Botswana Harvard Health Partnership (BHP) recently launched the ‘Tshireletso’ Study, which offers long-acting injectable cabotegravir (CABLA) to post-partum women immediately after delivery to prevent new HIV infections. The Minister of Health, Dr Edwin Dikoloti, launched the study.

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.

According to BHP, Tshireletso targets nursing mothers to maximise the public health impact of CAB-LA PrEP. Multiple studies have shown that the risk of acquiring HIV is two to four times higher in the postpartum period.

In Botswana, the prevalence of HIV increases from 10 percent in the first pregnancy to 22 percent in the second pregnancy to 39 percent in the third or higher pregnancy. Additionally, preventing HIV among women who are breastfeeding is key to eliminating new pediatric HIV infections. 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 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.

Why is long-acting 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 protecting against the acquisition of HIV infection. However, many people have a hard time 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 multiple sites in sub-Saharan Africa, including Botswana, and demonstrated that a 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. 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.

Who can participate in the Tshireletso Study?

Tshirelesto is a five-year study, funded by the National Institute of Child Health and Development (NIH/NICHD, USA) that 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 product has been received and enrollment will be initiated later. The study was reviewed and approved by the Ministry of Health’s Health Research and Development Committee (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 Communities Lead,” the

Tshireletso study will focus efforts not only on the safety and effectiveness of CAB-LA, but also on getting feedback from participants about their experience with CAB-LA. There will in-depth interviews with a subset of participants at multiple time points throughout the study to find out whether CAB-LA is acceptable and elicit suggestions to improve delivery. People who decline participation in the study will also be interviewed to help researchers understand why people may not want CAB-LA.