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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04847388
• Other study ID #: SinghRK2
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: March 2022
• Source: Singh, Ranjan Kumar, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 1. Anti-retroviral therapy naïve patients

Exclusion Criteria:

• 1. 'Transferred in' patients

Related Conditions & MeSH terms

• HIV Infections
• Substance-Related Disorders

Intervention

Drug:
• Substance like alcohol, marijuana, etc.
Cohort study

Locations

Country	Name	City	State
India	ART centre, Sadar Hospital	Khagaria	Bihar

Sponsors (1)

Lead Sponsor	Collaborator
Singh, Ranjan Kumar, M.D.

Country where clinical trial is conducted

India, 

References & Publications (3)

Griffin JB JR.. Substance Abuse. In: Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Boston: Butterworths; 1990. Chapter 206. Available from: https://www.ncbi.nlm.nih.gov/books/NBK319/

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. Epub 2005 Aug 22. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of substance abuse among anti-retroviral treatment naïve patients positive for HIV antibodies.	Calculate prevalence (%) dividing no. of HIV patients with substance abuse by total no. of enrolled HIV patient multiplied by 100.	One year
Secondary	CD4+ T cell counts at the first visit to ART centre in patients positive for HIV antibodies with substance addiction and without substance addiction.	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
Secondary	Opportunistic infections	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