Research Highlights & News

It is our pleasure to announce the results of our recent elections. Our new leaders of the Global CERs are:

• Latin America: Francisco Tenorio, Mexico City CRS, Mexico
• Sub-Saharan Africa: Mduduzi Ngubane, Isipingo CRS, Durban
• United States: Rafael Gonzalez, Bridge HIV CRS, San Francisco

Below are their nomination statements. We are so grateful to all of the candidates from all regions who stepped forward for consideration!! It is truly a privilege to work with such talented individuals.

• Francisco Tenorio, Mexico City CRS, Mexico City, Mexico:
  I am a Human Rights advocate with experience in education, sexual rights and youth engagement. I have collaborated with different organizations, universities and government institutions in education and research processes. I participated in the Ship for World Youth Program of the Cabinet Office of the Government of Japan and in the Contrapunctus Study Program of the Council of Europe. Since 2016, I have collaborated with the University of Washington as coordinator in Mexico of the study abroad program LGBTQ + Communities, Public Health, and Migration in Mexico and in other University of Washington projects. I have served as member of the Youth Advisory Group of the United Nations Fund of Population Office in Mexico - UNFPA Mexico during the period 2019-2020.  Since 2019, I have been working on research studies at Clínica Especializada Condesa as Community Educator. My professional and personal experiences in the last years have taught me how important it is to work together and to share spaces with different regions across the world. In them we can learn a lot, share experiences, good practices, and reflections. It will be an honor for me to be able to represent my country, Mexico, and the Latin America region in general, as well to contribute so that the research site in which I collaborate can enhance the activities of Community Education and Engagement. 
• Mduduzi Ngubane, Isipingo CRS, Durban, RSA:
  My name is Mduduzi Ngubane, a Community Liaison Officer for the SAMRC Isipingo Clinical Research site. I have worked in clinical research for almost 15 years where I worked  as Recruiter, Community Educator and a Liaison Officer.  I have experience working in Phase 1, Phase 2, Phase 2B, Phase 3, and Open Label Extension trials. I have written up abstracts for conferences, been part of stakeholder consultations prior to initiation of new protocols, and trained and supported  the Community Working Group/ CAB/ CAG. I feel being nominated for this role could assist me to raise issues to assist and support the engagement programme. I recently completed an AVAC course on strengthening stakeholder engagement. I hope this narrative will help you in considering me for this role.
• Rafael Gonzalez, San Francisco, CA:
  I am excited to express my strong interest in the U.S. CER Co-Chair position for the HVTN! I have worked with the HVTN for 7 years. In this time, I have grown from intern to Community Programs Manager. In between these two positions, I have worked as a clinical studies recruiter/community educator and as a research associate.  In my current position, I oversee clinical study recruitment, enrollment, and community engagement. In addition, I have sat on protocol teams (HVTN 706/HPX3002, HVTN123/HPTN088 and HVTN 405) and am a member of the CoVPN Community Working Group. Having this breadth of experience gives me a unique point of a view and understanding of the lifecycle of conducting a successful clinical trial at an individual site. This understanding allows me to represent Bridge HIV, as well as the HVTN, when collaborating with community as well as other external stakeholders such as local jurisdictions, health departments, and community-based organizations – with soul and science.

HPRU, SAMRC, in collaboration with scientists from CAPRISA, UCT, and Wits University, held a symposium on HIV, TB and COVID-19 vaccines. The four scientists highlighted lessons learned, strategies and next steps in vaccine development, current research results, and their views on what the future holds for these vaccines in public health and disease management.

