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
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