Can Undetectable (Viral Load) = Untransmissible (Virus) Change the Life Course of Adolescents Living the HIV in Africa
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The study will assist in developing an evidence-base to support the U=U integration into standard of care.
研究概览
简要总结
The scientific breakthrough related to Undetectable (viral load) = Untransmissible (virus) has had a major impact on motivation to take up and adhere to antiretroviral therapy among people living with HIV all over the world. The aim of the study is to work with MoHCC and other stakeholders to explore whether routine VL testing using DBS can provide sufficiently robust evidence of 'undetectability' to support introduction of U=U messaging in ALHIV. The study will provide scientific evidence on whether routine VL testing using DBS as available in LIC can provide sufficiently robust evidence of 'undetectability' and on the variability of an individual's virological response over 12 months. It will provide contextually orientated evidence to inform U=U messaging which has the potential to change the motivation of ALHIV to engage with their treatment and care.It will also explore responsible ways to disseminate this message to ALHIV living in Zimbabwe, and across the Southern African region.
详细描述
Rationale: Adolescents living with HIV (ALHIV) have the worst outcomes of all ages because of sub-optimal adherence driven by structural factors associated with poverty. This is exacerbated for adolescents by the limited opportunities to address mental health problems arising from the intersection of growing up in poverty and with HIV. The scientific breakthrough related to Undetectable (viral load) = Untransmissible (virus) has had a major impact on motivation to take up and adhere to antiretroviral therapy among people living with HIV all over the world. However, the discussion remains remarkably silent in high burden, low-income countries (LIC). Very few ALHIV in LIC are aware that having an undetectable viral load (VL) substantially reduces the risk of transmitting HIV to their sexual partners and children.
The aim of the study is to work with MoHCC and other stakeholders to explore whether routine VL testing using DBS can provide sufficiently robust evidence of 'undetectability' to support introduction of U=U messaging in ALHIV.
The specific objectives are:
- To determine viral load fluctuation between routine annual VL testing and the extent to which annual VL using DBS reflects short term fluctuations that occur in the interim.
- To determine what proportion of ALHIV with VL <1000 copies/uL on DBS have a plasma VL less than 200 copies/uL
- To explore the reasons for and adolescent's understandings of fluctuations in VL and what a VL<1000 copies/mL means to ALHIV
Methods: This mixed method study will be conducted in conjunction with key stakeholders. We will enrol 300 ALHIV with a recent VL<1000 copies/uL in three HIV clinics in Harare and follow them for 12 months. Of these, 100 will be randomly selected to undergo repeat VL testing, using both DBS and plasma samples at enrolment, 6 and 12 months. A purposive sample of twenty will be selected for a longitudinal qualitative study. Additionally, up to eight participatory workshops will be conducted with key stakeholders over the course of the study to co-develop a 'safe' way to message U=U for LIC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ALHIV aged 13-19 years who are aware of their HIV status for at least six months before enrolment (i.e., know the infection by its name and understand some of its implications).
- •ART initiation of not less than 6 months.
- •ALHIV accessing ART within the participating clinics.
- •Healthcare workers with direct contact with ALHIV and have been involved in viral load result counselling in participating clinics.
排除标准
- •Unable to provide informed assent/ and parental informed consent.
- •Requires urgent medical attention or has severe mental health problems that would invalidate the informed assent/consent process or else contraindicate participation.
结局指标
主要结局
The study will assist in developing an evidence-base to support the U=U integration into standard of care.
时间窗: Two years
To unpack some of the key challenges that undermine ALHIV's engagement and there will be workshops with policy makers to discuss the findings and explore their perceptions on the feasibility of implementing policies related to U=U in this age group. Their views will be elicited around whether they consider there is 'safe' U=U messaging for LIC that could be implemented logistically, clinically and socially.
The study will provide scientific evidence on whether routine VL testing using DBS as available in LIC can provide sufficiently robust evidence of 'undetectability' and on the variability of an individual's virological response over 12 months.
时间窗: One Year
The study will explore the sensitivity of viral load testing so that decisions can be made on the best use of resources in optimizing the care and support that can be given to ALHIV in the region.
次要结局
- It will generate peer-reviewed publications and educational resources.(Two years)