholder engagement that could inform efforts the world over to reach persistently underserved populations with HIV prevention at scale.

The introduction of PrEP in Kenya was backed by a substantial government commitment, and as of October 2019, Kenya counts 56,000 people who have started PrEP. The only country with higher numbers is the US at approximately 132,000 people. Since launching in 2016, Jilinde (a consortium of partners that includes Jhpiego, NASCOP, PS Kenya, ICRH-K and Avenir Health) has rapidly scaled up PrEP. Kenya surpassed a national target set with PEPFAR in 2018 by 559 percent, and there are plans for bold targets in 2020. But bringing PrEP to AGYW and helping them stay on PrEP for as long as they need remains an urgent matter—AGYW age 15-24 made up almost 25 percent of all new HIV infections in Kenya in 2018.

To get PrEP to the people who need it most, in 2017, implementers in Kenya embraced a marketing strategy called segmentation, which groups end-users by behaviors, attitudes, beliefs—rather than only demographics—and develops messages for each based on the traits they share. Segmentation in the context of HIV prevention then uses those groups to inform investments in products and programs designed to meet their needs.

Jilinde’s segmentation work drew from qualitative and quantitative research with end-users conducted by ThinkPlace and Busara Center for Behavioral Economics, and from a series of workshops with young women, civil society, key populations and NASCOP.

Messages and strategies for reaching each segment of end-users were prototyped, designed and piloted. The implementation process led by Jilinde brought in civil society organizations to an early-phase workshop, and included them in efforts to pilot outreach and messages based on what had been learned. Throughout, the team kept an ear out for the distinct fears, aspirations and needs of each segment—to develop messages that spur action.

Initially, Jilinde used a single message for AGYW in the 10 counties targeted for PrEP rollout—an upbeat Swahili slogan in primary colors that reads “KujiPrEP Ni Kujipanga Poa,” which when translated to English means: “PrEP yourself, and plan yourself well”.

Swahili slogan

“We built that message from insights that young people want to be in charge of their health, that no one will care about you more than yourself, and your health is a responsibility,” said Aigelgel Kirumburu, who brings communications and marketing expertise to Jilinde. Creating messages that increase awareness of PrEP among the general population is important especially when a new intervention is first introduced. As the program matured, reaching more AGYW was a priority. Developing tailored messages that recognized and resonated with different segments of AGYW helped to tap into their different motivators for seeking HIV prevention.

Staff also took notice of research from other settings that dug deep into the complex challenges young women face when it comes to primary prevention, sexual and reproductive health, stigma, community norms, parental attitudes, personal agency and the powerful influence of male partners in their lives.

“We looked at developmental science, Adolescent 360’s Nigeria Insights and HIV Prevention Market Manager’s Breaking the Cycle of Transmission and began to understand how hard it can be for a young girl to see her own risk as both real and preventable,” Aigelgel explained. “Plus, relationships are always a primary concern—they [AGYW] don’t want to do anything that puts important relationships at risk.” For example, key insights from the Breaking the Cycle of Transmission found that AGYW in South Africa overestimate their ability to judge risky partners, are rewarded in their environments for minimizing prevention and underestimating risk. In addition, seeking current prevention strategies often involves conflict with disapproving partners, parents, and health care professionals. Meanwhile, those providers who are empathetic often transmit erroneous information to young clients.

Aigelgel says in 2019 the team reexamined the segments they had defined among AGYW. It was time to develop more tailored messages for each of them and design outreach efforts to more effectively reach the various segments. Recognizing that AGYW’s relationship to PrEP varies and can change over time, Jilinde created specific messages for each segment around PrEP awareness, uptake, adherence, and discontinuation. “We’ve realized that one segment is very different from another. What may be important to one girl would not be important to the other,” says Aigelgel.

Table 1: Jilinde AGYW Segments

Jilinde AGYW Sgements Chart

Jilinde has been piloting this refined approach to engage each unique segment, work that continued through the end of 2019. When testing the new messages, Jilinde found that AGYW liked simple messages they could relate to.

“PrEP keeps me on top of my game” emerged as one message that was easy-to-understand, while AGYW thought “PrEP keeps me lit” and “Life is good when PrEP is Fly” were less clear.

“PrEP keeps me secure” and “PrEP is my future” resonated with girls who saw PrEP as a tool to cement their futures and care for their families.

Messages that didn’t spark an interest included: “PrEP is popular, using it makes me fit in” and “PrEP is fun.”

Messages that included a visual—such as photos of other AGYW in the community—got them interested in what the messages had to say.

Beyond messaging, other interventions also came out of the process. To foster girls’ sense of empowerment, Jilinde developed Brighter Future Events: community-based youth-focused gatherings. These events offer PrEP and reproductive health services alongside activities such as bead-making and entrepreneurship lessons, allowing girls to relate PrEP use to their aspirations. Additionally, satisfied PrEP users leverage the power of peer influence to identify eligible girls with whom to talk about PrEP and emphasize its benefits. PrEP users also hand out AGYW-friendly, relatable and easy-to-understand information and education materials (IEC), which reinforce the idea that PrEP is the “in” thing. This peer-to-peer engagement creates a safe space, providing ambivalent young women opportunity to discuss their reservations with their peers and hear testimonials in a non-judgmental environment.

Moving forward, Jilinde intends to incorporate preferred messages in a guide for peer educators, disseminate them to service providers, and promote unified communications for demand creation and service delivery. At the end of 2019, Jilinde transferred management of Kenya’s PrEP program over to the Kenya government’s NASCOP. As part of the transition, Jilinde has contributed to NASCOP’s technical guidance on demand creation, provided campaign materials for PrEP and transferred its PrEP communications materials and social media platforms to NASCOP. “It has been such an important priority to make this a smooth transition,” Aigelgel says.

Looking ahead in 2020, Jilinde will undertake formal research on the impact of its outreach strategies. Aigelgel emphasizes it is vital to continue to learn if AGYW like the messages, show up at Brighter Future Events, engage with the peer-driven conversations, use safe spaces, and respond to campaigns. Findings will be part of an iterative body of evidence to determine where the Kenyan government should invest and what interventions have the greatest impact.

For more resources on AGYW segmentation, see:

What’s All the Fuss About F/TAF? A Trailer for Action in 2020

What’s all the fuss about F/TAF for oral PrEP? The US Food and Drug Administration (FDA) approved drug maker Gilead’s Descovy (also known as F/TAF) as daily oral PrEP in October 2019, with one notable caveat: the label excluded those who are at risk from “receptive vaginal sex”, indicating that more data is needed for the drug to be approved as HIV prevention for cisgender women. The FDA’s supplemental approval requires Gilead to conduct safety and efficacy trial in cisgender women on a timeline that aims for data by 2025.

In the aftermath of this approval, there are questions about the differences between these two forms of PrEP, what contribution F/TAF might make to the pipeline of prevention, and the vital role of stakeholder engagement as Gilead drafts the study protocol for a trial of F/TAF in women. We explore all this and more in this episode of Px Pulse.

Materials