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Directly Observed Therapy for Non-adherent HIV-infected Adolescents--Lessons Learned, Challenges Ahead
Aditya Gaur*1, M Belzer2, P Britto3, P Garvie1, C Hu3, B Graham4, K Klingman5, M Neely6, G McSherry7, and P Flynn1
1St Jude Children`s Res Hosp, Memphis, TN, US; 2Children`s Hosp Los Angeles, CA, US; 3Harvard Sch of Publ Hlth, Boston, MA, US; 4Frontier Sci and Tech Res Fndn, Amherst, NY, US; 5Div of AIDS, NIAID, NIH, Bethesda, MD, US; 6Univ of Southern California, Los Angeles, US; and 7Univ of Med and Dentistry of New Jersey, Newark, US
Background: Second to gaining access to antiretrovirals,
maintaining medication adherence is perhaps the biggest global challenge to
optimizing HIV care. Directly observed therapy (DOT) works for patients with
tuberculosis, and shows promise for non-adherent HIV-infected adults, but
remains unexplored in HIV-infected adolescents. Given the unique needs and barriers
to adherence for adolescents, a pilot study to examine feasibility of a DOT
model was designed.
Methods: We selected 4 U.S. sites for this 24-week
Pediatric AIDS Clinical Trials Group (PACTG 1036B) pilot study. The DOT model incorporated
feedback from HIV-infected adolescents (PACTG 1036A). Behaviorally infected
adolescents with known medication adherence problems received once-a-day DOT
from trained DOT facilitators at a site of their choice in the community. Medications
taken more than once daily were self-administered. DOT frequency was weaned
based on patient’s ongoing adherence to medications (DOT/non-DOT). Assessment
of CD4 count, HIV RNA polymerase chain reaction (PCR), mental health, barriers
to adherence, and beliefs about medication was done at baseline, week 12, and
week 24. Patient feedback (exit survey) was obtained at the end of DOT.
Results: Over 1 year, we enrolled 20 patients, 65% female,
median age 21 years (range 18 to 24), median CD4 227 cells/μL (range 10 to
443), and median HIV-1 RNA level 4.6 log10 copies/mL (range 1.0 to 5.8);
10 (50%) patients had current or past history of major depression. For week-4, -8,
and -12 study visits, 17, 14, and 14 patients came, respectively. Compliance with
recommended DOT visits (e.g., able to meet the DOT facilitator) was a median
(range): week 4, 91% (64 to 100); week 8, 91% (33 to 100); and week 12, 83%
(57 to 100). Overall, 6 patients (30%; 95%CI 11.9 to 54.3) completed >90% of
their study specified frequency of DOT and successfully weaned to self-administered
therapy. Per exit survey reports (n = 14), 12 found meeting with the DOT
facilitator easy, 11 felt DOT increased motivation to take medications, 7 felt
sad when DOT ended, 10 were willing to continue or restart DOT given a choice,
and 100% would recommend DOT to a friend with adherence problems.
Conclusions: This pilot study demonstrates community-based DOT
for non-adherent HIV-infected adolescents is feasible. Ongoing analyses will identify
characteristics of successful DOT candidates. Overall patient feedback for this
intervention was positive, which combined with the logistical information
gained, will inform future DOT studies.
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