US gay youth PrEP study meets recruitment and adherence problems

Published: March 2, 2013

A small six-month pilot study of the feasibility and acceptability of pre-exposure prophylaxis (PrEP) in young gay men aged 18 to 22 in the US found that although participants reported adherence levels of 66% on average, their actual adherence (in the previous 48 hours, as measured by drug concentrations) fell from 65% to 20% during the study.

Young people’s mobility appeared to be the largest reason for poor PrEP adherence, with 60% reporting ‘being away from home’ as a reason they did not take their pills.

This was a placebo-controlled study, so participants did not know if they were actually taking PrEP. Halfway through this study, the results of the iPrEx PrEP trial were announced; at that point the study was unblinded and all participants were given the option to take PrEP. Adherence after unblinding will be reported in another paper, and it will be interesting to see if there is a difference in adherence when participants know they are taking PrEP.

The study enrolled 68 young gay men (mean age 20) from Chicago. The intention had originally been to enrol 100, but although 753 potential participants were contacted and 241 met eligibility criteria (the most relevant of which was having had unprotected anal sex at least once in the last year), only 68 were enrolled and 58 randomised. Only 17% of those initially assessed (via a mobile-phone risk assessment tool) attended a screening appointment, though in many cases this was because researchers capped enrolment at about five participants per month due to limited staffing at the trial site. Low staffing, the researchers told Aidsmap, led to long wait times for eligible participants and thus loss to follow-up when staff tried to contact them later. Once youth were enrolled in the study, however, retention was high: 98.5% consistently attended appointments.

Only four out of the 58 randomised men were of white ethnicity (7%): 53% were African-American and 37% were mixed race or of other ethnicity such as Hispanic. Even though a majority of participants had attended some tertiary education, a third of participants had spent at least one night in emergency accommodation, 17% had exchanged sex for money or a place to stay, and 15% had been ‘kicked out’ (the researchers’ phrase) of their family homes due to their sexual orientation.

Of the 743 initially contacted, 3% (22 individuals) were excluded because when screened they turned out to have HIV – a considerably higher undiagnosed positivity rate, say the researchers, than among gay youth in the US generally.

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