Randomised controlled trial of a sexual risk reduction intervention for STI prevention among men who have sex with men in the USA.

OBJECTIVES: Novel interventions to address sexual risk taking and slow rates of STIs are urgently needed, in particular among black men who have sex with men (MSM) in the USA. Serosorting, or limiting condomless sex acts to partners of the same HIV status, is commonly practised among MSM, yet can lead to STI and remains largely unaddressed by public health agencies. METHODS: A two-arm, randomised controlled trial was conducted from 2012 to 2015. This trial assessed the effects of a single-session, sexual partner selection and risk decision intervention (experimental arm) versus a single-session, Centers for Disease Control and Prevention-based, sexual risk reduction intervention (control arm) on psychosocial measures, sexual risk taking and STI. RESULTS: At study follow-ups, multiple beneficial changes were observed on sexual risk beliefs measures (ie, changes in serosorting and condom use beliefs, and HIV risk perceptions) and sexual risk taking among the experimental arm relative to the control arm. Overall main effects, however, of the intervention on STI outcomes on year-long follow-ups were non-significant. There was evidence for short-term effects on STI outcomes, and self-report of multiple STIs and STI symptoms demonstrated positive effects over the follow-up period. CONCLUSIONS: Brief interventions to address sexual risk taking can result in short-term beneficial outcomes and can be incorporated into currently existing infrastructure at healthcare agencies. Additional intervention will be necessary for demonstrating long-term results. TRIAL REGISTRATION NUMBER: NCT02128594.

Setting the bar high or setting up to fail? Interpretations and implications of the EXPLORE Study (HPTN 015).

Controlled studies show that HIV risk reduction counseling significantly increases condom use, reduces unprotected sex and prevents sexually transmitted infections. Nevertheless, without evidence of reducing HIV incidence, these interventions are generally discarded. One trial, the EXPLORE study, was designed to test whether ten sessions of risk reduction counseling could impact HIV incidence among men who have sex with men in six US cities. Based on epidemiologic models to define effective HIV vaccines, a 35 % reduction in HIV incidence was set a priori as the benchmark of success in this behavioral intervention trial. Results demonstrated a significant effect of the intervention, with more than a 35 % reduction in HIV incidence observed during the initial 12-18 months following counseling. Over an unprecedented 48-month follow-up, however, the effect of counseling on HIV incidence declined to 18 %. The current review examined how the scientific literature has thus far judged the outcomes of the EXPLORE study as well as the policy implications of these judgments. We identified 127 articles that cited the EXPLORE study since its publication. Among articles that discuss the HIV incidence outcomes, 20 % judged the intervention effective and 80 % judged the intervention ineffective. The overwhelmingly negative interpretation of the EXPLORE study outcomes is reflected in public policies and prevention planning. We conclude that using a vaccine standard to define success led to a broad discrediting of the benefits of behavioral counseling and, ultimately, adversely impacted policies critical to the field of HIV prevention.