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HIV InfectionsPhase 3NCT00203749

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

A Phase 3 study testing Community-Based HIV VCT and Standard clinic-based VCT in people with HIV Infections, run by University of California, Los Angeles at 5 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
Community-Based HIV VCT and Standard clinic-based VCT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192,814 participants
Where
5 sitesin 4 countries
Study dates
Dec 2004to Sep 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 34Show fewer
  • 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)

Who cannot join

  • 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
Show all 31Show fewer
  • 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

Trial locations and contacts

5 sites in 4 countries.

5 sites in 4 countries

South Africa2 sites
  • Human Sciences Research Council

    Pietermaritzburg, KwaZulu-Natal

  • University of the Witwatersrand

    Soweto, Johannesburg, Gauteng

Other trials in South Africa

Tanzania1 site
  • Muhimbili University

    Dar es Salaam

Other trials in Tanzania

Thailand1 site
  • Chiang Mai University

    Chiang Mai, Chiang Mai

Other trials in Thailand

Zimbabwe1 site
  • University of Zimbabwe

    Harare

Other trials in Zimbabwe

About this study

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

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.

Read the 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.

Conditions
HIV Infections
Being tested
Community-Based HIV VCT, Standard clinic-based VCT
Keywords
HIV, Testing, Counseling
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community-Based HIV VCTBehavioural

    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.

  • Standard clinic-based VCTBehavioural

    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).

Study groups in NCT00203749
Study groupRoleWhat they receive
1ExperimentalIntervention communities will receive the community-based VCT intervention community mobilization, mobile VCT, and post-test support services), as well as standard clinic-based VCT
Receives: Behavioral: Community-Based HIV VCT
2Active comparatorComparison communities will receive standard clinic-based VCT
Receives: Behavioral: Standard clinic-based VCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of recent HIV infection

    Measured: Measured at Year 3

Secondary outcomes (7)
  1. Less HIV risk behavior

    Measured: Measured at Year 3

  2. Higher rates of HIV testing

    Measured: Measured at Year 3

  3. More favorable social norms regarding HIV testing

    Measured: Measured at Year 3

  4. More frequent discussions about HIV

    Measured: Measured at Year 3

  5. More frequent disclosure of HIV status

    Measured: Measured at Year 3

  6. Less HIV-related stigma

    Measured: Measured at Year 3

  7. Fewer HIV-related life events

    Measured: Measured at Year 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionSep 2011
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
192,814 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00203749
Sponsor's protocol ID
U01MH066701
Other IDs
U01MH066701, U01MH066687, U01MH066688, U01MH066702, DAHBR 9A-ASPG
Status last verified
Dec 2013
First submitted
13 Sep 2005
Last updated
12 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25103167
  • 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.

    PubMed 23874597
  • 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.

    PubMed 21943026
  • 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.

    PubMed 21546309

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Community-Based HIV VCT and Standard clinic-based VCT in people with HIV Infections, run by University of California, Los Angeles at 5 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Africa, Tanzania, Thailand, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of recent HIV infection (time frame: Measured at Year 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00203749, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2013.

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Clinical Trial NCT00203749 | AzTrials