DOLPHIN-3

The challenge

Women living with HIV must take daily doses of oral antiretroviral therapy (ART) in order to suppress viral replication. Sticking to this routine can be particularly difficult after childbirth, when mothers also have to contend with the many demands of a new baby. Around half of new mothers with HIV do not adhere to daily ART schedules, which can affect their own health and increase the risk that the virus is transmitted to their baby during breastfeeding.

An additional complication is that women may not have disclosed their HIV status to those around them. Continuing to take ART medication without others knowing may be difficult after birth.

A possible solution could be the use of long-acting ART, based on cabotegravir and rilpivirine, as an alternative to daily oral ART. This treatment is administered as an injection every two months, greatly reducing the attention that women have to give to controlling HIV. It could also provide time for mothers to communicate their HIV status if they have yet to do so.

The project

The DOLPHIN-3 project is assessing the impact of a switch from daily oral ART to long-acting injectable ART during breastfeeding. The study, being undertaken in South Africa and Uganda, will determine the feasibility of the switch and its impacts on viral load, adherence and mother-to-child transmission of HIV. 

As injectable ART is more expensive than oral ART, long-term use may not be affordable in many sub-Saharan African settings. The trial design, therefore, incorporates a return to oral ART after the period of high vulnerability during breastfeeding. The project will monitor the pharmacokinetics of ART in mothers and babies during the time women spend on long-acting injectable ART and when they transition back to daily oral ART. The feasibility and practicality of returning to daily oral ART will also be investigated.

The project will explore the barriers and enablers of this potential new approach to HIV control through engagement with both mothers and health workers. It will also evaluate a screening tool that has been designed to identify the most vulnerable women – those at highest risk of non-adherence – so that they can be prioritised to receive long-acting injectable ART.

An extensive programme of engagement with communities, policymakers and other stakeholders will be undertaken to raise awareness of long-acting injectable ART and to shape the design of research activities. 

Impact

The DOLPHIN-3 project will generate valuable information on one potential use of a highly effective new medical intervention, long-acting injectable oral antiretroviral therapy (ART). It will:

• Reveal whether long-acting injectable ART leads to better viral suppression compared with daily oral ART, in real-world settings.
• Identify key factors associated with the successful implementation of the new care pathway, including the transition back to oral ART.
• Demonstrate whether a screening tool can identify those who would benefit most from long-acting injectable ART.

New mothers are a population that could benefit most from long-acting injectable ART. The DOLPHIN-3 project will identify the potential benefits to mothers and babies and reveal key factors affecting the success of implementation.