Clinical trial NCT04847388: Prevalence of Substance Abuse Among Anti-retroviral Treatment Naive Patients Positive for HIV Antibodies
Official title: Prevalence of Substance Abuse Among Anti-retroviral Treatment Naive Patients Positive for HIV Antibodies- A Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: CD4 T cell
HIV
Substance abuse
Lead sponsor: Singh, Ranjan Kumar, M.D.
Sponsor class: INDIV
First posted: 2021-04-19
Enrollment: 210
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment naive HIV seropositive patients

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.

Eligibility criteria: Inclusion Criteria:

* 1. Anti-retroviral therapy naïve patients

Exclusion Criteria:

* 1. 'Transferred in' patients

Primary outcomes:
measure: Prevalence of substance abuse among anti-retroviral treatment naïve patients positive for HIV antibodies.
timeFrame: One year
Secondary outcomes:
measure: CD4+ T cell counts at the first visit to ART centre in patients positive for HIV antibodies with substance addiction and without substance addiction.
timeFrame: One year
measure: Opportunistic infections
timeFrame: One year
Other outcomes:
Locations:
city: Khagaria
country: India
facility: ART centre, Sadar Hospital
state: Bihar
Study officials:
affiliation: Consultant Physician
name: Ranjan K Singh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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/
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