Enhanced Adherence Counselling, Pre-Post Study

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.

Conditions

• HIV Infection

Interventions

OTHER

Standardized enhanced adherence counseling package

A standardized package was developed to support the adherence counsellor and other cadres to ensure provision of quality EAC sessions for children, adolescents and their caregivers. The package included; 1) Orientation and on job mentorship on EAC processes to clinicians, nurses, peer educators and mentor mothers. 2) Using a communication's training curriculum, providers were trained on psychosocial support and communication skills for children and their caregivers. 3) Appointment management was done using appointment dairies or a digital platform that sends patients short message services (SMS) reminders 3 days and 1 day before a scheduled clinic day. 4)Home visits. - All home visits were done according to the EGPAF standard operation procedures (SOPs) drawn from the Kenya National guidelines. 5) Individualized case management -Each EAC client was allocated a case manager who ensured that the barriers to adherence were identified and tackled both at individual and community level.

Sponsors & Collaborators

• Centers for Disease Control and Prevention

  collaborator FED

• Elizabeth Glaser Pediatric AIDS Foundation

  lead OTHER

Principal Investigators

• Rose Masaba · Elizabeth Glaser Pediatric AIDS Foundation

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-04

Primary Completion

2020-08-20

Completion

2020-09-20

Countries

• Kenya

Study Locations