HIV Infections
Conditions
Keywords
HIV, Testing, Counseling
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.
Interventions
BEHAVIORALCommunity-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.
BEHAVIORALStandard 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).
Sponsors
National Institute of Mental Health (NIMH)
HIV Prevention Trials Network
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of recent HIV infection | Measured at Year 3 |
Secondary
| Measure | Time frame |
|---|---|
| Higher rates of HIV testing | Measured at Year 3 |
| More favorable social norms regarding HIV testing | Measured at Year 3 |
| More frequent discussions about HIV | Measured at Year 3 |
| Less HIV risk behavior | Measured at Year 3 |
| Less HIV-related stigma | Measured at Year 3 |
| Fewer HIV-related life events | Measured at Year 3 |
| More frequent disclosure of HIV status | Measured at Year 3 |
Countries
South Africa, Tanzania, Thailand, Zimbabwe
Outcome results
None listed