Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00203749

Purpose

This study will evaluate the effectiveness of a combination of clinic- and community-based voluntary counseling and testing programs in preventing HIV in African and Thai communities.

Condition	Intervention	Phase
HIV Infections	Behavioral: Community-Based HIV VCT Behavioral: Standard clinic-based VCT	Phase III

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	NIMH Project Accept: A Phase III Randomized Controlled Trial of Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Prevalence of recent HIV infection [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Less HIV risk behavior [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: Yes ]
Higher rates of HIV testing [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]
More favorable social norms regarding HIV testing [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: Yes ]
More frequent discussions about HIV [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]
More frequent disclosure of HIV status [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]
Less HIV-related stigma [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: Yes ]
Fewer HIV-related life events [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	228834
Study Start Date:	December 2004
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive the community-based VCT intervention	Behavioral: Community-Based HIV VCT COMMUNITY MOBILIZATION. This component of the intervention uses community outreach to enhance the uptake of VCT, thus increasing the rate of HIV testing and frequency of discussions about HIV and reducing stigma through community education and mobilization. EASY ACCESS TO VCT. This component is designed to remove practical barriers and increase safety of VCT. Mobile vans or temporary units set up at local community sites will provide free, anonymous VCT in specific, chosen sites where people gather, such as market areas, shopping centers, and community centers. POST-TEST SUPPORT SERVICES. This component is designed to build psychosocial support to improve the quality of life for individuals diagnosed with HIV. The expected outcomes include a reduction in social harm, an increase in social support through disclosure to those most likely to provide support, and a reduction in internalized stigma. Social support should also decrease the behavioral risk of further transmission.
2: Active Comparator Participants will receive standard clinic-based VCT in comparison communities	Behavioral: Standard clinic-based VCT Control communities will receive Standard Clinic-Based VCT (SVCT) instead of the community-based VCT (CBVCT) intervention. Each of these communities will have access to SVCT that reflects local access to health care. The training for VCT counselors will be the same in the CBVCT and SVCT communities; however, no active recruitment for participation in the SVCT services will be made beyond the standard procedures of each clinic for informing patients of services (e.g., telling individual patients that VCT is available, posting of a flyer in the clinic announcing VCT availability, etc). As such, no active outreach or community mobilization will be conducted by the study staff in the SVCT settings (although it is possible that such activities will occur due to local initiative).

Arms

Assigned Interventions

1: Experimental

Participants will receive the community-based VCT intervention

Behavioral: Community-Based HIV VCT

COMMUNITY MOBILIZATION. This component of the intervention uses community outreach to enhance the uptake of VCT, thus increasing the rate of HIV testing and frequency of discussions about HIV and reducing stigma through community education and mobilization.

EASY ACCESS TO VCT. This component is designed to remove practical barriers and increase safety of VCT. Mobile vans or temporary units set up at local community sites will provide free, anonymous VCT in specific, chosen sites where people gather, such as market areas, shopping centers, and community centers. POST-TEST SUPPORT SERVICES. This component is designed to build psychosocial support to improve the quality of life for individuals diagnosed with HIV.

The expected outcomes include a reduction in social harm, an increase in social support through disclosure to those most likely to provide support, and a reduction in internalized stigma. Social support should also decrease the behavioral risk of further transmission.

2: Active Comparator

Participants will receive standard clinic-based VCT in comparison communities

Behavioral: Standard clinic-based VCT

Control communities will receive Standard Clinic-Based VCT (SVCT) instead of the community-based VCT (CBVCT) intervention. Each of these communities will have access to SVCT that reflects local access to health care. The training for VCT counselors will be the same in the CBVCT and SVCT communities; however, no active recruitment for participation in the SVCT services will be made beyond the standard procedures of each clinic for informing patients of services (e.g., telling individual patients that VCT is available, posting of a flyer in the clinic announcing VCT availability, etc). As such, no active outreach or community mobilization will be conducted by the study staff in the SVCT settings (although it is possible that such activities will occur due to local initiative).

Detailed Description:

NIMH Project Accept is an HIV prevention trial in which 48 communities (10 in Tanzania [Kisarawe], 8 in Zimbabwe [Mutoko], 8 in South Africa/Vulindlela, 8 in South Africa/Soweto and 14 in Thailand [Chiang Mai]) are being randomized to receive either a community-based HIV voluntary counseling and testing (CBVCT) intervention plus standard clinic-based VCT (SVCT), or SVCT alone. The CBVCT intervention has three major strategies: (1) to make VCT more available in community settings; (2) to engage the community through outreach; and (3) to provide post-test support. These strategies are designed to change community norms and reduce risk for HIV infection among all community members, irrespective of whether they participated directly in the intervention.

A community-level intervention based on modifying community norms can change the environmental context in which people make decisions about HIV risk, and has the potential to alter the course of the HIV epidemic in developing countries. This is the first international randomized controlled Phase III trial to determine the efficacy of a behavioral/social science intervention with an HIV incidence endpoint.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Baseline Assessment:

Persons may be included in the baseline behavioral assessment if they meet all of the following criteria:

Reside in a community selected for the study
Are randomly selected and invited to participate from households that are themselves randomly selected and invited to participate
Aged 18-32 years
Has lived in the community at least 4 months in the past year
Sleeps regularly in their household at least 2 nights per week
Able and willing to provide verbal informed consent

Qualitative Cohort:

Persons may be included in the qualitative cohort if they meet all of the following criteria:

Participated in the baseline behavioral assessment
Aged 18-32 years at enrollment
Have not been away from the community for more than two months at a time in the last two years
Able and willing to provide written informed consent

