Research Literacy on a Plate: In-person HIV vaccines update for Zambian advocates

Daisy is Communications Advisor, AVAC, and based in Kenya. Chilufya is a passionate advocate for biomedical HIV prevention and research and alumnus of the AVAC Fellows program.

What does the “HVTN” in HVTN 702 stand for? And why do some trials, such as the mosaic vaccine trial HVTN705/HPX2008, carry two interchangeable tags? Also, what’s a mosaic vaccine, and why was it developed? Where are the studies happening, and when can we expect results?

Research literacy for HIV prevention advocates involves clarifying these types of questions. Current and accurate knowledge about clinical trials allows an advocate to engage confidently in the clinical trial ecosystem, which includes researchers, communities, ethics boards, and even funders. A recent gathering was a reminder of how effective it can be to conduct these sessions in an informal, low-tech setting, to invest in their knowledge of HIV prevention science.

At an early evening gathering in February, AVAC staffers joined a group of 20 advocates in Lusaka, Zambia for a research literacy session on HIV vaccines, in particular the three HIV vaccine efficacy trials planned or underway in Africa: HVTN 702, HVTN 705/HPX 2008, and the PrEPVacc trial.

Gathered together around a table in the relaxed restaurant environment of a Lusaka hotel, with snacks in hand, attendees turned to paper handouts (no tech) and gave their attention to the two-hour training. The session covered a basic introduction to vaccine science and the research process, the naming of the clinical trials, trial populations and study timelines. Attendees delved into the composition of HIV vaccines, posed questions, and learned things like how various vectors deliver immunogens, often with adjuvants added to improve the body’s immune response to a candidate vaccine.

The group discussed why it’s been so challenging to develop a highly efficacious HIV vaccine, and the exciting work in the field of broadly neutralizing antibodies, or bNAbs for short. Interaction, questions, answers, and some digressions—the group detoured into a conversation about why young women in East and Southern Africa are especially vulnerable to HIV—all of which encouraged vibrant engagement with the material.

In addition to the science, discussions included a look at other issues relevant to clinical trials for HIV prevention. Advocates in Africa play a critical role in two key areas: pushing their governments to allocate more resources for research, and helping community stakeholders understand increasingly complex trial designs.

Participants declared the after-hours session a hit. They found the discussion on vaccine research “very informative” and “beneficial and interactive.”

Clever Chilende of the Treatment Advocacy and Literacy Campaign (TALC) said, “The environment was very relaxing and enabled maximum participation!”

Chilende is also a Community Advisory Board member for several HIV prevention clinical trials in Zambia. He said he would use the information gained from the training “to create awareness among our members in the community”, and called for further sessions to “look at how the research sites are engaging with various stakeholders in order to have their buy-in and improve community participation in the process.”

Other topics attendees proposed were: Ethics in research; clinical trials involving adolescents; issues around vaccine-induced seropositivity; research on hormonal contraception and HIV risk; and community preparations for vaccine trials. All participants said “yes!” to attending a similar training in the future, and most of them said community engagement and partnership were cardinal to fostering support for research.

The same week in Lusaka, AVAC staff joined a meeting of Counselor Supervisor Officers (CSOs) working at IAVI-affiliated clinical research centers. This meeting provided an opportunity for a more formal research literacy talk covering HIV prevention trials broadly: vaccines, ARV-based prevention, antibody-mediated prevention, as well as the recently completed Evidence for Contraceptive Options and HIV Outcomes (ECHO) study. The upcoming open-label trials that will assess the use of oral PrEP and dapivirine ring in pregnant women (MTN-042 DELIVER, and MTN-043 B-PROTECTED), as well as the efficacy trials pipeline were discussed.

Dr. William Kilembe, Project Director of Zambia-Emory Research Initiative in Tuberculosis and TB/HIV (ZEHRP), joined both the advocates’ and CSO sessions. ZEHRP is one of the HVTN 705/HPX2008 vaccine trial sites in Zambia, and Dr Kilembe’s contribution grounded the discussion in details about how the study is being conducted, achievements, challenges, and community perceptions.

In case you’re still puzzling over the questions at the top:

  • “HVTN” stands for the HIV Vaccine Trial Network, the world’s largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. The network collaborates with research institutions in over 30 cities on five continents, and is currently conducting the HIV vaccine efficacy trials HVTN 702 and HVTN 705/HPX2008.
  • HVTN 705/HPX2008, a clinical trial also known as Imbokodo, is underway in Malawi, Mozambique South Africa, Zambia and Zimbabwe, testing a mosaic HIV vaccine candidate designed by the pharmaceuticals company Janssen to protect against the most common variants of HIV. Janssen is also sponsoring the trial, whose double tag simply represents the HIV Vaccine Trials Network’s (HVTN 705) and Janssen’s (HPX2008) naming systems.
  • The AVAC infographic: The Years Ahead in Biomedical HIV Prevention, gives a snapshot of HIV prevention efficacy trials, their products, locations, and timelines.

