Evaluation of Long-Acting Injectable (LAI) and Teen Clubs in Adolescents (ATTUNE).
NCT ID: NCT06721078
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1400 participants
INTERVENTIONAL
2025-02-28
2029-12-31
Brief Summary
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Detailed Description
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In Stage 1, the peer navigation intervention in a stepped-wedge, cluster-randomised trial implemented over 18 months in three 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 three years (about 7 visits). The stepped-wedge trial will be implemented in the first 18 months, after which participants will be followed for an additional 18 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
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Peer navigation effectiveness
To determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa.
Peer navigation effectiveness
To determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa.
Interventions
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Peer navigation effectiveness
To determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* Severe mental or physical illness preventing participation in informed consent activities.
12 Years
19 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Africa Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Moherndran Archary, PhD
Role: PRINCIPAL_INVESTIGATOR
Africa Health Research Institute
Central Contacts
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Other Identifiers
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A0005-6490/2023
Identifier Type: -
Identifier Source: org_study_id