Skip to main content

Category: Progress

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.

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.

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.