HIV InfectionsPhase 3NCT00554567
Utilization of HIV Clinical Services in Rural India
A Phase 3 study testing HIV Testing and Care Services in people with HIV Infections and Sexually Transmitted Infections, run by Institute of Health Management, Pachod, India at 1 site in India.
Trial summary
This community-based clinical trial based in two districts of rural Maharashtra, India compares utilization of an intervention model of "fully-decentralized," or rural primary clinic-based, HIV testing and care services, with a control model of the Indian government's partially-decentralized HIV services, offering… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Infections
- What is being tested?
- HIV Testing and Care Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2007to Feb 2011
- Phase
- Phase 3
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult Male Age 18 - 49 or Pregnant Female age 18 and older
- Capacity to give written informed consent
Who cannot join
- Refusal, or Physical or Mental incapacity to give written informed consent
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Health Management, Pachod (IHMP)
Pachod, Aurangabad District, Maharashtra, 431 121
About this study
Official title: Utilization of Decentralized HIV Testing and Care Services in Rural Maharashtra, India
This community-based clinical trial based in two districts of rural Maharashtra, India compares utilization of an intervention model of "fully-decentralized," or rural primary clinic-based, HIV testing and care services, with a control model of the Indian government's partially-decentralized HIV services, offering rural referral clinic testing and urban-based HIV care.
Read the detailed description
India has one of the highest estimated number of HIV cases globally. Sixty percent of its HIV cases occur in rural residents, yet there is no system of HIV testing or care services for them. Preliminary studies have identified very low HIV testing utilization among men and recently pregnant women in rural Maharashtra, even though these are, by government policy, high-priority target groups for rural HIV testing, diagnosis, and prevention.
This study will compare two models of rural HIV testing and care services in two districts of Maharashtra, India. The "Control" model is the Indian government's current strategy of "partially decentralized" rural-based HIV testing services at a secondary-level Community Health Center clinic, which serves a village group population of 30,000. HIV care including antiretroviral therapy is provided a the rural district headquarters in the district urban center. The "Intervention" model is a novel model of "fully decentralized" rural-based HIV testing which will be offered at the Community Health Center, two Primary Health Centers, and eight village-level sub-center clinics, and HIV care offered at a rural-based clinic.
The primary outcomes of this trial are to assess and compare utilization rates for these two types of HIV services models among rural adult men age 18-49 and pregnant women age 18 and older. Additionally, the secondary outcomes include comparing HIV clinical and behavioral risk characteristics of services utilizers in each model, and characteristics of utilizers versus non-utilizers between and within each model. Clinical care outcomes include WHO Clinical stage at time of HIV diagnosis and at first clinical care visit, and birth outcomes for HIV-infected pregnant women.
- Conditions
- HIV Infections, Sexually Transmitted Infections
- Being tested
- HIV Testing and Care Services
- Keywords
- HIV/AIDS, Voluntary Counseling and Testing, Rural India, HIV Care, Health Services Research
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV Testing and Care ServicesBehavioural
Fully-decentralized HIV Voluntary Counseling and Testing and referral for care
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Fully Decentralized HIV Testing and Care Services Receives: Behavioral: HIV Testing and Care Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization of HIV Testing
Measured: Annual
Secondary outcomes (6)
Proportion with Sexually Transmitted Infection History
Measured: Annual
Proportion with Behavioral HIV risk history
Measured: Annual
WHO Clinical Stage at time of HIV diagnosis
Measured: Quarterly
WHO Clinical Stage at first clinical care visit
Measured: Quarterly
Birth outcomes for HIV-infected pregnant women
Measured: Quarterly
Awareness of HIV Testing Services
Measured: Annual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startJan 2007
- Primary completionNov 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Health Management, Pachod, India
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Investigators
- Ashok Dyalchand, MD MPH, Principal investigator, Institute for Health Management, Pachod (IHMP), Maharashtra, IndiaGita Sinha, MD, Principal investigator, Johns Hopkins University School of Medicine, Baltimore, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554567
- Sponsor's protocol ID
- VCTUtilizationStudy2007
- Status last verified
- Dec 2008
- First submitted
- 5 Nov 2007
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sinha G, Dyalchand A, Khale M, Kulkarni G, Vasudevan S, Bollinger RC. Low utilization of HIV testing during pregnancy: What are the barriers to HIV testing for women in rural India? J Acquir Immune Defic Syndr. 2008 Feb 1;47(2):248-52.
