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

December 13, 2019 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

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Observational

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

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How is the study designed?

Design Details

Collaborators and Investigators

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Sponsor

Sponsor

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National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2010

Study Completion

Study Completion

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September 9, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 9, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 999910158
  • 10-I-N158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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