A Semi-Factorial Cluster-Randomized Trial to Estimate the Effect Size of Community Mobilization and VCT Vans on the Adoption of Voluntary Counseling and Testing (VCT) Services in Andhra Pradesh, India: THE MCVCT STUDY

This study is not yet open for participant recruitment.
Verified March 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01160575
First received: July 9, 2010
Last updated: March 14, 2014
Last verified: March 2013
  Purpose

With an estimated 2.5 million HIV-infected persons, India is home to one of the largest populations of HIV-infected persons in the world. Yet, it is estimated that less than 20% of the people living with HIV in India are aware of their status. Andhra Pradesh (AP), situated in south India, is the state with the highest HIV burden in India. Reports from AP suggest usage of voluntary counseling and testing (VCT) is low, especially among high-risk groups. VCT has been shown to have many benefits in addition to diagnosis of HIV infection such as reduction in risk behavior, partner referral, and serving as an entry point to the health care system. Community mobilization and VCT vans have been shown in the past to play a role in increasing utilization of VCT services in various developing countries similar to India. The primary objective of this protocol is to arrive at an effect size of community mobilization alone, and both community mobilization and VCT vans, on the adoption of VCT services in Andhra Pradesh, India. Secondary objectives include identifying barriers to VCT, assessing stigma in the community, and establishing a specimen repository at the YRGCARE infectious disease laboratory in Chennai, India. We will achieve these objectives by conducting a cluster randomized clinical trial with 3 arms: ARM 1: standard of care with pre-existing VCT centers (SVCT); ARM 2: community mobilization in the setting of pre-existing VCT centers (CVCT); ARM 3: community mobilization plus VCT van in addition to the pre-existing VCT centers (MCVCT). The overall study duration will be 6 months from randomization. To our knowledge, this is the first study to examine the role of community mobilization and VCT vans on the adoption of VCT in the Indian context. It will provide us with vital data that will be used to plan a larger powered study to evaluate the effectiveness of these interventions including sites from other parts of India. Additionally, this study will also provide us with important information on barriers to VCT in these communities.


Condition
HIV
AIDS
Epidemiology
Prevention

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Semi-Factorial Cluster-Randomized Trial to Estimate the Effect Size of Community Mobilization and VCT Vans on the Adoption of Voluntary Counseling and Testing (VCT) Services in Andhra Pradesh, India: THE MCVCT STUDY

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 10000
Study Start Date: June 2010
Detailed Description:

With an estimated 2.5 million HIV-infected persons, India is home to one of the largest populations of HIV-infected persons in the world. Yet, it is estimated that less than 20% of the people living with HIV in India are aware of their status. Andhra Pradesh (AP), situated in south India, is the state with the highest HIV burden in India. Reports from AP suggest usage of voluntary counseling and testing (VCT) is low, especially among high-risk groups. VCT has been shown to have many benefits in addition to diagnosis of HIV infection such as reduction in risk behavior, partner referral, and serving as an entry point to the health care system. Community mobilization and VCT vans have been shown in the past to play a role in increasing utilization of VCT services in various developing countries similar to India. The primary objective of this protocol is to arrive at an effect size of community mobilization alone, and both community mobilization and VCT vans, on the adoption of VCT services in Andhra Pradesh, India. Secondary objectives include identifying barriers to VCT, assessing stigma in the community, and establishing a specimen repository at the YRGCARE infectious disease laboratory in Chennai, India. We will achieve these objectives by conducting a cluster randomized clinical trial with 3 arms: ARM 1: standard of care with pre-existing VCT centers (SVCT); ARM 2: community mobilization in the setting of pre-existing VCT centers (CVCT); ARM 3: community mobilization plus VCT van in addition to the pre-existing VCT centers (MCVCT). The overall study duration will be 6 months from randomization. To our knowledge, this is the first study to examine the role of community mobilization and VCT vans on the adoption of VCT in the Indian context. It will provide us with vital data that will be used to plan a larger powered study to evaluate the effectiveness of these interventions including sites from other parts of India. Additionally, this study will also provide us with important information on barriers to VCT in these communities.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Greater than or equal to 18 years of age
    2. Client to the clinic based standard VCT center or the VCT van during the study period
    3. Provides informed consent
    4. Must be a resident of the community for at least 6 months.
    5. Willing to complete survey
    6. Willing to provide a blood sample obtained by finger-stick or venipuncture for HIV testing.
    7. Willing to have blood samples stored.

EXCLUSION CRITERIA:

  1. Participant is less than 18 years of age.
  2. Study staff feels participant is psychologically unfit to understand the consent
  3. Participant has already been enrolled in this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160575

Contacts
Contact: Thomas C Quinn, M.D. (410) 955-7635 tquinn@jhmi.edu

Locations
United States, Maryland
National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi Not yet recruiting
Bethesda, Maryland, United States, 20892
Contact: Thomas Quinn, M.D.    410-955-7635    tquinn@mail.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas C Quinn, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01160575     History of Changes
Other Study ID Numbers: 999910158, 10-I-N158
Study First Received: July 9, 2010
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Counseling
Epidemiology
HIV
AIDS
Prevention

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014