HIVNCT01160575
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
An observational study of HIV and AIDS, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV, AIDS, Epidemiology
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2010to 9 Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than or equal to 18 years of age
- Client to the clinic based standard VCT center or the VCT van during the study period
- Provides informed consent
- Must be a resident of the community for at least 6 months.
- Willing to complete survey
- Willing to provide a blood sample obtained by finger-stick or venipuncture for HIV testing.
- Willing to have blood samples stored.
Who cannot join
- Participant is less than 18 years of age.
- Study staff feels participant is psychologically unfit to understand the consent
- Participant has already been enrolled in this study
About this study
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.
Read the 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.
- Conditions
- HIV, AIDS, Epidemiology, Prevention
- Keywords
- Counseling, Epidemiology, HIV, AIDS, Prevention
- Medical subject headings
- Acquired Immunodeficiency Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study start23 Jun 2010
- Study completion9 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Thomas C Quinn, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160575
- Sponsor's protocol ID
- 999910158
- Other IDs
- 10-I-N158
- Status last verified
- 9 Sep 2014
- First submitted
- 9 Jul 2010
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Newmann S, Sarin P, Kumarasamy N, Amalraj E, Rogers M, Madhivanan P, Flanigan T, Cu-Uvin S, McGarvey S, Mayer K, Solomon S. Marriage, monogamy and HIV: a profile of HIV-infected women in south India. Int J STD AIDS. 2000 Apr;11(4):250-3. doi: 10.1258/0956462001915796.
PubMed 10772089Dandona L, Dandona R, Gutierrez JP, Kumar GA, McPherson S, Bertozzi SM; ASCI FPP Study Team. Sex behaviour of men who have sex with men and risk of HIV in Andhra Pradesh, India. AIDS. 2005 Mar 24;19(6):611-9. doi: 10.1097/01.aids.0000163938.01188.e4.
PubMed 15802980Simoes EA, Babu PG, John TJ, Nirmala S, Solomon S, Lakshminarayana CS, Quinn TC. Evidence for HTLV-III infection in prostitutes in Tamil Nadu (India). Indian J Med Res. 1987 Apr;85:335-8.
PubMed 3623641
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01160575
- Acronym / sponsor ID
- 999910158
- Conditions
- HIV, AIDS, Epidemiology, Prevention
- Keywords
- Counseling, Epidemiology, HIV, AIDS, Prevention
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 23 Jun 2010
- Study completion
- 9 Sep 2014
- First posted
- 12 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
Key exclusion criteria (3 listed)
- Participant is less than 18 years of age.
- Study staff feels participant is psychologically unfit to understand the consent
- Participant has already been enrolled in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Background: PubMed 10772089Newmann S, Sarin P, Kumarasamy N, Amalraj E, Rogers M, Madhivanan P, Flanigan T, Cu-Uvin S, McGarvey S, Mayer K, Solomon S. Marriage, monogamy and HIV: a profile of HIV-infected women in south India. Int J STD AIDS. 2000 Apr;11(4):250-3. doi: 10.1258/0956462001915796.
- Background: PubMed 15802980Dandona L, Dandona R, Gutierrez JP, Kumar GA, McPherson S, Bertozzi SM; ASCI FPP Study Team. Sex behaviour of men who have sex with men and risk of HIV in Andhra Pradesh, India. AIDS. 2005 Mar 24;19(6):611-9. doi: 10.1097/01.aids.0000163938.01188.e4.
- Background: PubMed 3623641Simoes EA, Babu PG, John TJ, Nirmala S, Solomon S, Lakshminarayana CS, Quinn TC. Evidence for HTLV-III infection in prostitutes in Tamil Nadu (India). Indian J Med Res. 1987 Apr;85:335-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas C Quinn, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and AIDS, run by National Institute of Allergy and Infectious Diseases (NIAID).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01160575, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.