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Sharing Objective Measures of Adherence to a Vaginal Microbicide Promotes Candor About Actual Use and Bolsters Motivation to Prevent HIV.
Kutner, Bryan Andrew; Giguere, Rebecca; Lentz, Cody; Kajura-Manyindo, Clare; Dolezal, Curtis; Butheliezi, Samkelisiwe; Gwande, Miriam; Nampiira, Susan; Ndlovu, Thakasile; Mvinjelwa, Priscilla; Mwenda, Wezi; Balán, Iván C.
Afiliação
  • Kutner BA; HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.
  • Giguere R; HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.
  • Lentz C; HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.
  • Kajura-Manyindo C; HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.
  • Dolezal C; HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.
  • Butheliezi S; South African Medical Research Council Clinical Trials Unit, Durban, South Africa.
  • Gwande M; University of Zimbabwe College of Health Sciences Clinical Trials Research Center, Harare, Zimbabwe.
  • Nampiira S; Makerere University - Johns Hopkins University Research Collaboration Clinical Research Site, Kampala, Uganda.
  • Ndlovu T; South African Medical Research Council Clinical Trials Unit, Durban, South Africa.
  • Mvinjelwa P; Emavundleni Clinical Research Site, Cape Town, South Africa.
  • Mwenda W; College of Medicine Clinical Research Site, Queen Elizabeth Central Hospital, Blantyre, Malawi.
  • Balán IC; HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA. ivan.balan@nyspi.columbia.edu.
AIDS Behav ; 25(3): 721-731, 2021 Mar.
Article em En | MEDLINE | ID: mdl-32920652
ABSTRACT
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
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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Infecções por HIV / Anti-Infecciosos Tipo de estudo: Clinical_trials Limite: Adult / Female / Humans Idioma: En Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Infecções por HIV / Anti-Infecciosos Tipo de estudo: Clinical_trials Limite: Adult / Female / Humans Idioma: En Ano de publicação: 2021 Tipo de documento: Article