Abstract

The purpose of this study was to examine the implementation, adherence and protocol fidelity for the Reducing Risky Relationships for HIV (RRR-HIV) study. The RRR-HIV study is a phase III trial of a randomized intervention to reduce human immunodeficiency virus (HIV) risk behaviors among incarcerated women in four US states: Connecticut, Delaware, Kentucky and Rhode Island. The intervention consists of five interventionist-led prison-based group sessions and a sixth individual community-based session. Data on adherence, implementation, acceptability and fidelity of the intervention were obtained from forms completed after the five prison-based sessions by both the interventionist and participant. Data from the sixth session were collected by the interventionist. Of the 363 women recruited to date, 173 (47.6%) have been randomly allocated to the experimental RRR intervention, of which implementation measures were available for 162 (93.6%). Almost three-quarters of women attended all five sessions, each of which lasted a median of 90 minutes, indicating successful implementation of the protocol across multiple study sites. Interventionists and participants alike reported that all of the topics for each session were discussed, suggesting adherence to the protocol. In addition, protocol interventionists indicated that more than 95% of the women were engaged/involved, interested, and understood the materials presented, indicating high levels of acceptability among the participants and fidelity to the intervention protocols. The majority of participants also answered all of the post-test questions correctly, which is another strong indicator of the fidelity to the intervention. Results suggest that the RRR-HIV study has been successfully implemented across multiple study sites. Adherence to the protocol, as well as protocol fidelity and acceptability, were also strong, which is essential to establish prior to examining outcome data.

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