The Botswana Harvard Health Partnership (BHP) on November 28, 2023 launched the Tshireletso Study which is offering long-acting injectable cabotegravir (CAB-LA) to post-partum women immediately after delivery to prevent new HIV infections. This study aims to determine whether starting long-acting injectable cabotegravir for HIV Pre-Exposure Prophylaxis (PrEP) immediately after delivery is a good strategy for preventing HIV infection in women in Botswana.
The study will further ascertain if the injection form of cabotegravir is acceptable and feasible for mothers who are breastfeeding. The study was launched by the Ministry of Health Deputy Permanent Secretary responsible for Health Policy, Research and Development, Mr Moses Keetile at the BHP Conference Room.
Keetile noted that in the absence of a proven HIV cure and or HIV vaccine, HIV prevention remains key. He said that the Ministry of Health is excited at the initiation of yet another study that targets a key at-risk population (mothers and babies) and was hoping for a positive outcome which would provide a new strategy to prevent HIV acquisition in this vulnerable population.
“We at the Ministry of Health recognize the importance of research and its impact on the transformation of policy and the establishment of evidence-based programmes. These efforts are also very much aligned the country’s aspiration of positioning Botswana as aknowledge-based economy. This necessarily speaks to a vision linked to science, technology, innovation, and creativity,” he said.
Study Physician, Dr Rogers Moeng gave a presentation on the evolution of PrEP, highlight on its history, benefits and challenges which include access and cost. Tshireletso Study Coordinator, Dr Marcella Yoseph explained that the study is building on the breakthrough of the HPTN 084 study which was carried out in multiple sites in sub-Saharan Africa, including Botswana, and demonstrated that CAB-LA injection taken once every eight weeks was safe and about ten times more effective than daily oral FTC/TDF (Truvada) for HIV prevention among women.
Dr Yoseph stated that following the positive results of the HPTN 084 Study, the United States Food and Drug Administration (FDA) approved CAB-LA for use as an HIV Pre-Exposure Prophylaxis (PrEP) agent in December 2021 and the World Health Organization (WHO) also recommended it as PrEP in July 2022. Botswana has included CAB-LA PrEP in the 2023 HIV treatment guidelines, though it is not yet available in the country.
She explained that Tshireletso study will be the first study to implement CAB-LA among people who are breastfeeding and intended to provide data on the real-world effectiveness of CAB-LA outside of a randomized controlled trial. She said that the study will also be the first to look at the effectiveness of CAB-LA in the immediate post-delivery period as well as the first study to evaluate implementation challenges.
“Tshireletso is targeting breastfeeding mothers to maximize the public health impact of CAB-LA PrEP. Multiple studies have shown that the risk of acquiring HIV is 2-4 times higher in the post-partum period. In Botswana, the prevalence of HIV increases from 10% in the first pregnancy, to 22% in the second pregnancy and to 39% in the third or higher pregnancy,” she explained.
Dr Yoseph added that preventing HIV among women who are breastfeeding is one of the elements to eliminating new pediatric HIV infections, explaining that when a nursing mother is prevented from acquiring HIV, her infant is also prevented from acquiring HIV through breastfeeding.
Dr Yoseph further revealed that breastfeeding women have often been excluded from research and end up being treated with older, less effective interventions. She said BHP has been a global leader in conducting high-impact studies that include pregnant and breastfeeding women, and researchers at BHP believe that the best way to protect them is through inclusion in well-designed research studies.
Tshirelesto is a 5-year study, funded by the National Institute of Child Health and Development (NIH/NICHD, USA) and aims to enroll 500 women without HIV and their infants (mother-infant pairs) who are admitted at the postpartum maternity ward after delivery and are followed up for 24 months. The study is taking place in Ga