Table 3.

Published Studies of Interventions Designed to Enhance Adherence Among HIV-Infected Youth

Reference Study Design	Population	Measures	Results and Health/Immune Outcomes
Glikman et al, 2007²³ Reviewed medical charts of HIV+ patients admitted to Comer Children’s Hospital for directly observed therapy. Patients hospitalized for 7 days	9 perinatally infected patients (median age, 13 years), 13 total admissions; 8 patients had been treated with numerous antiretroviral therapy regimens	Demographics, clinical/immune class category, previous/current antiretroviral medications, drug resistance tests, plasma HIV RNA level, and CD4+ cell count and percentage before and after directly observed therapy	Three patterns of change in plasma HIV RNA level were observed over time: (1) drop at the end of the directly observed therapy period, remaining low thereafter; (2) drop at the end of the period, but not sustained; (3) no change during or after directly observed therapy. Plasma HIV RNA level at end of directly observed therapy was lower than at admission in 8 patients (mean standard deviation, decrease of 0.8 +/− 0.55 log₁₀ copies/mL)
Lyon et al, 2003⁴⁵ Intervention: 6 biweekly family and youth education sessions; 6 biweekly youth-only education sessions. Devices to increase antiretroviral adherence introduced	23 HIV+ youths (ages 15–22 years) and 23 family members or “treatment buddies”; 18/23 youths completed a group	Baseline participant viral load, CD4+ count, and HIV knowledge compared with same measurements from 3 months after program completion. Survey administered pre-/post-intervention	91% of youths self-reported increased adherence after completing a group. 4 participants experienced a 1 log₁₀ reduction in viral load to levels below detection during intervention. 2 participants continued to decline use of antiretrovirals after intervention and demonstrated no decrease in viral load. Participants tested 5 devices and rated multiple alarm watch as best aid. Family/treatment buddies rated overall program highly helpful, citing social support as most valuable. Unanticipated benefit was increase in other health behaviors
McKinney et al, 2007¹³ Prospective observational study at 16 sites of 37 therapy-naive, HIV+ children and adolescents	37 therapy-naive HIV+ participants (43% age 14–21 years)	Participants observed for ≥ 96 weeks. Signs, symptoms, plasma HIV RNA level, CD4+ count, and safety laboratory tests measured	32/37 subjects (85%) achieved suppression of plasma HIV RNA level to < 400 copies/mL, and 26/37 (72%) maintained sustained suppression at < 50 copies/mL through week 96. Median baseline CD4+ count increased by 18%. Pill amount reduction (to once-daily) used as intervention
Parsons et al, 2006²⁴ Evaluated directly observed therapy of HIV+ children and adolescents with elevated viral loads and nonadherence. Retrospective chart review performed	19 child and adolescent admissions (58% age 13–16 years) included in analysis	Differences in CD4+ count and plasma HIV RNA level at admission, before discharge, and 6 months after discharge were evaluated using Wilcoxon signed-ranks test	Mean CD4+ count at discharge (492) and 6 months after discharge (429) were statistically significantly higher than at admission (262) (P < .01). Mean plasma HIV RNA level at discharge (4.7 log₁₀ copies/mL) and 6 months after discharge (5 log₁₀ copies/mL) were statistically significantly lower than at admission (5.7 log₁₀ copies/ mL) (P < .004). Majority of admissions (74%) involved a change in antiretroviral regimen. Directly observed therapy resulted in immediate, sustained (up to 6 months) reduction in plasma HIV RNA level and increase in CD4+ count
Puccio et al, 2006⁴³ Pilot–small sample. Patients received free cell phones with local service and reminder phone calls for 12 weeks. Call frequency was tapered at 4-week intervals	8 HIV+ adolescents and young adults (ages 16–24 years) beginning either their initial antiretroviral regimen or a new regimen	Participants received a cell phone with 250 free minutes and $10 for questionnaires. Calls were received for 12 weeks. Assessment at 4-week intervals to determine perceived intrusiveness and helpfulness of calls and missed medication doses. Assessment done at week 24 with the same questions	(1) 5/8 patients recruited completed the 12 weeks of cell phone reminders; (2) participants not experiencing institutionalization or major chaotic life changes did very well receiving phone calls, did well with adherence to medication doses, and experienced statistically significant decreases in plasma HIV RNA levels that tracked positively with adherence to call reminders; (3) initially, call reminders were reported to be “annoying, but helpful” but by 12-week follow-up, subjects reported calls to be “less annoying”
Purdy et al, 2008⁴² Retrospective chart review to identify subjects and glean relevant health and adherence information	5 patients (ages 14–19 years; all vertically acquired HIV) identified as having received directly observed therapy for ≥ 4 contiguous days after ≥ 8 weeks of a stable antiretroviral regimen	Retrospective chart review obtained plasma HIV RNA level before and after directly observed therapy intervention	All 5 participants were highly treatment experienced (median, 4 previous antiretroviral regimens), and all had genotypic evidence of resistance to antiretroviral drugs. All were prescribed a twice-daily regimen containing ritonavir-boosted protease inhibitors; 3 patients received more complex regimens because of their specific antiretroviral resistance. 4/5 patients had a decrease in plasma HIV RNA level while on directly observed therapy (ranging from 0.5–2.46 log₁₀ copies/mL; mean, 1.15 log₁₀ copies/mL). All patients later exhibited viral rebound
Rogers et al, 2001⁴⁴ Longitudinal study of cohort of adolescents enrolled in TREAT program to observe movement through Stages of Change Model toward acceptance of and adherence to antiretroviral therapy	288 HIV+ adolescents (ages 15–22 years) in REACH program: 147 receiving antiretroviral therapy, 29 receiving nonantiretroviral therapy, 112 no therapy (65 accepted TREAT program)	(1) Acceptability evaluated by reaction to program video (n = 65); (2) movement across Stages of Change Model assessed by comparing first recorded stage evaluation to last (n = 18); (3) acceptance of adherence measured from medical records. Adherence based on self-report, clinical judgment, and suppression of plasma HIV RNA level (n = 18)	(1) Acceptability of the program: 25% “expressed real approval,” 49% “were positive and found it helpful,” 25% “noncommittal,” and 1% “negative”; (2) Subject movement across Stages of Change Model: 78% (n = 14) moved forward, 11% (n = 2) no movement, 11% (n = 2) regressed; (3) Subject acceptance and adherence to antiretroviral therapy: 2/3 (n = 12) accepted and began antiretroviral therapy, and 1/2 (n = 6) maintained adherence “most to all of the time”

HIV+ indicates HIV seropositive.