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Generation of trust between study staff and trial participants enhances participants´ compliance to study procedures in a PrEP trial in the Andes
P. Goicochea1,2, L. Vargas1, J. Lama1, J. Bernales1, V. McMahan2, R.M. Grant2
1Investigaciones Medicas en Salud, Lima, Peru, 2Gladstone Instituteof Virology and Inmunology, University of California San Francisco, San Francisco, United States
Background: Compliance of study procedures in a clinical trial is necessary to answer the research question. We designed a research protocol to collect information from enrolled study participants in a pre-exposure prophylaxis (PrEP) trial in men who have sex with men (MSM) in four study sites in three cities (Lima and Iquitos in Peru, and Guayaquil in Ecuador) in two Andean countries aimed to identify barriers and facilitators to adherence to study medication and compliance with study procedures.
Methods: We used a qualitative approach to data collection including in-depth interviews (IDI) and focus group discussions (FGD) techniques coded and analyzed following the grounded theory approach.
Results: We did four FGD (38 study participants) , one for every study site; and 41 IDI with trial enrollees (approximately 10 per study site) categorized by level of adherence: a) excellent, b) good, c) regular, and d) poor. Participants reported that the generation of trust with the study site and personnel is one of the main reasons to attend scheduled study visits. This trust is enhanced by the quality of service at the study clinic and the good relationship that is established between the clinic receptionist, counselor, physician, nurse, lab technician and pharmacist, reflected, on one hand,the capacity the participant has to ask questions to study personnel and get them answered, and on the other, the professionalism of the personnel. Trust generates honesty in participants, who feel confident to report when they have not taken the study medication, given study staff the opportunity to counsel on adequate adherence strategies to avoid missing doses.
Conclusions: The establishment of a warm, non-judgmental atmosphere with trial participants at study clinics generates opportunities to provide adequate counseling and motivates participants to attend study visits within the window period, reducing the chances to be out of study medication.
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