Participation and Refusal in an Implementation Trial: Insights from the Accelerating Cervical Cancer Elimination through the Integration of Screen-and-Treat Services (ACCESS) Study

Background Patient recruitment and retention are major challenges in efforts to diversify clinical trials, particularly in resource-limited settings. Understanding factors that influence participation is critical for effective trial implementation. This study explores factors influencing participation and refusal in the Accelerating Cervical Cancer Elimination through the integration of Screen-and-treat Services (ACCESS) implementation trial among women living with HIV (WLHIV) in Nigeria. Methods A phenomenological qualitative approach was employed. In-depth interviews were conducted with 21 participants (12 acceptors, 9 decliners), purposively sampled from 12 NISA-MIRC HIV treatment facilities across Nigeria’s six geopolitical zones. Interviews were conducted in English, Hausa, or Yoruba and translated for thematic analysis. Data was analyzed using comparative thematic analysis to identify cross-cutting domains influencing decision-making. Results Nine themes emerged, including comprehension of information, fear and risk perception, perceived benefits and opportunities, logistical barriers, willingness to participate in the future, suggestions for improvement, privacy concerns, and preferred recruitment approaches. Acceptors overcame concerns through clear communication, emotional reassurance, trust, and perceived personal relevance. Decliners experienced “barrier dominance,” where unresolved fears, logistical constraints, mistrust, and poorly timed recruitment outweighed potential benefits. Both groups suggested improvements, such as enhanced communication, community outreach, confidentiality assurances, and logistical support. Conclusions Trial participation decisions reflect distinct cognitive, emotional, and structural pathways. Patient-centered communication, culturally appropriate explanations, trust-building, and logistical support are critical to improving trial recruitment and retention. Addressing these factors can enhance equitable participation and strengthen the quality and generalizability of trial evidence in Nigeria and similar low-resource contexts.