Follow-up Outcomes of Children, Adolescents and Young People on Darunavir-Based Third-line Antiretroviral Therapy - Observational Cohort from Nine African Countries.

BACKGROUND: We assessed clinical outcomes among children, adolescents and young people (< 25 years) on darunavir-based antiretroviral therapy (ART) in nine sub-Saharan African countries. SETTING: Third-line ART centers in Cameroon, Eswatini, Kenya, Lesotho, Nigeria, Rwanda, Uganda, Zambia and Zimbabwe. METHODS: From January 2019 to December 2022, we collected data from a cohort of children, adolescents and young people receiving third-line ART from 9 sub-Saharan African countries. Data on treatment continuity, viral suppression, death and clinic transfers were extracted from medical records and summarized. Cox proportional hazards models were used to identify factors independently associated with retention in care. RESULTS: Of 871 participants enrolled, median age 14.8 (range: 0.2 - 24.7) years, 488 (56.0%) male; 809 (92.9%) [median duration of follow-up of 28.3 months (IQR:17.5 - 45.2)] had final outcomes after initiating third-line ART. Of these, 711 (87.9%) were alive and in care at the end of study follow-up, 29 (3.6%) died, 30 (3.7%) transferred to other facilities, and 39 (4.8%) were lost to follow-up. Retention in care was less likely among males compared to females (aHR: 0.85, 95%CI 0.72-1.0), and in 10-14-year-olds compared to younger children. Adolescents (15-19 years) had higher mortality compared to children <10 years of age (aSHR: 4.20, 95% CI 1.37-12.87). Viral suppression was seen in 345/433 (79.7%), 249/320 (77.8%), and 546/674 (81.0%) patients with results at 6, 12 months and study end, respectively. CONCLUSION: A high proportion of children and young people receiving third-line ART in Sub-Saharan Africa, remain in care, and attain viral suppression during follow-up.

Advanced HIV disease in Homa Bay County, Kenya: Characteristics of newly-diagnosed and antiretroviral therapy-experienced clients.

Advanced HIV disease (AHD) remains a significant burden, despite the widespread use of antiretroviral therapy (ART) programs. Individuals with AHD are at a high risk of death even after starting ART. We characterized treatment naïve and treatment experienced clients presenting with AHD in western Kenya to inform service delivery and program improvement. We conducted a retrospective study using routinely collected program data from October 2016 to September 2019 for AHD clients in eight facilities in Homa Bay County, Kenya. Demographic and clinical data were abstracted from the medical records of AHD clients, defined as HIV-positive clients aged ≥ 5 years with documented CD4 count < 200 cells/mm3 and/or WHO clinical stage II/IV. Associations were assessed using Pearson's chi-square and Mann-Whitney Rank-Sum tests at 5% level of significance. Of the 19,427 HIV clients at the eight facilities, 6649 (34%) had a CD4 count < 200 cells/mm3 or a WHO III/IV stage. Of these, 1845 were randomly selected for analysis. Over half (991) of participants were aged 45 + years and 1040 (56%) were female. The median age was 46.0 years (interquartile range: 39.2-54.5); 1553 (84%) were in care at county and sub-county hospitals; and 1460 (79%) were WHO stage III/IV at enrollment. At ART initiation, 241 (13%) had tuberculosis, 192 (10%) had chronic diarrhea, and 94 (5%) had Pneumocystis jiroveci pneumonia. At the time of data collection, 89 (5%) participants had died and 140 (8%) were lost to follow-up. Eighteen percent (330) of participants were ART-experienced (on ART for ≥ 3 months). The proportions of ART-experienced and -naïve clients regarding age, sex and marital status were similar. However, a higher proportion of ART-experienced clients received care at primary care facilities, (93(28%) vs. 199 (13%); P < .001); were WHO stage 3/4 at AHD diagnosis, 273 (84%) vs. 1187 (79%) (P = .041); and had died or been LTFU, (124 (38%) vs. 105 (7%); P < .001). With increasing prevalence of patients on ART, the proportion of AHD treatment-experienced clients may increase without effective interventions to ensure that these patients remain in care.

Standardized enhanced adherence counseling for improved HIV viral suppression among children and adolescents in Homa Bay and Turkana Counties, Kenya.

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.