NCT04915469

Enhanced Adherence Counselling, Pre-Post Study

Completed NA Last updated 7 June 2021

What this trial tests

NA trial testing Standardized enhanced adherence counseling package in HIV Infection in 741 participants. Completed in 20 September 2020.

Timeline

4 March 2019

Primary endpoint
20 August 2020

20 September 2020

Quick facts

Lead sponsor	Elizabeth Glaser Pediatric AIDS Foundation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	741
Start date	4 March 2019
Primary completion	20 August 2020
Estimated completion	20 September 2020
Sites	1 location across Kenya

Drugs / interventions tested

• Standardized enhanced adherence counseling package

Conditions studied

• HIV Infection — all drugs for HIV Infection →

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Who can join

Under 19, any sex, with HIV Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adherence challenges and opportunities for optimizing care through enhanced adherence counseling for adolescents with suspected HIV treatment failure in Kenya.
   Gill MM, Ndimbii JN, Otieno-Masaba R, Ouma M, et al · · 2022 · cited 13× · PMID 35906574 · DOI 10.1186/s12913-022-08373-9
2. Standardized enhanced adherence counseling for improved HIV viral suppression among children and adolescents in Homa Bay and Turkana Counties, Kenya.
   Masaba RO, Woelk G, Herrera N, Siamba S, et al · · 2022 · cited 8× · PMID 36221325 · DOI 10.1097/md.0000000000030624