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 (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05278559

Collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP) (Other)

300

Enrollment

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS

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:

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.

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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Can Undetectable (Viral Load) = Untransmissible (Virus) Change the Life Course of Adolescents Living the HIV in Africa

Anticipated Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Mar 15, 2022

Anticipated Study Completion Date :

Mar 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Adolescents living with HIV - ALHIV with a viral load result of less than <1000 copies/mL and aged between 13-19 years

Outcome Measures

Primary Outcome Measures

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. [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.
The study will assist in developing an evidence-base to support the U=U integration into standard of care. [Two years]
To unpack some of the key challenges that undermine ALHIV's engagement andthere 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.

Secondary Outcome Measures

It will generate peer-reviewed publications and educational resources. [Two years]
Working with the Ministry of Health and Child Care to develop locally appropriate ways of incorporating U=U into routine HIV treatment and care among ALHIV in Zimbabwe. We have already set up a technical working group comprising members from the MoHCC, Africaid Zvandiri and UNICEF. This was made possible through a UNICEF supported small-scale resource development project which is supporting development of resources for ALHIV to improve their HIV literacy and particularly their literacy related to viral load testing, which has been relatively recently introduced into routine HIV care in Zimbabwe.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre for Sexual Health and HIV/AIDS Research Zimbabwe
European and Developing Countries Clinical Trials Partnership (EDCTP)

Investigators

Study Director: Frances. M Cowan, Proffesor, CeSHHAR Zimbabwe
Study Chair: Sarah Bernays, PhD, University of Sydney
Principal Investigator: Zivai Mupambireyi Nenguke, Centre for Sexual Health and HIV/AIDS Research Zimbabwe