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

NCT ID: NCT04847388

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-03-15

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.

Conditions

HIV Infections

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

ART-naive HIV Patients with substance abuse and without substance abuse

Group A Group B

Substance like alcohol, marijuana, etc.

Intervention Type: DRUG

Cohort study

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

Substance like alcohol, marijuana, etc.

Intervention Type: DRUG

Cohort study

Interventions

Substance like alcohol, marijuana, etc.

Cohort study

Intervention Type: DRUG

Other Intervention Names

Cannabis

Eligibility Criteria

Inclusion Criteria

• 1. Anti-retroviral therapy naïve patients

Exclusion Criteria

• 1. 'Transferred in' patients

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Singh, Ranjan Kumar, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Ranjan Kumar Singh

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ranjan K Singh

Role: PRINCIPAL_INVESTIGATOR

Consultant Physician

Locations

ART centre, Sadar Hospital

Khagaria, Bihar, India

Countries

India

References

Kapadia F, Vlahov D, Donahoe RM, Friedland G. The role of substance abuse in HIV disease progression: reconciling differences from laboratory and epidemiologic investigations. Clin Infect Dis. 2005 Oct 1;41(7):1027-34. doi: 10.1086/433175. Epub 2005 Aug 22.

Reference Type: BACKGROUND

PMID: 16142670 (View on PubMed)

Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Boston: Butterworths; 1990. Available from http://www.ncbi.nlm.nih.gov/books/NBK201/

Reference Type: BACKGROUND

PMID: 21250045 (View on PubMed)

NIDA. 2019, July 29. Drug Use and Viral Infections (HIV, Hepatitis) DrugFacts. Retrieved from https://www.drugabuse.gov/publications/drugfacts/drug-use-viral-infections-hiv-hepatitis on 2021, April 5

Reference Type: BACKGROUND

Other Identifiers

SinghRK2

Identifier Type: -

Identifier Source: org_study_id