HIV/AIDSNCT05278559
Can Undetectable (Viral Load) = Untransmissible (Virus) Change the Life Course of Adolescents Living in Africa
An observational study of HIV/AIDS, run by Centre for Sexual Health and HIV/AIDS Research Zimbabwe at 1 site in Zimbabwe.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- HIV/AIDS
- How many people
- 300 participants
- Where
- 1 siteZimbabwe
- Study dates
- 24 Mar 2022to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Undetectable (Viral Load) = Untransmissible (Virus) Change the Life Course of Adolescents Living the HIV in Africa
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.
Read the 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.
- 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
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents living with HIV | - ALHIV with a viral load result of less than <1000 copies/mL and aged between 13-19 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Two years
Secondary outcomes (1)
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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start24 Mar 2022
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Sexual Health and HIV/AIDS Research Zimbabwe
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Responsible party
- Sponsor
- Investigators
- Frances. M Cowan, Proffesor, Study director, CeSHHAR ZimbabweSarah Bernays, PhD, Study chair, University of SydneyZivai Mupambireyi Nenguke, Principal investigator, Centre for Sexual Health and HIV/AIDS Research Zimbabwe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278559
- Sponsor's protocol ID
- CeSHHAR
- Status last verified
- Sep 2023
- First submitted
- 4 Mar 2022
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are going to be sharing Clinical results and overall study findings
Publications
Kouamou V, Manasa J, Katzenstein D, McGregor AM, Ndhlovu CE, Makadzange AT. Drug resistance and optimizing dolutegravir regimens for adolescents and young adults failing antiretroviral therapy. AIDS. 2019 Sep 1;33(11):1729-1737. doi: 10.1097/QAD.0000000000002284.
PubMed 31361272Casale M, Carlqvist A, Cluver L. Recent Interventions to Improve Retention in HIV Care and Adherence to Antiretroviral Treatment Among Adolescents and Youth: A Systematic Review. AIDS Patient Care STDS. 2019 Jun;33(6):237-252. doi: 10.1089/apc.2018.0320.
PubMed 31166783Martelli G, Antonucci R, Mukurasi A, Zepherine H, Nostlinger C. Adherence to antiretroviral treatment among children and adolescents in Tanzania: Comparison between pill count and viral load outcomes in a rural context of Mwanza region. PLoS One. 2019 Mar 21;14(3):e0214014. doi: 10.1371/journal.pone.0214014. eCollection 2019.
PubMed 30897131Boerma RS, Boender TS, Bussink AP, Calis JC, Bertagnolio S, Rinke de Wit TF, Boele van Hensbroek M, Sigaloff KC. Suboptimal Viral Suppression Rates Among HIV-Infected Children in Low- and Middle-Income Countries: A Meta-analysis. Clin Infect Dis. 2016 Dec 15;63(12):1645-1654. doi: 10.1093/cid/ciw645. Epub 2016 Sep 22.
PubMed 27660236Webb D, Cluver L, Luo C. Evolution or extinction? Paediatric and adolescent HIV responses in the Agenda 2030 era. J Int AIDS Soc. 2018 Feb;21 Suppl 1(Suppl Suppl 1):e25071. doi: 10.1002/jia2.25071. No abstract available.
PubMed 29485744Nachega JB, Sam-Agudu NA, Mofenson LM, Schechter M, Mellors JW. Achieving Viral Suppression in 90% of People Living With Human Immunodeficiency Virus on Antiretroviral Therapy in Low- and Middle-Income Countries: Progress, Challenges, and Opportunities. Clin Infect Dis. 2018 May 2;66(10):1487-1491. doi: 10.1093/cid/ciy008.
PubMed 29324994Mbirimtengerenji ND. Is HIV/AIDS epidemic outcome of poverty in sub-saharan Africa? Croat Med J. 2007 Oct;48(5):605-17.
PubMed 17948947Mavhu W, Willis N, Mufuka J, Bernays S, Tshuma M, Mangenah C, Maheswaran H, Mangezi W, Apollo T, Araya R, Weiss HA, Cowan FM. Effect of a differentiated service delivery model on virological failure in adolescents with HIV in Zimbabwe (Zvandiri): a cluster-randomised controlled trial. Lancet Glob Health. 2020 Feb;8(2):e264-e275. doi: 10.1016/S2214-109X(19)30526-1. Epub 2020 Jan 7.
