Status:
COMPLETED
Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
HIV Prevention Trials Network
Conditions:
HIV Infections
Eligibility:
All Genders
16+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
192814 Patients enrolled
Trial Details
Trial ID
NCT00203749
Start Date
December 1 2004
End Date
September 1 2011
Last Update
December 12 2013
Active Locations (5)
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1
University of the Witwatersrand
Soweto, Johannesburg, Gauteng, South Africa
2
Human Sciences Research Council
Pietermaritzburg, KwaZulu-Natal, South Africa
3
Muhimbili University
Dar es Salaam, Tanzania
4
Chiang Mai University
Chiang Mai, Chiang Mai, Thailand