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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

192814 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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HIV Testing Counseling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Community-Based HIV VCT

Intervention Type BEHAVIORAL

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.

2

Comparison communities will receive standard clinic-based VCT

Group Type ACTIVE_COMPARATOR

Standard clinic-based VCT

Intervention Type BEHAVIORAL

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).

Interventions

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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.

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Thomas J. Coates

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Celentano, ScD, MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Thomas J Coates, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Stephen F Morin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Michael Sweat, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Michal Kulich, PhD

Role: PRINCIPAL_INVESTIGATOR

Charles University

Deborah Donnell, PhD

Role: PRINCIPAL_INVESTIGATOR

SCHARP, Fred Hutchinson Cancer Research Center

Linda Richter, PhD

Role: PRINCIPAL_INVESTIGATOR

Human Sciences Research Council

Glenda Gray, MBBCH, FCPaeds(SA)

Role: PRINCIPAL_INVESTIGATOR

University of Witwatersrand, South Africa

Jessie Mbwambo, MD

Role: PRINCIPAL_INVESTIGATOR

Muhimbili University

Alfred Chingono, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Zimbabwe

Suwat Chariyalertsak, MD, DrPH

Role: PRINCIPAL_INVESTIGATOR

Chiang Mai University

Locations

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University of the Witwatersrand

Soweto, Johannesburg, Gauteng, South Africa

Site Status

Human Sciences Research Council

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status

Muhimbili University

Dar es Salaam, , Tanzania

Site Status

Chiang Mai University

Chiang Mai, Chiang Mai, Thailand

Site Status

University of Zimbabwe

Harare, , Zimbabwe

Site Status

Countries

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South Africa Tanzania Thailand Zimbabwe

References

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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.

Reference Type DERIVED

PMID: 25103167 (View on PubMed)

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.

Reference Type DERIVED

PMID: 23874597 (View on PubMed)

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.

Reference Type DERIVED

PMID: 21943026 (View on PubMed)

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.

Reference Type DERIVED

PMID: 21546309 (View on PubMed)