Antiretroviral Adherence and Drug-level Monitoring

NCT05996094 | Unknown DMC

• 1 other identifier: 3578141P111242020012800013
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to investigate medication adherence and drug-level monitoring of antiretroviral agents in a cohort of people living with HIV in Indonesia. The study is conducted in outpatients receiving tenofovir-based regimens in a university medical centre.

Conditions

HIV Infections; AIDS; Antiretroviral Therapy, Highly Active; Adherence, Medication; Drug-level Monitoring

Keywords

Adherence; Adult; Pharmacokinetics; Tenofovir; Viral Load

Outcome Measures

Primary Outcomes (1)

• Adherence to antiretroviral therapy

  Adherence to antiretroviral therapy (ART) will be assessed using a validated Bahasa Indonesia version of self-reported adherence questionnaire. The questionnaire will recall ART use in the past week, past month, and past three months. The percentages of adherence will be calculated by the formula: (total number of dosage units prescribed - total number of times reported) / (total number of dosage units prescribed) × 100. The adherence scales range from 0 to 100% with higher scales denote higher adherence. Being highly adherent to ART is defined by having an adherence higher than 80%.

  Baseline and 6 months

Secondary Outcomes (3)

• Tenofovir concentrations

  Baseline (pre-dose, 1, and 4 h post-dose) and 6 months (random 3 - 16 h post-dose)

• Viral load

  Baseline and 6 months

• CD4 cell count

  Baseline and 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All people living with HIV receiving antiretroviral therapy who regularly visit the HIV clinic at a university medical centre in Surabaya, Indonesia, during study period.

You may qualify if:

• Adults with HIV who have been receiving antiretroviral therapy containing tenofovir-based regimens for at least six months

You may not qualify if:

• Pregnant and breastfeeding women, people with kidney failure, undergoing hemodialysis or peritoneal dialysis, uncontrolled diabetes, uncontrolled hypertension, and hypersensitivity to tenofovir

Sponsors & Collaborators

• Zamrotul Izzah: lead
• Universitas Airlangga: collaborator

Study Sites (1)

Universitas Airlangga Hospital

Surabaya, East Java, 60115, Indonesia

RECRUITING

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Medication Adherence

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Zamrotul Izzah

  Universitas Airlangga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zamrotul Izzah

CONTACT

6285655191257; zamrotulizzah@ff.unair.ac.id

Tri Pudy Asmarawati

CONTACT

tpasmarawati@fk.unair.ac.id

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 16, 2023
• Study Start: October 16, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)