Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

Summary

This is a cluster randomized trial to evaluate the effectiveness of integrated care centers (ICC) to improve access to HIV testing, prevention services, and treatment among high-risk populations of injection drug users (IDU) and men who have sex with men (MSM) in India. We will collect baseline ethnographic and survey data from approximately 27 IDU or MSM sites in India. We will use baseline data to select 22 sites for the trial (12 IDU and 10 MSM) and to stratify sites according to key baseline characteristics. We will perform stratified randomization to assign sites to either the ICC intervention or to standard services. ICCs, which will be either IDU or MSM-focused, will provide an accepting atmosphere in which members of vulnerable groups can drop-in, receive rapid HIV voluntary counselling and testing, risk reduction counseling and services, and antiretroviral therapy. ICCs will be scaled-up from existing governmental or non-governmental organizations and services provided at ICCs will be supported by the National AIDS Control Organization (NACO) of India. After providing services in communities for two years, we will conduct an evaluation survey (with biological and behavioral measures) of approximately 1000 subjects in the target populations in each of the 22 study sites. Integrated care centers have the potential to improve access to HIV prevention and treatment services among vulnerable, high-risk populations.

Conditions

• HIV Infection

Interventions

BEHAVIORAL

Integrated care centers

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• YR Gaitonde Centre for AIDS Research and Education

  collaborator OTHER

• Elton John AIDS Foundation

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Gregory M Lucas, MD · Johns Hopkins University

• Shruti Mehta, PhD · Johns Hopkins University

• David D Celentano, ScD · Johns Hopkins University

• Suniti Solomon, MD · YR Gaitonde Centre for AIDS Research and Education

• Aylur Srikrishnan, BA · YR Gaitonde Centre for AIDS Research and Education

• Suresh Kumar, MPH · YR Gaitonde Centre for AIDS Research and Education

• Sunil S Solomon, PhD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2017-06-30

Completion

2017-06-30

Countries

• India

Study Locations