| Literature DB >> 36221325 |
Rose Otieno Masaba1, Godfrey Woelk2, Nicole Herrera2, Stephen Siamba1, Rogers Simiyu1, Boniface Ochanda3, Gordon Okomo4, Justine Odionyi1, Michael Audo1, Eliud Mwangi1.
Abstract
Viral suppression is suboptimal among children and adolescents on antiretroviral therapy (ART) in Kenya. We implemented and evaluated a standardized enhanced adherence counseling (SEAC) package to improve viral suppression in children and adolescents with suspected treatment failure in Homa Bay and Turkana. The SEAC package, implemented from February 2019 to September 2020, included: standard procedures operationalizing the enhanced adherence counseling (EAC) process; provider training on psychosocial support and communication skills for children living with HIV and their caregivers; mentorship to providers and peer educators on EAC processes; and individualized case management. We enrolled children and adolescents aged 0 to 19 years with suspected treatment failure (viral load [VL] >1000 copies/mL) who received EAC before standardization as well as those who received SEAC in a pre-post evaluation of the SEAC package conducted in 6 high-volume facilities. Pre-post standardization comparisons were performed using Wilcoxon-Mann-Whitney and Pearson's chi-square tests at a 5% level of significance. Multivariate logistic regression was performed to identify factors associated with viral resuppression. The study enrolled 741 participants, 595 pre- and 146 post-SEAC implementation. All post-SEAC participants attended at least 1 EAC session, while 17% (n = 98) of pre-SEAC clients had no record of EAC attendance. Time to EAC following the detection of high VL was reduced by a median of 8 days, from 49 (interquartile range [IQR]: 23.0-102.5) to 41 (IQR: 20.0-67.0) days pre- versus post-SEAC (P = .006). Time to completion of at least 3 sessions was reduced by a median of 12 days, from 59.0 (IQR: 36.0-91.0) to 47.5 (IQR: 33.0-63.0) days pre- versus post-SEAC (P = .002). A greater percentage of clients completed the recommended minimum 3 EAC sessions at post-SEAC, 88.4% (n = 129) versus 61.1% (n = 363) pre-SEAC, P < .001. Among participants with a repeat VL within 3 months following the high VL, SEAC increased viral suppression from 34.6% (n = 76) to 52.5% (n = 45), P = .004. Implementation of the SEAC package significantly reduced the time to initiate EAC and time to completion of at least 3 EAC sessions, and was significantly associated with viral suppression in children and adolescents with suspected treatment failure.Entities:
Mesh:
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Year: 2022 PMID: 36221325 PMCID: PMC9542655 DOI: 10.1097/MD.0000000000030624
Source DB: PubMed Journal: Medicine (Baltimore) ISSN: 0025-7974 Impact factor: 1.817
Figure 1.Flow chart of study participant enrollment. Study participants with viral load >1000 copies/mL, enrolled pre-standardization and post standardization of the enhanced adherence counseling (EAC) package and followed through EAC to completion of minimum 3 sessions. In both groups, participants who completed at least 3 EAC sessions and had a repeat viral load were assessed for viral suppression.
Demographic and clinical characteristics of the study populations, pre and post-standardized enhanced adherence counseling periods.
| Characteristics | Pre-SEAC period (N = 595) | Post-SEAC period (N = 146) | Total |
|---|---|---|---|
| Gender | |||
| Female | 300 (50.4%) | 70 (48.0%) | 370 (49.9%) |
| Male | 295 (49.6%) | 76 (52.0%) | 371 (50.1%) |
| Age (yr) | |||
| Mean (SD) | 10.9 (4.5) | 11.3 (4.1) | 11.0 (4.4) |
| 0–9 | 227 (38.1%) | 44 (30.1%) | 271 (36.6%) |
| 10–14 | 229 (38.5%) | 67 (45.9%) | 296 (39.9%) |
| 15–19 | 139 (23.4%) | 35 (24.0%) | 174 (23.5%) |
| Viral load at EAC enrollment, median (IQR) copies/mL | 9560 (2580–42,410) | 3481 (1666–20,162) | 7970 (2150–37,700) |
| ART regimen before EAC | |||
| NNRTI-based | 420 (70.6%) | 66 (45.2%) | 486 (65.6%) |
| PI-based | 175 (29.4%) | 77 (52.7%) | 252 (34.0%) |
| Other | 0 (0%) | 3 (2.1%) | 3 (0.4%) |
| ART duration prior to EAC | |||
| Median (IQR), years | 6.3 (3.2–8.9) | 7.4 (4.3–9.4) | 6.6 (3.4–9.1) |
| County | |||
| Homa Bay | 523 (88%) | 129 (88%) | 652 (88.0%) |
| Turkana | 72 (12%) | 17 (12%) | 89 (12.0%) |
| County referral hospital | 377 (63.4%) | 87 (60.0%) | 464 (62.6%) |
| Health centers | 199 (33.4%) | 54 (37.2%) | 253 (34%) |
| Sub-county hospitals | 19 (3.2%) | 4 (2.8%) | 23 (3.1%) |
ART = antiretroviral therapy, EAC = enhanced adherence counseling, IQR = interquartile range, SD = standard deviation, SEAC = standardized enhanced adherence counseling, VL = viral load.
Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens include: AZT/3TC/NVP, AZT/3TC/EFV, ABC/3TC/NVP, ABC/3TC/EFV, TDF/3TC/EFV, TDF/3TC/NVP.
Protease inhibitor (PI)-based regimens include: AZT/3TC/LPV/r, ABC/3TC/LPV/r, ABC/3TC, ATV/r.
Other regimens include dolutegravir (DTG)-based regimen.
Enhanced adherence parameters for participants who completed 3 enhanced adherence counseling sessions as per guidelines.
| Characteristics | Level | Pre-SEAC period | Post-SEAC period | |
|---|---|---|---|---|
| (N = 363) | (N = 129) | |||
| EAC uptake by sex | Male | 179 (49.3) | 69 (53.5) | .420 |
| Female | 184 (50.7) | 60 (46.5) | ||
| EAC uptake by age (yr) | Median (IQR) | 11.0 (7.0–14.0) | 12.0 (9.0–14.0) | .250 |
| 0–9 | 139 (38.3) | 36 (27.9) | .039 | |
| 10–14 | 136 (37.5) | 64 (49.6) | ||
| 15–19 | 88 (24.2) | 29 (22.5) | ||
| Time to EAC uptake | Median (IQR) days | 49.0 (23.0–102.5) | 41 (20.0–67.0) | .006 |
| Minimum 3 EAC session completed | Number completing 3 EAC session | 363(61.1%) | 129(88.4%) | <.001 |
| Time to complete the minimum 3 EAC sessions | Median (IQR) days | 56.0 (34.0–77.0) | 46.0 (32.0–63.0) | .021 |
| VL testing | VLs done after 3 EAC sessions | 226(67.9%) | 86(72.9%) | .311 |
| VL results after 3 EAC sessions | Median (IQR) (copies/ml) | 3400 (623–25,200) | 1580 (245–8588) | .036 |
| Suppressed (<1000 copies/mL) | 76 (34.6) | 45 (52.3) | .004 | |
| Unsuppressed (≥1000 copies/mL) | 144 (65.4) | 41 (41.7) | ||
| Results unavailable | 6 | 0 |
EAC = enhanced adherence counseling, IQR = interquartile range, SEAC = standardized enhanced adherence counseling, VL = viral load.
Chi-square test.
Wilcoxon Rank sum test (difference in medians).
Factors associated with subsequent viral suppression in clients with viral load >1000 copies/mL.
| Variable | Levels | Unadjusted/crude OR (95% CIs) | Adjusted OR (AOR) |
|---|---|---|---|
| Study group | Pre-SEAC (ref) | – | – |
| Post-SEAC | 1.7 (1.1–2.8) | 1.7 (1.1–2.8) | |
| Facility type | Hospital (ref) | – | – |
| Health Center | 1.2 (0.8–1.9) | – | |
| Facility county | Turkana (ref) | – | – |
| Homa Bay | 3.5 (1.3–9.4) | 3.5 (1.3–9.6) | |
| ART regimen | NNRTI (ref) | – | – |
| PI-based | 1.5 (1.0–2.4) | 1.4 (0.9–2.3) | |
| Age (yr) | 0–9 (ref) | – | – |
| 10–14 | 1.2 (0.8–2.0) | – | |
| 15–19 | 0.9 (0.5–1.5) | – | |
| Gender | Male (ref) | – | – |
| Female | 1.3 (0.8–1.9) | – | |
| Time (days) to first EAC | Median (days) | 0.99 (0.99–1.00) | |
| Days between 1st and 3rd EAC | Median (days) | 0.99 (0.99–1.00) | |
| Time on ART Prior to EAC (years) | Median (years) | 1.0 (0.98–1.1) |
ART = antiretroviral therapy, CI = confidence interval, EAC = enhanced adherence counseling, NNRTI = non-nucleoside reverse transcriptase inhibitor, OR = odds ratio, SEAC = standardized enhanced adherence counseling.
adjusted for time to EAC/SEAC sessions, repeat VL results, age, VL at enrollment, regimen before EAC, ART duration prior to EAC, and type of facility.
significant bivariate, so included in multivariate analysis.
ART time was dropped from multivariate model, as it did not retain significance in full model. This analysis included all participants who had completed 3 EAC sessions as per guidelines.