Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04915469 |
| Other study ID # |
EG0202 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 4, 2019 |
| Est. completion date |
September 20, 2020 |
Study information
| Verified date |
May 2021 |
| Source |
Elizabeth Glaser Pediatric AIDS Foundation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Viral suppression among children and adolescents in Kenya is currently sub-optimal at 60% and
63% respectively. Under the current Kenya Ministry of Health Guidelines, clients with viral
load of >1000 copies/ml, should receive a minimum of three enhanced adherence counselling
(EAC) sessions offered every two weeks and have a repeat viral load conducted 3 months after
EAC completion. However, delivery of the EAC is not standardized and there is limited data
available to evaluate the effectiveness of the three counselling sessions. Observational data
from Elizabeth Glaser Pediatric AIDS Foundation (EGPAF)-supported sites in Homa Bay and
Turkana counties indicate that among children and adolescents with a viral load > 1000
copies/ml, approximately 40% received the recommended three minimum EAC sessions and, after
receiving EAC sessions, viral suppression was 33% in children aged below 9 years, 27% in
adolescents aged between 10-14 years, 38% in adolescents aged 15 to 19 years and 53% in
adults. The investigators propose to evaluate the implementation, effectiveness and
acceptability of a standardized EAC package implemented at EGPAF-supported sites.
Methods: The investigators will use mixed methods to evaluate specific clinical outcomes
(viral suppression) adherence, retention) among children and adolescents who receive the EAC
package after suspected treatment failure, and if applicable, after switch to second and
third line. The investigators will use a pre/post intervention assessment to evaluate the
effectiveness of the EAC package, and qualitative methods (in-depth individual interviews
(IDI) and focus group discussions (FGD)) to identify facilitators and barriers to accessing
EAC. A process evaluation will be conducted to determine whether the standardized EAC package
has been implemented as intended across sites. The study population is defined as children
aged 0-19 years receiving Antiretroviral therapy (ART) in selected EGPAF supported sites.
Policy Significance:
Dissemination of findings will be done through: internal evaluation report shared with
stakeholders, donors, and the Ministry of Health (MOH) and abstracts presented at local and
international conferences; and, manuscripts for publication in peer-reviewed journals.
Findings are expected to inform the continuous review and improvement of HIV Program delivery
in Kenya, as the ministry of health and partners strive to meet international standards.
Description:
BACKGROUND Viral suppression is a proxy for successful anti-retroviral therapy (ART) and is
the "3rd 90" of the (Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 strategy.
In Kenya, viral suppression among children and adolescents is sub-optimal at 60% and 63%
respectively. Potential barriers to viral suppression can be individual (knowledge deficit,
side effects, forgetting, substance abuse, depression, and pill burden), social (stigma, food
insecurity, and family relationships) and structural (clinic frequency, school, relationship
with health worker, long waiting times and lack of dose adjustment). Enhanced adherence
counselling (EAC) aims to identify and address barriers to adherence to enable viral
suppression. Following a client viral load of >1000 copies/ml, the Kenyan 2016 antiretroviral
therapy guidelines recommend a minimum of three EAC sessions offered two weeks apart. Changes
in viral load are detected through a repeat test conducted 3 months after EAC. Clients with
repeat VL < 1000 are considered to be virally suppressed and are, therefore, maintained on
the same Antiretroviral(ARV)drug regimen. Clients with persistent viral load above 1000
copies/ml are deemed to have failed first-line treatment, and are thereafter, switched to the
appropriate second line or third line ARV drug regimen.
Delivery of the EAC is not standardized and there is limited data available to evaluate the
effectiveness of the three counselling sessions. Observational data from EGPAF-supported
sites in Homa Bay and Turkana counties indicates that for children and adolescents with a
viral load > 1000 copies/ml, approximately only 40 percent received the recommended three
minimum EAC sessions. Following EAC, viral suppression was 33% in children aged below 9
years, 27% in adolescents aged between 10-14 years, 38% in adolescents aged 15 to 19 years
and 53% in adults. The investigators propose to evaluate the implementation, effectiveness
and acceptability of a standardized EAC package implemented at EGPAF-supported sites in Homa
Bay County.
Adherence to ART among Children with HIV in Kenya An estimated 98,000 children aged between
0-14 years are infected with HIV in Kenya. HIV/AIDS accounts for 15% of mortality among
children less than 5 years of age, while 50-60% of children infected with HIV at birth die
before their second birthday.
Adherence to ART, retention in care and achieving viral suppression are substantial
challenges in the management of infants and children on ART. Infants and children rely on
others to administer their medications and to ensure clinic attendance. Caregivers may face
barriers that can reduce medication adherence and clinic attendance. Some caregivers place
too much responsibility for managing medications on older children and adolescents before
they are developmentally able to undertake such tasks. Adherence may also be jeopardized by
social and health issues within a family (e.g. substance abuse, poor physical or mental
health, unstable family relations, and poverty). To improve outcomes for infants and children
on ART, Kenya guidelines recommend provision of caregiver education to all parents/guardians
of children receiving ART. To this end, a caregiver-specific treatment literacy curriculum
has been developed by the MOH for caregiver training.
Guidelines on use of Antiretroviral Drugs for Treating and Preventing HIV Infection in Kenya.
The 2016 Kenya Ministry of Health guidelines on the use of ART for treating and preventing
HIV recommend that ART should be started in all patients as soon as possible, preferably
within 2 weeks after confirmation of HIV infection. A patient preparedness assessment is
completed prior to initiating ART. Adherence support mechanisms need to be put in place for
same day ART initiation. Routine monitoring of treatment response in adults, adolescents and
children older than 2 years includes as assessment of VL at 6 months after ART initiation and
12 months after initiation of ART, and if suppressed (VL<1000 copies/ml3), annually
thereafter. Routine monitoring for infants, and children below 2 years is recommended at
baseline, 6 months and 12 months after initiation of ART, then annually thereafter if the
patient is stable and virally suppressed. Targeted VL is done for patients with suspected
treatment failure. Targeted VL is also done when considering regimen change or single drug
substitutions in patients who have been on ART for at least 6 months.
