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

NCT00203749 | Completed Phase 3 DMC

• 5 other identifiers: U01MH066701U01MH066687U01MH066688U01MH066702DAHBR 9A-ASPG
• Study Type: interventional
• Target: 192,814
• Locations: 4 countries
• Sites: 5

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.

Conditions

HIV Infections

Keywords

HIV; Testing; Counseling

Outcome Measures

Primary Outcomes (1)

• Prevalence of recent HIV infection

  Measured at Year 3

Secondary Outcomes (7)

• Less HIV risk behavior

  Measured at Year 3

• Higher rates of HIV testing

  Measured at Year 3

• More favorable social norms regarding HIV testing

  Measured at Year 3

• More frequent discussions about HIV

  Measured at Year 3

• More frequent disclosure of HIV status

  Measured at Year 3

Study Arms (2)

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

Behavioral: Community-Based HIV VCT

2

ACTIVE COMPARATOR

Comparison communities will receive standard clinic-based VCT

Behavioral: Standard clinic-based VCT

Interventions

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.

1

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).

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator
• HIV Prevention Trials Network: collaborator

Study Sites (5)

University of the Witwatersrand

Soweto, Johannesburg, Gauteng, South Africa

Location

Human Sciences Research Council

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Muhimbili University

Dar es Salaam, Tanzania

Location

Chiang Mai University

Chiang Mai, Chiang Mai, Thailand

Location

University of Zimbabwe

Harare, Zimbabwe

Location

Related Publications (4)

• 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.

  PMID: 25103167 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.

  PMID: 23874597 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.

  PMID: 21943026 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.

  PMID: 21546309 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 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

• Alfred Chingono, MSc

  University of Zimbabwe

  PRINCIPAL INVESTIGATOR

• Suwat Chariyalertsak, MD, DrPH

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: December 1, 2004
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

ZI (1); TH (1); TA (1); ZA (2)