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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Community-Based HIV VCT
Standard clinic-based VCT
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, Testing, Counseling

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of the Witwatersrand
  • Human Sciences Research Council
  • Muhimbili University
  • Chiang Mai University
  • University of Zimbabwe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

Comparison communities will receive standard clinic-based VCT

Outcomes

Primary Outcome Measures

Prevalence of recent HIV infection

Secondary Outcome Measures

Less HIV risk behavior
Higher rates of HIV testing
More favorable social norms regarding HIV testing
More frequent discussions about HIV
More frequent disclosure of HIV status
Less HIV-related stigma
Fewer HIV-related life events

Full Information

First Posted
September 13, 2005
Last Updated
December 11, 2013
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH), HIV Prevention Trials Network
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1. Study Identification

Unique Protocol Identification Number
NCT00203749
Brief Title
Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH), HIV Prevention Trials Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Testing, Counseling

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192814 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
Active Comparator
Arm Description
Comparison communities will receive standard clinic-based VCT
Intervention Type
Behavioral
Intervention Name(s)
Community-Based HIV VCT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard clinic-based VCT
Intervention Description
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).
Primary Outcome Measure Information:
Title
Prevalence of recent HIV infection
Time Frame
Measured at Year 3
Secondary Outcome Measure Information:
Title
Less HIV risk behavior
Time Frame
Measured at Year 3
Title
Higher rates of HIV testing
Time Frame
Measured at Year 3
Title
More favorable social norms regarding HIV testing
Time Frame
Measured at Year 3
Title
More frequent discussions about HIV
Time Frame
Measured at Year 3
Title
More frequent disclosure of HIV status
Time Frame
Measured at Year 3
Title
Less HIV-related stigma
Time Frame
Measured at Year 3
Title
Fewer HIV-related life events
Time Frame
Measured at Year 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Celentano, ScD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas J Coates, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen F Morin, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Sweat, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michal Kulich, PhD
Organizational Affiliation
Charles University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deborah Donnell, PhD
Organizational Affiliation
SCHARP, Fred Hutchinson Cancer Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda Richter, PhD
Organizational Affiliation
Human Sciences Research Council
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Glenda Gray, MBBCH, FCPaeds(SA)
Organizational Affiliation
University of Witwatersrand, South Africa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jessie Mbwambo, MD
Organizational Affiliation
Muhimbili University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alfred Chingono, MSc
Organizational Affiliation
University of Zimbabwe
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suwat Chariyalertsak, MD, DrPH
Organizational Affiliation
Chiang Mai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of the Witwatersrand
City
Soweto, Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Human Sciences Research Council
City
Pietermaritzburg
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Muhimbili University
City
Dar es Salaam
Country
Tanzania
Facility Name
Chiang Mai University
City
Chiang Mai
Country
Thailand
Facility Name
University of Zimbabwe
City
Harare
Country
Zimbabwe

12. IPD Sharing Statement

Citations:
PubMed Identifier
25103167
Citation
Coates TJ, Kulich M, Celentano DD, Zelaya CE, Chariyalertsak S, Chingono A, Gray G, Mbwambo JK, Morin SF, Richter L, Sweat M, van Rooyen H, McGrath N, Fiamma A, Laeyendecker O, Piwowar-Manning E, Szekeres G, Donnell D, Eshleman SH; NIMH Project Accept (HPTN 043) study team. Effect of community-based voluntary counselling and testing on HIV incidence and social and behavioural outcomes (NIMH Project Accept; HPTN 043): a cluster-randomised trial. Lancet Glob Health. 2014 May;2(5):e267-77. doi: 10.1016/S2214-109X(14)70032-4. Epub 2014 Apr 8.
Results Reference
derived
PubMed Identifier
23874597
Citation
Laeyendecker O, Piwowar-Manning E, Fiamma A, Kulich M, Donnell D, Bassuk D, Mullis CE, Chin C, Swanson P, Hackett J Jr, Clarke W, Marzinke M, Szekeres G, Gray G, Richter L, Alexandre MW, Chariyalertsak S, Chingono A, Celentano DD, Morin SF, Sweat M, Coates T, Eshleman SH. Estimation of HIV incidence in a large, community-based, randomized clinical trial: NIMH project accept (HIV Prevention Trials Network 043). PLoS One. 2013 Jul 11;8(7):e68349. doi: 10.1371/journal.pone.0068349. Print 2013.
Results Reference
derived
PubMed Identifier
21943026
Citation
Piwowar-Manning E, Fiamma A, Laeyendecker O, Kulich M, Donnell D, Szekeres G, Robins-Morris L, Mullis CE, Vallari A, Hackett J Jr, Mastro TD, Gray G, Richter L, Alexandre MW, Chariyalertsak S, Chingono A, Sweat M, Coates T, Eshleman SH. HIV surveillance in a large, community-based study: results from the pilot study of Project Accept (HIV Prevention Trials Network 043). BMC Infect Dis. 2011 Sep 24;11:251. doi: 10.1186/1471-2334-11-251.
Results Reference
derived
PubMed Identifier
21546309
Citation
Sweat M, Morin S, Celentano D, Mulawa M, Singh B, Mbwambo J, Kawichai S, Chingono A, Khumalo-Sakutukwa G, Gray G, Richter L, Kulich M, Sadowski A, Coates T; Project Accept study team. Community-based intervention to increase HIV testing and case detection in people aged 16-32 years in Tanzania, Zimbabwe, and Thailand (NIMH Project Accept, HPTN 043): a randomised study. Lancet Infect Dis. 2011 Jul;11(7):525-32. doi: 10.1016/S1473-3099(11)70060-3. Epub 2011 May 3.
Results Reference
derived

Learn more about this trial

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

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