An Adaptive Strategy for Preventing and Treating Lapses of Retention in HIV Care for Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 880
- 试验地点
- 1
- 主要终点
- Care engagement failure
研究概览
简要总结
Adolescents and young adults (AYA) with HIV face unique challenges to engagement in care and their ability to achieve optimal health outcomes. The investigators hypothesize that developmentally-tailored behavioral interventions will improve engagement in HIV care and viral suppression (per current MOH guidelines) among AYA with HIV in Kenya. This two stage study will initially randomize 880 AYA with HIV to either standard of care (SOC) or electronic navigation to prevent treatment lapse. Participants who have a lapse will be re-randomized to SOC, in-person peer navigation, or conditional cash transfers. Formative work will be conducted initially to tailor the interventions to AYA and then later to assess AYA perception, experience, and satisfaction with the interventions. We will evaluate the most effective and cost-effective intervention and sequence of interventions to inform HIV program managers, public policy makers, and other key stakeholders the best approaches to improve engagement of care of AYA with HIV.
详细描述
While the global response to HIV has reached close to 20 million persons with life-saving antiretroviral therapy (ART) and saved upwards of 60 million life-years, progress has been uneven and adolescents and young adults (AYA) aged 14-24 years represent a key group left behind. Compared to adults, AYA with HIV face more numerous, more diverse and more intense barriers to adherence and retention. The investigators will utilize a SMART study design in two stages among 880 AYA with HIV in Kenya to improve retention and viral suppression per the current MOH guidelines. In stage 1 AYA will be randomized 1:1 to either (1) standard of care education or counseling vs. (2) electronic navigation. Participants who do well (no lapses in retention, medication pick up and viral suppression) will be maintained on these low-intensity interventions, whereas those who fail will be re-randomized a second time to one of three re-engagement interventions (stage 2): (1) standard of care tracing, (2) a conditional cash transfer and (3) in-person peer navigation. The primary outcomes include (1) for prevention: lapse in engagement or viral non-suppression following current MOH guidelines; (2) for re-engagement: viral suppression six months after re-randomization; and (3) across six strategies: sustained viral suppression and sustained engagement in care at two years. The investigators anticipate that enrolling 880 AYA will result in 99% power to detect a 15% difference in the primary outcome between intervention groups. The investigators believe this study will yield evidence specific to AYA with HIV, quantify the relative magnitude of different sequenced interventions, capture the costs, and have direct relevance for public health programming to end the AIDS epidemic through engaging adolescents and young adults with HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infection, on or initiating ART,
- •14-24 years of age,
- •Living > 6 months in Kisumu County, Kenya in previous year,
- •Capable of informed consent (> 18 years) or with a legal caregiver available for consent (14-<18 years),
- •Access to a cell phone,
- •Ability to read or be read short message service (SMS) messages,
- •Willingness to be contacted by clinic upon missed appointment,
- •For AYA who report phone sharing must have disclosed to the person sharing the phone.
- •Additionally, we will include AYA who are aware of their HIV status or whose caregivers agree to assisted disclosure.
排除标准
- •AYA who participated in ADAPT-R,
- •Those planning to move out of Kisumu County, those acutely ill and requiring hospitalization,
- •Those who report sharing phones but have not disclosed to the person sharing the phone
研究组 & 干预措施
SOC-REC/CCT
SOC-REC/Conditional Cash Transfer (CCT)
干预措施: SOC-REC/CCT (Behavioral)
SOC-REC/SOC-OIC
Standard of care - routine education and counseling (SOC-REC)/SOC-Outreach and Intensified Counseling (OIC)
干预措施: SOC-REC/SOC-OIC (Behavioral)
SOC-REC/IP-NAV
SOC-REC/In-Person Peer Navigation (IP-NAV)
干预措施: SOC-REC/IP-NAV (Behavioral)
E-NAV/SOC-OIC
Electronic Navigation/SOC-OIC
干预措施: E-NAV/SOC-OIC (Behavioral)
E-NAV/CCT
E-Nav/Conditional cash transfer
干预措施: E-NAV/CCT (Behavioral)
E-NAV/IP-NAV
E-Nav/In-Person Peer Navigation
干预措施: E-Nav/IP-NAV (Behavioral)
结局指标
主要结局
Care engagement failure
时间窗: 24 months
Experiencing any of the following three events within the first year of follow-up: lapse in retention (defined as 14 days late for a scheduled visit) or unsuppressed HIV RNA following current MOH guidelines during routine monitoring, or death.
Re-engagement
时间窗: 24 months
Viral suppression (per current MOH guidelines) six months after re-randomization
Sustained viral suppression and engagement in care
时间窗: 24 months
Sustained viral suppression (per current MOH guidelines) and sustained engagement in care at 24 months
次要结局
- Qualitative evaluation of how interventions work(24 months)
- Explore alternative outcome definitions: Medication possession ratio(24 months)
- Explore alternative outcome definitions: HIV RNA levels(24 months)
- Cost effectiveness(24 months)
- Compare survival between arms(24 months)
- Composite of time to return and time to viral resuppression(24 months)
- Explore alternative outcome definitions: Mean visit adherence(24 months)