Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Behavioral: Community-Based HIV VCT Behavioral: Standard clinic-based VCT |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
- Prevalence of recent HIV infection [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]
- Less HIV risk behavior [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: Yes ]
- Higher rates of HIV testing [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]
- More favorable social norms regarding HIV testing [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: Yes ]
- More frequent discussions about HIV [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]
- More frequent disclosure of HIV status [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]
- Less HIV-related stigma [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: Yes ]
- Fewer HIV-related life events [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 228834 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive the community-based VCT 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. |
|
Active Comparator: 2
Participants will receive standard clinic-based VCT in comparison communities
|
Behavioral: 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).
|
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Thomas J Coates, PhD | 310-794-3580 | tcoates@mednet.ucla.edu |
| Contact: Greg Szekeres | 310-794-3579 | gszekeres@mednet.ucla.edu |
| South Africa | |
| University of the Witwatersrand | Recruiting |
| Soweto, Johannesburg, Gauteng, South Africa | |
| Contact: Precious Modiba modibap@hivsa.com | |
| Principal Investigator: Glenda Gray | |
| Human Sciences Research Council | Recruiting |
| Pietermaritzburg, KwaZulu-Natal, South Africa | |
| Contact: Heidi Van Rooyen hvanrooyen@hsrc.ac.za | |
| Principal Investigator: Linda Richter | |
| Tanzania | |
| Muhimbili University | Recruiting |
| Dar es Salaam, Tanzania | |
| Contact: Kathryn Curran kcurran@jhsph.edu | |
| Principal Investigator: Jessie Mbwambo | |
| Thailand | |
| Chiang Mai University | Recruiting |
| Chiang Mai, Thailand | |
| Contact: Surinda Kawichai surinda@loxinfo.co.th | |
| Principal Investigator: Suwat Chariyalertsak | |
| Zimbabwe | |
| University of Zimbabwe | Recruiting |
| Harare, Zimbabwe | |
| Contact: Andrew Timbe andrew@uz-ucsf.co.zw | |
| Principal Investigator: Alfred Chingono | |
| Principal Investigator: | David Celentano, ScD, MHS | Johns Hopkins University |
| Principal Investigator: | Thomas J Coates, PhD | University of California, Los Angeles |
| Principal Investigator: | Stephen F Morin, PhD | University of California, San Francisco |
| Principal Investigator: | Michael Sweat, PhD | Medical University of South Carolina |
| Principal Investigator: | Michal Kulich, PhD | Charles University |
| Principal Investigator: | Deborah Donnell, PhD | SCHARP, Fred Hutchinson Cancer Research Center |
| Principal Investigator: | Linda Richter, PhD | Human Sciences Research Council |
| Principal Investigator: | Glenda Gray, MBBCH, FCPaeds(SA) | University of the Witwatersrand |
| Principal Investigator: | Jessie Mbwambo, MD | Muhimbili University |
| Principal Investigator: | Alfred Chingono, MSc | University of Zimbabwe |
| Principal Investigator: | Suwat Chariyalertsak, MD, DrPH | Chiang Mai University |
More Information
Additional Information:
No publications provided by National Institute of Mental Health (NIMH)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Christopher M. Gordon, PhD, National Institute of Mental Health |
| ClinicalTrials.gov Identifier: | NCT00203749 History of Changes |
| Other Study ID Numbers: | U01 MH066701, U01 MH66687, U01 MH66688, U01 MH66702, DAHBR 9A-ASPG |
| Study First Received: | September 13, 2005 |
| Last Updated: | March 27, 2009 |
| Health Authority: | United States: Federal Government South Africa: Human Sciences Research Council and the University of the Witwatersrand Tanzania: National Institute of Medical Research and Muhimbili University Thailand: Thai Ministry of Public Health and Chiang Mai University Zimbabwe: Medical Research Council |
Keywords provided by National Institute of Mental Health (NIMH):
|
HIV Testing Counseling |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 22, 2013