VOICES - Issue 01 - HIV Vaccine Awareness Day
Inaugural edition of VOICES, an e-newsletter presenting community perspectives on clinical research...
Welcome to the inaugural edition of VOICES – an e-newsletter of perspectives from research counselors, nurses, and community engagement practitioners involved in biomedical HIV prevention research in Africa.
At a moment of promise for novel HIV prevention technologies, VOICES will profile counseling and engagement experiences, timely lessons from people on the front lines of HIV prevention research, and best practices. Because HIV prevention research would be impossible without the active participation of volunteers across communities affected by the epidemic, we’re eager to share the stories that go unreported in scientific conferences and peer-reviewed journals. In this inaugural edition, we highlight the benefits of effective counseling for acute HIV infection, the conundrum of progestogen-only contraceptives and implications for counseling and community education in HIV clinical trial settings, and the why and how of counseling supervision in clinical trials.
Senior Program Manager, Global Affairs
International AIDS Vaccine Initiative (IAVI)
Today marks 20 years since U.S. President Bill Clinton said that “only a truly effective, preventive HIV vaccine can limit and eventually eliminate the threat of AIDS.” With those words Clinton sparked the tradition of HIV Vaccine Awareness Day (HVAD) – a time to honor clinical trial volunteers, community members, health professionals, and scientists working toward a vaccine.
Their dedication – and scientific progress over the intervening years – have shown that an HIV vaccine is possible. More than 41,000 men and women have volunteered for HIV clinical research, yielding discoveries that may hold the key to a safe, effective, and available HIV vaccine. For example, in 2006 samples from a group of African trial volunteers revealed powerful HIV-blocking antibodies that continue to unlock the virus’s secrets in laboratories around the world.
Thanks to these brave individuals, today we can recognize a milestone in the search for a vaccine. For the first time, three different approaches are proceeding to efficacy trials simultaneously: two vaccine candidates and one vaccine-related approach. The largest AIDS vaccine trial of all time, HVTN 702, is using a reformulation of the first candidate to ever demonstrate some protection. That trial relies on more than 5,600 volunteers and is underway in South Africa, where more than 1,000 people each day become infected with HIV.
Besides offering the hope of an end to the epidemic, HIV vaccine research and development (R&D) is valuable to vaccine discovery for other diseases, and vice versa. For example, the building blocks of the most successful Ebola vaccine are being harnessed in the lab as a possible means to deliver an HIV vaccine. In addition, IAVI’s work, particularly in Africa and India, is giving rise to the next generation of scientific talent capable of conducting R&D for years to come.
We do not know exactly when we’ll have a vaccine, but two decades of progress reminds us that the day draws nearer. HIV is unlike any other virus and eliminating it will take not only a vaccine, but also unprecedented political will, funding, awareness, preparedness, and continued commitment to providing life-saving treatment.
We also know that our progress would be impossible without our collaborators and partners in clinical research centers, civil society organizations, industry, and governments around the world. These partners, and the thousands of individuals living with HIV and those who make themselves available for clinical trials, are our greatest motivator and greatest hope. Today is their day.
The World Health Organization’s recent revision of guidelines on the use of depot medroxyprogesterone acetate (DMPA) is a good example of a potentially perfect storm.
That’s the metaphor for circumstances whose seemingly random alliance secures the very best, or the very worst, possible outcome. DMPA, a contraceptive injection relied upon by 70 percent of women who use birth control in sub-Saharan Africa, may raise a woman’s risk of acquiring HIV. And it may not.
But given that women of childbearing age in sub-Saharan Africa are a population that is more vulnerable to HIV infection than others, the uncertainty embedded within these guidelines have the potential to be a game-changer.
Much-needed research is unfolding that will help answer the question of DMPA’s risk, but the topic has raised serious questions among counselors and community educators about how to communicate details to sexually active potential and/or enrolled female trial participants until that new evidence basis becomes available.
DMPA is a hormonal contraceptive known by the commercial name Depo Provera. As a progestogen-only injectable, it is in a category of contraceptives about which questions related to HIV have long lingered. That’s because progestogen is used successfully to stimulate viral infection in non-human primates. For women already at risk of HIV infection, the WHO advises counselors to mention the risk but not to limit access to DMPA.
