Enhanced Adherence Counselling, Pre-Post Study

NCT04915469 | Completed

• 1 other identifier: EG0202
• Study Type: interventional
• Target: 741
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Children; Adolescents; Viral suppression; Antiretroviral therapy

Outcome Measures

Primary Outcomes (1)

• Viral Suppression

  Viral load will be done following completion of at least 3 enhanced adherence counselling sessions. a patient with a viral load less than 1000 copies/ml3, will be considered to have suppressed

  This will be done after 3 months of EAC

Secondary Outcomes (5)

• Adherence to clinic visits and pharmacy pick-ups

  9 months

• Retention on ART

  At 9 months

• Lost to follow-up(LTFU)

  At 9 months

• Time to 1st EAC following diagnosis of suspected treatment failure

  baseline

• Average time to completion of EAC sessions

  at 3 months

Study Arms (2)

Pre-standardization group

NO INTERVENTION

Pre intervention- patient level data are abstracted 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.

Post-standardization group

OTHER

This group of participants will receive the standardized enhanced adherence package. After implementation of the standardized EAC package, data will be prospectively collected from participants with high viral load (\>1000 copies).

Other: Standardized enhanced adherence counseling package

Interventions

Standardized enhanced adherence counseling package OTHER

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.

Post-standardization group

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 0-19 years
• HIV positive
• On ART for at least 6 months
• Last VL \>1000 copies
• Parental/guardian consent
• Assent (for 10-17-year old)
• Consent (for 18-19-year old)
• Parent/guardian to a child/adolescent on ART with VL\>1000 copies
• Provides consent
• Working in the facility for at least 3 months
• Provides services to HIV positive children and adolescents on ART
• Provides consent

You may not qualify if:

• Already receiving EAC
• Receiving services at non-participating facility
• Not providing HIV services to children and adolescent

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Homa Bay county

Homa Bay, Kenya

Location

Related Publications (1)

• Gill MM, Ndimbii JN, Otieno-Masaba R, Ouma M, Jabuto S, Ochanda B. Adherence challenges and opportunities for optimizing care through enhanced adherence counseling for adolescents with suspected HIV treatment failure in Kenya. BMC Health Serv Res. 2022 Jul 29;22(1):962. doi: 10.1186/s12913-022-08373-9.

  PMID: 35906574 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Rose Masaba

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director Public Health Evaluations

Model Details: This is a pre-post study design. The post-group receive an intervention of a standardized enhanced adherence counseling package

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 7, 2021
• Study Start: March 4, 2019
• Primary Completion: August 20, 2020
• Study Completion: September 20, 2020
• Last Updated: June 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)