Enhanced Adherence Counselling, Pre-Post Study - Trial NCT04915469

Timeline & Enrollment

Primary Outcome

Viral Suppression

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.

ICD-10 Classifications