BHP launches Tshireletso Study

. Long-Acting Injectable Cabotegravir for HIV prevention in newly delivered

mothers in Botswana

The Botswana Harvard Health Partnership (BHP) has today 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.  The Minister of Health, Dr Edwin Dikoloti, launched the study at the BHP Conference Room.

The goal of Tshireletso is to safely deliver the best HIV prevention strategy to the group that needs it the most. CAB-LA is one of the newer medications for pre-exposure prophylaxis (PrEP) and is highly effective in preventing new HIV infections.  Tshireletso will be the first study to implement CAB-LA among people who are breastfeeding.

Why study PrEP in breas1eeding?

Tshireletso is targeting nursing mothers to maximise 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 to 39% in the third or higher pregnancy. Additionally, prevenSng HIV among women who are breasYeeding is key to eliminaSng new pediatric HIV infecSons. When a breastfeeding mother is prevented from acquiring HIV, her infant is also prevented from acquiring HIV through breastfeeding. Breastfeeding women have often been excluded from research and end up being treated with older, less effective interventions. BHP has been a global leader in conducSng high-impact studies that include pregnant and breasYeeding women, and researchers at BHP believe that the best way to protect them is through inclusion in well-designed research studies.

Why is long-ac8ng injectable PrEP needed?

Botswana has been using a pill called ‘Truvada’ or tenofovir (TDF)/ emtricitabine (FTC) for PrEP. When taken every day, Truvada can be protecSve against the acquisiSon  of HIV infecSon. However, many people have a hard Sme remembering to take a daily pill, so researchers looked for other ways to give PrEP that would make adherence easier.  The HPTN 084 study was carried out in mulSple sites in sub-Saharan Africa, including Botswana, and demonstrated that a CAB-LA injecSon taken once every eight weeks was safe and about ten :mes more effec:ve than daily oral FTC/TDF (Truvada) for HIV preven:on among women. Following the posiSve results of the HPTN 084 Study, the United States Food and Drug AdministraSon (FDA) approved CAB-LA for use as an HIV Pre-Exposure Prophylaxis (PrEP) agent in December 2021 and the World Health OrganizaSon (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.

Who can par8cipate in the Tshireletso Study?

Tshirelesto is a 5-year study, funded by the NaSonal InsStute of Child Health and Development (NIH/NICHD, USA) that aims to enroll 500 women without HIV and their infants (mother-infant pairs) who are admiced at the postpartum maternity ward ader delivery and are followed up for 24 months. The study product has been received and enrollment will be iniSated ader this launch. The study was reviewed and approved by the Ministry of Health’s Health Research and Development Commicee (HRDC) and is being conducted in Gaborone and Molepolole.

How does Tshireletso support the goals of World AIDS Day?

In the spirit of the 35th  World AIDS Day under the theme “Let Communi8es  Lead,” the

Tshireletso study will focus efforts not only on the safety and effecSveness of CAB-LA, but also on geing feedback from parScipants about their experience with CAB-LA.   We will be conducSng in-depth interviews with a subset of parScipants at mulSple Sme points throughout the study to find out whether CAB-LA is acceptable and elicit suggesSons to improve delivery. We will also interview people who decline parScipaSon in the study to help us understand why people may not want CAB-LA.  As we all work together to end the HIV epidemic in Botswana, we believe feedback from the community will be criScal to help inform the future rollout of CAB-LA in Botswana, ensuring that people can access whichever HIV prevenSon strategy fits best in their lives. As we commemorate the 35th World AIDS Day the Botswana Harvard Health Partnership joins the world in a clarion call and commitment towards ending the HIV/AIDS epidemic.

More about the Botswana Harvard Health Partnership

Established in 1996, the Botswana Harvard Health Partnership, formerly called the Botswana Harvard AIDS Institute Partnership, is a world renowned public health institute established through a partnership between the Government of Botswana represented by the Ministry of Health and Harvard University in the US represented by the Harvard T.H. Chan School of Public Health. As a world-class research center, BHP is the leading HIV/AIDS research institution in Botswana and its mission is to fight HIV/AIDS and emerging health challenges through innovative research, education and capacity building that impacts policy and practice. Areas of research include clinical and basic science; epidemiology, socio-behavioral science and community-based bio-clinical research relevant to the AIDS epidemic and other emerging public health challenges.