For patients with persistently high VL (>1,000 copies/ml) after 6 months after initiating
ART, and for those who were previously suppressed but found to have high viral load (VL>1000
copies/ml) after more than 6 months after initiating ART, the guidelines recommend at least 3
patient-focused enhanced adherence counselling sessions within a 3-month period to address
possible barriers before repeating the viral load test
Evaluation Goals and Objectives Goal: To evaluate clinical outcomes (viral suppression,
adherence, retention) among children and adolescents with suspected treatment failure who
receive the standardized enhanced adherence counselling package as compared to clinical
outcomes for children and adolescents with suspected treatment failure who received services
before standardization of enhanced adherence counselling package.
Overview of Evaluation Design This study uses a mixed method design. The investigators will
use a pre-post design to evaluate specific treatment outcomes among children and adolescents
receiving the standardized EAC package after suspected treatment failure and after switch to
second- and third-line drug regimens. The investigators will conduct qualitative interviews
and abstract patient outcome data to evaluate the effectiveness of the standardized EAC
package, and qualitative methods (in-depth individual interviews and focus group discussions)
to identify facilitators and barriers to accessing EAC. A process evaluation will be
conducted to determine whether the standardized package of EAC was implemented as intended.
The study will use both qualitative and quantitative data collection and analysis methods.
Pre-intervention, the investigators will abstract patient level data retrospectively from the
charts of patients with VL >1000 copies/ml on demographic characteristics and clinical
outcomes and facility level data from summary forms for up to 24 months prior to the
implementation of the standardized EAC package. Viral suppression will be evaluated at 6 and
12 months. After implementation of the standardized EAC package, data will be prospectively
collected from participants with high viral load (>1000 copies). After receiving the
standardized EAC package, participants who are not suppressed will be switched to either
second or third line and data will be collected prospectively from them at every visit. The
investigators will use quantitative and qualitative methods of individual interviews, focus
group discussions, and patient satisfaction surveys to assess acceptability of EAC and
related services, as well as perceptions of facilitators and barriers to services pre and
post intervention. Data related to EAC coverage will be abstracted from facility records.
Coverage is defined as the proportion of patients with suspected treatment failure (STF) who
receive a repeat viral load. A repeat viral load is only done after the completion of EAC and
good adherence. Timelines will be determined using time from date when first high VL is
documented in patient's chart to date of standardized EAC intervention (initiation and
completion). This information will be abstracted from patient charts.
Study Population The study population will include HIV-positive male and female children and
adolescents aged 0-19 years who are enrolled on ART at EGPAF supported sites and have
suspected treatment failure. The investigators will interview parents/caregivers, peer
educators/adherence counselors and health care providers in the same facilities to assess the
barriers and facilitators, including satisfaction with care, to accessing EAC, both pre and
post-intervention. For children below 9 years, the investigators will interview their
caregivers.
. Sites Selection There are 171 facilities supported by EGPAF under the Timiza90 project in
Homa Bay County. Among these, the investigators purposively selected seven high-volume
facilities in order to provide sufficient numbers of children and adolescents with suspected
treatment failure to include in the evaluation.
Sample size and Sampling Strategy The investigators purposively selected facilities that had
the greatest number of unsuppressed patients based on viral load tests done between October
2017 to September 2018. In the selected facilities, the investigators captured data from the
records of all patients who were unsuppressed over the period Oct 2016 - Sep 2018,
(pre-intervention). Similarly, investigators captured data from the records of all patients
who were unsuppressed for the post-implementation period, February 2019 - September 2020.
Sample size was calculated with an estimated 80% power at a 95% confidence level to
demonstrate a minimum 10% increase in viral suppression due to the standardized EAC, adjusted
for facility clustering (design effect 1.5), and estimates of missing records or lost to
follow-up (+20%). The investigators used probability proportional-to-size sampling, based on
the volume of VL tests by facility and age group; 0-9, 10-14, 15-19 years.
The investigators assume a 4:1 pre/post implementation number of clients unsuppressed for the
0-9-year age group and 3:1 pre/post implementation number of clients unsuppressed for the
10-14- and 15-19- year age groups. Table 3 presents these data, considering missing records
for the retrospective cohort, or lost-to-follow up/missing records for
prospective/post-intervention cohort, which may subsequently reduce the power to be able to
demonstrate a difference. These estimates are unadjusted for facility clustering; the
investigators will adjust for any clustering in the analysis.
Challenges and limitations Challenges and limitations to the evaluation include the quality
of the patient records and their potential for missing data, the potential for response and
response bias, the need for skilled interviewers and facilitators for the interviews and
FGDs.
Analysis of patients' record data may be limited by poor data quality including missing data
and data entry error especially for the retrospective data. The amount and patterns of
missing data will be evaluated and appropriate statistical methods, as they may be
applicable, will be used to account for the missing data in the analyses. The investigators
will mitigate error resulting from data entry by re-entering a 5 percent random sample of the
records on an ongoing basis. This subsequent data entry will be carried out by a different
data entry clerk from the original clerk. Deviations of >10 percent will result in retraining
of the data entry staff.
Challenges with FGDs and IDIs include the potential for response bias, (the respondents may
report what the interview would like to hear), differential non-response, (participants who
refuse to be interviewed may be different to those who agree), and recall bias, (participants
may selectively recall stakeholders and events).
