Thailand National Community Advisory Board

Amidst the 80-plus participants at AVAC’s African Partners’ Forum, one face may have stood out more than any other. The one participant from Thailand, an AVAC partner of almost eight years, brought into the room a global perspective and a wealth of research advocacy expertise— that, despite his solitary role and his sometimes quiet demeanor, was palpable throughout the three days.

Udom is a consultant for AVAC working on community engagement in HIV research, and a consultant for the Retrovirology Department of Armed Forces Research Institute of Medical Sciences (AFRIMS) on CAB constitution since 2010. His work at AVAC is to promote community participation in HIV research and Good Participatory Practice (GPP) implementation in the country. Udom is also a member of the National Subcommittee on HIV Vaccine Development and the National Subcommittee on Biomedical HIV Prevention representing the Thai civil society involving in HIV/AIDS. One of the founders of Thailand National Community Advisory Boards (NCAB) on HIV research.

Through the Thai NGO Coalition on AIDS, he has championed the AVAC/UNAIDS Good Participatory Practices—both with research entities and national bodies—and has helped move the dial on stakeholders’ roles in the research process in Thailand. We asked him to share his experiences with the group, in particular development of a National Community Advisory Board. Here are some of his words:

Community participation in HIV research in Thailand can be divided roughly into two stages – before RV144 stage, and RV144 (and beyond) stage. RV144 was the world’s largest HIV vaccine efficacy trial and conducted in Thailand. In Thailand, the concept of community participation in HIV research was rarely mentioned before the RV144 vaccine trial. In the pre-RV144 era, almost all HIV studies in Thailand were treatment, and participants were AIDS patients of the hospitals that also contain research centers. Hence there was no need to engage others besides the patients and their families. Recruitment strategies of that time were word of mouth, banners posted around the hospitals, and pamphlets. For HIV prevention trials such as HIV vaccine, recruitment might involve one or two meetings with villagers of the target area and the local health officers.

Due to its sheer size and the resources that came with it, RV144 inadvertently changed all of these. A few Thai AIDS activists heard about the trial for the first time at an international AIDS conference and were upset for being left out. They thus demanded that the researchers discuss the plan of the trial with the communities living in the target area to prepare them. Attempting to pacify the NGOs, the researchers held several meetings to discuss the ways to move forward with them. Even though both sides agreed that community participation was necessary, they couldn’t agree on the approach or the definition of community. At the same time, the model of the community advisory board (CAB) had been used in the USA for quite some time. The Thai NGOs involved in the meetings seized on the idea of CAB because it allows laypersons to become involved in HIV research, and it was romantically linked to AIDS activism. From then on, CAB became popular among Thai NGOs. Later on, some institutes conducting HIV research in the country also adopted the CAB model to appease Thai AIDS activists (or agitators depending on viewpoint) and to fulfill requirement of the trials’ sponsors. As a result, several CABs were desultorily formed; a couple of CABs were formed even before the responsible research institutes had a study to consult them with.

Unfortunately only the name (of CAB) is adopted. Most CABs in Thailand are not clear about their roles and responsibilities. In the beginning, a couple of CABs existed in name only. There was no meeting, no activity. The selection (of CAB members) process was, and still is, not clearly defined. Criterion for CAB members is ambiguous; some CABs include researchers and members of research teams as bona fide members. In many cases, CAB members were selected based on their deferential attitude toward researchers and staff rather than their qualifications, experiences, or representativeness. The only CAB activity is bimonthly meetings that dedicated mainly to routine update of the trials with very little (or no time) for other discussion. CAB members are not consulted about the meeting agenda ahead of the meeting. The consultations sought from CAB members in the meeting are limited to informed consent forms and, occasionally, educational/communication materials. Most CABs, except one, have never seen protocols of the studies about which they are to give advice. A few CAB members think that the purpose of informed consent is to absolve the researchers from legal responsibility. Many CAB members think that CAB is an additional arm of the research team to recruit people for the trials.

In general CAB members receive no formal or structured training on relevant topics including clinical research and research ethics. Other activities that could improve CAB capability are also lacking such as orientation for new members, mentoring and coaching for new and old members who may benefit from such activities, or reading materials to improve their research knowledge. Regarding capacity building for CAB, the only exception is the youngest CAB formed about 3 years ago by a bio-ethicist working with a few AIDS activists who have CAB experience. This particular CAB has regular CAB training sessions built into their bimonthly CAB meetings as well as annual training workshop and orientation for new members.

