A Randomized Noninferiority Trial of Standard Versus Enhanced Risk Reduction and Adherence Counseling for Individuals Receiving Post-Exposure Prophylaxis Following Sexual Exposures to HIV

Positive Health Program, Department of Internal Medicine, San Francisco General Hospital, San Francisco, California, USA.
Clinical Infectious Diseases (Impact Factor: 8.89). 07/2011; 53(1):76-83. DOI: 10.1093/cid/cir333
Source: PubMed


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.
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.
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.
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.

Full-text preview

Available from:
  • Source
    • "We suggest that providers may require additional training in counseling, and how to tailor services to patients' needs. Targeted individuals with high risk behaviors with enhanced counseling may be interesting [29]. Mobile phone or internet-based strategies might also enhance follow-up rates [30]. "
    [Show abstract] [Hide abstract] ABSTRACT: Objectives The care of exposed individuals to HIV remains a challenge regarding follow-up completion and HIV-testing of the partner. Identifying patients with risk of not fulfilling HIV-testing follow-up completion (FC), among patients demanding non-occupational post-exposure prophylaxis (nPEP), may improve clinical practice. Methods A retrospective chart review was conducted in a single French HIV-infection care center. FC predictors were assessed in a multivariate logistic regression model (Likelihood ratios test). Results Between 2009 and 2013, 646 sexual exposures to HIV were evaluated for nPEP, of which 507 effectively received nPEP (78%). FC rate was 30% (194/646). In the multivariate analysis, FC rates rose with age of exposed individuals (OR, 1.04 [0.25-4.28]; p<0.001) and decreased with the year of sexual exposure (OR, 0.74 [0.65-0.85]; p<0.001). FC was associated with sexual encounter with a sex worker (OR, 4.07 [0.98-16.82]; p<0.001) and nPEP use (OR, 2.69 [2.37-3.06]; p<0.001). nPEP early discontinuation was associated with decreased FC rates (OR, 0.18 [0.08-0.39]; p<0.001). No documented nPEP failure was identified. However, five Men who have Sex with Men (MSM) nPEP recipients for unprotected anal receptive intercourse subsequently seroconverted to HIV more than 6 months after nPEP. Seroconversion to HIV was associated with the lack of FC (p = 0.04) and multiple presentations for nPEP over the study period (p = 0.002). Conclusions We identified significant predictors of not fulfilling sequential HIV-testing. They appear to be linked with a self-perceived HIV risk, especially in young adults recently exposed. Enhanced counseling in targeted individuals with high risk behaviors and using smartphone and internet-based strategies may be interesting retention in care options.
    Full-text · Article · Dec 2015 · PLoS ONE
  • Source
    [Show abstract] [Hide abstract] ABSTRACT: Postexposure prophylaxis after sexual exposure to human immunodeficiency virus (HIV) is recommended by state and national agencies. A cross-sectional survey of 117 Los Angeles County sites found that 17 sites (14.5%) offer postexposure prophylaxis. Ten sites (8.5%) offer postexposure prophylaxis to patients who are uninsured. General availability of postexposure prophylaxis should be a public health priority.
    Preview · Article · May 2009 · Clinical Infectious Diseases
  • Source
    Full-text · Article · Dec 2011 · AIDS (London, England)
Show more