In-person research literacy trainings will continue to be part of AVAC’s regular research translation and advocacy offerings, which include publications, the Px Wire newsletter, primers and fact sheets, infographics, Advocates’ Network updates, webinar series, P-Values blog, Px Pulse podcast, media cafés for science journalists, and a new online learning and networking platform known as Engage!

For opportunities to participate in short trainings in your area, or for assistance in organizing one, contact us at [email protected].

Activists on the Frontlines of the PEPFAR Planning Process: Week 1

Emily Bass is AVAC’s Director of Strategy & Content.

Every year, programs under the US Government’s President’s Emergency Plan for AIDS Relief (PEPFAR) make plans, set targets and define approaches for more than 50 countries around the world. This year, the process began on March 4, and will continue for three weeks in Johannesburg, with countries arriving in groups for the Regional Planning Meetings (RPM).

The first week wrapped up today, Friday, and AVAC was there along with partners from around the world, including strong representation from the Coalition to build Momentum, Power, Activism, Strategy and Solidarity in Africa, or COMPASS Africa, a unique North-South coalition focused on supporting data-driven activism and advocacy for impact in Malawi, Tanzania and Zimbabwe. Both Malawi and Tanzania were part of the first week’s planning meeting—so the impact of COMPASS was in full effect. With two more weeks to go in the planning process—and opportunities to input into the final Strategic Direction Summaries for the countries who have already met—here are some highlights to celebrate and issues to follow.

Negotiating National Policy Shifts is Possible—and Powerful

PEPFAR planning meetings focus on US government dollars, but the impact of those dollars depends on the policy environment in a given country. In recent years, more country government representatives have started to attend, creating an opportunity for decision-making about national policies and approaches that PEPFAR alone cannot control. In Tanzania and Malawi, COMPASS Africa partners included the Malawian Civil Society Advocacy Forum (CSAF), the Tanzanian DSDUT coalition and northern NGOs, AVAC, Health GAP, MPact, and amfAR.

Before the gathering, activists flagged a number of policy shifts that could improve impact and save lives in Tanzania, including moving from a pilot to a national program with PrEP; allowing HIV testing to be performed by frontline health workers, not just nurses; allowing multi-month ART prescriptions for up to six months for stable patients; and a clear Ministry of Health policy prohibiting forced anal exams for men suspected of being men who have sex with men (MSM). By the end of the week, the Government of Tanzania had agreed to all of these shifts, and Tanzanian civil society had been both bold and supportive in articulating the value of these approaches, a reminder that PEPFAR is not the only focus in these planning meetings. Country-level civil society has a crucial role to play in voicing the needs and priorities of people most at risk of and living with HIV, and using the moment to secure national policy shifts. Congratulations Team Tanzania!

In Malawi, COMPASS partners from CSAF researched and drafted a “People’s COP”—part of the broader PEPFAR Watch project led by Health GAP, independent of COMPASS, in Kenya, Uganda and South Africa. AVAC’s Maureen Luba, the COMPASS regional Advocacy Advisor and a powerful member of Malawian civil society, worked alongside David Kamkwamba of the Network of Journalists Living with HIV and AIDS (JONEHA), chair of the CSAF, Edna Tembo of the Coalition of Women Living with HIV and AIDS (COWLHA), Health GAP’s Lotti Rutter and other civil society to advocate for demands based on the People’s COP. This potent coalition worked with government, the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) and PEPFAR to negotiate many breakthroughs. These included a major shift in viral load monitoring, such that every PLHIV will now receive annual VL test and results. Other key wins included expansion of the program for voluntary medical male circumcision (VMMC) to three additional districts via a collaborative effort between GFATM and PEPFAR, investment in additional human resources for health, and funding for the scale-up of PrEP—a first in Malawi—to 10 districts in 2019-2020. Congratulations Team Malawi!

Getting Specific, Saving Lives: Civil society demands to protect informed choice and rights-based services for women and girls

Every country makes its own plans, but all receive some common marching orders from the US Office of the Global AIDS Coordinator, or OGAC. This year, these imperatives include accelerated rollout of dolutegravir (DTG)-based treatment regimens and ambitious scale-up of index testing, an approach that asks a person who’s tested HIV-positive (the “index” client) to provide the names and contact information of his or her biological children and sexual and needle-sharing partners, who are then followed up for testing. DTG leapt into the headlines earlier this year when a study from Botswana found a “safety signal” (an inconclusive but worrisome finding) that women who became pregnant while on DTG-based regimens were at slightly higher risk of a fetal abnormality known as neural tube defects (NTDs) compared to those taking efavirenz-based regimens. However, DTG is a well-tolerated drug with fewer side effects; people who take it achieve viral load suppression quickly and durably. In fact, at this week’s CROI conference, while PEPFAR negotiations were going on, South African scientists presented the finding that HIV-positive women who don’t start treatment until late pregnancy will reduce their viral load more quickly on DTG-containing regimens, making them less likely to pass HIV to their infants compared to women on efavirenz-containing regimens. (Check out our Twitter feed for a range of real-time CROI updates and stay tuned for an overview of the conference next week.)