The idea of the national CAB was born during the implementation of RV144. A few AIDS activists involved in community engagement of the trial wanted to create an autonomous coordinating CAB to promote cross-learning between existing CABs. After informal discussions with other NGO workers who were CAB members of various research institutes and a meeting to discuss the idea, the national CAB was formed in May 2014. The goal of the National CAB is to promote ethical HIV clinical research through meaningful community participation. The national CAB wants to focus on capacity building in HIV research and research ethics for existing CABs and relevant community members. Members of the national CAB are selected from six HIV CABs in the country. Notwithstanding the name, the national CAB receives no funding from government agency or research institutes.

Almost from the beginning all associated research institutes, except one, are supportive of the national CAB. Only one research institute reckons that the national CAB has to be linked to specific institute/s and formalized by a government body.The national CAB meets every 2 months to discuss various topics that are not specific to trials or institutes but related to wider issues such as the national guidelines on HIV prevention and treatment, ethics of HIV research on vulnerable populations, and the drafts of the national law on human subjects research. The national CAB also conducts activities including GPP training for CABs and community groups, annual NCAB workshop, and training on research ethics for CABs and community groups.

It is too early to gauge the impact of the national CAB. For Thailand, this kind of CAB, an independent and NGO-initiated CAB, is unprecedented. Presently key HIV research institutes and a few HIV-related national bodies are aware of the national CAB and have no object regarding its existence or function. A chairperson of a national sub-committee related to HIV wants the national CAB to serve as additional IRB in parallel with other IRBs in reviewing biomedical HIV prevention trials conducted in Thailand. This is an important challenge for the national CAB considering its tender age and the members’ combined experience. To fulfill the expectation, members of the national CAB have to significantly improve their knowledge on HIV science and research ethics. They also have to expand their involvement horizontally and vertically. It is naïve to expect that this will be easy or encounter no opposition or resistance from other stakeholders. In the end it is left to members of the national CAB to prove that they are relevant and capable of the responsibility.

Rectal Microbicides and Real World Preferences: Discussions at the Partners Forum

Cindra Feuer is an AVAC staff member.

The Partners’ Forum rectal microbicide breakout session could not have come at a more strategic time. By the latter part of this year, the first Phase II rectal microbicide gel study, MTN 017, will come to an end with results expected in early 2016. However, it doesn’t seem likely that this product—which is a reformulated, reduced-glycerin cousin of the 1% tenofovir vaginal gel evaluated in CAPRISA 004, VOICE and, most recently FACTS 001—will move into the Phase III efficacy trial that has been discussed as the next step after MTN 017.

There are many reasons why the Phase III may not happen. There has been anecdotal evidence from MTN-017 and community gel discussion that the gel is not really lube-like (the applicator used to apply the gel means that it ends up in a different part of the rectum than what is lubricated during anal sex). There has also been criticism of the pre-filled applicator (the same one used in the trials of vaginal gel), with some finding it uncomfortable and burdensome to carry around and use. MTN 017 was designed to gather this kind of feedback. These reports are part of what has caused the field to pause. The recent disappointment from the FACTS trial has added to this.

FACTS 001 found that, even though women used the gel about 50 percent of the time, this level of adherence wasn’t high enough to reduce risk of HIV. In the meantime, daily oral PrEP is available today for people at risk of HIV, including the same men and transwomen who might want a rectal microbicide; long-acting injectable ARVs for prevention and treatment are also on the horizon.

The breakout session on rectal microbicides at the AVAC Partners Forum deliberated on new directions, demands and next steps for the rectal microbicide field. Participants felt strongly that there was a need and desire for rectal microbicides even with the advent of oral PrEP. They declared strongly that research should continue.

The second key message took some serious consideration, weighing the urgency of the need and desire for a rectal microbicide against the realities of what is available today, and the promise of the longer-term pipeline. But in the end, the group decided that its recommendation was that anecdotal evidence from MTN 017 should be taken seriously and rectal tenofovir gel shouldn’t move into phase III because of lack of acceptability of the applicator and the fact that the gel does not function like a lubricant—meaning two products would still need to be used. The group heard a description of Microbicide Trials Network’s (MTN) proposed Phase II Adonis Study design comparing different strategies for delivering a rectal microbicide, looking beyond the current applicator.

The group also weighed in on longer-term efforts and agreed on the need to: Keep a robust pipeline moving through development, including dapivirine gel Phase I to start this year; douche microbicides; and preclinical compounds especially Griffithsin, a non-ARV microibicide.

And, of course, the group was all in favor of continuing rectal microbicide research in South Africa, one of the homes to MTN 017, the first rectal gel study on the continent.

