Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-26 @ 7:21 PM
Study NCT ID:
NCT05278559
Status:
UNKNOWN
Last Update Posted:
2023-09-14
First Post:
2022-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Undetectable (Viral Load) = Untransmissible (Virus) Change the Life Course of Adolescents Living in Africa
Sponsor:
Centre for Sexual Health and HIV/AIDS Research Zimbabwe
Organization:
Study Overview
Official Title:
Can Undetectable (Viral Load) = Untransmissible (Virus) Change the Life Course of Adolescents Living the HIV in Africa
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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:
1. 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.
2. To determine what proportion of ALHIV with VL \<1000 copies/uL on DBS have a plasma VL less than 200 copies/uL
3. 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.
Potential impact: 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.
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:
1. 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.
2. To determine what proportion of ALHIV with VL \<1000 copies/uL on DBS have a plasma VL less than 200 copies/uL
3. 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.
Potential impact: 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: