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Author: toni.imaginavet

End of Follow-up of children in MAMAH

The last follow-up visit of children in the MAMAH trial was in July 2023 in Mozambique. In total, the trial enrolled 666 participants who were randomized to receive either DHA-PPQ or placebo. 641 children were born in the trial who were followed up for one year. After the end of follow-up, sample analysis of children is being finalized as well as data entry and data base cleaning.

Safety and efficacy of dihydroartemisinin–piperaquine for intermittent preventive treatment of malaria in pregnant women with HIV from Gabon and Mozambique: a randomised, double-blind, placebo-controlled trial

The findings from the EDCTP-funded MAMAH trial, which was conducted between 2019 and 2023 in 5 sites in semi-rural areas in Gabon and Mozambique, showed that dihydroartemisinin-piperaquine (DHA-PPQ) as malaria intermittent preventive treatment during pregnancy (IPTp) administered concomitantly with prophylactic co-trimoxazole in pregnant women living with HIV is safe and reduces the risk of clinical malaria and overall Plasmodium falciparum infection.

The article which was published in January 2024 in The Lancet Infectious Diseases, highlights the potential of DHA-PPQ as a safe and effective strategy for malaria prevention in pregnant women living with HIV. An announcement of the article is available on the EDCTP website.

Participation at the 11th EDCTP Forum, Paris 7th – 10th November 2023 – Partnering for Global Health Research Innovation and Impact in Africa – Celebrating EDCTP: two decades and beyond.

The 11th EDCTP Forum was held in Paris, France from 7th to 10th November 2023 at the Palais des Congrès de Paris. It marked the 20th anniversary of the EDCTP and presented the new programme EDCTP3. The EDCTP Forum is a biennial event that provides an international platform for the presentation and discussion of cutting-edge research addressing the burden of poverty-related and neglected infectious diseases in sub-Saharan Africa and the capacity development and networking activities that support this goal. At the forum, research progress and achievements of the first 20 years of EDCTP were discussed as well as scientific challenges to be addressed in the next decade.

The MAMAH consortium members attended with the following contributions:

  • Evaluation of the safety and efficacy of dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in HIV-infected pregnant women: a multi-centre, double-blind, placebo-controlled trial (MAMAH project) (oral presentation by Raquel Gonzalez)
  • A paradigm shift towards local and gender balanced leadership, promoting equitable partnerships and next generation African leaders (Symposium with oral presentation by Ghyslain Mombo-Ngoma)

More information about the 11th EDCTP Forum programme can be found here.

    Last participant recruited and end of follow-up of women

    The last MAMAH participant was recruited on 26th November 2021 in Manhiça, Mozambique. With 26 months of duration, the recruitment phase exceeded the initially planned duration by six months. The lower than expected recruitment rates were due to different factors, including the onset of the SARS-CoV-2 pandemic during 2020. The last delivery took place in June 2022and follow-up of women was completed in July 2022. Follow-up of children is ongoing and expected to be completed in June 2023.

    2nd in-person investigators’ meeting in Barcelona – November 2022

    For the second time since the launch of the MAMAH project, investigators from all partner institutions came together in a face-to-face meeting. The meeting took place on the 29th and 30th of November 2022, in the facilities of ISGlobal in Barcelona.

    Collaborating together in a room works much better than via Zoom…”

    Text by Meral Esen (EKUT)

    From 29th November until 1st December 2023, the second MAMAH and first MA-CoV investigator in-person meeting took place at ISGlobal in Barcelona after four years of online meetings. Some partners participated remotely.

    The first MAMAH investigator meeting had taken place already in 2018 in Lisbon and a second face-to-face meeting was scheduled for 2020. Due to the restrictions of the Covid-19 pandemic, during the last years, travelling was not possible for most of the consortium members including researchers from Mozambique, Gabon, Germany, Austria and Spain.

    “Finally, we were able to meet in Barcelona, where we stayed together for almost three days, free from other commitments and disruptions that usually occur when you are at your workplace attending an online meeting” and “We had a really fruitful meeting – much more efficient than online e.g. via zoom” was stated from all the participants who joined the meeting on site.

    Each site presented their achievements and challenges during the project, and all of the partners discussed any problems that had occurred and were mostly resolved during the studies. Plans for future activities were also presented and discussed. There was enough time for fruitful discussions and side meetings that resulted in new ideas for ancillary as well as for follow-up studies.

    All in all, the scientists were very happy that the two studies turned out so well despite the challenges of the pandemic and its aftermath. They are keen to finalize the studies and to gain new knowledge in the field of maternal and infant health.

    MAMAH preliminary results at the 2022 Annual ASTMH Meeting – October 2022

    The 2022 Annual ASTMH Meeting took place from 30th October until 3rd November 2022 in Seattle, WA, USA. Scientists from across the globe discussed latest issues in global health and tropical medicine.

    Partners from the MAMAH consortium attended in-person and virtually. Principal investigator Dr. Raquel González presented preliminary results of the MAMAH trial at the symposium on “Latest Research with Policy Relevance for the Treatment and Prevention of Malaria in Pregnancy in the Most Vulnerable, High-Risk Groups in Sub-Saharan Africa”.

    Find more information on the ASTMH Annual Meetings here.

    The full compilation of malaria sessions at the 2022 ASTMH annual meeting is available here.

    Participation in the 10th EDCTP Forum, Maputo 17th – 21st, October 2021 – Equity in research for health

    The 10th EDCTP Forum was held as a virtual meeting hosted from the Joaquin Chissano International Conference Centre in Maputo from 17-20 October 2021. The Forum theme was Equity in research for health.

