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Completed

NCT Number: NCT04847388

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

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.

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Key information

About this study

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:

  • Study of prevalence of substance abuse among anti-retroviral treatment naïve patients positive for HIV antibodies.
  • To compare opportunistic infections prevalent in patients positive for HIV antibodies with substance addiction and without substance addiction.
  • 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-
  • Anti-retroviral therapy naïve patients 2. Age > 12 years Exclusion criteria-
  • 'Transferred in' patients
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Anti-retroviral therapy naïve patients

Exclusion criteria

  • 1. 'Transferred in' patients

Treatment and study plan

Substance like alcohol, marijuana, etc.

Drug

Cohort study

Other names: Cannabis

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Singh, Ranjan Kumar, M.D.

Indiv

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2021
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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