Throughout the first 3 months, the participants had monthly study visits with subsequent quarterly visits; at each of these visits, participants had the option to opt out or continue taking the tablets. The investigators monitored all participants for 1 year and analyzed blood samples for evidence that the participants were adhering to the treatment regimen. At the 3-month mark, investigators found tenofovir (evidence of adherence) in more than half, or 57% of participants; 82% of the participants opted to continue treatment. However, at the 6-month mark, tenofovir was only detected in 38% of participants and only 64% opted to continue treatment. By the end of the year, 38% of participants tested positive for tenofovir. The most commonly cited reasons for stopping treatment were either headaches or nausea.
According to the press release, all participants were given a HIV preventive package, which consisted of the following:
- HIV testing
- Management of sexually transmitted infections
- Counseling dedicated to reducing risk of infection
- Access to condoms
- Post-exposure prophylaxis
- Counseling on ongoing need for oral PrEP
- Counseling for boys regarding male circumcision to reduce risk of infection
They were also provided with 3 “preventive components” tailored specifically for their population:
- Option to receive daily/weekly reminder text messages to take their tablet
- Adherence clubs: meeting with community healthcare worker for counseling and support for taking the oral tablet as PrEP
- Option to receive real-time reports on the level of tenofovir in their blood during study visits
“The trend toward lower adherence to Truvada for PrEP as study visits became less frequent parallels what was observed in a study of PrEP in adolescent gay and bisexual boys, suggesting that monthly study visits may support greater adherence to oral PrEP among adolescents over time,” Protocol Chair and International AIDS Society President Linda-Gail Bekker, MBChB, PhD, commented in the press release.
Researchers hope that these results could help support the “development of evidence-based guidelines for the use of Truvada as oral PrEP in adolescents.”
The National Institute of Allergy and Infectious Diseases (NIAID) contributed funding to the study.
Feature Picture Source: National Institutes of Health
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