P42.11
Background: Adherence counseling interventions have become a critical component of biomedical HIV prevention trials. Yet, little is known about how well counselors learn and deliver them. We present interim findings about implementing the participant-centered adherence counseling intervention being used in MTN-017.
Methods: Counselors at seven study sites completed two days of training on delivering the standardized intervention. Next, they conducted two practice sessions, at least one of which had to meet pre-determined fidelity criteria for approval to see study participants. All sessions were audio-recorded. For each counselor, the practice sessions, the first ten study sessions, and one of every five subsequent sessions were rated for fidelity. Ratings were used to guide monthly group coaching sessions with the counselors.
Results: Twenty-six counselors completed the two-day training. For 15 counselors (58%), both practice sessions met fidelity criteria; for seven counselors (27%), one session met criteria; and for four counselors (15%), neither did. To date, 226 of 227 counseling sessions conducted have been recorded. Of the eight counselors who have completed ten study sessions, six met fidelity criteria on 80% or more of their sessions, but two met criteria on 50% or less of the sessions. Fidelity ratings varied over time. Fidelity ratings of the individual components of the sessions suggest that lower ratings were mostly attributable to skipping components of the session, not to conducting them incorrectly.
Conclusions: Recording adherence counseling sessions during biomedical trials is feasible and acceptable to counselors and participants. After 2 days of training, the majority of counselors, though not all, were able to accurately deliver the intervention. Over time, counselors appear vulnerable to lapses in fidelity. Findings highlight the need to assess efficacy of training for such interventions and for continued monitoring and coaching throughout the study to ensure fidelity.
