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

Completed

• Conditions: HIV Infections
• Interventions: Drug: Substance like alcohol, marijuana, etc.

• Registration Number: NCT04847388
• Lead Sponsor: Singh, Ranjan Kumar, M.D.

Brief Summary

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.

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 Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-11
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-19
• Status Verified: 2022-03
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• 1. Anti-retroviral therapy naïve patients

Exclusion Criteria

• 1. 'Transferred in' patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ART-naive HIV Patients with substance abuse and without substance abuse	Substance like alcohol, marijuana, etc.	Group A Group B
Group A and B	Substance like alcohol, marijuana, etc.	Group A: ART-naive HIV seropositive with H/O substance abuse Group B: ART-naive HIV seropositive without H/O substance abuse

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
CD4+ T cell counts at the first visit to ART centre in patients positive for HIV antibodies with substance addiction and without substance addiction.	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.
Opportunistic infections	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

Trial Locations

Locations (1)

ART centre, Sadar Hospital; 🇮🇳 Khagaria, Bihar, India