AIDS and Behavior

, Volume 16, Issue 5, pp 1243–1259 | Cite as

Supporting Study Product Use and Accuracy in Self-Report in the iPrEx Study: Next Step Counseling and Neutral Assessment

  • K. R. AmicoEmail author
  • Vanessa McMahan
  • Pedro Goicochea
  • Lorena Vargas
  • Julia L. Marcus
  • Robert M. Grant
  • Albert Liu
Original Paper


The recent successes of biomedical HIV prevention approaches have sparked considerable debate over the scalability, feasibility, and acceptability of pre-exposure prophylaxis (PrEP) as a widespread prevention strategy for men who have sex with men and trans-gender. Anticipated difficulties with PrEP adherence and concerns about resources required to best support it have tempered enthusiasm of PrEP demonstration projects and roll-out. While no evidence-based approach for supporting PrEP use is presently available, a number of approaches have been developed in the context of double-blind, randomized, placebo-controlled trials of PrEP that can provide guidance in moving forward with real world support of open label PrEP use. We present the development, implementation and evaluation of feasibility and acceptability of next-step counseling (NSC) and neutral assessment (NA), the adherence support and promotion of accurate reporting approaches used in the late phases of the iPrEx study. Evaluation of the approach from the perspective of implementers of over 15,000 NSC sessions in seven different countries with almost 2,000 iPrEx participants provided support for NSC, its brevity (averaging ~14 min per follow-up session) and overall acceptability and feasibility. NA also was generally well supported, with a majority of study staff believing this approach was feasible and acceptable; however, lower acceptability for certain aspects of NA was noted amongst staff reporting NA was different from their previous interview approach. Quantitative and qualitative data gathered from implementers were used to make modifications for supporting PrEP use in the open-label extension of iPrEx.


PrEP Adherence iPrEx Intervention Self-report Next step counseling Neutral assessment 


Los recientes éxitos de las intervenciones biomédicas para la prevención del VIH han generado debate en relación a la cobertura, viabilidad y aceptabilidad de la profilaxis pre-exposición como una estrategia de prevención a ser usada por hombres que tienen sexo con hombres y mujeres transexuales. Las dificultades relacionadas a la adherencia y las preocupaciones acerca de los recursos que se requerirían para respaldar el servicio en condiciones óptimas han aplacado el entusiasmo para la implementación de proyectos de demostración de PrEP. Visto que no existe una estrategia basada en la evidencia que respalde el uso de PrEP, éstas se han desarrollado en el contexto de los ensayos clínicos aleatorizados, doble-ciego y controlados con placebo, los mismos que pueden servir de guía para el respaldo de su uso en el mundo real. Presentamos aquí el diseño, implementación y evaluación de la viabilidad y aceptabilidad de la Consejería del Siguiente Paso (NSC por sus siglas en inglés) y Evaluación Neutral (NA por sus siglas en inglés) de apoyo a la adherencia y a la promoción del reporte correcto de uso de la medicación durante la última fase del estudio iPrEx. La evaluación de esta estrategia por parte de los implementadores de más de 15,000 sesiones de NSC, en 7 países diferentes con casi 2,000 participantes de iPrEx, proporcionó sustento a la NSC, su brevedad (~14 min por sesión de seguimiento), su aceptabilidad y viabilidad. La NA, en general, también fue bien apoyada, y una gran mayoría del personal manifestó que el enfoque es factible y aceptable; sin embargo, se notó menor aceptabilidad de algunos aspectos de la NA entre aquellos miembros del personal que reportaron que la NA era diferente con respecto a la estrategia que usaban anteriormente. Los datos cuantitativos y cualitativos proporcionados por los implementadores se usaron para modificar las estrategias de soporte al uso de PrEP en la extensión de etiqueta abierta del iPrEx.



This work greatly benefited from the contributions and insights from Ed Wolf, consultant to AWG and NSC trainer, and the site team members implementing and otherwise supporting NSC and NA over the course of the iPrEx study. As with all iPrEx study findings and contributions, we are greatly indebted to the men and trans women around the world who participated in the global iPrEx study. This research was supported by a Grant UO1 AI064002 to Robert Grant.

Conflict of interest

The authors report no financial conflicts of interest.


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Copyright information

© Springer Science+Business Media, LLC 2012

Authors and Affiliations

  • K. R. Amico
    • 1
    • 2
    Email author
  • Vanessa McMahan
    • 3
  • Pedro Goicochea
    • 3
  • Lorena Vargas
    • 4
  • Julia L. Marcus
    • 3
  • Robert M. Grant
    • 3
    • 5
  • Albert Liu
    • 6
  1. 1.Center for Health Intervention and Prevention, University of ConnecticutStorrsUSA
  2. 2.Applied Health ResearchBrightonUSA
  3. 3.Gladstone Institute of Virology and ImmunologySan FranciscoUSA
  4. 4.Investigaciones Medicas en SaludIquitosPeru
  5. 5.University of CaliforniaSan FranciscoUSA
  6. 6.San Francisco Department of Public HealthSan FranciscoUSA

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