VITAL Start (Video-Intervention to Inspire Treatment Adherence for Life) for Adolescents, a Randomized Controlled Trial of a Video Intervention to Improve Adherence, Retention, and Viral Load Suppression Among Adolescents Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,800
- 试验地点
- 64
- 主要终点
- Adolescent Viral Load Measure
研究概览
简要总结
This a two-arm randomized controlled trial whose objective is to explore the impact of VITAL Start for Adolescents (VS4A), a video-based antiretroviral treatment (ART) adherence intervention, on a range of implementation and effectiveness outcomes. The study will be conducted in health facilities which provide HIV care to teens/adolescents in the Machinga and Balaka districts of Malawi with approximately 900 teens living with HIV and their treatment supporters (dyads). Dyads will be individually randomized on a 1:1 ratio to receive either the intervention or the standard of care. The VS4A intervention is designed to support Information, Motivation, and Behavioral skills (IMB) around adolescent ART adherence as well as strategies for enhancing treatment supporter social support. The intervention consists of: 1) a two-session video package with associated activities that both the adolescent and their treatment supporter will be asked to watch and participate in; 2) ART refill for the adolescent; 3) and intensive adherence counselling for those with a high viral load. The primary outcomes are adoption of the intervention and adolescent viral load suppression. The overall hypothesis is that VS4A will achieve high adoption and improve adolescent viral suppression.
详细描述
Adolescents living with HIV (ALHIV)-an estimated 1.7 million globally-face ongoing challenges with HIV medication adherence, retention, and viral load suppression (VLS). With both high rates of incident infection and some of the lowest VLS rates, ALHIV experience high mortality with approximately 100 deaths per day. Successful interventions to improve retention and VLS among ALHIV in low- and middle-income countries (LMIC) remain limited. Video-based counseling interventions have improved HIV knowledge, disclosure, and treatment adherence in other populations and offer a scalable way to deliver standardized content while reducing health care worker burden. Yet, they remain underused for ALHIV in sub-Saharan Africa.
One of the first video-based interventions integrated into HIV care in Malawi was piloted with preliminary findings showing high satisfaction among patients and providers, as well as improvements in ART knowledge, adherence, and retention. Building on these results, the investigators propose to adapt and evaluate VITAL Start (Video-intervention to Inspire Treatment Adherence for Life) for Adolescents (VS4A), a video-based counseling package tailored for ALHIV.
Through a two-arm randomized controlled trial, the aim is to assess the impact of VS4A on implementation and clinical outcomes. Adolescent-treatment supporters from up to 26 health facilities in Malawi will be randomized to receive either the VS4 intervention or the standard of care (SOC). Implementation outcomes will be compared between the VS4A arm and the standard of care arm. The effectiveness outcome of adolescent viral suppression will be compared between the two arms.
The findings from this trial will provide an intervention that standardizes and improves knowledge and behavior at critical teaching moments through an engaging and culturally sensitive experience and inform scalable strategies to improve adolescent HIV care and advance progress toward long-term viral suppression and well-being for ALHIV.
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
- Single (Outcomes Assessor)
盲法说明
Data analysts and the study biostatistician will be masked to randomization arm until they have a locked dataset.
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents
- •Inclusion Criteria:
- •10-19 years of age
- •In care at the health facility
- •Aware of their HIV status
- •Provide informed consent (if aged 18+ years) or assent and guardian informed consent (if aged 10-17 years).
排除标准
- •if their ability to provide informed consent or assent is impaired
- •Treatment supporters
- •Inclusion Criteria:
- •>18 years old
- •named as a treatment supporter of an adolescent study participant
- •willing to provide informed consent for oneself
- •Exclusion Criteria: if their ability to provide informed consent is impaired
研究组 & 干预措施
Video-Based ART Adherence Counseling
干预措施: Video-based ART adherence counseling (Behavioral)
Standard of Care
干预措施: Standard of Care (SOC) (Behavioral)
结局指标
主要结局
Adolescent Viral Load Measure
时间窗: By 47 weeks
Adolescents will have their viral load assessed via dried blood spot. Results will be analyzed and those with a result of \<1000 copies/ml will be considered virally suppressed. All others will be considered non-suppressed: \>=1000 copies/ml or having no viral load measurement, lost, or died.
Adoption of VS4 intervention at teen club
时间窗: By Week 24
Proportion of health facilities in the experimental arm that participated in implementation strategy.
Adolescent Viral Load Measure
时间窗: By 47 weeks
Adolescents will have their viral load assessed via dried blood spot. Results will be analyzed and those with a result of \<1000 copies/ml will be considered virally suppressed. All others will be considered non-suppressed: \>=1000 copies/ml or having no viral load measurement, lost, or died.
Adoption of VS4 intervention at teen club
时间窗: By Week 24
Proportion of health facilities in the experimental arm that participated in implementation strategy.
次要结局
- Adolescent behavioral adherence(By Week 36)
- Reach(By Week 12)
- Implementation fidelity(By Week 24)
- Adolescent behavioral adherence(By Week 36)
- Reach(By Week 12)
- Implementation fidelity(By Week 24)
研究者
Saeed Ahmed
Associate Professor of Pediatrics, Principal Investigator
Baylor College of Medicine