The consensus, even before reaching Johannesburg, has been that DTG should be available to everyone who wants it, including women, in the context of contraceptive choices, and that index testing should be done with close attention to the impact on the index client, who might experience violence, stigma or “outing” as a sex worker, MSM or about his or her HIV status if the follow up is not done well.

For DTG, many countries, including Uganda, are adopting a written informed consent form that women must sign before starting the drug. In practice, this means many women aren’t receiving the medication because over-burdened health workers, who are also anxious about client’s health, may find it much easier to prescribe a regimen that seems less risky and doesn’t require a form. So, a step that’s supposed to protect women actually could put a needed drug further out of reach. As Lillian Mworeko, Executive Director of the International Community of Women Living with HIV Eastern Africa (ICW-EA) said, “Paper signing may be great, but it isn’t giving us what we need – what we are talking about is informed decision-making.”

AVAC and ICW-EA, a member of COMPASS, are longtime collaborators, and ICW-EA is supporting sexual and reproductive health advocacy across the region, along with other partners. Here is sample language that was developed this week, to consider adapting for inclusion in all 2019 PEPFAR Strategic Direction Summaries:

  • On index testing: As part of the massive scale-up of index testing, PEPFAR [Country Name] will gather data on the results of the routine violence screening (conducted at every ART visit) for individuals who have submitted contact names, after those contacts have been traced, in order to identify increases in violence associated with index testing contact tracing. Specific attention to promoting and protecting the human rights of women and girls, along with key populations, is essential. Women often learn their HIV status before their male counterparts.
  • On DTG transition: Initiation of DTG transition should start by date XX, be completed by XX, and include tracking of initiation by gender against the stated target [percentage of PLHIV to transition to DTG-containing regimens]. There should be real time review of whether there is gender parity in the percent of men and women transitioning to DTG regimens. If a gap emerges, with fewer women initiating, a rapid assessment of initiation procedures, including consent forms if utilized, should be undertaken. PEPFAR should also conduct assessment of % of ART sites that have FP on-site programmatically and that have stocks of contraceptives, tx/SRHR literacy investment to ensure there are expert clients (women) to do counseling on contraceptives and antiretroviral options. TLE to TLD transitioning should be coupled with treatment literacy led by the community. Women in child-bearing age should be given full information on benefits and risks of using DTG-based regimen and be given options to make informed decision and choice on whether or not be initiated on TLD. The rollout should be based on a human-rights based and woman-centered approach. Women who chose to remain on TLE should be given TLE 400mg for optimization.

Activists Need to Take on Testing: Here’s how!

Index testing isn’t the only hot topic in the arena of HIV testing. Recency testing—which can tell whether a person acquired HIV in the last six months—is also a focus of PEPFAR 2019, as is a rebalancing of testing approaches, or modalities, to emphasize “yield” (the number of people newly tested positive) and reduce costs. What gets counted is what matters. As AVAC has said for many years, a yield-focused approach risks omitting the needs of people who test HIV-negative, and who may be at risk. In addition, there are many questions about how to implement recency testing and to rebalance testing approaches in ways that achieve the desired aims. AVAC, amfAR and CHANGE together co-authored an issue brief on HIV testing strategies that PEPFAR has cited as a valuable guide to these issues—check it out and bring these concerns and questions into your PEPFAR country planning process.

Keep Watch on the Key Population Investment Fund

PEPFAR’s Key Population Investment Fund (KPIF) was first announced two and a half years ago. At the time, it was envisioned as a companion to the DREAMS Innovation Challenge, which would resource frontline groups to provide the services and spaces needed most for some of the groups hardest hit by the epidemic. This year brought the latest information on this long-awaited fund. The resources will flow, via USAID and CDC, directly to local organizations (if a pass-through is required, that organization won’t collect an overhead). What precisely will the funds be able to pay for? Here the language was finely-parsed and left some activists with questions. It is clear that the impact of the funds will be measured in terms of uptake of services, including HIV testing, and linkage to ART or PrEP. But the funds themselves can, PEPFAR says, be provided to groups that do things other than service delivery—such as supporting structural interventions like housing or human rights protections, that make it easier for people to test, choose biomedical strategies and remain in care. This is a tricky notion. Tying KPIF money to performance against PEPFAR indicators is a way of pushing back against what Ambassador Debbi Birx has called “feel good” programs that count people reached, without delineating what they received or what impact was had. (This refers to the KP_PREV indicator, which is poorly defined and deserves a closer look, as Ambassador Birx has acknowledged.) On the other hand, tying performance to these indicators could close space for frontline groups that do the essential work of keeping key and vulnerable populations alive and healthy, by combating injustices, stigma and human rights abuses or advocating around mental health concerns or education, as examples. AVAC and COMPASS partner MPact are actively monitoring the rollout of the newest iteration of the KPIF. We will be meeting with USAID and CDC to learn more in the coming weeks and months. Join us!

Want to learn more about how to inform PEPFAR—from in Johannesburg or afar? Check out these resources:

CROI 2019: Navigating the conference on-site and online

The annual Conference on Retroviruses and Opportunistic Infections (CROI) kicks off on Monday, March 4th in Seattle.

Take a look at this year’s program, search abstracts and follow events through webcasts, aidsmap’s full coverage of the entire conference, AVAC.org’s dedicated page for CROI 2019 and AVAC’s social media updates.

Daily CROI press conferences will be webcast live and available for playback. They can also be viewed via Zoom video conferences or over the phone. Click here for full details.

Among highlights anticipated are data from HPTN 071 (a study looking at the impact of combination prevention on population-level incidence in South Africa and Zambia); the DISCOVER trial (Gilead’s study of daily F/TAF for PrEP in cisgender men and transgender women who have sex with men); the ATLAS and FLAIR studies of long-acting injectable treatment, and so much more.

AVAC and partners will be there, and we look forward working with all of you post-CROI!

What’s New?

Check out these new resources and updates on AVAC.org and PrEPWatch.org.

Pushing the Field Forward

Read Describing–and Doing–the Work: AVAC in print and in the streets, featured on our P-Values blog, for AVAC’s overview of articles featured in a special issue of Current Opinion in HIV and AIDS. AVAC staff members Emily Bass, Laura Fitch, Anabel Gomez and Maureen Luba Milambe joined collaborators in advocacy and human-centered design to co-author two important articles that each highlight our core business of bold, evidence-informed advocacy and action.

Doing It Right: Anatomy of an effective stakeholder consultation

What made the early stakeholder consultation for the Microbicides Trials Network study MTN-042, or DELIVER, such a powerful tool for meaningful engagement when so many other meetings under the name of “stakeholder engagement” are perfunctory occasions? Read our blog to find out!

Diving Deep into Demand Creation

The OPTIONS Consortium—a USAID-funded initiative to expedite and sustain access to antiretroviral-based HIV prevention products—has developed a five-part video series, featured on PrEPWatch.org, that explores key aspects of demand creation for PrEP. Watch them to learn more about what it means to generate useful insights, and how to apply those insights to reach the people who need PrEP the most. And be sure to check out the complementary PrEP Communications Accelerator to help fast track PrEP uptake through strategic communications and demand creation.

Putting Data to Use as Advocates

Listen to a recording of amfAR’s recent webinar Data To Win in the COPs to see its databases on PEPFAR Monitoring, Evaluation and Reporting (MER) come to life as a tool for advocacy. Created as part of the COMPASS Africa collaboration, this web tool gives HIV advocates access to a wide range of PEPFAR program data, such as district-level data with descriptions of what each indicator means, how the results are measured, and how the data can be interpreted. These data are presented in a variety of formats including data visualization, maps and downloadable PDFs.

PrEP Use Around the World: Global PrEP Tracker update

For details on the status of PrEP around the world, download the latest version of the Global PrEP Tracker available on PrEPWatch.org. It provides data on programs, number of enrollments, regulatory status and more—updated February 2019!

Making Our Px Pulse Podcast Even Better!

AVAC wants to hear from you! A year-and-a-half and 15 episodes later, we want to know how well Px Pulse serves your needs. Take this 10-minute survey, and we’ll apply what we learn to bring you insights and information about advocacy for HIV prevention research in the year ahead.

Announcing the 2019 Fellows

Early in February, we proudly announced our 2019 Fellows. These seven advocates, representing the 10th class of AVAC Fellows, will be taking on a variety of priority issues and engaging their communities and governments in Kenya, India, Malawi, Nigeria, South Africa, Uganda and Zimbabwe. We hope you’ll find ways to collaborate with them and with us as the field faces major challenges and opportunities in the year ahead from the results of the ECHO and DISCOVER trials to the evolving rollout of oral PrEP, the possible approval of the dapivirine vaginal ring, a new urgency around condom programming and more.

Anatomy of Effective Stakeholder Consultation: A look at best practices from a consultation for MTN 042

Jeanne Baron is AVAC’s web editor and producer of Px Pulse. Manju Chatani-Gada is AVAC’s Director of Partnerships & Capacity Strengthening.

Incorporating stakeholder engagement early and deeply in the development of a clinical trial for HIV prevention research is for us a clarion call. Including a diverse cross-section of expertise and perspectives at the outset, especially of those who may rely on these strategies to prevent HIV, helps research stay on track to eventually deliver options people will trust and use.

