Clinical trial NCT05278559: Can Undetectable (Viral Load) = Untransmissible (Virus) Change the Life Course of Adolescents Living in Africa
Official title: Can Undetectable (Viral Load) = Untransmissible (Virus) Change the Life Course of Adolescents Living the HIV in Africa
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: HIV/AIDS
Keywords: AIDS - Acquired Immuno Dificiency Syndrome
ALHIV - Adolescents Living with HIV
CATS - Community Adolescents Treatment Supporters
DBS - Dried blood spot
MoHCC - Ministry of Health and Child Care
U=U - Undetectable = Untransimmisible
VL - Viral load
Lead sponsor: Centre for Sexual Health and HIV/AIDS Research Zimbabwe
Sponsor class: OTHER
Collaborators: name: European and Developing Countries Clinical Trials Partnership (EDCTP)
First posted: 2022-03-14
Enrollment: 300
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We are recruiting adolescents aged 13-19 years both males and females. We are taking all the ALHIV in the age range even those who are married and have children.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: One Year
measure: The study will assist in developing an evidence-base to support the U=U integration into standard of care.
timeFrame: Two years
Secondary outcomes:
measure: It will generate peer-reviewed publications and educational resources.
timeFrame: Two years
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: Beatrice Road Infectious Hospital
Study officials:
affiliation: CeSHHAR Zimbabwe
name: Frances. M Cowan, Proffesor
role: STUDY_DIRECTOR
affiliation: University of Sydney
name: Sarah Bernays, PhD
role: STUDY_CHAIR
affiliation: Centre for Sexual Health and HIV/AIDS Research Zimbabwe
name: Zivai Mupambireyi Nenguke
role: PRINCIPAL_INVESTIGATOR
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