STAR ANC Trial Conducts Randomisation
By Davie Chalira
It is finally done – the much-awaited public randomisation ceremony for the secondary distribution of HIV self-test kits through antenatal care (ANC) clinics and HIV testing services for new HIV positive clients, popularly known as STAR-ANC, has finally been conducted. The STAR-ANC is a cluster-randomised trial with a government health facility as the unit of randomisation.
At this ceremony, 27 facilities from Chikwawa, Zomba, Mulanje and Blantyre were randomised to one of three trial arms. Arm 1 is the standard of care (SOC) which involves a simple written personal invitation to the partner to attend the clinic for HIV testing services and post-test services. Arm 2 involves SOC plus one self-test kit per sexual partner, called ST only. Arm 3 involves self-testing (ST) with partners offered a $10 monetary incentive equivalent in local currency.
The ceremony, which took place at Malawi-Liverpool Wellcome Trust premises in Blantyre, attracted the attendance of facility representatives from each of the 27 facilities as well as representatives of the District Health Office from the four districts.
During the ceremony the Protocol Lead, Augustine Choko, started by giving a short presentation to explain the background of the study, the rationale and expectations among other things, which brought excitement amongst the representatives who eagerly wait for the trial to start. Augustine explained the procedure for the randomisation and asked representatives to split into three groups according to the letters of their randomisation allocation.
As a group they chose a team name and a team captain. Group A, chose to be called Portugal, with their captain Pepsy Nangwale; Group B was called Uruguay, captain Alex Ntakati; while Group C was called Mexico with Bertha Chafwala as their captain. The next part involved the team captains drawing a golf ball as the final choice of a trial arm to be implemented at their facilities. The captain for team Portugal was the first and drew the ST with partners offered a $10 incentive. The captain for team Uruguay drew the SOC and the captain for team Mexico drew the ceremonious final ball with ST only.
STAR-ANC is a scale up of a Phase II trial known as Partner-Provided HIV Self-Testing and Linkage (PASTAL), which was conducted at three health facilities in urban Blantyre between August 2017 and January 2018. The results of this trial showed that providing first time antenatal care attendees with HIV self-test kits to take home increased male partner testing from 17% to 95%.
The study is expected to begin recruitment in July, 2018 and run for a period of six months.
STAR-ANC is one of the two cluster-randomised trials for STAR Phase 2. The second one involves distribution of HIV self-test kits through community elected and owned systems. The STAR-ANC trial is being run on behalf of Unitaid by local partners Malawi-Liverpool Wellcome Trust and Population Services International (PSI) in collaboration with the Government of Malawi Ministry of Health with support from the London School of Hygiene & Tropical Medicine (LSHTM).
A participant picking a ball representing a trial arm during the ceremony