A regional gathering in Johannesburg to discuss the design of a trial called MTN 042 showcases several elements that make early stakeholder consultation a powerful tool when so many other meetings under the name of stakeholder engagement are perfunctory occasions.

Photos from the stakeholder engagement meeting

Also known as DELIVER, MTN-042 will be conducted by the Microbicides Trial Network (MTN) which is funded by the US National Institutes of Health. This study is one of a handful stepping in to fill a vacuum that exists around HIV primary prevention for pregnant women. Data suggest that women are much more likely to become infected during pregnancy and even more likely in the postpartum period. For many women, this represents a significant proportion of their reproductive years. Despite this heightened risk, research often excludes pregnant women in order to protect the developing fetus from possible adverse effects. But this leads to a dearth of data on safe and effective biomedical HIV prevention, such as PrEP, during pregnancy.

MTN 042 will investigate the safety of oral PrEP and the dapivirine ring as HIV prevention for pregnant women. It will also provide information on what kind of trial design will be both acceptable and produce useful results for studies involving pregnant women.

For almost a decade AVAC and the MTN have collaborated on stakeholder consultations, over the years refining our approach based on feedback from hundreds of participants. This work represents a vital aspect to the larger work of Good Participatory Practice, which we encourage readers to learn more about here. The Stakeholders Consultations on MTN-042 in 2018 reflect our best practices in consultations to date.

Manju Chatani-Gada, co-convener of the consultation explains what happened in Johannesburg and why following practices and principles like these mean studies like MTN-042 are better set up for success.

Don’t Confuse an Update with a Consultation

“We often hear of large stakeholder meetings, held right before a trial starts. These meetings can be an important platform to explain the study’s goals, timeline and details about the intervention under investigation, but the meeting participants are not being consulted. Participant feedback may be interesting but will not be used to amend the trial. This is an update,” says Chatani-Gada. In contrast, a consultation poses questions, creates the conditions for an exchange of knowledge, and uses a transparent process for applying the findings to the study’s ultimate design.

At the AVAC/MTN stakeholder consultation, “The [MTN] team made clear what they were taking from this consultation into their protocol meeting, which immediately followed the consultation” says Chatani-Gada.

The agenda of the subsequent meeting to refine the MTN-042 protocol was shaped around issues and recommendations raised at the stakeholder consultation. As the consultation report describes, the next version of the protocol incorporated several of the suggestions made at the consultation. “Not everybody does that. Things are changing but civil society stakeholders have sometimes felt that they have been invited to rubberstamp fully developed plans.”

feedback from the meeting

Get Stakeholders to the Table Early

The consultative process should start with the development of the protocol, which spells out the rationale, objectives, methods and other details of a clinical research study. The protocol should reflect insights that have been gathered from an early and comprehensive discussion with key stakeholders. Ideally, community members should also be part of protocol committees themselves.

“At this meeting the investigators gained insights about how to shape fundamental aspects of the study so that people will feel comfortable supporting it,” says Chatani-Gada. For example, stakeholders encouraged researchers to follow up with infants born during or after the study for a longer period, and to find ways to establish a better baseline for adverse and healthy outcomes in pregnancy in the relevant communities. In addition to this early regional consultation, there are important country-level consultations. Those will follow in 2019 in Malawi, South Africa, Uganda and Zimbabwe and will include a larger number of women from the proposed trial communities as participants.

Include the Right People and Spotlight Community Voices

It’s critical that the leadership of a study understand the experiences and concerns of potential trial participants and their immediate and broader communities. Relying only on community advisory boards to filter this information may obscure pressures that could complicate the progress of the trial down the road.

“Trial participants, like all people, have complex lives and sometimes face challenging conditions as they make decisions. Researchers need to hear directly from them, and a diversity of other stakeholders too, to better understand those challenges and respond accordingly. Research must fit into the lives of the people in the trial rather than have them fit their lives to research,” says Chatani-Gada.

The researchers behind MTN-042 saw this first hand at the Johannesburg regional consultation. They needed to know if research involving pregnant women could even get through a review process in the places where the proposed trials would take place: Malawi, South Africa, Uganda and Zimbabwe. To explore this question, 35 people were invited to the discussion: researchers; regulators; representatives from ethics committees, ministries of health and the WHO; advocates with expertise on HIV prevention and women’s health and empowerment; and two women from one of the trial-site communities. Both had recently been in a study investigating PrEP use and safer conception. (In these earlier studies, women who became pregnant exited the study. MTN-042 will exclusively study PrEP among women who are already pregnant.)

As people in the room began to share a consensus about moving forward, these two women offered unique and powerful perspectives. Their participation in those earlier trials meant they were relatively knowledgeable about clinical trials and also concerned about their HIV risk. When they were asked, “Would you continue to take PrEP during your pregnancy if you were offered it?” their answers differed. One said, “No, I would not be comfortable joining this trial until I knew the drug was safe.” The other said she would have taken it because she is worried about her exposure to HIV and what it would mean to her child if she got infected.

