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

NCT05278559 | Unknown DMC

• 1 other identifier: CeSHHAR
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  One Year

• The study will assist in developing an evidence-base to support the U=U integration into standard of care.

  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.

  Two years

Secondary Outcomes (1)

• It will generate peer-reviewed publications and educational resources.

  Two years

Study Arms (1)

Adolescents living with HIV

\- ALHIV with a viral load result of less than \<1000 copies/mL and aged between 13-19 years

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Beatrice Road Infectious Hospital

Harare, 00000, Zimbabwe

Location

Related Publications (30)

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MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Frances. M Cowan, Proffesor

  CeSHHAR Zimbabwe

  STUDY DIRECTOR

• Sarah Bernays, PhD

  University of Sydney

  STUDY CHAIR

• Zivai Mupambireyi Nenguke

  Centre for Sexual Health and HIV/AIDS Research Zimbabwe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 14, 2022
• Study Start: March 24, 2022
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: As from January 2024
• Access Criteria: Request access from Zivai

Locations

ZI (1)