Prevalence of Substance Abuse Among Anti-retroviral Treatment Naive Patients Positive for HIV Antibodies

March 16, 2022 updated by: Ranjan Kumar Singh, Singh, Ranjan Kumar, M.D.

Prevalence of Substance Abuse Among Anti-retroviral Treatment Naive Patients Positive for HIV Antibodies- A Cohort Study

Individuals utilise substances to elevate their mood. Alcohol, cannabis, nicotine, cocaine, and methamphetamine are examples of substances. Excessive usage of a drug that is harmful to oneself and society is referred to as substance addiction/abuse. People who inject drugs and share needles, as well as drugs that impair judgement and lead to unprotected intercourse with an infected partner, have been related to risky sex behaviour and unsafe sex, both of which increase the risk of HIV infection. Several factors, including immunologic and virologic conditions affecting host susceptibility, underlying comorbidities among drug users, use of antiretroviral therapy, and viral strain, as well as pharmacodynamic aspects of drug use, such as the pattern and type of drug administration and the route of administration, may mediate the relationship between drug use and HIV disease progression. Exacerbation of HIV progression has been shown in patients with substance addiction in laboratory research.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study of substance abuse among treatment naïve HIV patients

Background: People take substances to improve their mood. Alcohol, cannabis, nicotine, cocaine, and methamphetamine are examples of substances. Excessive usage of a drug that is harmful to oneself and society is referred to as substance addiction/abuse. These medicines have been associated to risky sex behaviour and unsafe sex, increasing the likelihood of obtaining HIV infection in two ways. People inject drugs and share needles, and drugs impair judgement, resulting in unprotected intercourse with an infected partner.

The relationship between drug use and HIV disease progression may be mediated by several factors, including immunologic and virologic conditions affecting host susceptibility, underlying comorbidities among drug users, use of antiretroviral therapy, and viral strain, as well as pharmacodynamic aspects of drug use, such as the pattern and type of drug administration and the route of administration. Laboratory based studies show exacerbation of HIV progression among patient with drug addiction.

Aim and objectives:

  1. Study of prevalence of substance abuse among anti-retroviral treatment naïve patients positive for HIV antibodies.
  2. To compare opportunistic infections prevalent in patients positive for HIV antibodies with substance addiction and without substance addiction.
  3. To compare CD4+ T cell counts at the first visit to ART centre in patients positive for HIV antibodies with substance addiction and without substance addiction. Methods- Inclusion criteria-

1. Anti-retroviral therapy naïve patients 2. Age > 12 years Exclusion criteria-

  1. 'Transferred in' patients
  2. Age < 12 years. A prospective cohort studies. At Anti-retroviral therapy centre, Sadar Hospital Khagaria.

Flow chart- First visit of HIV seropositive patient-----History/clinical examination of patients H/o substance abuse (nature of substance. ? drug dependence/abuse)-------search of opportunistic infections-----------CD4 T cell count-----anti-retroviral drugs and treatment of OI, if present------follow up biweekly (first month)-----then monthly follow up for six months------CD4+ T cell count.

Study Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Bihar
      • Khagaria, Bihar, India, 851204
        • ART centre, Sadar Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Treatment naive HIV seropositive patients

Description

Inclusion Criteria:

  • 1. Anti-retroviral therapy naïve patients

Exclusion Criteria:

  • 1. 'Transferred in' patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ART-naive HIV Patients with substance abuse and without substance abuse
Group A Group B
Drug: Substance like alcohol, marijuana, etc.
Cohort study
Other Names:
  • Cannabis
Group A and B
Group A: ART-naive HIV seropositive with H/O substance abuse Group B: ART-naive HIV seropositive without H/O substance abuse
Drug: Substance like alcohol, marijuana, etc.
Cohort study
Other Names:
  • Cannabis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of substance abuse among anti-retroviral treatment naïve patients positive for HIV antibodies.
Time Frame: One year
Calculate prevalence (%) dividing no. of HIV patients with substance abuse by total no. of enrolled HIV patient multiplied by 100.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD4+ T cell counts at the first visit to ART centre in patients positive for HIV antibodies with substance addiction and without substance addiction.
Time Frame: One year
Compare mean/SD of CD4+ T cell counts (cells/mm^3) of HIV patients in both groups at first visit to the centre by applying chi-square test.
One year
Opportunistic infections
Time Frame: One year
Comparing prevalence of opportunistic infections in both groups i.e. patients of HIV with substance abuse and Patients of HIV without substance abuse
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singh, Ranjan Kumar, M.D.

Investigators

  • Principal Investigator: Ranjan K Singh, Consultant physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

April 11, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SinghRK2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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