“This was a gut check and a reminder not to make assumptions about what decisions people will ultimately make. A minister of health, a researcher, a member of the ethics committee is not going to be asked to join a trial. Researchers need to confront these truths and recognize different women will make different choices. Women are not homogenous; their needs are diverse. We can’t presume we know what they need or want, ” says Chatanti-Gada.

Put Everyone in the Room on Equal Footing

To create the conditions for open dialogue, the facilitators set the tone early on in the meeting. “We started the consultation with civil society partners talking about what HIV prevention means to them. So people can get quite personal about how HIV prevention comes up in their lives.This opener grounded the discussion in real-world considerations,” says Chatani-Gada.

“We set the tone by encouraging an informal setting. We relied on first names. There was no Minister So-and-So, or Dr. So-and-So. Everyone participating has to see each other as equally credible and influential, and techniques such as these foster those values.”

It’s also important that everyone involved can engage with the science being presented. “As we often do, we convened a pre-meeting for civil society and community participants in the days before the consultation. Often, we exclude researchers from these sessions. It’s a safe space to break down research terms, wade into the content, and raise questions and concerns. Participants from the pre-meetings routinely tell us these pre-meetings build their confidence in discussing research. It equips them to dig into the material and direct the conversation.”

Encourage Discussion and Questions with New Meeting Practices

It’s important to use multiple methodologies to engage the participants, such as presentations, testimonials, panel discussions, real-time surveys and such. MTN often uses a digital instant-response system to probe important questions. Participants see a question on a screen and can anonymously select from multiple-choice answers. Everyone can see the results in real-time.

“Very interesting conversations flow from these sessions, and it gives the investigators a chance to explore issues that still concern stakeholders.” It also gives researchers immediate answers to the most critical questions they have about a protocol.

For example, this process revealed that almost all participants wanted changes to the makeup of an interim review panel. They suggested African experts be selected over American ones with similar credentials, and a greater number of community representatives should be on it as should experts on pharmacokinetics, drug interactions and certain regulatory matters.

Chatani-Gada also says this set of questions and answers represents concrete findings from the consultation—an overview of what the investigators learned from the participants, which makes transparent how the consultation findings will be carried forward for further consideration.

Commit to Ongoing Stakeholder Engagement

One-off meetings achieve little of lasting value. Instead, broad stakeholder meetings and community-level engagement must be ongoing. They are all critical for research literacy, awareness of HIV prevention and recruitment for the trials. A strong partnership between the research field and civil society relies on continuing dialogue with many different ways to offer feedback.

Follow up is Essential

For example, local organizations will work in partnership with AVAC and MTN to co-convene country-level meetings on MTN-042. Their leadership at the very beginning of the planning stages mean they will help shape the agenda and participant list in the national and local consultations to come, and increase interest. It also means these local partners will play an ongoing role in garnering support for the study’s success. “By working together, the community, civil society and the researchers carry the field forward together. And that’s what we need for HIV prevention research to succeed.”

AVAC’s Podcast Px Pulse, Switching It Up In 2019

AVAC wants to hear from you! We launched our podcast, Px Pulse, in late 2017 and since then we have produced 15 episodes bringing you interviews, first-person reflections and rich discussions covering issues facing HIV prevention research and advocacy. Now it’s time for us to take stock and learn more about what you want from Px Pulse and how to deliver it. Whether or not you have ever listened to AVAC’s Px Pulse, we’d like your feedback!

Please take 5-10 minutes and fill out this brief survey!

We’ll invest your feedback into generating future episodes that cover your priorities in a style you find compelling and in a format that works for you!

Announcing the 2019 AVAC Advocacy Fellows

AVAC is delighted to announce the 2019 AVAC Advocacy Fellows – the 10th class of the Fellows Program!

AVAC’s Advocacy Fellows Program was launched in 2009 to expand the capacity of advocates and organizations to monitor, support and help shape biomedical HIV prevention research and implementation in countries where research is ongoing and/or new interventions are being rolled out. The program is guided by AVAC’s commitment to effective and sustainable advocacy that grows from organizational and individual interests, priorities and partnerships.

In the 10 years of the program, we are proud to have identified and supported 70 Fellows. Each of these advocates have identified gaps and made their own commitment to advancing HIV prevention tools, policies and programs that meet the needs of their communities and countries. Alumni fellows continue to champion HIV prevention, often leading or playing key roles in moving the prevention agenda forward in their countries and regionally. Please visit the Advocacy Fellows page to learn more about the current and alumni Fellows and to meet the 2019 group.

