Caregiver Peer Support and ART Adherence Among Children

NCT04222270 | Completed

• 1 other identifier: IHVN_IAS_Peds_CaPS
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Adherence for children living with HIV is a by-proxy phenomenon dependent on caregivers (parents, relatives or unrelated guardians) who may or may not be living with HIV. The complexity of paediatric formulations and dosing for ART regimens often poses challenges for caregivers, making ART administration and achievement of viral suppression quite a difficult task for young children. Peer support for caregivers presents a potentially feasible and impactful approach to improve ART adherence and facilitate achievement of viral suppression among children. However, there is a scarcity of robust evidence on the impact of caregiver support as a treatment adherence strategy for children. The study is a two-arm cluster randomized controlled trial that includes 78 unsuppressed children living with HIV (0-10 years old) and their caregivers at six cluster sites in Nigeria. It will:

• Explore facilitators and barriers to ART adherence among young children to develop a caregiver peer mentor training curriculum and interventional programme.
• Test the impact of caregiver peer support, a locally adapted behavioural intervention, to improve adherence and promote achievement of viral suppression among children. The intervention will target caregivers of children, measuring outcomes at child level after 12 months of follow up. The intervention arm will receive structured caregiver-to-caregiver peer support while the control arm will receive routine standard of care with no such support. The researchers will compare ART drug-pickup rates and viral suppression for children living with HIV at specific time points for both arms.

Conditions

HIV; Adherence

Keywords

Children; HIV; Caregivers; Peer; Mentors; suppression

Outcome Measures

Primary Outcomes (1)

• Antiretroviral therapy (ART) drug pickup adherence

  Primary outcome of ART adherence: assessed by clinic visit-aligned drug-pickups. • % drug-pickup = (actual no. drug-pickups/expected no. drug-pickups) x 100, where expected no. pickups based on appointment schedule applicable to period under consideration. Accounts for CLHIV with varying clinic schedules per viral suppression status. "Grace period" of ± 7 days applied to all expected drug-pickup dates regardless of schedule. Pickups outside grace periods considered invalid. Investigators will determine and compare drug-pickup rates at 6/12/18 months post-enrollment.

  18 months study duration

Secondary Outcomes (2)

• Rate of viral suppression

  18 months study duration

• Prevalence of HIV drug resistance

  Baseline

Study Arms (2)

Intervention

EXPERIMENTAL

Caregiver peer support from Champion caregivers (Peer mentors) to caregivers of unsuppressed children living with HIV (CLHIV) on child care and medication adherence strategies to enhance achievement of viral suppression: Champion Caregivers (Peer Mentors) will be assigned to the intervention arm and will be trained to support 10-15 caregivers for 18 months post enrollment. Champion Caregivers (CCs) be trained using an adapted Mentor-Mother Peer Support curriculum and topics will include pediatric treatment gaps, ARV formulations/dosing, adherence counseling, and virological failure/suppression. Champion caregivers will conduct monthly-to-quarterly 30 min to 1 hr clinic-aligned caregiver group training sessions and home visits at least once quarterly, targeting Child living with HIV (CLHIV) adherence, age-appropriate disclosure, and keeping clinic appointments. The intervention arm will in addition to peer support intervention, receive routine standard of care at the health facility.

Behavioral: Champion Caregiver peer mentoring support to caregivers on child care and medication adherence to enhance achievement of viral suppression

Control

NO INTERVENTION

Unsuppressed Children living with HIV and their caregivers recruited in the control arm will receive no champion caregiver peer support intervention but will continue to receive the standard of care at their health facilities which include routine care, including age-appropriate antiretroviral therapy and clinic appointments (typically every 2-3 months). Routine, albeit brief (5-10 min) adherence counselling is provided to CLHIV/caregivers by trained healthcare workers (HCWs) at every visit. In Nigeria, routine VL is done at 6 months post-ART initiation and repeated 12 months post- initiation 20. VL is done yearly thereafter for suppressed clients. Those unsuppressed receive 3-months' enhanced adherence counselling (EAC) (15-30 min) by Healthcare workers, with intensified appointment schedules and repeat VL upon EAC completion. This rigorous intervention continues until viral suppression is achieved or ART is switched; drug resistance testing (DRT) is not routine.

Interventions

Champion Caregiver peer mentoring support to caregivers on child care and medication adherence to enhance achievement of viral suppression BEHAVIORAL

Caregiver to caregiver peer support intervention through group/one-on-one education and counselling

Intervention

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6 months to 10 years
• On ART for ≥6 months
• Adult ≥18 to 65 years old (regardless of gender/HIV status/education)
• Caring for study-eligible child
• Primary caregiver: adult living in same household as CLHIV, responsible for providing the child's care at home, administering ART and bringing child to clinic

You may not qualify if:

• Child/ward of Champion Caregiver
• Will not be receiving care at site for ≥12 months
• Severe/debilitating AIDS-related or-unrelated illness
• Study baseline VL result is \<1,000 copies/ml
• Not available to participate for ≥6 months. In the setting, CLHIV often have sequential caregivers; Investigators will account for this potential transitional care in 6-month time-periods. In case of caregiver unavailability/demise, another eligible caregiver will be recruited.

Sponsors & Collaborators

• Institute of Human Virology, Nigeria: lead
• University of Maryland, Baltimore: collaborator
• University of Pittsburgh: collaborator
• University of Stellenbosch: collaborator
• University of Georgia: collaborator

Study Sites (1)

Maitama District Hospital

Abuja, Federal Capital Territory, 900001, Nigeria

Location

Study Officials

• Tongdiyen Jasper

  Institute of Human Virology, Nigeria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Continuous Quality Improvement Officer Pediatrics

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 9, 2020
• Study Start: December 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)