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| ID | Type | Description | Link |
|---|---|---|---|
| U01MH066701 | U.S. NIH Grant/Contract | View source | |
| U01MH066687 | U.S. NIH Grant/Contract | View source | |
| U01MH066688 | U.S. NIH Grant/Contract | View source | |
| U01MH066702 | U.S. NIH Grant/Contract | View source | |
| DAHBR 9A-ASPG |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| HIV Prevention Trials Network | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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 |
|
| 2 | Active Comparator | Comparison communities will receive standard clinic-based VCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community-Based HIV VCT | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of recent HIV infection | Measured at Year 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Less HIV risk behavior | Measured at Year 3 | |
| Higher rates of HIV testing | Measured at Year 3 | |
| More favorable social norms regarding HIV testing |
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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:
Qualitative Cohort:
Persons may be included in the qualitative cohort if they meet all of the following criteria:
Intervention:
Persons may access community-based counseling and testing (in CBVCT communities) through the study if they meet all of the following criteria:
Persons may access post-test support through the study if they meet all of the following criteria:
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:
Post-Intervention Assessment:
Persons may be included in the post-intervention assessment if they meet all of the following criteria:
Exclusion Criteria:
Baseline Assessment:
Persons will be excluded from the baseline behavioral assessment if they meet any of the following criteria:
Qualitative Cohort:
Persons will be excluded from the qualitative cohort if they meet any of the following criteria:
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:
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:
Control:
Post-Intervention Assessment:
Persons will be excluded from the post-intervention assessment if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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, Czech Republic | 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 Witwatersrand, South Africa | Principal Investigator |
| Jessie Mbwambo, MD | Muhimbili University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the Witwatersrand | Soweto, Johannesburg | Gauteng | South Africa | |||
| Human Sciences Research Council |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25103167 | Derived | 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. | |
| 23874597 |
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| Standard clinic-based VCT | 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). |
|
| Measured at Year 3 |
| More frequent discussions about HIV | Measured at Year 3 |
| More frequent disclosure of HIV status | Measured at Year 3 |
| Less HIV-related stigma | Measured at Year 3 |
| Fewer HIV-related life events | Measured at Year 3 |
| Alfred Chingono, MSc | University of Zimbabwe | Principal Investigator |
| Suwat Chariyalertsak, MD, DrPH | Chiang Mai University | Principal Investigator |
| Pietermaritzburg |
| KwaZulu-Natal |
| South Africa |
| Muhimbili University | Dar es Salaam | Tanzania |
| Chiang Mai University | Chiang Mai | Chiang Mai | Thailand |
| University of Zimbabwe | Harare | Zimbabwe |
| Derived |
| 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. |
| 21943026 | Derived | 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. |
| 21546309 | Derived | 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. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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