Caregiver Peer Support and ART Adherence Among Children

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

Interventions

BEHAVIORAL

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

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

Sponsors & Collaborators

• University of Maryland, Baltimore

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Stellenbosch

  collaborator OTHER

• University of Georgia

  collaborator OTHER

• Institute of Human Virology, Nigeria

  lead OTHER

Principal Investigators

• Tongdiyen Jasper · Institute of Human Virology, Nigeria

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

10 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-12-01

Primary Completion

2023-11-30

Completion

2023-11-30

Countries

• Nigeria

Study Locations