The seven 2019 Advocacy Fellows were selected from a pool of over 120 applicants from 20+ countries. We are happy to welcome our youngest cadre of fellows and our first fellow ever from India. We thank all of the applicants and their proposed host organizations for the time and effort put into the application process. We’re also grateful to the independent review committee of advocates, scientists and former Fellows and Hosts who guided our decision-making.

Join us in welcoming the seven 2019 Advocacy Fellows and the organizations that will host them:

The 2019 Fellows’ year begins in April at a time when there are several critical issues confronting the HIV prevention field including anticipated results from the ECHO and DISCOVER trials; consideration for programs and policies for the rollout of oral PrEP—and possibly the dapivirine vaginal ring; prioritization of condom programming; bringing the voice of community advocates to the center of the research agenda and much more. We hope you’ll find ways to collaborate with the new Fellows in 2019 and beyond.

A Call for Applications for the 2020 Fellows Program will be announced mid-2019. If you would like to be notified or have any questions, please email us at [email protected].

And stay tuned for more information about the 10 years of the Advocacy Fellows program!

Describing—and Doing—the Work: AVAC in print and in the streets

In a special issue of Current Opinion in HIV and AIDS, published in January 2019, AVAC staff members Emily Bass, Laura Fitch, Anabel Gomez and Maureen Luba Milambe joined collaborators who work in advocacy and human-centered design to co-author two important articles. Each highlight our core business of bold, evidence-informed advocacy and action. The articles are:

These articles are behind a paywall for now. If you are interested in obtaining a copy and cannot get access, please contact us here, as AVAC is committed to sharing information and generating discussion without barriers. Publishing work like this in peer-reviewed journals is an advocacy tactic, as it puts critical ideas and histories into the “official” record. The good news is that the content in the articles is robustly reflected in our ongoing work and in our other publications.

In Demand creation for primary biomedical prevention: identifying lessons across intervention to inform daily oral preexposure prophylaxis programs, co-authors Emily Bass, Laura Fitch, Anabel Gomez and consultant Rebecca Loar, make the case that today’s primary prevention programming isn’t yet harnessing the potential of human-centered design, and that lessons from the rollout of voluntary medical male circumcision (VMMC) must be urgently brought to bear on newer strategies like PrEP. To find out more about how and why, check out the 2018 AVAC Report, and the work of the Prevention Market Manager.

In Civil society demand for accountability to achieve 90-90-90 targets: lessons from Eastern and Southern Africa, Maureen Luba and colleagues use case studies from Kenya, Malawi and Uganda, among other countries, to show how African AIDS activism has shaped the global response, and must continue to do so. These case studies capture work that’s opened the PEPFAR process to civil society engagement. These stories demonstrate how, through innovative North-South partnership, civil society has successfully unlocked what had been a closed and relatively unaccountable process for setting goals and allocating resources. This work is ongoing in many forms and on many fronts, including via the Coalition to Mobilize Power, Activism, Strategy and Solidarity (COMPASS) Africa, a multi-country activist effort that AVAC is proud to work on with allies in the global North and South. Learn more about this work and about PEPFAR engagement here.

Key Points from the Articles

From Demand creation for primary biomedical prevention: identifying lessons across intervention to inform daily oral preexposure prophylaxis programs:

  • The literature on demand creation for other HIV biomedical primary prevention strategies have much to teach anyone interested in seeing interventions reach the people who need them. For example, one study of the demand creation for VMMC from Zambia and Zimbabwe details the benefits derived from using demand-side thinking to segment potential end-users.
  • Studies on condoms suggest the risk failure if demand creation is neglected. The authors note falling investment in demand creation coincided with an increase in new HIV diagnoses in Burkino Faso. And other condom studies described problems such as a lack of market analytics and “inadequate sustained demand creation for targeted segments of the population including young people, men who have sex with men, and sex workers.”
  • The urgency behind all of these findings becomes clear when one considers reports like one cited in the article from a Kenyan demonstration project that found high rates of discontinuation of PrEP across key populations groups. But that does not mean people don’t want PrEP. It can’t be emphasized enough, VMMC saw significant gains after efforts at demand creation underwent a process incorporating demand-side thinking.
  • Even more chilling, the authors point out, “failure to integrate and act on the lessons learned from VMMC delivery could imperil future investment in PrEP and other key interventions… Indeed, unmerited statements about who will or will not choose to use adherence-dependent methods such as daily oral PrEP or a future microbicide are already being made with some regularity.”
  • Demand creation and services for delivering primary prevention must be designed with care, both must address the varied needs of people at risk of HIV. Until then, no one will know what works.

