HivATTUNENCT06721078
Evaluation of Long-Acting Injectable (LAI) and Teen Clubs in Adolescents (ATTUNE).
A study testing Peer navigation effectiveness in people with Hiv, run by Africa Health Research Institute at 12 sites in South Africa.
Trial summary
This is a 2-stage study assessing the effect of peer navigation (support from peers) and long-acting injectable antiretroviral therapy (ART) on viral suppression and retention in care among adolescents living with HIV and receiving care in South Africa. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Peer navigation effectiveness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 12 sitesSouth Africa
- Study dates
- 9 Feb 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged between 12 - <19, at enrolment
- Living with HIV
- Aware of their HIV status
- Receiving ART for at least six months
- Able to read and/or speak English, isiZulu, Sepedi, Afrikaans, Xhosa, or Sesotho
- Willing and able to consent to study activities
Show all 9Show fewer
- Willing and able to get parental consent for study activities
- (Stage 1, objective 2 only) Age ≥ 18 years and Caregiver of an adolescent with HIV
- (Stage 1, objective 2 only) Age ≥ 18 years and provides clinical services or is a policy maker involved in adolescents with HIV
Who cannot join
- Inability to read and/or speak English, isiZulu, Sepedi, Afrikaans, Xhosa, or Sesotho
- Severe mental or physical illness preventing participation in informed consent activities.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
South Africa12 sites, 12 recruiting
- Not yet recruiting
Eerste River Hospital
Cape Town, Western Cape, 8001
HAST Medical Officer, Dr Zesca Meyer, +27 21 444 7144, Zesca.Meyer@westerncape.gov.za
Prof Brian Van Wyk
- Not yet recruiting
Michael Mapongwana CHC
Cape Town, Western Cape, 8001
Sr Sinoxolo Nkohla, CNP, +27 21 361 3353, sinoxolo.nkohla@westerncape.gov.za
Prof Brian Van Wyk
- Recruiting
Cato Manor CHC
Durban, KwaZulu-Natal, 4001
CEO, Mrs MM Mkhize, +27 31 216 4647, lungile.mayoyo@kznhealth.gov.za
Prof Moherndran Archary
- Recruiting
KwaMashu CHC
Durban, KwaZulu-Natal, 4001
Operational Manager, Mr CM Mthimkhulu, +27 31 501 1777, cyprian.mthimkhulu@gov.za
Prof Moherndran Archary
- Recruiting
Charlotte Maxeke Hospital
Johannesburg, Gauteng, 2001
Prof M Mulaudzi ( Paediatrics HOD ), +27 11 488 3285, Mphelekedzeni.mulaudzi@wits.ac.za
Prof Lee Fairlie
- Recruiting
Rahima Moosa Mother and Child Hospital
Johannesburg, Gauteng, 2001
Senior Clinical Manager, Dr MM Khoza, +27 11 470 9000, makhanani.khoza@gauteng.gov.za
Prof Lee Fairlie
- Recruiting
Mtubatuba CHC
Mtubatuba, KwaZulu-Natal, 3935
Operational Manager, Ms TH Mahlaba, +27 35 550 9999, thobilemahlaba02@gmail.com
Prof Moherndran Archary
- Recruiting
Somkhele CHC
Mtubatuba, KwaZulu-Natal, 3935
Operational Manager, Ms Mpumelelo Mazibuko, +27 35 550 9999, madzimpume@gmail.com
Prof Moherndran Archary
- Not yet recruiting
Kgabo CHC
Pretoria, Gauteng, 0001
Primary Health Care Manager, Dr Mpho Moshime-Shabangu, +27 12 451 9004, Mpho.Moshime@gauteng.gov.za
Prof Lee Fairlie
- Not yet recruiting
KT Motubatse CHC
Pretoria, Gauteng, 0001
Primary Health Care Manager, Dr Mpho Moshime-Shabangu, +27 012 451 9004, Mpho.Moshime@gauteng.gov.za
Prof Lee Fairlie
- Not yet recruiting
Soshanguve Block JJ
Pretoria, Gauteng, 0001
Primary Health Care Manager, Dr Mpho Moshime-Shabangu, +27 12 4519004, Mpho.Moshime@gauteng.gov.za
Prof Lee Fairlie
- Not yet recruiting
Soshanguve Block TT
Pretoria, Gauteng, 0001
Primary Health Care Manager, Dr Mpho Moshime-Shabangu, +27 12 451 9004, Mpho.Moshime@gauteng.gov.za
Prof Lee Fairlie
About this study
This is a 2-stage study assessing the effect of peer navigation (support from peers) and long-acting injectable antiretroviral therapy (ART) on viral suppression and retention in care among adolescents living with HIV and receiving care in South Africa.