There was recognition for a revived African advocates voice in support of these demands on the IRMA listserv, which is closely followed by a range of researchers and leaders in the field, including scientists at the MTN and NIH—as well as PrEP, vaccine and all-around prevention researcher Linda-Gail Bekker of the South African Desmond Tutu HIV Foundation who declared at the Forum, “If you aren’t following IRMA, you haven’t lived!”

Burning the Candle at Both Ends: An Advocacy Forum Discussion on “Injectable Prevention”

Ntando Yola has worked for eight years in HIV prevention research at the Desmond Tutu HIV Foundation (DTHF) in Cape Town. In his role as a Community Engagement Coordinator he has worked closely with various national and international HIV prevention Networks. His work has involved working with various community stakeholders, developing and implementing community education programmes, forming partnerships with health service providers and other community based organizations as key stakeholders HIV prevention research. He was also a 2013 AVAC Fellow.

At the 2015 AVAC Partners’ Forum, there was a lot of interest in advocates and activists about the important role scientific research has to play in addressing HIV. How important was it? So important that at a roundtable discussion that started after the day was scheduled to end, a small but dedicated group of participants spent over an hour talking about the current pipeline of “injectable prevention” which includes long acting injectable PrEP (I am currently working at DTHF in Cape Town, where an LAI PrEP trial is getting underway), vaccine trials and, someday, passive immunization (right now these antibodies can only be administered via a three-hour transfusion, as we learned at an incredibly accessible presentation by self-described “lab rat’ Penny Moore).

It was clear from this “after hours” discussion that, whilst the focus of community involvement primarily by researchers is within trial communities, there is a need for basic concepts of research and processes to be understood by these broader groups. Addressing this as a gap can go a long way into creating an even more supportive environment for trials and research. Since when civil society understands core concepts and questions related to biomedical research, they are more likely to engage, inform and participate. This would further ensure a natural progression of successful science to real life public health policy and implementation. Whilst globally, initiatives by organizations like AVAC seek to address this, strong and sustained partnerships between science and civil society with countries remain a lingering question as to how this should happen and whose responsibility it is.

I developed a slide set that summarized the pipeline we grappled with and some of the key findings and suggestions that came out of this meeting. There were more questions than answers, as you’ll see. If you want to learn more, raise new questions—or get involved in providing some answers—please be in touch!

Talkin’ About a Revolution: Partners in Action at the AVAC Advocacy Forum 2015

What happens when nearly 90 advocates, largely from sub-Saharan Africa, get together for three days of strategizing, information sharing and debate?

Momentum, commitment, fierce questioning and profound urgency seize the room. If those sound like the ingredients of a revolution—well, you’re not far off.

That’s AVAC’s perspective, looking at our annual Advocacy Partners’ Forum that concluded last week in Johannesburg, South Africa. This is the fifth year of the Partners’ Forum, which is an annual, in-person gathering of an expanding network of partners working on the frontlines of prevention research and implementation around the world.

Every year brings different issues to reflect on. We follow the research, the money, the plans at country level for implementing treatment and combination prevention.

This year, these threads led us to a nexus of issues that cry out for immediate, consolidated action. These include:

  • Expanding the number of countries sorting out where and how oral PrEP can be used as a prevention option for individuals at risk;
  • Engaging with UNAIDS’ “Fast Track Targets” that include the “90-90-90” goals for HIV testing, ART initiation and virologic suppression—but are not limited to it, as primary prevention mustn’t be left behind;
  • Analyzing the research pipeline of vaccines, passive immunization and injectable PrEP to try to understand what’s happening when, where and why; and
  • Dissecting the phrase “key populations” to understand where it works for—and against—a robust response.

The meeting is small relative to the number of advocates and activists needed to catalyze change on these and other issues. We’re working with partners to develop strategic campaigns to amplify a number of issues raised at the meeting—and you can delve into the presentations from the meeting here.

Even better, in the days and weeks to come, P-Values—AVAC’s blog—will include a series of vibrant first-hand reflections from participants about their work and thoughts from the meeting. We hope you’ll bookmark the blog, reach out directly to authors who pique your interest and above all join the growing, unstoppable movement calling for a prevention revolution that can decisively end AIDS.

The work you’re doing in your communities and countries today and every day is the heart and soul of this movement—and we hope you’ll use this network and introduce all of us to new ones as we stay the course in 2015 and beyond.

