The Impact of Pharmacists' Interventions on the Quality of Life of HIV-TB Co-infection Outpatients in Indonesia

NCT04325438 | Completed

• 1 other identifier: HIVTB-INDO2017
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

Rationale: The co-infection of human immunodeficiency virus (HIV) and tuberculosis (TB) diseases presents further problems to patient's adherence due to high pill burden and adverse effects in the drug combination therapy. This situation is also a risk of the increase of multi-drug resistant TB and may affect the quality of life of patients. However, the prevalence of non-adherence has not been studied much in these patients in Indonesia, especially in West Java with several HIV patients who are still struggling with TB as their opportunistic infection. Pharmacist interventions in several studies have resulted in a better outcome of patients' therapy, especially in patients who need long-term adherence and compliance with drug treatment. It is hypothesized that patients' quality of life of HIV-TB co-infection patients will be improved with the intervention conducted by the pharmacist. Objective: In general, the study aimed to evaluate the utility of study participants with specific aims to describe the number of DRP and interventions applied, to describe drug concentration in selected participants (TB drugs: Rifampicin and Pyrazinamide), to compare changes of CD4+ cell counts and plasma HIV RNA (viral load) between baseline and after of intervention, to assess participants compliance and persistence to medication therapy, and descriptive analysis on the direct and indirect costs. Study design: This is a prospective, cluster-randomized study with a stepped-wedge design. Clusters correspond to participating centers. A randomly selected center is crossed-over into the intervention with calculation after the start of inclusions within 6-months follow-up in 3 different clinics in Indonesia (Bekasi City Public Hospital, Persahabatan Public Hospital Jakarta and Cipto Mangunkusumo general hospital). Intervention: Interventions are given by a pharmacist as a drug consultant is an intervention concerning the drug treatment of HAART and anti-TB. Monthly, patients will have a discussion regarding their medication and drug-related problems they experience. The pharmacist will identify drug-related problems before and during treatment and solve the problems. Main study parameters/endpoints: change from baseline utility (quality of life) at 6 months Secondary endpoints: changes from baseline in CD4+, VL, adherence, persistence at 6 months and total costs.

Conditions

Pharmaceutical Care; HIV/AIDS; Tuberculosis

Keywords

Pharmaceutical care; Pharmacists' interventions; human immunodeficiency virus; tuberculosis

Outcome Measures

Primary Outcomes (1)

• Monthly evaluation on the participants' quality of life (utility) using the EQ5D-5L questionanire between groups

  To compare the differences in the utility score between the intervention group and control group every study month for 6 months. Utility will be evaluated into 2 scores, i.e utility score (score range: 0-1) and visual analog scale (score range: 0-100). The higher the score the better the utility

  baseline, 1,2,3,4,5, and 6 months

Secondary Outcomes (4)

• Comparison of difference in CD4 cell counts between groups

  Baseline and 6 months

• Comparison of difference in plasma HIV RNA (viral load) between groups

  Baseline and 6 months

• Comparison of difference in participants' medication adherence between groups

  Baseline and 6 months

• Comparison of difference in participants' persistence to attend the study sessions between groups

  Baseline and 6 months

Study Arms (2)

Pharmaceutical Care

EXPERIMENTAL

Groups with usual care by health professionals and additional health interventions provided by pharmacists. Number of intervention groups in each cluster is different, depending on the starting time of the intervention.

Other: Pharmaceutical Care

Non-Pharmaceutical Care

NO INTERVENTION

Groups with usual care from health providers other than pharmacists. Number of intervention groups in each cluster is different, depending on the starting time of the intervention.

Interventions

Pharmaceutical Care OTHER

Pharmaceutical care interventions are categorised into 2 aspects: 1. Pharmacists' expertise aspect: medications review, identification and solution for the drug-related problem, adverse events, and other medication-related clinical problems. Therapeutic drug monitoring (TDM) is performed for any dose adjustment to the Rifampicin. 2. Motivational behavioral intervention to improve medication adherence (i.e. medications information and counseling to study participants).

Pharmaceutical Care

Eligibility Criteria

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

You may qualify if:

• patients aged 18 years or older;
• diagnosed with the HIV disease and co-infected with the definite TB disease (PTB or EPTB) during the study period, proven by geneXpert (if applicable), positive smear sputum, and chest X-ray;
• definite TB patients who are found infected with HIV;
• attending for outpatient care;
• can read and write in Indonesian language;
• not pregnant;
• taking ARV/HAART at the time of research and is just about to start TB treatment and receive first line of TB drugs;
• taking ARV/HAART at the time of research and in TB treatment until maximum 3 months from the first consumption of TB drugs and receive first line of TB drugs;
• HIV patients on TB therapy but have not received ARV/HAART yet;
• and patients who are willing to take part in this study (signing the informed consent).

You may not qualify if:

• Patients who are diagnosed with only the HIV disease or with other non-TB diseases as reported in their medical records, such as hepatitis C;
• patients who have enrolled in another clinical trial that may change the nature of basic treatment;
• patients with limited clinical condition due to their severe condition and therefore are not able to attend outpatient visit, such as stroke.

Sponsors & Collaborators

• Bekasi City Public Hospital: lead
• University of Groningen: collaborator

Study Sites (3)

Persahabatan public hospital

Jakarta, Jakarta Timur, Indonesia

Location

Bekasi city hospital

Bekasi, West Java, 17134, Indonesia

Location

Ciptomangunkusumo public hospital

Jakarta Pusat, Indonesia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Tuberculosis

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lusiana R Idrus, Master

  University of Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Model Details: Stepped wedge design trial

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: March 27, 2020
• Study Start: April 1, 2017
• Primary Completion: February 28, 2019
• Study Completion: March 30, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: September 2019
• Access Criteria: Full data only available for investigators

Locations

ID (3)