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

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Descriptive Information Fields

Brief Title ^†

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

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

Brief Summary

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.

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

HIV Infections

Intervention ^†

Behavioral: Community-Based HIV VCT
Behavioral: Standard clinic-based VCT

MEDLINE PMIDs

Links

Project Web site This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

228834

Start Date ^†

December 2004

Completion Date

August 2011

Eligibility 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

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

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

Location Countries ^†

South Africa, Tanzania, Thailand, Zimbabwe

Administrative Information Fields

NCT ID ^†

NCT00203749

Organization ID

U01 MH66701

Secondary IDs ^††

U01 MH66687, U01 MH66688, U01 MH66702, DAHBR 9A-ASPG

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

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

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

September 2008

First Received Date ^†

September 13, 2005

Last Updated Date

September 22, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.