Abstract
Introduction The availability of modern contraception including long-acting reversible contraceptives (LARC), is a fundamental component of post-abortion care. A randomized controlled trial (RCT) in South Africa compared immediate to interval insertion of the copper intrauterine device (IUD) after second trimester medical abortion (MA). Immediate insertion resulted in higher use at 6 weeks post-abortion, however expulsion rates were higher than interval insertion. This process evaluation sheds light on barriers and facilitators to the implementation of the study intervention.MethodsWe performed a process evaluation alongside the RCT in which we reviewed clinical records for fidelity to the RCT protocol and conducted in-depth interviews with 14 staff providing healthcare to RCT participants and 24 RCT participants. Research questions explored barriers and facilitators to implementation of immediate IUD insertion, contraceptive decision-making, and the potential impact of context and supplementary trial activities on trial findings. Interviews were recorded and transcribed, with translation into English if needed. We performed a triangulated thematic analysis at the level of the transcribed interview text.ResultsIn the RCT, there were 8 crossovers from the immediate to the delayed arm: 5 had a clinical contraindication to the IUD post-MA and 3 changed their mind about the IUD. In deviation of the RCT protocol 10 women in the delayed arm were given the 3 monthly injectable instead of oral contraceptives. Doctors and nurses were generally in favour of immediate insertion and said it could be incorporated into standard care if women wanted this. This contrasted with the need for interventions by the research team to reinforce adherence by staff to the allocated intervention over the trial duration. For women, convenience, protection from pregnancy and privacy issues were paramount and they expressed preference for engagement with staff who knew their abortion history, and with whom they had an established connection. Clinical trials registration: clinicaltrials.gov/ (ID NCT03505047), Pan African Trials Registry (www.pactr.org), ID PACTR201804003324963ConclusionsWomen and staff favour immediate IUD insertion after second trimester medical abortion, but service delivery may require structures that ensure continuity of care, communication that mitigates loss to follow up and training of staff to ensure competence.
Contraceptive adherence among HIV-infected women in Malawi: a randomized controlled trial of the copper intrauterine device and depot medroxyprogesterone acetate
