New study starts on choice in prevention methods
Kampala, Uganda | FLAVIA NASSAKA | Something unusual is happening at the Makerere University – John Hopkins University (MUJHU) research collaboration facility at Mulago hill in Kampala.
The walls of the aging building have been freshly painted white with carefully coated patches of hot colours; reds, orange, and blues. The old style plain walls, typical of a laboratory, are out, together with the huge tables, machines and sample storage fridges. In their place, are rooms accessorised with artistic designs made out of carefully crafted wood and pieces of African Kitengi cloth – to depict what’s trending for a typical Ugandan youth.
“We want participants to feel relaxed, happy and stimulated by the environment that surrounds them by using art deco that can lift their mood,” says Dr. Carolyn Akello, a researcher at the facility.
Akello is part of a group of scientists who recently launched a study on HIV in young girls aged between 16 and 21. The Researchers expect 60 participants – 20 from age group 16 to 17 and 40 from age group 18 to 21.
The girls enrolled in the study are all HIV negative. But they are required to be enrolled on two HIV prevention methods; the HIV drugs Truvada and the Dapivirine vaginal ring. They will use these as a form of prevention from the virus or Pre- Exposure Prophylaxis (PrEP).
The study dubbed REACH; short for “Reversing the Epidemic in Africa with Choices in HIV Prevention” is the first of its kind in the country to target this age group. It enrolled its first participant on Feb.06 and targets to enroll 299 others at five research sites in Uganda, Kenya, South Africa and Zimbabwe.
Akello who is one of the investigators told The Independent on Feb.07 that this is a Phase 2 trial aimed at establishing the safety and acceptability of drugs. The efficacy of the two drugs was already confirmed in previous studies.
Across all the four countries participating, the new study is expected to take about three years to conduct, with results being anticipated in late 2022 or early 2023.
Dr. Clementia Nakabiito a senior microbicide researcher who led the previous study on the Dapivirine vaginal ring in older women explains that the study will be conducted within 18 months. The participants will be enrolled on Truvada for six months and then on the vaginal ring laced with HIV drug dapivirine for six months before asking them to choose the type they want for the final six months.
“Our aim is to give people choices. In the final episode we will be able see if more girls prefer the ring or the tablet. Those on the ring will be required to change it monthly and the pill is supposed to be swallowed every day,” Nakabiito says.
The participants will, after a specific period of time, be routinely tested to see the levels of the drug in their blood. This will help to determine adherence.
A similar study has already been done in the United States of America where by 96 girls ages 15-17 were randomly assigned to use the dapivirine ring or a placebo (ring without drug) for a month for six months.
Results of this study were released in 2017 and found the ring to be well-tolerated and acceptable. Adherence was also high with 95% of the rings returned after use having drug levels indicating consistent use during the previous month.
Truvada PrEP has been approved for use among key vulnerable populations in Uganda; including sex workers and sero-discodant couples. The ring, even as it has been proved to be effective among older women in clinical trials, is still going through regulatory procedures in order for it to be approved for general use.
If approved, the ring would be the first biomedical prevention method specifically for women and this according to another researcher; Dr. Brenda Mirembe, might happen in two years’ time. She says that’s why it’s important for them to get additional information on how it’s likely to perform among girls as young as 16 years old. These, according to her, present a big challenge for the HIV/AIDS prevention fight in the country.
Statistics from the recent Uganda Population – based HIV Impact Assessment (UPHIA) report show high levels of new infections among girls between ages 15 to 24 years. The prevalence among this age group is 9% against the national average of 6%. When compared to males of the same age, prevalence is almost four times higher. The trend carries through to adulthood, where women are disproportionately affected; with 8.8% of adult women living with the virus compared to 4.3% of men.
Scientists argue that to reverse this grim picture, there is need to avail women with more devices and methods that they can monopolise to prevent them from contracting the disease, even as they face challenges of gender-based violence (including sexual abuse), lack of social protection and information about how they cope with these inequities and injustices.
The other challenge is that even when these devices and methods become available, they remain out of reach for most women and girls. For instance, Nakabiito says, the devices go through a lot of approvals and yet when these are completed, policy makers also take long to provide the products. She gives Truvada as an example where even as Uganda was one of the countries where efficacy of PrEP was established, it cannot be generally accessed by those in need unless it is through demonstration sites. She says if this initiative alone became more available, it can greatly reduce the numbers of new infections.