Evaluation and Performance Measurement Plan (EPMP) Final Report: Enhanced Adherence Study

Overview

BACKGROUND

HIV viral suppression is an indicator of successful anti-retroviral therapy (ART) and is the “3rd 95” of the UNAIDS 95-95-95 treatment target to end the HIV/AIDS epidemic. Suppressing viral load among people living with HIV to less than 1,000 copies/ml is essential for reducing HIV-associated morbidity, mortality, and further virus transmission. Although Kenya has made considerable progress towards reaching the “3rd 95” in the adult population, with approximately 90% of adults 15–64 years on ART virally suppressed as of 2018, viral suppression among children and adolescents remains suboptimal at 67.1%. Barriers to providing effective HIV services to adolescents and young people include limited access to HIV information and services, stigma, and discrimination, among others.

PURPOSE

In order to improve health outcomes among children and adolescents living with HIV (CALHIV), the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) implemented a standardized enhanced adherence counseling (SEAC) package that aligns with the Kenya National guidelines on ART use for treatment and prevention of HIV in EGPAF-supported health facilities in Homa Bay and Turkana Counties. We conducted an evaluation of the SEAC with the overall objective of evaluating implementation and effectiveness of a standardized EAC package offered to virally unsuppressed children and adolescents (0-19 years of age) as compared to the current EAC package at EGPAF-supported sites in Homa Bay and Turkana Counties. The SEAC package included enhanced appointment management, home visits and individualized HIV case management among other interventions.

METHODOLOGY

We purposively selected six EGPAF-supported health facilities that had the greatest number of virally unsuppressed CALHIV in Homa Bay and Turkana Counties between October 2017 to September 2018. We used a mixed methods approach to: 1) evaluate key program implementation and patient outcome indicators pre and post-SEAC standardization using routinely collected program data; and, 2) assess care giver and provider perceptions of EAC, and facilitators and barriers to receiving or providing these services. The study was conducted from February 2019 to September 2020. Key indicators assessed in the pre-/post-SEAC standardization periods are timeliness and completion of EAC sessions.

DATA ANALYSIS

We described and compared the demographic and clinical characteristics, and outcomes of patients in the pre- SEAC and SEAC periods. The results were presented using frequencies and proportions based on characteristics such as sex, age, ART regimen before EAC, County and type of health facility. Depending on the distribution, we used mean, standard deviations, median and interquartile range to describe continuous variables. We further assessed factors associated with viral non-suppression using univariate and multivariable logistic regression. Thematic content analysis was used for qualitative analysis.

LIMITATIONS

The main limitation was the use of retrospective data to assess key process and outcome indicators in the pre- EAC standardization period. Because these data had already been collected when the evaluation was initiated, the study team was not able to fully address gaps in data quality and completeness. Poor filing systems in most of the health facilities resulting in missing or lost files, contributed to missing data.

FINDINGS

A total of 741 clients were included in the analysis: 595 in pre-SEAC and 146 in post-SEAC period. Whereas 16.5% (98/595) of the pre-SEAC patients did not attend an EAC visit, all (100%) of post-SEAC participants attended at least one (the first) EAC visit. The time between high viral load test result to first EAC visit was reduced by 8 days, from a median of 49 (IQR: 23.0-102.5) pre-SEAC, to 41 (IQR: 20.0-67.0) days post-SEAC (p=0.006). Time to completion of at least 3 sessions was reduced by 12 days; from a median of 59 (IQR: 36.0- 91.0) pre-SEAC, to 47.0(IQR: 33.0-63.0) days among clients in the SEAC period (p=0.002). Similarly, a significantly greater percentage of patients completed the recommended minimum 3 EAC sessions in the post- (91.1%) as compared to pre-SEAC (81.1%) periods (p=0.004). Finally, a greater proportion of clients who received EAC post-standardization had viral suppression after 3 sessions (55% [67/122] vs. 39.6% [145/373]; pvalue= 0.023). In the multivariable model, SEAC was significantly associated with viral suppression (odds ratio
[OR] 1.6; 95% Confidence Interval [CI] 1.1-2.3).

Findings from the qualitative analysis showed that participants generally expressed satisfaction with the quality of care received and stated that they were supported to understand their condition and monitor progress. However, there were concerns regarding clinic flow with the organization of services, as adolescents and caregivers outlined that they would sometimes dedicate whole days to attending the clinic and attributed this to disorganization in retrieving files (resulting in patients not being seen on a ‘first-come, first-serve basis), low number of providers available, and patient volume.

Regarding clinic safety and privacy, majority of adolescents cited stigma as a barrier to clinic attendance and were concerned with being seen in clinic waiting areas, or even on their way into the HIV clinic. Health care workers (HCW) associated late receipt of test results or non-disclosure of HIV status with poor adherence among adolescents. There were requests from caregivers to receive facility support for disclosure either through individual or group counseling.

Regarding retention, a challenge to appointment keeping was school-related conflicts. Some students did not want to explain their absence from school, or found appointments coincided with class sessions or examinations. Observations during data abstraction revealed that health care workers did not appropriately capture qualitative components of EAC, such as their assessment of patients’ barriers to adherence and adherence plans. HCW explained that this was due to lack of appropriate tools to capture the required information and hence tended to mostly rely on recall.

KEY TAKEAWAYS

Standardization of EAC improved all EAC process and patient outcome indicators measured in the evaluation, including completion of EAC and viral load suppression. Programs could strive to adopt standardized EAC, and implement it with fidelity in all facilities to ensure that all patients with suspected treatment failure are able to benefit. Tools for documenting qualitative components of EAC sessions can be refined, and HCW would benefit from additional training on proper documentation to improve the quality of the information captured and utility for patient management.

Despite improvement in viral suppression after standardization of EAC, overall suppression remained suboptimal. Programs could identify and mitigate other barriers to viral suppression in this group of patients. Children and adolescents may benefit from a comprehensive multidisciplinary and holistic approach including barrier identification and management of existing treatment failure towards VL suppression and optimal clinical outcome.