These questions will be answered by the ECHO trial, which is ongoing in sub-Saharan Africa. In this randomized control trial, 7,800 HIV-negative women in four countries will be divided into three groups using three different kinds of non-reversible birth control. The study, whose full name is “Evidence for Contraceptive Options & HIV Outcomes,” will examine possible links to HIV infection using a hormonal injectable contraceptive, levonorgestrel implant, or a copper intrauterine device. But the ECHO trial will not yield results until November 2018, adding to the uncertainty surrounding DMPA.
So what should counselors tell participants/volunteers who come to their research centers/clinics?
According to the WHO, women who are at risk of HIV infection should be advised of the possible risk from DMPA and helped to consider other contraceptive options. The following methods do not pose a link to HIV risk: combined oral contraceptive pills, combined injectable contraceptives, combined contraceptive patches and rings, progestogen-only pills, and both levonorgestrel and etonogestrel implants.
The ECHO trial should be explained along with simple details about how women can learn the results when they eventually become available.
Joseph Nzioka – KEMRI/Wellcome Trust, Kenya
Acute HIV research counseling presents an important and unique opportunity for HIV prevention and intervention by mitigating new infections. Because individuals in the acute stage of HIV infection (AHI) have an elevated potential to transmit HIV, they play a critical role in the growth of the epidemic. Although AHI presents the most infectious period of the HIV infection phase, it often passes unnoticed or undiagnosed. Since clients often present with symptoms that are similar to other common illnesses like malaria and/or flu, they frequently have no idea that HIV could be the cause of their symptoms. AHI samples also further the science for HIV treatment such as vaccine research by providing current active virus samples that give scientists a critical current look at the HIV virus.
With the introduction and implementation of the immediate antiretroviral therapy (ART) treatment guidelines and the call to meet the UNAIDS targets of 90-90-90, AHI diagnosis and treatment must be a priority for all research counselors. Research counseling offers a direct and focused method to target those with AHI symptoms, engage, and counsel them ‘to take the test.’ Since the commonly used HIV rapid test may be negative or discrepant during AHI, AHI is often diagnosed by a laboratory test whose results may not be immediate. New, gene-based testing machines, currently being phased in across studies, will offer quicker results in the future.
Research counseling first screens the client for study, and tests eligibility including the consent process. Next, the counselor must adequately prepare the client for possible AHI results and outcomes. This counseling is critical in helping the client understand and accept the test outcome they might receive when laboratory results are available.
Since clients may be in shock if their test results are positive for AHI, research counselors must be prepared to support their clients and help them to see past the devastating diagnosis to treatment and care. The counselor must help the client cope with their emotional response to a new-found HIV status. Supporting such clients requires an advanced level of empathy, attention, and active listening.
Once a client is diagnosed with AHI, opportunities for HIV prevention and intervention include immediate ART initiation shown to have a positive health outcome for the client while also reducing HIV transmission to sex partners. Secondary prevention in some cases can also include partner notification and possible post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP).
Opportunities for immediate treatment, partner notification, PEP, and PrEP require research counsellors to encourage their clients to take the AHI test, accept its results, accept immediate treatment, notify their partner to also take the test, and most importantly adhere to treatment. Acquiring the right skills to accurately diagnose AHI will facilitate our target to get to zero!
Sister Bontle Modibedi represents hundreds of research nurses involved in HIV clinical research working tirelessly behind the scenes to find solutions to the HIV epidemic. Bontle joined the South Africa based Perinatal HIV Research Unit (PHRU) vaccine team in 2013. She is the research nurse who vaccinated the first trial volunteer in the world with the ALVAC/Bivalent subtype C regimen in HVTN 100; then again, vaccinated the first trial volunteer to receive the same regimen in the efficacy trial HVTN 702. She occupies a very special place in HIV vaccine history as the pioneer nurse in Africa for the pox-protein vaccines!
As we observe HIV Vaccine Awareness Day 2017, we wish to celebrate Sr. Bontle, and many like her in Africa, and the rest of the world.
Doreen Asio – MRC/UVRI, Uganda
Counseling supervision is a formal arrangement for counselors to discuss their work regularly with someone who is experienced in both counseling and supervision. It is widely accepted that all counselors, whether experienced or just starting out, will benefit from having regular professional supervision. A supervisor acts in a mentoring role, providing emotional support as well as information and guidance. Supervision is perhaps the most important component in the development of a competent practitioner. It is within the context of supervision that trainees begin to develop a sense of their professional identity and to examine their own beliefs and attitude regarding clients and therapy.