    The MAMAH Consortium members attended virtually and live from Maputo, with two mini-oral presentations and posters:

    • Caring for African women: progress and main achievements of the EDCTP2- MAMAH project for malaria prevention among HIV-infected pregnant women from Gabon and Mozambique (presented by Raquel González)

    • Pharmacokinetic assessment of dihydroartemisinin-piperaquine (DHA-PPQ) administered as Intermittent Preventive treatment (IPTp) to HIV-infected pregnant women on antiretroviral drugs and cotrimoxazole prophylaxis: a sub-study of the EDCTP2- MAMAH project (presented by Lia Betty Dimesa)

    Download here the information brochure.

    Go to the Tenth EDCTP Forum website.

    Read the articles on the Tenth EDCTP Forum blog.

    ISGlobal Project Coordinator and Technical Coordinator visit Gabon– November 2019

    On the 10th November 2019, Clara Menéndez (Project Coordinator) and Raquel González (Technical coordinator) visited Lambaréné. They participated in the 2nd African Congress of Clinical Trials (ACCT) organized by CERMEL and they visited MAMAH study sites in Lambaréné. Meetings with project team were held and trial’s procedures reviewed.

    ISGlobal Technical Coordinator visits MAMAH Gabon sites – April 2019

    On the 1st April, Dr. Raquel González, ISGlobal project technical coordinator travelled to Gabon to meet the local team and visit the study sites. The following health facilities were visited: The Centre Hospitalier Universitaire Mère-Enfant Fondation Jeanne-Ebori, in Libreville, the Hôpital Régional de Lambéréné and the laboratory of CERMEL. Participant’s flow and study procedures were reviewed with the team. Also, challenges of project implementation were discussed.

    BNITM researchers visit ISGlobal – July 2019

    Johannes Mischlinger, MAMAH researcher from the Bernhard-Nocht-Institut für Tropenmedizin (BNITM, Germany) visited ISGlobal on the 8th July 2019. Mischlinger met with ISGlobal team (Mireia Piqueras, Raquel González) and Mercè Brunet (Head of the Pharmacology and Toxicology Department at the Hospital Clinic of Barcelona). The laboratory facilities where the MAMAH PK sub-study samples will be processed were also visited. Procedures and details of the pharmacokinetics studies were discussed.

    First MAMAH DSMB Meeting – February 2019

    On the 14th February 2019, the DSMB members (Valérie Briand, Kassoum Kayentao, Antonella Bacchieri) and the ISGlobal team (Raquel González, Aina Casellas, Clara Pons, Mireia Piqueras) attended in Barcelona the First MAMAH DSMB Meeting. Markus Zeitlinger, also DMSB member, and Efrain Pantoja, safety monitor, participated remotely in the meeting. The protocol of the MAMAH trial was reviewed, as well as all safety issues concerning the study drugs and the safety monitoring procedures. The terms of reference for the board were established and agreed.

    Start of PK sub-study in January 2021

    The first women were enrolled in the sparse PK sub-study in Gabon and Mozambique in January 2021. The rich-PK will require hospitalization of the participants to facilitate sample collection at specified time points and will start soon.

    Half sample size (n=332) reached in October 2020

    Despite of the difficulties following COVID-19 pandemic, 332 women were enrolled in the clinical trial on 28th October 2020, which means that half of the sample size has already been achieved. The recruitment is expected to end on 31st August 2021.

    Delay of the start of the pharmacokinetics study due to COVID-19 pandemic

    It is urgently required to study the drug interactions of the DHA-PPQ, antiretroviral treatments and cotrimoxazole prophylaxis before large numbers of pregnant women and their infants are exposed to both drugs concomitantly. For this, a pharmacokinetics study (PK sub-study) was designed to be performed on a sub-sample of pregnant women participating in the trial. The PK sub-study expects to enroll 200 women (enrolled in two different schemes, the sparse and the rich) that are already part of the clinical trial, in order to assess potential interactions between antimalarial and antiretroviral drugs. The PK sub-study was planned to start in early 2020, however due to the COVID-19 pandemic and its related mobility restrictions, the implementation of the sub-study was postponed.

    Expansion of the study facilities in Manhiça

    In order to overcome the recruitment pitfalls in Gabon, the CISM expanded enrolment of participants to nearby Palmeira health post on 16th September 2020. It is estimated that approximately 100 participants will be enrolled in Palmeira in 12 months. The first participant was recruited on the same day the screening of potential participants started.

    Opening of the second site in Gabon, in Libreville

    Despite the challenges related to the COVID-19 pandemic, the CERMEL team managed to set up a second recruiting site in Gabon, at the Jeanne Ebory Hospital, in Libreville. Screening of potential participants started on 19th May 2020 and few weeks after the first participant was recruited (10th June). The opening of this second site was already planned in the original design of the study to increase the number of participants enrolled in the country.

    First participant enrolled in November 2019 in Mozambique

    The screening of potential participants started on 25th November 2019 in Manhiça and the first participant was enrolled on 26th November 2019. Participants in the trial receive the first dose of the treatment at the antenatal care visit and the two subsequent administrations (in the two following days) at home. During these visits, the corresponding treatment is administered and the correct use of the LLITNs is monitored.

    First participant enrolled in September 2019 in Gabon

    The screening of potential participants started on 18th September 2019 and the first participant was recruited on 20th September 2019. As part of the study, she was allocated to one of the study arms in a blinded way, received HIV treatment, cotrimoxazole prophylaxis and a long lasting insecticide treated net (LLITN). The achievement of this project milestone constitutes the starting point of the clinical trial, where a total of 664 women will be enrolled.