PubMed 31924539Brown K, Williams DB, Kinchen S, Saito S, Radin E, Patel H, Low A, Delgado S, Mugurungi O, Musuka G, Tippett Barr BA, Nwankwo-Igomu EA, Ruangtragool L, Hakim AJ, Kalua T, Nyirenda R, Chipungu G, Auld A, Kim E, Payne D, Wadonda-Kabondo N, West C, Brennan E, Deutsch B, Worku A, Jonnalagadda S, Mulenga LB, Dzekedzeke K, Barradas DT, Cai H, Gupta S, Kamocha S, Riggs MA, Sachathep K, Kirungi W, Musinguzi J, Opio A, Biraro S, Bancroft E, Galbraith J, Kiyingi H, Farahani M, Hladik W, Nyangoma E, Ginindza C, Masangane Z, Mhlanga F, Mnisi Z, Munyaradzi P, Zwane A, Burke S, Kayigamba FB, Nuwagaba-Biribonwoha H, Sahabo R, Ao TT, Draghi C, Ryan C, Philip NM, Mosha F, Mulokozi A, Ntigiti P, Ramadhani AA, Somi GR, Makafu C, Mugisha V, Zelothe J, Lavilla K, Lowrance DW, Mdodo R, Gummerson E, Stupp P, Thin K, Frederix K, Davia S, Schwitters AM, McCracken SD, Duong YT, Hoos D, Parekh B, Justman JE, Voetsch AC. Status of HIV Epidemic Control Among Adolescent Girls and Young Women Aged 15-24 Years - Seven African Countries, 2015-2017. MMWR Morb Mortal Wkly Rep. 2018 Jan 12;67(1):29-32. doi: 10.15585/mmwr.mm6701a6.
PubMed 29329280Natukunda J, Kirabira P, Ong KIC, Shibanuma A, Jimba M. Virologic failure in HIV-positive adolescents with perfect adherence in Uganda: a cross-sectional study. Trop Med Health. 2019 Jan 17;47:8. doi: 10.1186/s41182-019-0135-z. eCollection 2019.
PubMed 30679930Ngarina M, Popenoe R, Kilewo C, Biberfeld G, Ekstrom AM. Reasons for poor adherence to antiretroviral therapy postnatally in HIV-1 infected women treated for their own health: experiences from the Mitra Plus study in Tanzania. BMC Public Health. 2013 May 7;13:450. doi: 10.1186/1471-2458-13-450.
PubMed 23647555The Lancet Hiv. U=U taking off in 2017. Lancet HIV. 2017 Nov;4(11):e475. doi: 10.1016/S2352-3018(17)30183-2. No abstract available.
PubMed 29096785Calabrese SK, Mayer KH. Providers should discuss U=U with all patients living with HIV. Lancet HIV. 2019 Apr;6(4):e211-e213. doi: 10.1016/S2352-3018(19)30030-X. Epub 2019 Feb 13. No abstract available.
PubMed 30772420Eisinger RW, Dieffenbach CW, Fauci AS. HIV Viral Load and Transmissibility of HIV Infection: Undetectable Equals Untransmittable. JAMA. 2019 Feb 5;321(5):451-452. doi: 10.1001/jama.2018.21167. No abstract available.
PubMed 30629090WHO. Dolutegravir (DTG) and the fixed dose combination of tenofovir/lamivudine/dolutegravir (TLD). Briefing Note, April 2018. Briefing Note [Internet]. 2018.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Undetectable (Viral Load) = Untransmissible (Virus) Change the Life Course of Adolescents Living the HIV in Africa
- ClinicalTrials.gov ID
- NCT05278559
- Acronym / sponsor ID
- CeSHHAR
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre for Sexual Health and HIV/AIDS Research ZimbabweUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents living with HIV | – | –- ALHIV with a viral load result of less than <1000 copies/mL and aged between 13-19 years |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 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.
Time frame: Two years
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.
1 secondary outcome
It will generate peer-reviewed publications and educational resources.
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Background: PubMed 31361272Kouamou V, Manasa J, Katzenstein D, McGregor AM, Ndhlovu CE, Makadzange AT. Drug resistance and optimizing dolutegravir regimens for adolescents and young adults failing antiretroviral therapy. AIDS. 2019 Sep 1;33(11):1729-1737. doi: 10.1097/QAD.0000000000002284.
- Background: PubMed 31166783Casale M, Carlqvist A, Cluver L. Recent Interventions to Improve Retention in HIV Care and Adherence to Antiretroviral Treatment Among Adolescents and Youth: A Systematic Review. AIDS Patient Care STDS. 2019 Jun;33(6):237-252. doi: 10.1089/apc.2018.0320.
- Background: PubMed 30897131Martelli G, Antonucci R, Mukurasi A, Zepherine H, Nostlinger C. Adherence to antiretroviral treatment among children and adolescents in Tanzania: Comparison between pill count and viral load outcomes in a rural context of Mwanza region. PLoS One. 2019 Mar 21;14(3):e0214014. doi: 10.1371/journal.pone.0214014. eCollection 2019.
- Background: PubMed 27660236Boerma RS, Boender TS, Bussink AP, Calis JC, Bertagnolio S, Rinke de Wit TF, Boele van Hensbroek M, Sigaloff KC. Suboptimal Viral Suppression Rates Among HIV-Infected Children in Low- and Middle-Income Countries: A Meta-analysis. Clin Infect Dis. 2016 Dec 15;63(12):1645-1654. doi: 10.1093/cid/ciw645. Epub 2016 Sep 22.