You can access the symposium recording (video) and presentations below:

• Dr. Reshmi Dassaye (HPRU): Basic science of vaccines and current HPRU vaccine trials
• Dr. Nigel Garret (CAPRISA): HIV vaccines
• Prof Tom Scriba (UCT): TB vaccines
• Prof Shabir Madhi (Wits): COVID-19 vaccines

HPRU, SAMRC, in collaboration with researchers from Wits University, University of KwaZulu Natal, Desmond Tutu HIV Centre - UCT, UNISA, and the University of Pretoria held a symposium on Ethically acceptable consent approaches to adolescent research in South Africa. The presentations included reviewing international trends regarding ethical consent for adolescents, reflecting on the ethical-legal concerns in advancing child health, and looking at current consent approaches in SA. The symposium concluded with several suggestions to address the challenges to obtaining consent for adolescent research in SA. You can access the symposium video and presentations below:

• Prof Ameena Goga: Ethically acceptable consent approaches to adolescent research in South Africa
• Prof. Ames Dhai: International framework for consent in adolescent research
• Prof. Ann Strode: The advancement of child health caught up in an ethical‐legal power play
• Prof. Linda-Gail Bekker: Experiences from adolescent studies in Cape Town
• Prof. Melody Labuschaigne: Minors in research and consent issues
• Prof. Theresa Burges: Adolescent research and consent approaches in South Africa 

Read more.

Articles available on the New England Journal of Medicine

• Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition
• The AMP Trials — A Glass Half Full

AMP Trial - Protocol-specific Bulletin #158

• The first set of results of the AMP study was a success and researchers were able to show that the type of antibody (called VRC01) that was used in the AMP studies can prevent acquisition of some types of HIV.
• The overall reduction in HIV infections, compared to placebo, was 19%, and this reduction was some way off statistical significance, so scientifically speaking did not count as a reduction at all.
• The antibody worked if it could neutralize or block the strain of HIV that one was exposed to.
• Investigators found that only 30% of the HIV strains circulating in the regions where the trials were conducted were sensitive to VRC01.
• The results suggest that it will likely take two or three antibodies to prevent acquisition of the many different global strains of HIV.
• But, for the first time, scientists have a very precise threshold for its efficacy and know that it will contribute to prevention regimens using combinations of bNAbs – combinations that are currently undergoing trials.
• This is like what we see with the medicines approved to treat people living with HIV (the medicines called antiretroviral therapy or ART) where we use combinations of multiple drugs. The good news is that researchers are already doing studies testing other antibodies that may be able to be combined with antibodies like VRC01^1,2,3. 

HPRU contributed 195 participants from the Bothas Hill (n=72) and Chatsworth (n=123) sites led by Dr Mammekwa Mokgoro and Dr Logashvari Naidoo (Principal Investigator) together with the site CRSLs and SCs. 

This led to the product to be tested in an “open label” trial (MTN 025), which will assess its use by previous participants in more “real life” situations. We hope that the additional data obtained by the open label HOPE study will lead to licensure of the first women- initiated HIV prevention technology. We anticipate the results in the latter part of 2018. Should we be successful, the study will have implications on policy as well as public health

J.M. Baeten et al. Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women. NEJM DOI: 10.1056/NEJMoa1506110

HPRU is contributing to the HVTN’s (HIV Vaccine Trials Network) mission “to fully characterize the safety, immunogenicity, and efficacy of HIV vaccine candidates with the goal of developing a safe, effective vaccine as rapidly as possible for prevention of HIV infections globally”; as well as HPTN’s (HIV Prevention Trials Network) mission “dedicated to the discovery and development of new and innovative research strategies to reduce the acquisition and transmission of HIV”. In this regard, the following studies have been undertaken: HVTN 100; HVTN 111; HVTN 702; HVTN 703/HPTN 081; HVTN 705.

A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women

Translating PrEP uptake by adolescents. Developing a Gender-Enhanced PrEP Information-Motivation Workshop for Young South African Women

Innovative trial with combined prevention interventions. To start 2019.

African scientists should lead in developing an Aids jab for Africa, 29 November 2021

Handan Wand and Gita Ramjee. The effects of injectable hormonal contraceptives on HIV seroconversion and on sexually transmitted infections. AIDS 2012. 26:375-380