An observational study in HIV/AIDS, sponsored by Centre for Sexual Health and HIV/AIDS Research Zimbabwe. Enrolling by invitation at 1 site in Zimbabwe. Open to participants aged 13 Years to 19 Years. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by Centre for Sexual Health and HIV/AIDS Research Zimbabwe · Observational
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.
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:
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.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's planned enrollment of 300 is close to the median of 287 across 503 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →This is the only study on the registry with Centre for Sexual Health and HIV/AIDS Research Zimbabwe as lead sponsor.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
- ALHIV with a viral load result of less than \<1000 copies/mL and aged between 13-19 years
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.
Time frame: 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.
Time frame: Two years
It will generate peer-reviewed publications and educational resources.
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.
Time frame: Two years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — We are going to be sharing Clinical results and overall study findings
Supporting information: Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: As from January 2024
Access criteria: Request access from Zivai
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Acquired Immunodeficiency Syndrome →