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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203749
• Other study ID #: U01MH066701
• Secondary ID: U01MH066701U01MH
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: December 11, 2013
• Start date: December 2004
• Est. completion date: September 2011

Study information

• Verified date: December 2013
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentSouth Africa: Human Sciences Research Council and the University of the WitwatersrandTanzania: National Institute of Medical Research and Muhimbili UniversityThailand: Thai Ministry of Public Health and Chiang Mai UniversityZimbabwe: Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192814
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

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.
• 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).

Locations

Country	Name	City	State
South Africa	Human Sciences Research Council	Pietermaritzburg	KwaZulu-Natal
South Africa	University of the Witwatersrand	Soweto, Johannesburg	Gauteng
Tanzania	Muhimbili University	Dar es Salaam
Thailand	Chiang Mai University	Chiang Mai
Zimbabwe	University of Zimbabwe	Harare

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	HIV Prevention Trials Network, National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

South Africa,  Tanzania,  Thailand,  Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of recent HIV infection		Measured at Year 3	No
Secondary	Less HIV risk behavior		Measured at Year 3	Yes
Secondary	Higher rates of HIV testing		Measured at Year 3	No
Secondary	More favorable social norms regarding HIV testing		Measured at Year 3	Yes
Secondary	More frequent discussions about HIV		Measured at Year 3	No
Secondary	More frequent disclosure of HIV status		Measured at Year 3	No
Secondary	Less HIV-related stigma		Measured at Year 3	Yes
Secondary	Fewer HIV-related life events		Measured at Year 3	No

External Links

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