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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


Phase 3
16 Years
N/A
Open (Enrolling)
Both
HIV Infections

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Prevalence of recent HIV infection

Outcome Time Frame:

Measured at Year 3

Safety Issue:

No

Principal Investigator

David Celentano, ScD, MHS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Federal Government

Study ID:

U01 MH066701

NCT ID:

NCT00203749

Start Date:

December 2004

Completion Date:

August 2011

Related Keywords:

  • HIV Infections
  • HIV
  • Testing
  • Counseling
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

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