P23.08
Background: Achieving optimal adherence is a challenge to evaluating oral and topical PrEP. Based on lessons from previous trials, we developed a package of interventions in FACTS 001 to address adherence barriers. FACTS 001 is a phase III licensure trial of tenofovir 1% gel assessing safety and effectiveness in preventing HIV and HSV-2 in women when used pericoitally. We report on feedback from staff implementing these adherence interventions.
Methods: We developed tools to identify adherence issues and give monthly feedback to participants: Returned used applicators were visually inspected for evidence of vaginal insertion; a checklist assessed missed visits, relationship status, and gel use; an Excel tool calculated adherence levels by dividing half the number of used gel applicators by the number of reported sex acts. Additional interventions aimed to instil positive social norms included posters, motivational SMS, speeches by former trial participants, and a barometer of average adherence levels.
Results: These tools helped refine counselling messages, target interventions at specific participants, and feedback individuals' adherence progress over time. The positive norms campaign used multiple methods to promote regular gel use. The images and messages resonated with the everyday lives of South African women, recognizing the challenges of incorporating gel use, and suggested ways of overcoming these challenges. Intensive training, monitoring and support at site visits are essential to ensure that staff is able to implement these approaches to promoting adherence.
Conclusions: Honing in on core motivators and barriers of adherence and leveraging positive peer opinion, we attempted to build positive trial norms to optimise adherence to gel. It has been essential to use tools implemented at an individual level to identify participants that need more support combined with campaigns aimed at creating a positive image of the gel and a supportive context, particularly when contextual factors influence gel use.
