跳至主要内容
临床试验/NCT04915469
NCT04915469已完成不适用

Evaluation of Enhanced Adherence Counseling as a Strategy to Optimize Adherence, Retention and Viral Suppression Among Children and Adolescents, in Homa Bay County, Kenya

Elizabeth Glaser Pediatric AIDS Foundation1 个研究点 分布在 1 个国家目标入组 741 人开始时间: 2019年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
741
试验地点
1
主要终点
Viral Suppression

研究概览

简要总结

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.

详细描述

BACKGROUND Viral suppression is a proxy for successful anti-retroviral therapy (ART) and is the "3rd 90" of the (Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 strategy. In Kenya, viral suppression among children and adolescents is sub-optimal at 60% and 63% respectively. Potential barriers to viral suppression can be individual (knowledge deficit, side effects, forgetting, substance abuse, depression, and pill burden), social (stigma, food insecurity, and family relationships) and structural (clinic frequency, school, relationship with health worker, long waiting times and lack of dose adjustment). Enhanced adherence counselling (EAC) aims to identify and address barriers to adherence to enable viral suppression. Following a client viral load of >1000 copies/ml, the Kenyan 2016 antiretroviral therapy guidelines recommend a minimum of three EAC sessions offered two weeks apart. Changes in viral load are detected through a repeat test conducted 3 months after EAC. Clients with repeat VL < 1000 are considered to be virally suppressed and are, therefore, maintained on the same Antiretroviral(ARV)drug regimen. Clients with persistent viral load above 1000 copies/ml are deemed to have failed first-line treatment, and are thereafter, switched to the appropriate second line or third line ARV drug regimen.

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 EGPAF-supported sites in Homa Bay and Turkana counties indicates that for children and adolescents with a viral load > 1000 copies/ml, approximately only 40 percent received the recommended three minimum EAC sessions. Following EAC, 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 in Homa Bay County.

Adherence to ART among Children with HIV in Kenya An estimated 98,000 children aged between 0-14 years are infected with HIV in Kenya. HIV/AIDS accounts for 15% of mortality among children less than 5 years of age, while 50-60% of children infected with HIV at birth die before their second birthday.

Adherence to ART, retention in care and achieving viral suppression are substantial challenges in the management of infants and children on ART. Infants and children rely on others to administer their medications and to ensure clinic attendance. Caregivers may face barriers that can reduce medication adherence and clinic attendance. Some caregivers place too much responsibility for managing medications on older children and adolescents before they are developmentally able to undertake such tasks. Adherence may also be jeopardized by social and health issues within a family (e.g. substance abuse, poor physical or mental health, unstable family relations, and poverty). To improve outcomes for infants and children on ART, Kenya guidelines recommend provision of caregiver education to all parents/guardians of children receiving ART. To this end, a caregiver-specific treatment literacy curriculum has been developed by the MOH for caregiver training.

Guidelines on use of Antiretroviral Drugs for Treating and Preventing HIV Infection in Kenya.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •for children and adolescents
  • •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)
  • •Inclusion criteria for parents/caregivers
  • •Parent/guardian to a child/adolescent on ART with VL>1000 copies
  • •Provides consent
  • •Inclusion criteria for service providers, Peer educators, Adherence/Psychosocial support counselors
  • •Working in the facility for at least 3 months
  • •Provides services to HIV positive children and adolescents on ART
  • •Provides consent

排除标准

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

研究组 & 干预措施

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).

干预措施: Standardized enhanced adherence counseling package (Other)

结局指标

主要结局

Viral Suppression

时间窗: This will be done after 3 months of EAC

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rose Otieno Masaba

Associate Director Public Health Evaluations

Elizabeth Glaser Pediatric AIDS Foundation

研究点 (1)

Loading locations...

相似试验