As millennials communicate extensively by text, investigators designed a study to improve rates of retention and medication adherence in young men who have sex with men.
It’s been well documented that pre-exposure prophylaxis, or PrEP, works exceedingly well at preventing HIV infection in vulnerable individuals—but only if it’s taken exactly as directed. Unfortunately, clinicians have found that certain populations are less likely than others to adhere to the medication regimen. Young men who have sex with men have been particularly resistant to using PrEP consistently, compromising its effectiveness and putting them more at risk of infection.
Looking to improve methods of engagement with young men who have sex with men, a team of investigators from the San Francisco Department of Public Health—along with colleagues from clinics and schools of medicine and public health nationwide—put together a study to assess the usefulness of PrEPmate, a 2-way text-messaging platform designed to offer timed reminders to take medication and show up for study visits. The study, which took place from April 2015 to March 2016, enrolled 121 male (including a handful of transgender and genderqueer) subjects from a single Chicago health care clinic. All were between the ages of 18 and 29 and did not have HIV, although they were deemed at-risk because they not only had engaged in anal sex with men, but they had an additional risk factor including: not using a condom during anal sex, having at least 3 sexual partners, having a new sexually transmitted infection, or having a sexual partner who already had HIV. Participants were excluded if they’d used PrEP during the prior year.
In a 2:1 ratio, the subjects were then randomly assigned to either the PrEPmate arm of the trial or the standard of care arm, so that 81 participants comprised the PrEPmate cohort and 40 comprised the standard of care cohort. The subjects in the PrEPmate part of the trial received daily texts reminding them to take their medication, once-a-week text messages to check in on how they were doing on the PrEP regimen, and reminder messages when they had a follow-up visit scheduled; these visits occurred at 4 weeks, 12 weeks, 24 weeks, and 36 weeks. PrEPmate also allowed the subjects to text back if necessary. In addition to the texts they received, subjects were educated about PrEP and given access to a web-based support group where they could talk about PrEP with each other. Seven subjects in this group dropped out of the study early due to various factors.
The standard of care regimen also involved being educated about PrEP, along with a short counseling session about the importance of staying on the medication and how to mitigate the risk of infection. The men in this study arm received pagers so they could reach a health care practitioner at any time, and they were reminded of upcoming appointments via phone calls. There was no texting involved. Six subjects in this group left the study early.
Both attendance at study visits and adherence to PrEP were higher in the PrEPmate arm of the trial. Subjects in the PrEPmate group made it to 86% of their visits compared with 71% of those following the standard of care. PrEPmate subjects also were more likely to have protective levels of HIV drugs in their system at each visit than those in the standard of care arm. Overall, subjects using PrEPmate reported that it was helpful and they were interested in using it once the study ended.
The study did have limitations, say its authors. “[O]nly 57% of PrEPmate arm participants had protective drug levels at 9 months,” Albert Liu, MD, MPH, clinical research director of Bridge HIV, part of the San Francisco Department of Public Health, as well as an author of the study, told Contagion®. “This suggests that additional efforts, including strategies to address cost/insurance and access issues, may be required to sustain long-term adherence in youth.”
When asked whether PrEPmate might show better results with men outside the 18-to-29-year-old demographic, Dr. Liu stated, “We haven’t yet tested PrEPmate in older men who have sex with men, but we are interested in evaluating this intervention in different age groups, including younger (under 18) and older individuals.”
Although young men who have sex with men are at significant risk of acquiring HIV, in general, this group has demonstrated relatively low rates of adherence to PrEP—particularly those young men who have sex with men who are nonwhite. In fact, new infections in young men who have sex with men are disproportionately concentrated in African-American and Latino men.
“There are a number of structural factors that contribute to the higher rates of new HIV infections among men who have sex with men of color, including limited access to health care and prevention services, stigma, homophobia, discrimination, and medical mistrust,” said Dr. Liu. “Young men who have sex with men also have lower HIV testing rates and awareness of their HIV status.” He also mentioned barriers faced by young men who have sex with men such as finding it tough to get to clinics and pay for care, disliking the idea of taking a daily pill, worrying about side effects, and not truly believing they’re at high risk.
Although PrEPmate has not yet been rolled out to the general population, Dr. Liu’s team is working on new studies that will test PrEPmate in a variety of health settings. “Our results demonstrate that a highly scalable mobile health intervention can increase both retention and adherence to PrEP among young men who have sex with men when evaluated in a randomized clinical trial,” he said. “Clinicians and PrEP programs can consider using a text-messaging approach similar to PrEPmate as a strategy to support youth taking PrEP.”