Discussing counseling sessions with a supervisor and getting feedback enables practicing counselors to gain an objective insight into their own performance and skills. This debriefing is an important element of the supervisory relationship, enabling the counselor to look objectively at the issues raised in the counseling session and their response to them. Due to the sensitive content of many client issues it is easy for a counselor to become over-involved and for professional boundaries to become blurred; a supervisor will quickly spot this tendency and can intercede to stop it becoming problematic.
Good counseling also requires the counselor to relate practice to theory and vice versa. Supervision can help the counselor to evolve practice and in this sense is one aspect of continued training. The supervisor can ensure that the counselor is addressing the needs of the client, can monitor the relationship between the counselor and client to maximize the therapeutic effectiveness of the relationship, and ensure that ethical standards are adhered to throughout the counseling process. Though not concerned primarily with training, personal therapy, or line management, supervisors will encourage and facilitate the ongoing self-development, continued learning, and self-monitoring of the counselor.
What to Consider When Choosing a Supervisor
Because this role is so important, it is essential that counselors find a good supervisor. Not only someone who is qualified, but someone who really cares about the counselor and their clients, and isn’t afraid to ask the hard questions. And, just like a counseling relationship, it is also imperative that counselors have a good, trusting relationship with their supervisor.
Supervisors should be sufficiently experienced and qualified in counseling or in a closely related field for others to have confidence in their professional skills. The less experience the counselor has, the more experience the supervisor should have. The precise nature of their profession is less important than their skill in counseling and rapport with the counselor concerned. Ideally, the supervisor should have some training in supervision. The main focus of the counselor’s work should also be taken into consideration: one-to-one, couples, families, groups.
The counselor should fully comprehend the training, methods, and theoretical orientation of the proposed supervisor. Since counselors work from different philosophical backgrounds, it is important at an initial interview for the counselor to discover whether the potential supervisor is someone with whom it will be possible to work and learn.
Be aware, choosing a line manager as supervisor can lead to difficulties, since conflicts of interest may arise between the needs of the unit or institution (the priority of the line manager) and the needs of the counselor. If line management supervision is mandatory, then there must be access to other consultative support.
Finally, it is essential to bear in mind that ultimately the supervisor must place responsibility to the client over and above responsibility to the counselor. Effective clinical supervision ensures that clients are competently served. Supervision ensures that counselors continue to increase their skills, which in turn increases treatment effectiveness, client retention, and staff satisfaction.
In our follow-up article, look out for personal therapy – who counsels the counselor and/or counselor supervisor?
Compiled by Pedzisai Gaza,
HIV Pathogenesis Program (HPP),
8th South African AIDS Conference (SA AIDS)
June 13-16, 2017; Durban, South Africa
More information: http://www.saaids.co.za
6th Regional Changing Faces, Changing Spaces Conference
June 14-16, 2017, Nairobi, Kenya
More information: http://www.uhai-eashri.org/ENG
STI & HIV World Conference
July 9-12, 2017, Rio De Jeneiro, Brazil
More information: http://stihivrio2017.com
9th International AIDS Society (IAS) Conference on HIV Science
July 23-26, 2017, Palais des Congrès in Paris, France
More information: http://www.ias2017.org
ANAC2017 (Association of Nurses in AIDS Care) Conference
November 2-4, 2017, Fairmont Dallas, Texas, USA
Registration open May 2017
More information: http://www.nursesinaidscare.org
Biomedical HIV Prevention Summit
December 4-5, 2017, New Orleans, Louisiana, USA
Scholarship application deadline: August 4, 2017
Registration deadline: November 3, 2017
More information: http://www.biomedicalhivsummit.org
International Conference on HIV/AIDS and STI’s in Africa (ICASA)
December 4-9, 2017, Cote d'Ivoire
Abstract submission deadline: July 28, 2017
Scholarship application deadline: July 29, 2017
Registration deadline: July 31, 2017
More information: http://emtct-iatt.org/event/icasa-2017-international-conference-on-hivaids-and-stis-in-africa