Triggered Escalating Real-time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: The TERA Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 16
- 主要终点
- Percentage of Participants With Plasma Human Immunodeficiency Virus - Type I Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/mL at Week 12
研究概览
简要总结
Youth Living with HIV (YLWH) often face unique challenges achieving high and sustained rates of adherence to their antiretroviral therapy (ART). Poor adherence can lead to unsuppressed virus, more advanced HIV disease and poorer health outcomes, eventually exhausting treatment options. To date however, there are few demonstrated interventions for youth failing first line therapy. This study evaluated a novel intervention that used remote coaching through video enabled counseling sessions, an Electronic Dose Monitoring (EDM) pill bottle that notified an adherence coach when youth failed to open/close the device around dose time, and problem solving outreach by the coach in response to not dosing from the EDM. This intensive 'boot camp' strategy was implemented for 12 weeks followed by observation through 48 weeks.
详细描述
This was a Phase II, two-arm, randomized, open-label study. Eligible participants had failed ART therapy, defined as having a detectable plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) ≥200 copies/ml within 45 days of enrollment despite having been prescribed ART for at least 24 weeks. They could continue the same ART regimen or start a new once daily regimen. Participants were stratified by age (<18 vs. ≥18 years of age) and randomized in equal proportions to receive the study intervention (TERA) or standard of care (SOC), with no enrollment limits in each stratum. Target accrual was 120 participants to be enrolled over one year.
TERA was a time-limited (12 weeks) intervention approach that (a) used wireless electronic dose monitoring (EDM) to identify dose-times passing with no bottle opening, (b) sent a text asking about the delay, (c) evaluated response to the text and (d) initiated follow-up by an adherence coach depending on the response and if the bottle remained unopened for a designated period post dosing. Phone based outreach used problem solving discussion with an adherence coach, who could use an agreed-upon contact tree to reach the youth through other individuals. This "boot camp" strategy was used to unsettle or disrupt established non-adherence behaviors and factors promoting ongoing non-adherence.
Participants were followed for 48 weeks, with clinic visits at entry and weeks 4, 12, 24, 36 and 48. Audio computer assisted self-interviews (ACASI) were conducted every 12 weeks to collect information on adherence, motivation and skills, social support, mental and physical health functioning. Viral loads, medication and medical histories were also collected at each study visit.
The primary objective of the study was to compare HIV-virologic suppression (VLS) rates at 12 weeks. Secondary objectives included comparing VLS rates and EDM rates of ART adherence at 24, 36, and 48 weeks as well as patterns of adherence over time.
Major changes after the start of enrollment:
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
- 13 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmation of HIV-1 Infection as documented in the participant's medical record by at least two of the following criteria:
- •Reactive HIV screening test result with an HIV antibody or HIV antibody/antigen-based, Food and Drug Administration (FDA)-licensed assay followed by a positive supplemental assay (e.g., HIV-1 Western Blot, HIV-1 indirect immunofluorescence, HIV-1/HIV-2 discriminatory immunoassay);
- •Plasma HIV-1 quantitative ribonucleic acid (RNA) assay >1,000 copies/mL;
- •Positive HIV-1 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay; or
- •Positive plasma HIV-1 RNA qualitative assay
- •Participant aware of his or her HIV infection, as determined by site staff
- •Documented plasma HIV-1 RNA plasma ≥200 copies/mL within 45 days of the date of the enrollment visit
- •Prescribed antiretroviral therapy for at least 24 weeks or more prior to documented plasma HIV-1 RNA plasma ≥200 copies/mL.
- •Prescribed a once-daily (one or more pills once a day) ART regimen with at least two active agents (per clinician judgment or genotype evidence) at enrollment
- •Able to communicate in spoken and written English
- •Currently has a cellular phone that is also able to send and receive text messages
- •Willing and able to provide at least one additional contact phone number (preferably two) to contact participant
- •Able and willing to provide written informed assent/consent and able to obtain written parental or guardian permission (if required as specified by the site, by state law, and/or Institutional Review Board policy, and detailed in each site's Protocol Implementation Plans) to be screened for and to enroll in this study
排除标准
- •Gross cognitive limitations, acute emotional instability, or medical or mental health illness that in the opinion of site personnel would impair the individual's ability to provide informed consent and/or interfere with the protocol's objectives
- •Concurrent participation in interventional studies addressing adherence unless approved in advance by study team
- •Positive pregnancy test at the time of enrollment. If participant becomes pregnant while on study, they may continue on study
- •Currently using or planning to use an electronic dose monitoring and reminder device outside of the study
结局指标
主要结局
Percentage of Participants With Plasma Human Immunodeficiency Virus - Type I Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/mL at Week 12
时间窗: 12 weeks post enrollment
Participants with HIV-1 RNA \< 50 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA \>= 50 copies/mL or with no HIV-1 RNA measurement within the week 12 window are classified as failures.
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 12
时间窗: 12 weeks post enrollment
Participants with HIV-1 RNA \< 200 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA \>= 200 copies/mL or with no HIV-1 RNA measurement within the week 12 window are classified as failures.
次要结局
- Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 Weeks(48 weeks post enrollment)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24, 36 and 48(24, 36 and 48 weeks post enrollment)
- Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Weeks 24, 36 and 48(24, 36 and 48 weeks post enrollment)
- Percentage of Days With Dose Taken From Weeks 0-12, >12-24, >24-36 and >36-48(Enrollment through 48 weeks)
- Incidence Rate of 7-day Gaps Between Dosing for Weeks 0-12, >12-24, >24-36 and >36-48(Enrollment through 48 weeks)
- Percentage of Days With Dose Taken Within Defined Acceptable Window (+/- 4 Hours) From Weeks 0-12, >12-24, >24-36 and >36-48(Enrollment through 48 weeks)