Design of the Indian NCA study (Indian national collaboration on AIDS): a cluster randomized trial to evaluate the effectiveness of integrated care centers to improve HIV outcomes among men who have sex with men and persons who inject drugs in India

Sunil S. Solomon, Gregory M. Lucas, David D. Celentano, Allison M. McFall, Elizabeth Ogburn, Lawrence H. Moulton, Aylur K. Srikrishnan, M. Suresh Kumar, Santhanam Anand, Suniti Solomon, Shruti H. Mehta

Research output: Contribution to journalArticle

Abstract

Background: Globally, men who have sex with men and people who inject drugs remain disproportionately affected by HIV, but they have not been the focus of prevention and treatment interventions in many resource-limited settings. Methods/Design: This cluster-randomized trial (conducted from June 2012 to June 2017), evaluates whether single-venue, integrated delivery of core HIV services to vulnerable high-risk populations improves service utilization and consequently, HIV testing and other outcomes along the HIV care continuum. Core services include: HIV counseling and testing, information, education and communication, condom distribution, needle and syringe exchange programs, opioid agonist therapy, management of sexually transmitted infections, tuberculosis screening, diagnosis, and treatment, and antiretroviral therapy. Stratified restricted randomization was used to allocate 22 Indian cities (10 men who have sex with men and 12 people who inject drugs sites) at a 1:1 ratio to either the intervention or control condition. Integrated care centers were scaled-up and implemented in the 11 intervention cities and outcomes will be assessed by pre- and post-intervention surveys at intervention and control sites. As men who have sex with men and people who inject drugs are hidden populations, with no sampling frame, respondent-driven sampling will be used to accrue samples for the two independent cross-sectional surveys. Discussion: For an AIDS-free generation to be realized, prevention, care and treatment services need to reach all populations at risk for HIV infection. There is a clear gap in access to services among men who have sex with men and people who inject drugs. Trials need to be designed to optimize utilization of services in these populations. Trial registration: ClinicalTrials.gov Identifier: NCT01686750 Date of Registration: September 13, 2012

Original languageEnglish (US)
Pages (from-to)1-14
Number of pages14
JournalBMC Health Services Research
Volume16
Issue number1
DOIs
StatePublished - Nov 14 2016

Fingerprint

India
Acquired Immunodeficiency Syndrome
HIV
Pharmaceutical Preparations
Needle-Exchange Programs
Population
Therapeutics
Continuity of Patient Care
Condoms
Random Allocation
Sexually Transmitted Diseases
Opioid Analgesics
HIV Infections
Counseling
Tuberculosis
Cross-Sectional Studies
Communication
Education

Keywords

  • HIV/ADS
  • India
  • Men who have sex with men
  • People who inject drugs

ASJC Scopus subject areas

  • Health Policy

Cite this

@article{d840f91dc27141bfaabc0f44fa18d660,
title = "Design of the Indian NCA study (Indian national collaboration on AIDS): a cluster randomized trial to evaluate the effectiveness of integrated care centers to improve HIV outcomes among men who have sex with men and persons who inject drugs in India",
abstract = "Background: Globally, men who have sex with men and people who inject drugs remain disproportionately affected by HIV, but they have not been the focus of prevention and treatment interventions in many resource-limited settings. Methods/Design: This cluster-randomized trial (conducted from June 2012 to June 2017), evaluates whether single-venue, integrated delivery of core HIV services to vulnerable high-risk populations improves service utilization and consequently, HIV testing and other outcomes along the HIV care continuum. Core services include: HIV counseling and testing, information, education and communication, condom distribution, needle and syringe exchange programs, opioid agonist therapy, management of sexually transmitted infections, tuberculosis screening, diagnosis, and treatment, and antiretroviral therapy. Stratified restricted randomization was used to allocate 22 Indian cities (10 men who have sex with men and 12 people who inject drugs sites) at a 1:1 ratio to either the intervention or control condition. Integrated care centers were scaled-up and implemented in the 11 intervention cities and outcomes will be assessed by pre- and post-intervention surveys at intervention and control sites. As men who have sex with men and people who inject drugs are hidden populations, with no sampling frame, respondent-driven sampling will be used to accrue samples for the two independent cross-sectional surveys. Discussion: For an AIDS-free generation to be realized, prevention, care and treatment services need to reach all populations at risk for HIV infection. There is a clear gap in access to services among men who have sex with men and people who inject drugs. Trials need to be designed to optimize utilization of services in these populations. Trial registration: ClinicalTrials.gov Identifier: NCT01686750 Date of Registration: September 13, 2012",
keywords = "HIV/ADS, India, Men who have sex with men, People who inject drugs",
author = "Solomon, {Sunil S.} and Lucas, {Gregory M.} and Celentano, {David D.} and McFall, {Allison M.} and Elizabeth Ogburn and Moulton, {Lawrence H.} and Srikrishnan, {Aylur K.} and Kumar, {M. Suresh} and Santhanam Anand and Suniti Solomon and Mehta, {Shruti H.}",
year = "2016",
month = "11",
day = "14",
doi = "10.1186/s12913-016-1905-5",
language = "English (US)",
volume = "16",
pages = "1--14",
journal = "BMC Health Services Research",
issn = "1472-6963",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Design of the Indian NCA study (Indian national collaboration on AIDS)