PubMed 18340657Celentano DD. Is HIV screening in the labor and delivery unit feasible and acceptable in low-income settings? PLoS Med. 2008 May 6;5(5):e107. doi: 10.1371/journal.pmed.0050107.
PubMed 18462015
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Decentralized HIV Testing and Care Services in Rural Maharashtra, India
- ClinicalTrials.gov ID
- NCT00554567
- Acronym / sponsor ID
- VCTUtilizationStudy2007
- Conditions
- HIV Infections, Sexually Transmitted Infections
- Keywords
- HIV/AIDS, Voluntary Counseling and Testing, Rural India, HIV Care, Health Services Research
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Institute of Health Management, Pachod, IndiaUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- Jan 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 7 Nov 2007 (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.
This community-based clinical trial based in two districts of rural Maharashtra, India compares utilization of an intervention model of "fully-decentralized," or rural primary clinic-based, HIV testing and care services, with a control model of the Indian government's partially-decentralized HIV services, offering rural referral clinic testing and urban-based HIV care.
Detailed description
India has one of the highest estimated number of HIV cases globally. Sixty percent of its HIV cases occur in rural residents, yet there is no system of HIV testing or care services for them. Preliminary studies have identified very low HIV testing utilization among men and recently pregnant women in rural Maharashtra, even though these are, by government policy, high-priority target groups for rural HIV testing, diagnosis, and prevention.
This study will compare two models of rural HIV testing and care services in two districts of Maharashtra, India. The "Control" model is the Indian government's current strategy of "partially decentralized" rural-based HIV testing services at a secondary-level Community Health Center clinic, which serves a village group population of 30,000. HIV care including antiretroviral therapy is provided a the rural district headquarters in the district urban center. The "Intervention" model is a novel model of "fully decentralized" rural-based HIV testing which will be offered at the Community Health Center, two Primary Health Centers, and eight village-level sub-center clinics, and HIV care offered at a rural-based clinic.
The primary outcomes of this trial are to assess and compare utilization rates for these two types of HIV services models among rural adult men age 18-49 and pregnant women age 18 and older. Additionally, the secondary outcomes include comparing HIV clinical and behavioral risk characteristics of services utilizers in each model, and characteristics of utilizers versus non-utilizers between and within each model. Clinical care outcomes include WHO Clinical stage at time of HIV diagnosis and at first clinical care visit, and birth outcomes for HIV-infected pregnant women.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: HIV Testing and Care ServicesFully Decentralized HIV Testing and Care Services |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult Male Age 18 - 49 or Pregnant Female age 18 and older
- Capacity to give written informed consent
Key exclusion criteria (1 listed)
- Refusal, or Physical or Mental incapacity to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV Testing and Care ServicesFully-decentralized HIV Voluntary Counseling and Testing and referral for care | Behavioural | Intervention Arm |
Primary outcome
Utilization of HIV Testing
Time frame: Annual
6 secondary outcomes
Proportion with Sexually Transmitted Infection History
Time frame: Annual
Proportion with Behavioral HIV risk history
Time frame: Annual
WHO Clinical Stage at time of HIV diagnosis
Time frame: Quarterly
WHO Clinical Stage at first clinical care visit
Time frame: Quarterly
Birth outcomes for HIV-infected pregnant women
Time frame: Quarterly
Awareness of HIV Testing Services
Time frame: Annual
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Results publication: PubMed 18340657Sinha G, Dyalchand A, Khale M, Kulkarni G, Vasudevan S, Bollinger RC. Low utilization of HIV testing during pregnancy: What are the barriers to HIV testing for women in rural India? J Acquir Immune Defic Syndr. 2008 Feb 1;47(2):248-52.
- Results publication: PubMed 18462015Celentano DD. Is HIV screening in the labor and delivery unit feasible and acceptable in low-income settings? PLoS Med. 2008 May 6;5(5):e107. doi: 10.1371/journal.pmed.0050107.
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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.
Ashok Dyalchand, MD MPH principal investigator
Institute for Health Management, Pachod (IHMP), Maharashtra, India
Gita Sinha, MD principal investigator
Johns Hopkins University School of Medicine, Baltimore, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HIV Testing and Care Services in people with HIV Infections and Sexually Transmitted Infections, run by Institute of Health Management, Pachod, India at 1 site in India.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Utilization of HIV Testing (time frame: Annual). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00554567, which also lists 2 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 8 Mar 2016.