Intervention:

Persons may access community-based counseling and testing (in CBVCT communities) through the study if they meet all of the following criteria:

>16 years of age
Able and willing to provide verbal informed consent

Persons may access post-test support through the study if they meet all of the following criteria:

>16 years of age
Able and willing to provide verbal informed consent
Proof of having been tested for HIV at a Project Accept CBVCT venue, irrespective of test result

Control:

Persons may access standard clinic-based counseling and testing (in both SVCT and CBVCT communities) through the study if they meet all of the following criteria:

>16 years of age
Able and willing to provide verbal informed consent

Post-Intervention Assessment:

Persons may be included in the post-intervention assessment if they meet all of the following criteria:

Reside in a community selected for the study
Are randomly selected to be offered to participate from households that are themselves randomly selected to be offered to participate
Aged 18-32 years
Has lived in the community at least 4 months in the past year
Sleeps regularly in their household at least 2 nights per week
Able and willing to provide informed consent (written for biological assessment; verbal for behavioral assessment)

Exclusion Criteria:

Baseline Assessment:

Persons will be excluded from the baseline behavioral assessment if they meet any of the following criteria:

Are not a member of the study community or are not randomly selected to be offered to participate
Are below 18 or above 32 years of age
Has not lived in the community at least 4 months in the past year
Does not sleep regularly in their household at least 2 nights per week
Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the assessment

Qualitative Cohort:

Persons will be excluded from the qualitative cohort if they meet any of the following criteria:

Not a participant in the baseline behavioral assessment
Less than 18 or greater than 32 years of age at enrollment
Have been away from the community for more than two months at a time in the last two years
Demonstrate signs of being visibly distraught, emotionally unstable, or under the influence of psychoactive agents that would invalidate the consent process or otherwise contraindicate participation in the qualitative assessment
Have concrete plans to leave the community, thus removing possibility of follow up

Intervention:

Persons will be excluded from accessing counseling and testing (CBVCT) through the study (and will be referred to existing alternate services) if they meet any of the following criteria:

<16 years of age
Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation

Persons will be excluded from accessing post-test support through the study (and will be referred to existing alternate services) if they meet any of the following criteria:

<16 years of age
Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation

Control:

<16 years of age
Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation

Post-Intervention Assessment:

Persons will be excluded from the post-intervention assessment if they meet any of the following criteria:

Are not a member of the study community or are not randomly selected to be offered to participate
Are below 18 or above 32 years of age
Has not lived in the community at least 4 months in the past year
Does not sleep regularly in their household at least 2 nights per week
Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the assessment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203749

Contacts

Contact: Thomas J Coates, PhD	310-794-3580	tcoates@mednet.ucla.edu
Contact: Greg Szekeres	310-794-3579	gszekeres@mednet.ucla.edu

Locations

South Africa, Gauteng
University of the Witwatersrand	Recruiting
Soweto, Johannesburg, Gauteng, South Africa
Contact: Precious Modiba modibap@hivsa.com
Principal Investigator: Glenda Gray
South Africa, KwaZulu-Natal
Human Sciences Research Council	Recruiting
Pietermaritzburg, KwaZulu-Natal, South Africa
Contact: Heidi Van Rooyen hvanrooyen@hsrc.ac.za
Principal Investigator: Linda Richter
Tanzania
Muhimbili University	Recruiting
Dar es Salaam, Tanzania
Contact: Kathryn Curran kcurran@jhsph.edu
Principal Investigator: Jessie Mbwambo
Thailand
Chiang Mai University	Recruiting
Chiang Mai, Thailand
Contact: Surinda Kawichai surinda@loxinfo.co.th
Principal Investigator: Suwat Chariyalertsak
Zimbabwe
University of Zimbabwe	Recruiting
Harare, Zimbabwe
Contact: Andrew Timbe andrew@uz-ucsf.co.zw
Principal Investigator: Alfred Chingono

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	David Celentano, ScD, MHS	Johns Hopkins University
Principal Investigator:	Thomas J Coates, PhD	University of California, Los Angeles
Principal Investigator:	Stephen F Morin, PhD	University of California, San Francisco
Principal Investigator:	Michael Sweat, PhD	Medical University of South Carolina
Principal Investigator:	Michal Kulich, PhD	Charles University
Principal Investigator:	Deborah Donnell, PhD	SCHARP, Fred Hutchinson Cancer Research Center
Principal Investigator:	Linda Richter, PhD	Human Sciences Research Council
Principal Investigator:	Glenda Gray, MBBCH, FCPaeds(SA)	University of the Witwatersrand
Principal Investigator:	Jessie Mbwambo, MD	Muhimbili University
Principal Investigator:	Alfred Chingono, MSc	University of Zimbabwe
Principal Investigator:	Suwat Chariyalertsak, MD, DrPH	Chiang Mai University

More Information

Additional Information:

Click here for more information about this study. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	National Institute of Mental Health ( Christopher M. Gordon, PhD )
Study ID Numbers:	U01 MH066701, U01 MH66687, U01 MH66688, U01 MH66702, DAHBR 9A-ASPG
Study First Received:	September 13, 2005
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00203749 History of Changes
Health Authority:	United States: Federal Government; South Africa: Human Sciences Research Council and the University of the Witwatersrand; Tanzania: National Institute of Medical Research and Muhimbili University; Thailand: Thai Ministry of Public Health and Chiang Mai University; Zimbabwe: Medical Research Council

Keywords provided by National Institute of Mental Health (NIMH):

HIV
Testing
Counseling

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Antibodies
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009