Assessing the Implementation Fidelity of a Patient-Centered, Combination Adherence Strategy to Support HIV Antiretroviral Therapy and Pre-Exposure Prophylaxis Adherence During Pregnancy and Breastfeeding in Malawi.

The use of antiretroviral drugs has been proven effective in preventing and treating HIV; however, adherence remains a challenge. In two parallel pilot studies, we implemented a combination adherence intervention involving patient-centered counseling and adherence supporter training, tailored for HIV treatment (ART) or prevention (PrEP) during pregnancy and breastfeeding. The intervention included Integrated Next Step Counseling (iNSC), focused on well-being and medication adherence, with an option to involve a social support member. Independent auditors assessed implementation fidelity for 151 participants (51 women living with HIV and 100 PrEP-eligible women) by scoring iNSC sessions using a standard checklist. High fidelity was observed overall in both study populations, with variability between counselors observed. The results demonstrate the ability to assess implementation fidelity in a behavioral intervention aimed at supporting adherence to antiretroviral drugs among pregnant women and offers critical information on the complexities of implementation of iNSC in a real-world setting.