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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Community-Based HIV VCT; Behavioral: Standard clinic-based VCT

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.

• Study Type: Interventional
• Enrollment (Actual): 192814
• Phase: Phase 3

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Soweto, Johannesburg, Gauteng, South Africa
      • University of the Witwatersrand
  • KwaZulu-Natal
    • Pietermaritzburg, KwaZulu-Natal, South Africa
      • Human Sciences Research Council
• Tanzania
  • Dar es Salaam, Tanzania
    • Muhimbili University
• Thailand
  • Chiang Mai, Thailand
    • Chiang Mai University
• Zimbabwe
  • Harare, Zimbabwe
    • University of Zimbabwe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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.
Active Comparator: 2; Comparison communities will receive standard clinic-based VCT	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of recent HIV infection	Measured at Year 3

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Mental Health (NIMH); HIV Prevention Trials Network
• Investigators: Principal Investigator: 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; 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

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): December 12, 2013
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Counseling; HIV; Testing
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: U01MH066701 (U.S. NIH Grant/Contract); U01MH066687 (U.S. NIH Grant/Contract); U01MH066688 (U.S. NIH Grant/Contract); U01MH066702 (U.S. NIH Grant/Contract); DAHBR 9A-ASPG (National Institute of Mental Health (NIMH-DAHBR))