Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand

This study has been completed.
Sponsor:
Collaborators:
HIV Prevention Trials Network
Information provided by (Responsible Party):
Thomas J. Coates, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00203749
First received: September 13, 2005
Last updated: December 11, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Prevalence of recent HIV infection [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 192814
Study Start Date: December 2004
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intervention communities will receive the community-based VCT intervention community mobilization, mobile VCT, and post-test support services), as well as standard clinic-based VCT
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
Comparison communities will receive standard clinic-based VCT
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203749

Locations
South Africa
University of the Witwatersrand
Soweto, Johannesburg, Gauteng, South Africa
Human Sciences Research Council
Pietermaritzburg, KwaZulu-Natal, South Africa
Tanzania
Muhimbili University
Dar es Salaam, Tanzania
Thailand
Chiang Mai University
Chiang Mai, Thailand
Zimbabwe
University of Zimbabwe
Harare, Zimbabwe
Sponsors and Collaborators
University of California, Los Angeles
HIV Prevention Trials Network
Investigators
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 University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas J. Coates, Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00203749     History of Changes
Other Study ID Numbers: U01 MH066701, U01MH066701, U01MH066687, U01MH066688, U01MH066702, DAHBR 9A-ASPG
Study First Received: September 13, 2005
Last Updated: December 11, 2013
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 University of California, Los Angeles:
HIV
Testing
Counseling

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014