Read the detailed description
This study aims to deploy peer-navigated support (psychosocial support, HIV education, appointment reminders, adherence support, sexual and reproductive health, and healthcare navigation) to facilitate viral suppression and retention in care as adolescents living with HIV transition into adult care. The study population includes adolescents from South Africa aged 12 to less than 19 years, living with HIV, aware of their HIV status and receiving ART for at least six months.
In Stage 1, the peer navigation intervention in a stepped-wedge, cluster-randomised trial implemented over 18-24 months in two 6-month steps across 12 clinics will be evaluated. In addition, during Stage 1, user and key stakeholder preferences will be evaluated for the uptake and use of long-acting injectable ART, perform a costing and economic analysis and a program evaluation of the public health impact of the intervention. In Stage 2, an individually-randomised trial will be nested in a subset of clinics to evaluate long-acting injectable ART in adolescents with HIV.
The study procedures include a peer navigation intervention in Stage 1, alongside a user and key stakeholder preferences evaluation for the uptake and use of long-acting injectable ART and a cost and economic evaluation.
The study duration is two years (about 5-7 visits). The stepped-wedge trial will be implemented in the first 18 months, after which participants will be followed for an additional 12 months to assess the sustainability of the intervention. The nested individually-randomised trial of long-acting ART will be conducted during the second 18-month period.
- Conditions
- Hiv
- Being tested
- Peer navigation effectiveness
- Keywords
- peer navigation, long acting injectables, antiretroviral therapy
- 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.
Peer navigation effectivenessBehavioural
To determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa.
| Study group | Role | What they receive |
|---|---|---|
| Peer navigation effectiveness | Other | To determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa. Receives: Behavioral: Peer navigation effectiveness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peer navigation - viral suppression (effectiveness)
To determine the effectiveness of peer navigation on viral suppression among adolescents living with HIV in South Africa using the endpoint of viral load suppression (VL <50 copies/ml) over 18 months.
Measured: 18 months
Peer navigation - retention in care (effectiveness)
To determine the effectiveness of peer navigation on retention among adolescents living with HIV in South Africa using the endpoint of retention (at least 1 health care visit in the last 90 days) over 18 months.
Measured: 18 months
Secondary outcomes (7)
Peer navigation - viral suppression (sustainability)
To assess the sustainability of the impact of peer navigation on viral suppression among adolescents living with HIV in South Africa using the endpoint of viral load suppression (VL <50 copies/ml) at 18 and/or 24 months.
Measured: 36 months
Peer navigation - retention (sustainability)
To assess the sustainability of the impact of peer navigation on retention in care among adolescents living with HIV in South Africa using the endpoint of retention (at least 1 health care visit in the last 90 days) at 24 months and 36 months.
Measured: 36 months
long-acting injectable ART - acceptability
To identify the preferred user characteristics influencing the acceptability of long-acting injectable ART for adolescents with HIV with a qualitative evaluation of preferred user characteristics. Nine focus group discussions (FGDs) will be conducted with key stakeholders (caregivers of ALHIV, ALHIV ages 12 to less than 19, and adolescent HCWs/policy makers) to identify preferred user characteristics.
Measured: 36 months
Economic evaluation analysis of providing LAI
The cost analysis and economic impact of long-acting injectable antiretroviral therapy on viral suppression and care retention in adolescents living with HIV and receiving care in South Africa. Average per patient treated per year; average cost per patient retained; average cost per patient virally suppressed; incremental cost per additional person virally suppressed; incremental cost per additional person retained; incremental cost per life year saved (ART)
Measured: 36 months
Economic evaluation analysis of providing peer navigation
The cost analysis and economic impact of peer navigation on viral suppression and care retention in adolescents living with HIV and receiving care in South Africa. Average per patient treated per year; average cost per patient retained; average cost per patient virally suppressed; incremental cost per additional person virally suppressed; incremental cost per additional person retained; incremental cost per life year saved (ART).
Measured: 36 months
Cost-effectiveness analyses of providing LAI
A time and motion evaluation will be conducted. The estimated average staff time-spend with patients triangulated with the cost of clinical staff salaries from public sector salaries, the type and number of laboratory tests per patient (patient medical records), and cost per test (National Health Laboratory Service, NHLS). Medication costs will also be monitored (patient medical records, published national drug unit costs), and consumable resources will be used during study procedures (staff interviews, government tenders from the National Department of Health, National Treasury). The total floor space required for the study will be calculated, and a market-related average rental cost per square meter will be applied to estimate the cost of the building. Utility costs will be obtained for the facility and applied by square meter.
Measured: 36 months
Cost-effectiveness analyses of providing peer navigation
A time and motion evaluation will be conducted. The estimated average staff time-spend with patients triangulated with the cost of clinical staff salaries from public sector salaries, the type and number of laboratory tests per patient (patient medical records), and cost per test (National Health Laboratory Service, NHLS). Medication costs will also be monitored (patient medical records, published national drug unit costs), and consumable resources will be used during study procedures (staff interviews, government tenders from the National Department of Health, National Treasury). The total floor space required for the study will be calculated, and a market-related average rental cost per square meter will be applied to estimate the cost of the building. Utility costs will be obtained for the facility and applied by square meter.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start9 Feb 2026
- Primary completionMar 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In Stage 1, we will evaluate the peer navigation intervention in a stepped-wedge, cluster-randomised trial.