From Civil society demand for accountability to achieve 90-90-90 targets: lessons from Eastern and Southern Africa:

  • Relentless work from national and global advocates has resulted in critical gains in access to HIV treatment and prevention but has not been well-documented. This article begins to address that absence with several case studies. Together, they tell the story of advocates turning to innovative methods to gain the attention of decision-makers, mustering evidence and persuasive arguments, and bringing meaningful change.
  • This history makes the case for scaling-up the capacity of civil society as a priority to gain control of the epidemic.
  • The stories illustrate three unique and vital functions attributed to civil society:
    a) Through innovative North-South partnerships, civil society has unlocked what had been a closed and relatively unaccountable process for setting goals and allocating resources.

    b) Civil society invigorates discussions, replacing status quo assumptions with fresh analysis. This pressure creates new possibilities, improved strategies and greater impact from interventions.
    c) Civil society’s continual demand for accountability and its ability to push an agenda led to institutionalizing a more open process for decisions on policy, programs and funding.

  • UNAIDS reports that missing the 2020 fast track targets (fewer than 500,000 new cases and fewer than 500,000 deaths from HIV annually) by only five years will mean a million more deaths and two million more cases by 2030. As the authors make clear, the unique role played by civil society is a matter of life and death. The power of advocacy must be leveraged with a greater commitment to fund and support it.

Refining the HIV clinical trials enterprise

New opportunities for innovation and discovery in HIV research are within our grasp. By 2020, the National Institutes of Health will refine its science-driven HIV clinical trials enterprise to deliver the innovative, efficient results needed to turn the corner on the HIV/AIDS pandemic.

Every 7 years, NIH competitively renews its funding of the HIV clinical trials networks operating in the United States and internationally. NIH began this renewal process in 2017, embarking on conversations with stakeholders and the research community to define the questions that will drive the next wave of HIV treatment and prevention innovation, and set in motion the process by which we may seek answers to those questions. These conversations have helped shape the focus and priorities of NIH’s HIV clinical trial networks through 2027.

In January 2019, NIH released six Funding Opportunity Announcements (FOAs) inviting proposals on HIV prevention, therapeutic, and vaccine networks; laboratory centers; and statistical and data management centers. A FOA for HIV clinical trial units is planned.

Learn more about the FOAs and the network refinement process with the resources and information available on this site. The following resources may be of particular interest to potential applicants:

For information about the refinement of the HIV clinical trials enterprise, view background>, videos and blog posts.

Don’t Miss These New Resources on AVAC.org

Happy New Year! We hope that you started your year refreshed for important work ahead–and to help get you started, we’ve rounded up a few select resources from AVAC.org that we hope you’ll consider as you set your agenda for 2019. We think these cross-cutting and thought-provoking tools help to frame the most pressing issues facing HIV prevention in the year ahead.

Px Wire: 10 questions for 2019
The final Px Wire of 2018 lays out 10 questions on issues confronting the HIV prevention field. We raise questions and offer brief analysis of: NIH funding and the future of research on user-initiated prevention options; anticipated results from the ECHO and DISCOVER trials; how programs and policies for rolling out oral PrEP—and possibly the dapivirine vaginal ring—need to evolve; how condom programming should be prioritized, and so much more. The centerspread features an infographic linking the timeline of prevention research with the pace that’s needed for implementation.

Next-Generation Trial Design
Has HIV prevention research seen its last placebo-controlled efficacy trial? As trials become increasingly complex, researchers are exploring how to continue to successfully study new strategies. AVAC has two new resources to help you understand the issue and the implications for advocacy and stakeholder engagement.

amfAR’s new database on PEPFAR
The PEPFAR Monitoring, Evaluation and Reporting (MER) Database, is a new web tool created as part of the COMPASS Africa collaboration. It gives HIV advocates access to a wide range of PEPFAR program data, such as district-level data with descriptions of what each indicator means, how the results are measured, and how the data can be interpreted. These data are presented in a variety of formats including data visualization, maps and downloadable PDFs.

Special Supplement on GPP
In October, the Journal of the International AIDS Society published a special supplement, Science, Theory and Practice of Engaged Research: Good Participatory Practice and beyond. It documents good participatory practices and explores their value to stakeholder engagement at clinical trials across research areas, geographies and populations. You might also like how one of the authors of the JIAS supplement laid out the issues in this piece, cross-posted on AVAC’s blog, P-Values.

Women Need Effective Choices: Do research dollars reflect this priority?
A growing number of voices are recognizing the importance of choice in HIV prevention – including a year-beginning statement from Maureen Goodenow, the Director of the Office of AIDS Research at the National Institutes of Health. The need for better choices is especially imperative for women who carry a disproportionate burden of HIV risk compared to men. The Resource Tracking for HIV Prevention R&D Working Group’s annual report looks closely at investment trends and features an infographic depicting the status of 2017 investment in research investigating PrEP for women.

Young Women Demand Inclusion
The best way to understand the diverse needs of those who face a risk of HIV is to listen to the people themselves. At the HIV Research for Prevention conference in Madrid in October, a group from the Young Women’s Leadership Initiative organized a protest to demand their inclusion in the process of planning for research. Read their statement, get inspired and heed the call in your work in 2019!