Clinical trial NCT00203749: Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV
Testing
Counseling
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: HIV Prevention Trials Network
First posted: 2005-09-20
Enrollment: 192814
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of recent HIV infection
timeFrame: Measured at Year 3
Secondary outcomes:
measure: Less HIV risk behavior
timeFrame: Measured at Year 3
measure: Higher rates of HIV testing
timeFrame: Measured at Year 3
measure: More favorable social norms regarding HIV testing
timeFrame: Measured at Year 3
measure: More frequent discussions about HIV
timeFrame: Measured at Year 3
measure: More frequent disclosure of HIV status
timeFrame: Measured at Year 3
measure: Less HIV-related stigma
timeFrame: Measured at Year 3
measure: Fewer HIV-related life events
timeFrame: Measured at Year 3
Other outcomes:
Locations:
city: Soweto, Johannesburg
country: South Africa
facility: University of the Witwatersrand
state: Gauteng
city: Pietermaritzburg
country: South Africa
facility: Human Sciences Research Council
state: KwaZulu-Natal
city: Dar es Salaam
country: Tanzania
facility: Muhimbili University
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
city: Harare
country: Zimbabwe
facility: University of Zimbabwe
Study officials:
affiliation: Johns Hopkins University
name: David Celentano, ScD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Thomas J Coates, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Stephen F Morin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Michael Sweat, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charles University
name: Michal Kulich, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: SCHARP, Fred Hutchinson Cancer Research Center
name: Deborah Donnell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Human Sciences Research Council
name: Linda Richter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Witwatersrand, South Africa
name: Glenda Gray, MBBCH, FCPaeds(SA)
role: PRINCIPAL_INVESTIGATOR
affiliation: Muhimbili University
name: Jessie Mbwambo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zimbabwe
name: Alfred Chingono, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Chiang Mai University
name: Suwat Chariyalertsak, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.