How to set up a cohort in Africa: the experience in the EARTH study
by Avy Violari
In 2018, nearly 2 years after starting protocol development, the EARTH study enrolled its first participant in Soweto, South Africa. The study enrolled infants who tested HIV positive and initiated treatment within three months of life. The overall aim of the EARTH study, which stands for Early Anti-Retroviral Treatment in HIV-infected Children, is to study the natural history of early treated children in order to identify those with an excellent HIV control.
At the beginning of the HIV epidemic, infected babies were frequently admitted to the Chris Hani Baragwanath Hospital’s paediatric wards with nearly 40% of all admissions being HIV related in the year 2000. Today, building on sixteen years of success in reaching and implementing PMTCT and paediatric treatment programmes, our team of doctors and counsellors embark on extensive awareness efforts highlighting the importance of early treatment so that we can identify and treat the low number of children who are infected at birth.
Given the high coverage of treatment in the Soweto area, recruiters and counsellors had to approach enrolment into EARTH in multiple ways. Forging collaborations with NGO’s, other paediatric clinics in the area, the hospital, the neonatal unit and reminding them of the study and its objectives and significance was an important part of setting up the study. After receiving local authority approval, recruiters were placed in obstetric units and worked hand in hand with midwives to identify affected mums and took time to explain the study to them before the baby was born. They were then advised to contact the study team if the child was positive and if they wanted to participate in the study. Study staff were also present in immunisation clinics offering participation to mothers of infected babies and assisting nurses with tracing missing HIV results, ultimately expanding to seven obstetric units and five immunisation clinics. The majority would come to the research site, while some would prefer to receive treatment at their local clinic.
Sister Mirriam Kunene and Dr. Afaaf Liberty recall that 60-70% of mothers were genuinely shocked to find out the baby was HIV infected. “I took the ARV’s as they told me, I did exactly what I was told to do… why is my child positive?….”, the expectation being that PMTCT would have prevented all transmissions. Every case of transmission was evaluated to identify loopholes in the prevention cascade. Usually it was a late antenatal booking or an HIV positive test in the later months of pregnancy resulting in later initiation of ARV’s to the mother. Some mothers, however, couldn’t tolerate ARV’s in pregnancy and stopped treatment or didn’t take ARV’s at all.
Some mothers refused participation in EARTH due to disclosure issues and plans to leave the Soweto area. While starting ARV’s as soon as possible is of high priority, sometimes the enrolment had to be done over 2 visits as mothers were not able to cope with all the information provided.
Despite still struggling to accept their own HIV status and the babies’ results, all the mothers accepted ARV treatment for the baby without hesitation. However, not all of them achieved the best outcomes, mainly due to psychosocial issues.
The social worker, Faith, assesses all the mothers, as mental health issues and undiagnosed depression are very common. She provides life skills, does home visits and tries to anticipate real life situations and how to get around giving medication. Over several sessions the mothers and the social worker think about who will take care of the baby should the mother be sick. This is necessary as some mothers don’t want to take ARV’s after pregnancy. Social worker Faith and counsellor Nkata both agree that the best outcomes are seen when both parents are involved in the infant’s management.
Avy Violari is a Paediatrician and head of paediatric research at the Perinatal HIV Research Unit which is based at the Chris Hani Baragwanath Hospital, in South Africa. She is the principal investigator in several clinical trials addressing the treatment, prevention and control of HIV in Children.