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Sustainable Adherence and Prevention of HIV Drug Resistance in Adolescents

NCT03928834 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-11-25

No results posted yet for this study

Summary

The overall goal of this study is to determine if implementation of a package of interventions that includes DBS-based VL monitoring, coupled with an evidence-based intervention to improve ART adherence using cognitive-behavioral principles and genotyping for those with persistent viremia decreases 12-month virologic failure rates among HIV-infected adolescents compared with standard of care (SOC).

Conditions

  • Medication Adherence
  • HIV Drug Resistance

Interventions

BEHAVIORAL

Adapted Nzira Itsva

Adolescents will be provided an enhanced adherence package consisting of VL testing using DBS, including the NI intervention and low-cost genotyping and drug resistance monitoring. Participants receiving the intervention will have their first session after recruitment and enrollment, and will schedule up to 4 additional booster sessions at a time convenient for them spaced approximately 1 month apart. This may be modified after the formative assessment.

Sponsors & Collaborators

  • King's College London

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • University of Zimbabwe

    lead OTHER

Principal Investigators

  • Chiratidzo E NDHLOVU, MD · University of Zimbabwe

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-31
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • Zimbabwe

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03928834 on ClinicalTrials.gov