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Africa Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Prof Moherndran Archary, MBChB, PhD, Principal investigator, Africa Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721078
- Sponsor's protocol ID
- A0005-6490/2023
- Other IDs
- 1UG1MD019435-01
- Acronym
- ATTUNE
- Status last verified
- Mar 2026
- First submitted
- 19 Nov 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-Acting Injectable (LAI) and Teen Clubs in Adolescents (ATTUNE).
- ClinicalTrials.gov ID
- NCT06721078
- Acronym / sponsor ID
- ATTUNE / A0005-6490/2023
- Conditions
- Hiv
- Keywords
- peer navigation, long acting injectables, antiretroviral therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Africa Health Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 6 Dec 2024 (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.
This is a 2-stage study assessing the effect of peer navigation (support from peers) and long-acting injectable antiretroviral therapy (ART) on viral suppression and retention in care among adolescents living with HIV and receiving care in South Africa.
Detailed description
This study aims to deploy peer-navigated support (psychosocial support, HIV education, appointment reminders, adherence support, sexual and reproductive health, and healthcare navigation) to facilitate viral suppression and retention in care as adolescents living with HIV transition into adult care. The study population includes adolescents from South Africa aged 12 to less than 19 years, living with HIV, aware of their HIV status and receiving ART for at least six months.
In Stage 1, the peer navigation intervention in a stepped-wedge, cluster-randomised trial implemented over 18-24 months in two 6-month steps across 12 clinics will be evaluated. In addition, during Stage 1, user and key stakeholder preferences will be evaluated for the uptake and use of long-acting injectable ART, perform a costing and economic analysis and a program evaluation of the public health impact of the intervention. In Stage 2, an individually-randomised trial will be nested in a subset of clinics to evaluate long-acting injectable ART in adolescents with HIV.
The study procedures include a peer navigation intervention in Stage 1, alongside a user and key stakeholder preferences evaluation for the uptake and use of long-acting injectable ART and a cost and economic evaluation.
The study duration is two years (about 5-7 visits). The stepped-wedge trial will be implemented in the first 18 months, after which participants will be followed for an additional 12 months to assess the sustainability of the intervention. The nested individually-randomised trial of long-acting ART will be conducted during the second 18-month period.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In Stage 1, we will evaluate the peer navigation intervention in a stepped-wedge, cluster-randomised trial.
| Arm | Type | Receives |
|---|---|---|
| Peer navigation effectiveness | Other | Behavioral: Peer navigation effectivenessTo determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Aged between 12 - <19, at enrolment
- Living with HIV
- Aware of their HIV status
- Receiving ART for at least six months
- Able to read and/or speak English, isiZulu, Sepedi, Afrikaans, Xhosa, or Sesotho
Key exclusion criteria (2 listed)
- Inability to read and/or speak English, isiZulu, Sepedi, Afrikaans, Xhosa, or Sesotho
- Severe mental or physical illness preventing participation in informed consent activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer navigation effectivenessTo determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa. | Behavioural | Peer navigation effectiveness |
Primary outcome
Peer navigation - viral suppression (effectiveness)
Time frame: 18 months
To determine the effectiveness of peer navigation on viral suppression among adolescents living with HIV in South Africa using the endpoint of viral load suppression (VL <50 copies/ml) over 18 months.
Peer navigation - retention in care (effectiveness)
Time frame: 18 months
To determine the effectiveness of peer navigation on retention among adolescents living with HIV in South Africa using the endpoint of retention (at least 1 health care visit in the last 90 days) over 18 months.
7 secondary outcomes
Peer navigation - viral suppression (sustainability)
Time frame: 36 months
Peer navigation - retention (sustainability)
Time frame: 36 months
long-acting injectable ART - acceptability
Time frame: 36 months
Economic evaluation analysis of providing LAI
Time frame: 36 months
Economic evaluation analysis of providing peer navigation
Time frame: 36 months
Cost-effectiveness analyses of providing LAI
Time frame: 36 months
Cost-effectiveness analyses of providing peer navigation
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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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.
Prof Moherndran Archary, MBChB, PhD principal investigator
Africa Health Research Institute
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer navigation effectiveness in people with Hiv, run by Africa Health Research Institute at 12 sites in South Africa.
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 9 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Africa. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Moherndran Archary, MBChB, PhD (+27834461973, mo.archary@ahri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peer navigation - viral suppression (effectiveness) (time frame: 18 months). 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?
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 3 Apr 2026.