Implementation of a fidelity monitoring process to assess delivery of an evidence-based adherence counseling intervention in a multi-site biomedical HIV prevention study

ABSTRACT

Pre-Exposure Prophylaxis (PrEP) trials often implement counseling to support product adherence. Counseling fidelity can vary significantly across providers and time. Fidelity monitoring can ensure that counseling is delivered as designed. We describe the process, feasibility, and outcomes of monitoring Options counseling fidelity in an open-label study of the dapivirine vaginal ring MTN-025/HOPE. After initial training, 63 counselors from 14 sites in Sub-Sahara Africa audio-recorded counseling sessions with study participants. Sessions were rated by a New York-based team that included bilingual emigres from the study countries. Completed session rating forms were sent to counselors to provide feedback and counseling difficulties were discussed during monthly calls. Of 1456 study participants, 85.7% consented to at least one session, and 20% to all sessions, being audio-recorded. Among 9926 study visits in which Options was expected to occur, 5366 (54.1%) Options sessions were audio-recorded, of which 1238 (23.1%) were reviewed; 1039 (83.9%) were rated as “good” or “fair.” Eleven counselors who failed to consistently deliver the intervention were reassigned to back-up status. This study demonstrates the feasibility and benefits of monitoring counseling fidelity using audio-recordings in a multi-site, multi-language, multi-country PrEP trial. Given the investment necessary to conduct such trials, providing counseling oversight is highly warranted.

KEYWORDS:

• Counseling
• fidelity
• motivational interviewing
• HIV
• Africa

Acknowledgments

The authors wish to thank the entire HOPE study team, especially the HOPE study counselors and participants. This study was designed and implemented by the Microbicide Trials Network (MTN), funded by the National Institute of Allergy and Infectious Diseases through individual grants (UM1AI068633, UM1AI068615 and UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health (NIH). Dr. Balan is also supported by The HIV Center for Clinical and Behavioral Studies through a center grant (P30-MH43520, PI: Remien) from the National Institute of Mental Health. The vaginal rings used in this study were developed and supplied by the International Partnership for Microbicides (IPM). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. All authors have read and approved the final manuscript. IB designed the counseling intervention and wrote the paper. CL, RG, and CTR provided research support to IB, rated counseling sessions, and assisted in writing the paper. AJM managed the clinical trial. TPP, NMM, SH, JMB and LST designed the clinical trial and critically reviewed the paper.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This study was designed and implemented by the Microbicide Trials Network (MTN), funded by the National Institute of Allergy and Infectious Diseases through individual grants (UM1AI068633, UM1AI068615 and UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health (NIH).