Partners’ Forum Blog Post Series

Song of the Soul: A VMMC Advocate Puts Her Activism into Poetry at Partners Forum 2015

Khanyisa Dunjwa is a community leader in sexual health and rights in South Africa where she is a member of the SANAC Women’s Sector. As a 2014 AVAC Fellow hosted by NACOSA, Khanyisa paved the way for voluntary medical male circumcision in the Eastern Cape province of South Africa, where traditional male circumcision is part of a widespread initiation rite marking young men’s transition to adulthood.

The poem evokes Khanyisa’s motivation to merge aspects of medical male circumcision with traditional circumcision at a newly established pre-initiation camp in the Eastern Cape. Since implementation of the camps, rates of deaths and other adverse events dropped in the region. A Department of Health report documenting the program and outcomes is pending.

Having concluded a remarkable Fellowship, Khanyisa is pursuing larger scale rollout of the initiation camps and working to support The Eastern Cape Aids Council Civil Society Task Team on Safe Initiation. She also advocates for PrEP and other women’s prevention strategies.

Khanyisa presented this poem along with a poster at the Fellows Wrap-up & Orientation Workshop that took place before and after the AVAC Partner’s Forum in Johannesburg in March.

A voice with no space

my traditional leaders enhance traditional governance
my traditional leaders get support from my government
my community has evolved
i decided to get involved
my community is confronted by a monster
you will get details in my poster
initiation of boys makes us hopeful
sadly when it goes wrong it leaves us shameful
my traditional leaders value traditional circumcision
pity, they don’t see value added of medical male circumcision
wait a minute, my mothers voice is on mute
i need to push
she pushed when she gave birth
i need her voice to prevent death

by Khanyisa Dunjwa

Funding opportunity: HIV Vaccine Research and Design (HIVRAD) Program

The purpose of this Funding Opportunity Announcement (FOA) is to support multi-component, multi-disciplinary projects that address important scientific questions relevant to AIDS prophylactic vaccine discovery research. Extensive modeling of vaccine concepts in non-human primates may be included.
Details at: http://grants.nih.gov/grants/guide/pa-files/PAR-15-164.html#sthash.4hgMh…

A New CUREiculum Launched

The number of HIV cure-related publications has risen exponentially in recent years. This is due in part to a burst of funding and scientific interest around HIV cure research in the last decade. At the 2014 Conference on Retroviruses and Opportunistic Infection (CROI), it became clear at a community meeting that we needed to provide resources to increase scientific literacy around HIV cure research. These resources to increase understanding can help manage expectations around HIV cure, but can also provide the foundation for ethical research. Scientific literacy is a way to allow community members to meaningfully engage around the research. Potential study participants can be also informed about the risks, benefits and scientific merits of a study. The CUREiculum concept was developed out of this need to make HIV cure science accessible to as many people as possible.

The CUREiculum initiative was launched at CROI 2015, one year later. The CUREiculum is a suite of tools developed by a collaboration between community educators, advocates and research institutions. Each module contains a set of learning tools that is designed to be used by either an individual learner or as part of a training session or workshop. In addition to an annotated PowerPoint slide deck and various participatory activities, each module contains a set of references chosen for their accessible content about specific topic areas.

On February 21st, 2015 the CUREiculum partnered with the defeatHIV Community Advisory Board (CAB) and the Seattle Public Library to hold the first of two kick off events. The meeting at the library had a diverse crowd of individuals simply interested in HIV cure research. Audience members learned about the Basics of HIV Cure Research, Pediatric Research on HIV Cure and Gene Therapy in HIV Cure Research. Audience members asked a range of thoughtful questions about obtaining informed consent from pregnant women and the potential risks of altering genes in the human body. A reception was held on February 22, following the annual Community Cure Workshop. This reception celebrated the involvement of the CUREiculum collaborators.

The complete suite of CUREiculum modules includes:

  • HIV/AIDS and Cure Basics
  • Stakeholder Engagement in HIV Cure Research
  • Regulatory Issues in HIV Cure Research
  • Ethics of HIV Cure Research
  • Informed Consent in HIV Cure Research
  • Participation in HIV Cure Studies
  • Concepts in Basic Sciences and Translational Research – The Main Pathways
  • Measuring the Latent HIV Reservoir
  • Early Antiretroviral Treatment
  • Pediatric HIV Cure Research
  • Latency Reversing Agents
  • Therapeutic Vaccines and Immune-Based Therapies
  • Gene Therapy and Stem Cell Transplant
  • Animal Models in HIV Cure Research
  • Combination Approaches and Conclusions – The Science Looking Forward

For more information about the CUREiculum please contact:

HIV Prevention on the Line: Time to Mobilize — Again

This post first appeared on the Huffington Post.

