A randomized noninferiority trial of standard versus enhanced risk reduction and adherence counseling for individuals receiving post-exposure prophylaxis following sexual exposures to HIV.

BACKGROUND: The National HIV/AIDS Strategy proposes to scale-up post-exposure prophylaxis (PEP). Intensive risk reduction and adherence counseling appear to be effective but are resource intensive. Identifying simpler interventions that maximize the HIV prevention potential of PEP is critical. METHODS: A randomized noninferiority study comparing 2 (standard) or 5 (enhanced) risk reduction counseling sessions was performed. Adherence counseling was provided in the enhanced arm. We measured changes in unprotected sexual intercourse acts at 12 months, compared with baseline; HIV acquisition; and PEP adherence. Outcomes were stratified by degree of baseline risk. RESULTS: We enrolled 457 individuals reporting unprotected intercourse within 72 h with an HIV-infected or at-risk partner. Participants were 96% male and 71% white. There were 1.8 and 2.3 fewer unprotected sex acts in the standard and enhanced groups. The maximum potential risk difference, reflected by the upper bound of the 95% confidence interval, was 3.9 acts. The difference in the riskier subset may have been as many as 19.6 acts. The incidence of HIV seroconversion was 2.9% and 2.6% among persons randomized to standard and enhanced counseling, respectively, with a maximum potential difference of 3.4%. The absolute and maximal HIV seroconversion incidence was 9.9% and 20.4% greater in the riskier group randomized to standard, compared with enhanced, counseling. Adherence outcomes were similar, with noninferiority in the lower risk group and concerning differences among the higher-risk group. CONCLUSIONS: Risk assessment is critical at PEP initiation. Standard counseling is only noninferior for individuals with lower baseline risk; thus, enhanced counseling should be targeted to individuals at higher risk.

Linking a motivational interviewing curriculum to the chronic care model.

BACKGROUND: Unhealthy lifestyle choices frequently cause or worsen chronic diseases. Many internal medicine residents are inadequately trained to provide effective health behavior counseling, in part, due to prioritization of acute care in the traditional model of medical education and to other systemic barriers to teaching psychosocial aspects of patient care. AIM: To address this gap in training, we developed and piloted a curriculum for a Primary Care Internal Medicine residency program that links a practical form of motivational interviewing (MI) training to the self-management support (SMS) component of the chronic care model. PARTICIPANTS AND SETTING: All 30 primary care residents at Alameda County Medical Center were trained in the curriculum since it was initiated in 2007 during the California Academic Chronic Care Collaborative. PROGRAM DESCRIPTION: Residents participated in three modules during which the chronic care model was introduced and motivational interviewing skills were linked to the model's self-management support component. This training was then reinforced in the clinical setting. Case-based interactive instruction, teaching videotapes, group role-plays, faculty demonstration, and observation of resident-patient interactions in the clinical setting were used to teach the curriculum. PROGRAM ASSESSMENT: A preliminary, qualitative assessment of this curriculum was done from a program standpoint and from the perspective of the learners. Residents reported increased sense of confidence when approaching patients about health behavior change. Faculty directly observed residents during clinical encounters using MI and SMS skills to work more collaboratively with patients and to improve patient readiness for self-management goal setting. CONCLUSION: A curriculum that links motivational interviewing skills to the chronic care model's self-management support component and is reinforced in the clinical setting is feasible to develop and implement. This curriculum may improve residents' confidence with health behavior counseling and with preparing patients to become active participants in management of their chronic conditions.

Seroconversion following nonoccupational postexposure prophylaxis against HIV.

BACKGROUND: The efficacy of antiretroviral postexposure prophylaxis (PEP) against infection with human immunodeficiency virus (HIV) following occupational exposures has prompted the use of PEP after nonoccupational exposures. There are, however, important differences between occupational and nonoccupational exposures, and the effectiveness of PEP following nonoccupational exposure is unknown. We sought to describe the occurrence and circumstances of HIV seroconversion following nonoccupational PEP. METHODS: HIV uninfected individuals reporting potential sexual or injection drug use exposures to HIV in the preceding 72 h received a 28-day regimen of antiretroviral therapy and counseling in a nonrandomized trial. The level of HIV antibody was measured 12 weeks after PEP initiation. RESULTS: Of 877 exposed subjects, 702 were evaluable 12 weeks after exposure. Seroconversion was detected in 7 subjects (1%; 95% confidence interval, 0.4%-2%). Three seroconverters reported having no exposures after PEP initiation and, thus, probably represent evidence of chemoprophylactic failure. In the other 4 subjects, additional exposures to HIV after PEP initiation or detection of HIV RNA in plasma specimens obtained at baseline precluded determination of the source of seroconversion. No exposure source was available to assess genetic concordance with the seroconverter's virus. CONCLUSIONS: As for occupational exposure, PEP is not completely effective in preventing HIV infection following nonoccupational exposure. Therefore, primary prevention remains essential. In contrast to the occupational setting, the potential source of exposure is rarely available for testing in the nonoccupational setting, and exposures are often not isolated. Thus, it is often impossible to determine whether seroconversion resulted from failure of PEP or from other exposures, posing difficulties for future comparative studies seeking to evaluate the effectiveness of PEP.

Use of postexposure prophylaxis against HIV infection following sexual exposure does not lead to increases in high-risk behavior.

BACKGROUND: The effectiveness of postexposure prophylaxis (PEP) following occupational exposure to HIV has prompted advocacy for PEP following sexual or drug-use exposures. OBJECTIVE: To evaluate the concern that the availability of PEP for sexual or drug-use exposures might result in behavioral disinhibition. DESIGN: Non-randomized trial of 397 adults with high-risk sexual or drug-use exposures within the prior 72 h. INTERVENTIONS: Antiretroviral medication for 4 weeks and five counseling sessions. MAIN OUTCOME MEASUREMENTS: Participants were followed for 12 months for repeat request for PEP and for changes compared with pre-enrollment in overall high-risk behavior and the acquisition of sexually transmitted diseases (STD) and HIV. RESULTS: After 12 months following receipt of PEP, the majority of participants (83%) did not request a repeat course of PEP. At 12 months after exposure, 73% of participants reported a decrease compared with baseline in the number of times they had performed high-risk sexual acts; 13% reported no change, and 14% had an increase. Most participants (85%) had no change in the incidence of STD; 8.5% had a decrease and 6.8% an increase. Three homosexual men seroconverted for HIV (none associated with the presenting exposure) for a rate of 1.2/100 person-year, equivalent to rates in San Francisco among all homosexual men. CONCLUSIONS: After receipt of PEP consisting of antiretroviral medication and behavioral counseling following a potential sexual exposure to HIV, most individuals do not increase high-risk behavior. Coupled with prior safety and feasibility data, this lack of behavioral disinhibition suggests that use of PEP should be routinely considered following high-risk sexual exposures.