T2 - a cluster randomized trial to evaluate the effectiveness of integrated care centers to improve HIV outcomes among men who have sex with men and persons who inject drugs in India

AU - Solomon, Sunil S.

AU - Lucas, Gregory M.

AU - Celentano, David D.

AU - McFall, Allison M.

AU - Ogburn, Elizabeth

AU - Moulton, Lawrence H.

AU - Srikrishnan, Aylur K.

AU - Kumar, M. Suresh

AU - Anand, Santhanam

AU - Solomon, Suniti

AU - Mehta, Shruti H.

PY - 2016/11/14

Y1 - 2016/11/14

N2 - Background: Globally, men who have sex with men and people who inject drugs remain disproportionately affected by HIV, but they have not been the focus of prevention and treatment interventions in many resource-limited settings. Methods/Design: This cluster-randomized trial (conducted from June 2012 to June 2017), evaluates whether single-venue, integrated delivery of core HIV services to vulnerable high-risk populations improves service utilization and consequently, HIV testing and other outcomes along the HIV care continuum. Core services include: HIV counseling and testing, information, education and communication, condom distribution, needle and syringe exchange programs, opioid agonist therapy, management of sexually transmitted infections, tuberculosis screening, diagnosis, and treatment, and antiretroviral therapy. Stratified restricted randomization was used to allocate 22 Indian cities (10 men who have sex with men and 12 people who inject drugs sites) at a 1:1 ratio to either the intervention or control condition. Integrated care centers were scaled-up and implemented in the 11 intervention cities and outcomes will be assessed by pre- and post-intervention surveys at intervention and control sites. As men who have sex with men and people who inject drugs are hidden populations, with no sampling frame, respondent-driven sampling will be used to accrue samples for the two independent cross-sectional surveys. Discussion: For an AIDS-free generation to be realized, prevention, care and treatment services need to reach all populations at risk for HIV infection. There is a clear gap in access to services among men who have sex with men and people who inject drugs. Trials need to be designed to optimize utilization of services in these populations. Trial registration: ClinicalTrials.gov Identifier: NCT01686750 Date of Registration: September 13, 2012

AB - Background: Globally, men who have sex with men and people who inject drugs remain disproportionately affected by HIV, but they have not been the focus of prevention and treatment interventions in many resource-limited settings. Methods/Design: This cluster-randomized trial (conducted from June 2012 to June 2017), evaluates whether single-venue, integrated delivery of core HIV services to vulnerable high-risk populations improves service utilization and consequently, HIV testing and other outcomes along the HIV care continuum. Core services include: HIV counseling and testing, information, education and communication, condom distribution, needle and syringe exchange programs, opioid agonist therapy, management of sexually transmitted infections, tuberculosis screening, diagnosis, and treatment, and antiretroviral therapy. Stratified restricted randomization was used to allocate 22 Indian cities (10 men who have sex with men and 12 people who inject drugs sites) at a 1:1 ratio to either the intervention or control condition. Integrated care centers were scaled-up and implemented in the 11 intervention cities and outcomes will be assessed by pre- and post-intervention surveys at intervention and control sites. As men who have sex with men and people who inject drugs are hidden populations, with no sampling frame, respondent-driven sampling will be used to accrue samples for the two independent cross-sectional surveys. Discussion: For an AIDS-free generation to be realized, prevention, care and treatment services need to reach all populations at risk for HIV infection. There is a clear gap in access to services among men who have sex with men and people who inject drugs. Trials need to be designed to optimize utilization of services in these populations. Trial registration: ClinicalTrials.gov Identifier: NCT01686750 Date of Registration: September 13, 2012

KW - HIV/ADS

KW - India

KW - Men who have sex with men

KW - People who inject drugs

UR - http://www.scopus.com/inward/record.url?scp=84999266389&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84999266389&partnerID=8YFLogxK

U2 - 10.1186/s12913-016-1905-5

DO - 10.1186/s12913-016-1905-5

M3 - Article

C2 - 27842543

VL - 16

SP - 1

EP - 14

JO - BMC Health Services Research

JF - BMC Health Services Research

SN - 1472-6963

IS - 1

ER -