- Background: PubMed 29485744Webb D, Cluver L, Luo C. Evolution or extinction? Paediatric and adolescent HIV responses in the Agenda 2030 era. J Int AIDS Soc. 2018 Feb;21 Suppl 1(Suppl Suppl 1):e25071. doi: 10.1002/jia2.25071. No abstract available.
- Background: PubMed 29324994Nachega JB, Sam-Agudu NA, Mofenson LM, Schechter M, Mellors JW. Achieving Viral Suppression in 90% of People Living With Human Immunodeficiency Virus on Antiretroviral Therapy in Low- and Middle-Income Countries: Progress, Challenges, and Opportunities. Clin Infect Dis. 2018 May 2;66(10):1487-1491. doi: 10.1093/cid/ciy008.
- Background: PubMed 17948947Mbirimtengerenji ND. Is HIV/AIDS epidemic outcome of poverty in sub-saharan Africa? Croat Med J. 2007 Oct;48(5):605-17.
- Background: PubMed 31924539Mavhu W, Willis N, Mufuka J, Bernays S, Tshuma M, Mangenah C, Maheswaran H, Mangezi W, Apollo T, Araya R, Weiss HA, Cowan FM. Effect of a differentiated service delivery model on virological failure in adolescents with HIV in Zimbabwe (Zvandiri): a cluster-randomised controlled trial. Lancet Glob Health. 2020 Feb;8(2):e264-e275. doi: 10.1016/S2214-109X(19)30526-1. Epub 2020 Jan 7.
- Background: PubMed 29329280Brown K, Williams DB, Kinchen S, Saito S, Radin E, Patel H, Low A, Delgado S, Mugurungi O, Musuka G, Tippett Barr BA, Nwankwo-Igomu EA, Ruangtragool L, Hakim AJ, Kalua T, Nyirenda R, Chipungu G, Auld A, Kim E, Payne D, Wadonda-Kabondo N, West C, Brennan E, Deutsch B, Worku A, Jonnalagadda S, Mulenga LB, Dzekedzeke K, Barradas DT, Cai H, Gupta S, Kamocha S, Riggs MA, Sachathep K, Kirungi W, Musinguzi J, Opio A, Biraro S, Bancroft E, Galbraith J, Kiyingi H, Farahani M, Hladik W, Nyangoma E, Ginindza C, Masangane Z, Mhlanga F, Mnisi Z, Munyaradzi P, Zwane A, Burke S, Kayigamba FB, Nuwagaba-Biribonwoha H, Sahabo R, Ao TT, Draghi C, Ryan C, Philip NM, Mosha F, Mulokozi A, Ntigiti P, Ramadhani AA, Somi GR, Makafu C, Mugisha V, Zelothe J, Lavilla K, Lowrance DW, Mdodo R, Gummerson E, Stupp P, Thin K, Frederix K, Davia S, Schwitters AM, McCracken SD, Duong YT, Hoos D, Parekh B, Justman JE, Voetsch AC. Status of HIV Epidemic Control Among Adolescent Girls and Young Women Aged 15-24 Years - Seven African Countries, 2015-2017. MMWR Morb Mortal Wkly Rep. 2018 Jan 12;67(1):29-32. doi: 10.15585/mmwr.mm6701a6.
- Background: PubMed 30679930Natukunda J, Kirabira P, Ong KIC, Shibanuma A, Jimba M. Virologic failure in HIV-positive adolescents with perfect adherence in Uganda: a cross-sectional study. Trop Med Health. 2019 Jan 17;47:8. doi: 10.1186/s41182-019-0135-z. eCollection 2019.
- Background: PubMed 23647555Ngarina M, Popenoe R, Kilewo C, Biberfeld G, Ekstrom AM. Reasons for poor adherence to antiretroviral therapy postnatally in HIV-1 infected women treated for their own health: experiences from the Mitra Plus study in Tanzania. BMC Public Health. 2013 May 7;13:450. doi: 10.1186/1471-2458-13-450.
- Background: PubMed 29096785The Lancet Hiv. U=U taking off in 2017. Lancet HIV. 2017 Nov;4(11):e475. doi: 10.1016/S2352-3018(17)30183-2. No abstract available.
- Individual participant dataSharing planned: Yes. We are going to be sharing Clinical results and overall study findings
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances. M Cowan, Proffesor study director
CeSHHAR Zimbabwe
Sarah Bernays, PhD study chair
University of Sydney
Zivai Mupambireyi Nenguke principal investigator
Centre for Sexual Health and HIV/AIDS Research Zimbabwe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, run by Centre for Sexual Health and HIV/AIDS Research Zimbabwe at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: One Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05278559, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.