In 2015, the International AIDS Society (IAS) will hold a conference in Vancouver, returning to the city for a large-scale meeting the first time since the 1996 AIDS Conference that heralded the beginning of the era of highly active antiretroviral treatment. And in 2016, the IAS will convene the large, biennial International AIDS Conference in Durban, South Africa—16 years after the 2000 conference that revolutionized global expectations of AIDS treatment in low-income settings.

The 1996 and 2000 conferences are by many accounts the two most significant global AIDS meetings that have ever taken place. And it is possible, if the right steps are taken, the right funds committed, the right programs implemented and the right partners engaged that the 2015 and 2016 meetings could prove to be watershed moments in the field.

These are big “ifs.”

The most pressing and fundamental question is one of financial resources. If global investment doesn’t match the price tag for expanded, comprehensive prevention, then all the plans and targets in the world are irrelevant.

But if it does, then by 2016, we could begin to see evidence of downward slopes that confirm we’re on track to beginning to end the AIDS epidemic in our lifetime.

AVAC, the HIV advocacy organization that I direct, just released Prevention on the Line, a report in which we talk about target setting and the importance of having specific strategies, clear definitions and strong commitments.

We also talk about the need for short-term action. The world cannot wait until 2020 to find out whether the AIDS response is on track to end the epidemic by 2030. Indicators of progress or problems are already available—and the picture will be even clearer by the time the Vancouver and Durban conferences take place.

There is no better use of these large, costly AIDS meetings than to take honest stock of the global response and galvanize action on a global scale.

Both the 1996 and 2000 conferences are remembered as momentous turning points. They’re also remembered for the grief and urgency of the time. People who lived through the early years of the AIDS epidemic remember the dawn of the HAART era as a moment of exhaustion and grief, as well as celebration.

And while Durban started a revolution in AIDS drugs for Africa, it took four long years—and an unconscionable number of lives—before that revolution realized its goals.

Today the AIDS response is poised at another moment that could be a revolution, providing that it does not dissipate into rhetoric or dissolve into underfunded documents and plans.

Will Vancouver 2015 be the meeting where science, rights and action get in sync and revolutionize the epidemic once again? Will Durban 2016 lead to massive mobilization for decisive action on ending the epidemic?

Let’s use the memories of those who did not live to return to Vancouver and Durban—as well as our own memories and histories—to fuel the continued fight for lasting change.

Funding Opportunity: Methodologies to enhance understanding of HIV-associated social determinants

National Institutes of Health
This Funding Opportunity Announcement (FOA) invites applications that propose to understand social determinants of health as they relate to HIV infection and disease outcomes in order to identify mutable targets for inclusion in structural interventions. Details at: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-16-200.html

Support the Global Response to HIV/AIDS, Tuberculosis, and Malaria

The United States Congress is currently considering the future budget of the President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Members of Congress are encouraging you to reach out to your representatives and advocate for strong funding.

Barbara Lee, a member of Congress from California, provides more information in a note below, including a call to sign on to her letter to other members of Congress.

Dear Colleague:

I urge you to sign on to the letter below requesting funding to support the President’s Emergency Plan for AIDS Relief (PEPFAR), the Global Fund to Fight AIDS, Tuberculosis, and Malaria in the FY 2016 State and Foreign Operations appropriations bill.

The U.S.’s bipartisan commitment to PEPFAR and the Global Fund not only saves lives, but also contributes directly to stability, security and economic growth worldwide. Our strong support for PEPFAR and the Global Fund, coupled with scientific advances and lessons learned from a decade of implementation, has the potential to turn the tide on HIV/AIDS and help us meet our target of achieving an AIDS-free generation.

These contributions are just a fraction of 1% of the federal budget, yet enable PEPFAR and the Global Fund to continue its critical, life-saving work and influence the organization’s ability to leverage additional resources from other donors. Strong support for both PEPFAR and the Global Fund will enhance U.S. leadership in the world and increase our ability to meet seminal global health goals that are within reach.

A copy of the letter is below. If you need further information or would like to sign on, please contact Monica Pham in Rep. Lee’s office ([email protected]).

Sincerely,
Barbara Lee
Member of Congress

Letters to Congress

A letter to members of the United States House of Representatives is below. Click here to download a letter for the United States Senate.

The Honorable Kay Granger
Chairwoman
Appropriations Subcommittee for
State and Foreign Operations
U.S. House of Representatives
Washington, DC 20515

The Honorable Nita Lowey
Ranking Member
Appropriations Subcommittee for
State and Foreign Operations
U.S. House of Representatives
Washington, DC 20515