Evaluating counseling outcome on adherence to prophylaxis and follow-up after sexual HIV-risk exposure: a randomized controlled trial

Abstract

Objective. Post-exposure prophylaxis (PEP) is recommended for the management of sexual HIV-risk exposure. However, a high percentage of exposed patients discontinue both their 28-day prophylaxis course before 15 days and HIV testing follow-up before M3. The objective of this study is to assess the efficacy of a counseling intervention in enhancing both adherence to PEP and HIV testing follow-up.

Methods. Between 1 June 2004 and 31 December 2005, 54 patients exposed to sexual HIV-risk exposure were included in a multicenter, prospective, controlled, randomized trial, comparing a group receiving a counseling intervention in addition to traditional medical management (intervention group (IG), n=28) vs. a control group (CG, n=26). Patients in the IG received interactive counseling interventions focused on adherence to PEP and to HIV testing follow-up, led by specially trained nurses. The main outcome measures were proportion of patients achieving 100% adherence to PEP as evaluated on D15 by a self-completed patient questionnaire and on HIV testing on D45 and M3.

Results. Groups were well balanced at baseline for age, sex, and circumstances of exposure. The proportion of 100% adherent patients to PEP was significantly higher in the IG compared to the CG (54% vs. 23%, p=0.036). Patients in the IG were more likely to complete the HIV testing follow-up at D45 (86% vs. 54%, p=0.023) and M3 (68% vs. 38%, p=0.056).

Conclusions. This study suggests the effectiveness of a counseling program to enhance adherence to both PEP and HIV testing follow-up after sexual exposure.

Keywords:

• HIV
• randomized controlled trial
• non-occupational post-exposure prophylaxis
• adherence
• counseling

Acknowledgements

This study would not have been possible without the contributions of:

The counseling nurses: P. Asplanato, M. Borghi, V. Dessens, A. Slous, B. Tolu, and G. Valentini.

The attending physicians: V. Rahelinirina, F. De Salvador, I. Perbost, V. Mondain, E. Cua, P.M. Roger, F. Sanderson, E. Rosenthal, P.Y. Jeandel, N. Bagot, N. Tieulé, S. Roth, P. Heudier, J.G. Fuzibet, C. Ceppi, H. Vinti, J.P. Cassuto, S. Bregigeon, M.P. Drougoul, and J.A. Gastaut.

The senior nurses and nursing supervisors: C. Audibert Bathail, J. Massiera, C. Rascle, I. Pietri, and F. Fiorillo.

Hospital Managers and Medical Staff Officers: M. Rubolini, M.A. Guerrero, M. Mazard, J. Durant, and N. Chevalier.

The Public Health Departments’ staff: N. Oran, J.N. Mazza, M. Eck, G. Fabre

J. Schneider, Counseling Trainer, “ACCES”.

This study was funded by the French Ministry of Health within the framework of the National Hospital Clinical Research Projects (Projets Hospitaliers de Recherche Clinique: PHRC) for 2002.