Sustainable Adherence and Prevention of HIV Drug Resistance in Adolescents

NCT03928834 | Withdrawn

• 1 other identifier: GH002118-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Adolescents; HIV drug resistance; Genotyping; Dried blood spots

Outcome Measures

Primary Outcomes (2)

• To determine VL suppression rates in adolescents in SOC and intervention arm

  Arm-specific VL suppression rates will be estimated by the proportion of adolescents on ART that have a VL less than 1000 copies/mL at 12 months from study enrolment.

  12 months

• To determine the prevalence of Drug Resistance Mutations(DRMs) among adolescents on ART with a VL≥1000

  Prevalence of DRMs within each drug class will be determined: frequency of single-drug class DRMs vs. dual-class DRMs vs. triple-class DRMs. Frequencies will be assessed for clinically-relevant point mutations to national 1st- and 2nd-line ART regimens

  12 months

Study Arms (2)

Adapted Nzira Itsva Intervention

EXPERIMENTAL

Participants will be attending clinics that provide an enhanced adherence package to the adolescents consisting of viral load (VL) testing using DBS, including the Nzira Itsva(NI) intervention and low-cost genotyping and drug resistance monitoring

Behavioral: Adapted Nzira Itsva

Standard of Care( SOC)

NO INTERVENTION

Participants will be attending clinics that provide the standard of care (SOC) VL testing and management to adolescents

Interventions

Adapted Nzira Itsva BEHAVIORAL

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.

Adapted Nzira Itsva Intervention

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• HIV-positive adolescents aged 10-19 years who know their status
• On ART for at least 6 months as per clinic records: the patient will have attended the clinic as shown in clinic records at least once since initiation AND will have re-filled their ART at least once since initiation as shown in clinic records..
• Planning to stay in care at that facility for at least 12 months

You may not qualify if:

• Participant and/or caregiver unable to give consent and assent
• Those participants who the healthcare worker considers to be too ill to participate

Sponsors & Collaborators

• University of Zimbabwe: lead
• King's College London: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

University of Zimbabwe

Harare, 000, Zimbabwe

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Chiratidzo E NDHLOVU, MD

  University of Zimbabwe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, cluster-randomized trial 1\) clinics that provide the Standard of care (SOC)VL testing and management to adolescents and 2) clinics that provide an enhanced adherence package consisting of VL testing using Dried Blood Spots(DBS), including the Nzira Itsva ( NI) intervention and low-cost genotyping and drug resistance monitoring.

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 26, 2019
• Study Start: August 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

ZI (1)