Sharing Objective Measures of Adherence to a Vaginal Microbicide Promotes Candor About Actual Use and Bolsters Motivation to Prevent HIV.

Discrepancies between self-reported and actual adherence to biomedical HIV interventions is common and in clinical trials can compromise the integrity of findings. One solution is to monitor adherence biomarkers, but it is not well understood how to navigate biomarker feedback with participants. We surveyed 42 counselors and interviewed a subset of 22 to characterize their perspectives about communicating with participants about residual drug levels, an objective marker of adherence, within MTN-025/HOPE, a Phase 3b clinical trial of a vaginal ring to prevent HIV. When biomarkers indicated low drug levels that mismatched high adherence by self-report, counselors encountered barriers to acceptance and comprehension among participants. However, discrepancies between low self-report and higher drug levels generally stimulated candor. Women recollected times they had not used the product and disclosed problems that counselors thought might otherwise have remained forgotten or concealed. Navigating conversations toward HIV prevention was easier at mid-range drug levels and when women indicated motivation to prevent HIV. Ratings of residual drug level offered a somewhat objective measure of adherence and protection that counselors perceived as meaningful to participants and as a valuable catalyst for broaching conversation about HIV prevention. However, communication about drug levels required that counselors navigate emotional barriers, respond skillfully to questions about accuracy, and pivot conversations non-judgmentally away from numerical results and toward the priority of HIV prevention. Findings suggest a role for biomarker feedback in future clinical trials as well as other clinical contexts where biomarkers may be monitored, to motivate disclosure of actual adherence and movement toward HIV prevention.Clinical Trial Number NCT02858037.

RESUMEN: Discrepancias entre la adherencia auto-reportada y la verdadera a intervenciones biomédicas de VIH pueden comprometer los ensayos clínicos. Una solución es monitorear la adherencia por medio de ensayos biológicos, pero no se entiende bien cómo comunicar estas medidas a los participantes. En MTN-025/HOPE, un ensayo fase 3b de un anillo vaginal para prevenir VIH, encuestamos a 42 consejeros de adherencia y entrevistamos a un subconjunto de 22 para caracterizar sus perspectivas sobre comunicar una medida objetiva de adherencia al anillo, el nivel residual de droga (RDL por sus siglas en inglés). Los consejeros reportaron que los participantes apreciaron la retroalimentación del RDL como una indicación de su protección de VIH. Niveles más altos de droga estimularon euforia y alivio mientras niveles mas bajos resultaron en desilusión. Una postura no crítica y el apoyo a la autonomía de elegir otras alternativas al anillo promovieron divulgación de las razones por la falta de adherencia. Hablar del monitoreo de RDL como "protección" en vez de "adherencia" ayudó a cambiar el enfoque desde resultados numéricos hasta la meta mayor del ensayo de prevenir el VIH. Personalizar la retroalimentación de medidas objetivas de adherencia requiere una conversación cuidadosa para minimizar las actitudes defensivas. La retroalimentación personalizada también se puede implementar de forma que motive la divulgación de la falta de adherencia y evoque un compromiso a prácticas de prevención. Enfatizar las motivaciones de las mujeres a prevenir el VIH, en vez de los resultados numéricos, puede incentivar a los usuarios consistentes a continuar y a los usuarios inconsistentes a usar métodos alternativos de prevención.

Acceptability of drug detection monitoring among participants in an open-label pre-exposure prophylaxis study.

In the world of HIV pre-exposure prophylaxis (PrEP) research, there is emerging interest in providing study participants with pharmacokinetic results from drug level testing to guide adherence counseling. The iPrEx randomized control trial was the first study to produce meaningful results of PrEP in humans. In the iPrEx open-label extension (OLE) study, blood plasma samples collected in the first 12 weeks of study participation were tested for the presence of tenofovir/emtricitabine--the drugs which compromise PrEP. Study clinicians shared results (detectable/undetectable) with participants at their 24-week visit. We evaluated the acceptability of receiving these results among a subset of iPrEx OLE participants. We conducted in-depth interviews (n = 59) with participants (those with and those without drug detected) enrolled in Boston, Chicago, and San Francisco to assess their experiences with receiving drug detection feedback. Incorporating drug detection results into the clinical study visit was well received and no negative reactions were expressed. For about half of participants, receiving their drug detection lab result was useful while for others it was not important. In a few cases, no drug detected results led to increased efforts to take PrEP consistently and in most cases enhanced open discussion of missed doses. Participants reported a desire for greater specificity, particularly quantitative drug levels needed for protection. We recommend exploring strategies to increase the salience of drug level results, including using feedback to target adherence counseling, and reducing the time between specimen collection, testing, and receipt of results. Future studies should evaluate the feasibility and impact of providing more specific quantitative drug levels using biomarkers of longer term PrEP exposure, i.e., hair/dried blood spots.