NCT06721078

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for not_applicable hiv

Timeline
43mo left

Started Feb 2025

Longer than P75 for not_applicable hiv

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Feb 2025Dec 2029

First Submitted

Initial submission to the registry

November 19, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

December 6, 2024

Status Verified

November 1, 2024

Enrollment Period

3.8 years

First QC Date

November 19, 2024

Last Update Submit

December 3, 2024

Conditions

Hiv

Keywords

peer navigationlong acting injectablesantiretroviral therapy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    18 months

Secondary Outcomes (7)

  • Peer navigation - viral suppression (sustainability)

    36 months

  • Peer navigation - retention (sustainability)

    36 months

  • long-acting injectable ART - acceptability

    36 months

  • Economic evaluation analysis of providing LAI

    36 months

  • Economic evaluation analysis of providing peer navigation

    36 months

  • +2 more secondary outcomes

Other Outcomes (1)

  • Providing long-acting injectable ART and peer navigators

    36 months

Study Arms (1)

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.

Behavioral: Peer navigation effectiveness

Interventions

Peer navigation effectivenessBEHAVIORAL

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

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Inability to read and/or speak English, isiZulu, Sepedi, Afrikaans, Xhosa, or Sesotho
  • Severe mental or physical illness preventing participation in informed consent activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Moherndran Archary, PhD

    Africa Health Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moherndran Archary, PhD

CONTACT

+27834461973mo.archary@ahri.org

Leora Sewnarain, HDE

CONTACT

+27739634573leora.sewnarain@ahri.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: In Stage 1, we will evaluate the peer navigation intervention in a stepped-wedge, cluster-randomised trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2024

First Posted

December 6, 2024

Study Start

February 1, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

December 6, 2024

Record last verified: 2024-11