Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2022 Mar;26(3):698-708.
doi: 10.1007/s10461-021-03429-z. Epub 2021 Aug 14.

Inconsistent Counselor Fidelity in Delivering an Evidence-Based Adherence Intervention During a PrEP Trial

Affiliations
Clinical Trial

Inconsistent Counselor Fidelity in Delivering an Evidence-Based Adherence Intervention During a PrEP Trial

Iván C Balán et al. AIDS Behav. 2022 Mar.

Abstract

Evidence-based adherence counseling interventions must be delivered with fidelity to ensure that their effectiveness is retained, but little is known regarding how counselors in biomedical HIV trials deliver these interventions. Forty-two counselors from the MTN-025/HOPE Study, which was conducted in 14 sites in sub-Saharan Africa, participated. They completed a quantitative assessment and consented for their HOPE counseling session ratings to be analyzed. Twenty-two (52%) self-identified as research nurses and 20 (48%) as counselors. Of 928 session ratings, 609 (66%) were classified as Good, 188 (20%) as Fair, and 131 (14%) as Poor, based on pre-established criteria. Overall mean ratings for session tasks and global components (each rated from 1 to 5) were 4.12 (SD = 0.45; range 2.46-4.73) and 4.02 (SD = 0.64; range 1.75-4.79), respectively. Twenty-six (62%) counselors attained Good or Fair ratings on at least 85% of their sessions, but 33% of counselors had more than 25% of their sessions rated as Poor; three counselors (7%) never met criteria for a Good session. Even after extensive training, counselors' fidelity to the intervention varied. Our findings highlight the value of fidelity monitoring using session audio-recordings, the importance of ongoing coaching and support, and the need to plan for counselors with consistently poor fidelity.

Las intervenciones de consejería de adherencia basadas en la evidencia deben ser realizadas con fidelidad para asegurar que retengan su efectividad, pero se sabe poco sobre cómo los consejeros en ensayos biomédicos de VIH realizan estas intervenciones. Cuarenta y dos consejeros participaron del Estudio MTN-025/HOPE, el cual se llevó a cabo en 14 sitios en África subsahariana. Completaron un cuestionario cuantitativo y dieron su consentimiento para el análisis de las calificaciones de sus sesiones de consejería para HOPE. Veintidós (52%) se identificaron como enfermeras investigadoras y 20 (48%) como consejeros. De 928 sesiones calificadas, 609 (66%) fueron clasificadas como Buenas, 188 (20%) como Suficientes, y 131 (14%) como Mediocres, basado en criterios preestablecidos. Las calificaciones promedias de las tareas de las sesiones y de los componentes globales (calificados de 1 a 5) fueron de 4.12 (SD = 0.45; rango 2.46–4.73) y de 4.02 (SD = 0.64; rango 1.75–4.79), respectivamente. Veintiséis (62%) consejeros lograron calificaciones Buenas o Suficientes en al menos el 85% de sus sesiones, pero para el 33% de los consejeros, más del 25% de sus sesiones fueron calificadas como Mediocres; tres consejeros (7%) nunca cumplieron con los criterios de una Buena sesión. Aún después de una capacitación intensiva, la fidelidad a la intervención variaba. Nuestros hallazgos destacan el valor de monitorear para la fidelidad usando audio-grabaciones de las sesiones, la importancia de la instrucción y el apoyo continuo, y la necesidad de planear qué medidas tomar cuando hay consejeros que no son fieles a la intervención.

Keywords: Adherence; Counseling; Evidence-based interventions; Fidelity monitoring; HIV prevention.

PubMed Disclaimer

Conflict of interest statement

Conflicts of interest: The authors declare no conflicts of interest.

Figures

Figure 1.
Figure 1.
Individual counselor performance per counseling session rated during the HOPE Study.

References

    1. Amico KR, Mansoor LE, Corneli A, Torjesen K, van der Straten A. Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials. AIDS Behav. 2013;17(6):2143–2155. - PMC - PubMed
    1. Amico KR, McMahan V, Goicochea P, Vargas L, Marcus JL, Grant RM, Liu A. Supporting study product use and accuracy in self-report in the iPrEx study: next step counseling and neutral assessment. AIDS and Behav. 2012;16(5):1243–1259. - PubMed
    1. Safren SA, Mayer KH, Ou SS, et al. Adherence to early antiretroviral therapy: results from HPTN 052, a phase III, multinational randomized trial of ART to prevent HIV-1 sexual transmission in serodiscordant couples. J Acq Def Synd. 2015; 69(2):234–240. - PMC - PubMed
    1. Baer JS, Ball SA, Campbell BK, Miele GM, Schoener EP, Tracy K. Training and fidelity monitoring of behavioral interventions in multi-site addictions research. Drug Alcohol Depen. 2007; 87(2-3):107–118. - PMC - PubMed
    1. Baer JS, Wells EA, Rosengren DB, Hartzler B, Beadnell B, Dunn C. Agency context and tailored training in technology transfer: A pilot evaluation of motivational interviewing training for community counselors. J Subst Abuse Treat. 2009; 37(2):91–202. - PMC - PubMed

Publication types