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
| Status: | Not yet recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | June 2010 |
| Contact: | Thomas C Quinn, M.D. |
| Email: | tquinn@jhmi.edu |
| Phone: | (410) 955-7635 |
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.
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.
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.
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.
- 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
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Bethesda, Maryland 20892
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