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Background: The PROMISE trials enrolled 5398 asymptomatic HIV-infected pregnant women not eligible for antiretroviral treatment (ART) and randomly assigned different antiretroviral strategies to assess vertical transmission during pregnancy and post-delivery, infant safety, and maternal health. The START study subsequently demonstrated clear benefit in initiating ART regardless of CD4 count. The PROMISE study team informed active participants of these results and strongly recommended that women not receiving ART immediately initiate treatment to optimise their own health. We summarize PROMISE participants'' responses to these recommendations and their reasons given to either accept or decline early ART.
Methods: A mixed methods approach was used to gather responses from participants receiving the START information. Staff actively contacted participants to return to the clinic and delivered START results, utilising a structured script and assessing comprehension. Women not on ART were advised to accept the offer to initiate ART, during a client-centred counselling session. Women selected their primary reason for accepting or rejecting the offer of early ART from a set of closed options. We report the uptake of early ART and the primary reasons in support of their decisions.
Results: The 1483 women not on ART were advised to initiate ART. The offer was accepted by 984 women (66%) but 499 (34%) declined. Acceptance rates by country varied.


HIV-infected mothers accepting Early ART after single counseling session
[HIV-infected mothers accepting Early ART after single counseling session]


Women declined ART as they wanted more time to consider (200/494-40%) and felt well and knew CD4 count was high (89/494-18%). The women accepting early ART did so for health concerns (444/792-56%) and because of the recommendation given by the protocol team (348/792-44%).
Conclusions: A substantial number of women were not willing to initiate early ART after a single counselling session. Over one third needed more time to consider the offer to start early ART for their own health. This finding is important to ART programme implementers scaling up test-and-treat strategies.