- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01160575
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
13 december 2019 uppdaterad av: 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.
Studieöversikt
Status
Indragen
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 99 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
INCLUSION CRITERIA:
- 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.
EXCLUSION CRITERIA:
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- Dandona 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.
- Simoes 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
23 juni 2010
Avslutad studie
9 september 2014
Studieregistreringsdatum
Först inskickad
9 juli 2010
Först inskickad som uppfyllde QC-kriterierna
9 juli 2010
Första postat (Uppskatta)
12 juli 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 december 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 december 2019
Senast verifierad
9 september 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 999910158
- 10-I-N158
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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