The Impact of Structured Caregiver Peer Support (CaPS) on ART Adherence and Viral Suppression Among Children Living With HIV in Nigeria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Antiretroviral therapy (ART) drug pickup adherence
研究概览
简要总结
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.
详细描述
Study Purpose and Intervention: The purpose of the study is to evaluate the impact of structured peer support (PS) to caregivers in achieving treatment adherence among children living with HIV in Nigeria. The study adopts a behavioral intervention that engages "expert" caregivers (Champion Caregivers) whose CLHIV wards have achieved viral suppression, to provide structured peer support to other caregivers towards achieving treatment adherence (ART drug-pickup adherence and viral suppression) for their CLHIV. Using a previously-tested structured PS model, Champion Caregivers will receive comprehensive skills-training, including counselling techniques and pediatric ART formulations/administration techniques, and will use standardized logbooks to document client interactions.
Study Aims and Objectives Recent data from Institute of Human Virology Nigeria (IHVN)-supported facilities in the study setting show viral suppression averaging 42.5% among CLHIV <10 years and 61% for those 10-19 years old. Clearly, younger children need prioritization for viral suppression interventions. The structured Mentor Mother PS model was successful in improving viral suppression among HIV-infected women in the same study setting. The PS intervention's structure lies in a focused curriculum, standardized schedules, documentation for client interactions, and performance evaluations. Prior programmatic data indicate that 30-40% of CLHIV have lost at least one biological parent by age 10 years. However, especially for double orphans or indigent/ill single parents, relatives/unrelated guardians (who may or may not be HIV-infected) step in as primary caregivers. Sustained support, education and motivation for caregivers is thus important for optimal CLHIV treatment outcomes. Prescription refill/drug pickup has been a useful, convenient and cost-containing measure of ART adherence in prior studies especially in resource-limited settings. Use of integrase inhibitors is at its infancy in Nigeria. Dolutegravir scale-up started in earnest in 2018; as such, there are no appreciable numbers of children on this drug in early 2019. Approximately 92% of children in the target population are on nevirapine or efavirenz-based regimens. The rest are receiving Lopinavir or atazanavir-based regimens. Drug resistance testing (DRT) is not routine and there is currently no in-country capability to test integrase inhibitor resistance. There is currently no available data from randomized trials evaluating caregiver PS interventions for CLHIV adherence and viral suppression. Given the above context and information, investigators propose a two-arm cluster-randomized Caregiver Peer Support (CaPS) trial at 6 clinics and among 96 CLHIV six months-10 years of age.
Study Design, Methods and Research Participants:
CaPS is a two-arm cluster randomized controlled trial to be conducted at secondary healthcare facilities in two neighboring states: Federal Capital Territory (FCT) and Nasarawa State. Secondary facilities are targeted because majority of children and adolescents living with HIV in Nigeria are managed at secondary health facilities.
Site Eligibility Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CLHIV(Child Living with HIV)-Inclusion Criteria:
- •Age 6 months to 10 years
- •On ART for ≥6 months
- •Caregiver-Inclusion Criteria:
- •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
排除标准
- •Child Living with HIV-Exclusion Criteria:
- •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
- •Caregiver-Exclusion Criteria:
- •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.
结局指标
主要结局
Antiretroviral therapy (ART) drug pickup adherence
时间窗: 18 months study duration
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.
次要结局
- Rate of viral suppression(18 months study duration)
- Prevalence of HIV drug resistance(Baseline)
研究者
Tongdiyen Laura Jasper
Continuous Quality Improvement Officer Pediatrics
Institute of Human Virology, Nigeria