title: Evaluation of the Tsima community mobilization intervention to improve engagement in HIV testing and care in South Africa: study protocol for a cluster randomized trial.
abstract: HIV transmission can be decreased substantially by reducing the burden of undiagnosed HIV infection and expanding early and consistent use of antiretroviral therapy (ART). Treatment as prevention (TasP) has been proposed as key to ending the HIV epidemic. To activate TasP in high prevalence countries, like South Africa, communities must be motivated to know their status, engage in care, and remain in care. Community mobilization (CM) has the potential to significantly increase uptake testing, linkage to and retention in care by addressing the primary social barriers to engagement with HIV care-including poor understanding of HIV care; fear and stigma associated with infection, clinic attendance and disclosure; lack of social support; and gender norms that deter men from accessing care.
  
  
  
  Using a cluster randomized trial design, we are implementing a 3-year-theory-based CM intervention and comparing gains in HIV testing, linkage, and retention in care among individuals residing in 8 intervention communities to that of individuals residing in 7 control communities. Eligible communities include 15 villages within a health and demographic surveillance site (HDSS) in rural Mpumalanga, South Africa, that were not exposed to previous CM efforts. CM activities conducted in the 8 intervention villages map onto six mobilization domains that comprise the key components for community mobilization around HIV prevention. To evaluate the intervention, we will link a clinic-based electronic clinical tracking system in all area clinics to the HDSS longitudinal census data, thus creating an open, population-based cohort with over 30,000 18-49-year-old residents. We will estimate the marginal effect of the intervention on individual outcomes using generalized estimating equations. In addition, we will evaluate CM processes by conducting baseline and endline surveys among a random sample of 1200 community residents at each time point to monitor intervention exposure and community level change using validated measures of CM.
  
  
  
  Given the known importance of community social factors with regard to uptake of testing and HIV care, and the lack of rigorously evaluated community-level interventions effective in improving testing uptake, linkage and retention, the proposed study will yield much needed data to understand the potential of CM to improve the prevention and care cascade. Further, our work in developing a CM framework and domain measures will permit validation of a CM conceptual framework and process, which should prove valuable for community programming in Africa.
  
  
  
  NCT02197793 Registered July 21, 2014.
authors.affiliation: Center for AIDS Prevention Studies, Department of Medicine, University of California San Francisco, 550 16th Street, 3rd Floor, San Francisco, 94158-2549, CA, USA. sheri.lippman@ucsf.edu.|MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Road, Parktown 2193, Johannesburg, South Africa. sheri.lippman@ucsf.edu.
authors.forename: Sheri A
authors.initials: SA
authors.lastname: Lippman
authors.affiliation: MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Road, Parktown 2193, Johannesburg, South Africa.|Gillings School of Global Public Health, University of North Carolina, 135 Dauer Dr., Chapel Hill, 27599, NC, USA.
authors.forename: Audrey
authors.initials: A
authors.lastname: Pettifor
authors.affiliation: Sonke Gender Justice, 4th Floor Westminster House, 122 Longmarket Street, 8001, Cape Town, South Africa.
authors.forename: Dumisani
authors.initials: D
authors.lastname: Rebombo
authors.affiliation: MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Road, Parktown 2193, Johannesburg, South Africa.|Gillings School of Global Public Health, University of North Carolina, 135 Dauer Dr., Chapel Hill, 27599, NC, USA.
authors.forename: Aimée
authors.initials: A
authors.lastname: Julien
authors.affiliation: MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Road, Parktown 2193, Johannesburg, South Africa.|Umeå Centre for Global Health Research, Division of Epidemiology and Global Health, Department of Public Health and Clinical Medicine, Umeå University, 90187, Umeå, Sweden.
authors.forename: Ryan G
authors.initials: RG
authors.lastname: Wagner
authors.affiliation: Center for AIDS Prevention Studies, Department of Medicine, University of California San Francisco, 550 16th Street, 3rd Floor, San Francisco, 94158-2549, CA, USA.
authors.forename: Mi-Suk
authors.initials: MS
authors.lastname: Kang Dufour
authors.affiliation: MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Road, Parktown 2193, Johannesburg, South Africa.|Department of Population Health, London School of Hygiene and Tropical Medicine, Keppel Street London WC1E 7HT, London, UK.
authors.forename: Chodziwadziwa Whiteson
authors.initials: CW
authors.lastname: Kabudula
authors.affiliation: Center for AIDS Prevention Studies, Department of Medicine, University of California San Francisco, 550 16th Street, 3rd Floor, San Francisco, 94158-2549, CA, USA.
authors.forename: Torsten B
authors.initials: TB
authors.lastname: Neilands
authors.affiliation: MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Road, Parktown 2193, Johannesburg, South Africa.
authors.forename: Rhian
authors.initials: R
authors.lastname: Twine
authors.affiliation: Gillings School of Global Public Health, University of North Carolina, 135 Dauer Dr., Chapel Hill, 27599, NC, USA.
authors.forename: Ann
authors.initials: A
authors.lastname: Gottert
authors.affiliation: MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Road, Parktown 2193, Johannesburg, South Africa.
authors.forename: F Xavier
authors.initials: FX
authors.lastname: Gómez-Olivé
authors.affiliation: MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Road, Parktown 2193, Johannesburg, South Africa.
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Tollman
authors.affiliation: Clinical HIV Research Unit, Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Helen Joseph Hospital, Perth Road, Westdene, 2092, Johannesburg, South Africa.
authors.forename: Ian
authors.initials: I
authors.lastname: Sanne
authors.affiliation: Sonke Gender Justice, 4th Floor Westminster House, 122 Longmarket Street, 8001, Cape Town, South Africa.|Division of Social and Behavioural Sciences, School of Public Health, University of Cape Town, Falmouth Rd, Observatory 7925, Cape Town, South Africa.
authors.forename: Dean
authors.initials: D
authors.lastname: Peacock
authors.affiliation: MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Road, Parktown 2193, Johannesburg, South Africa.|Umeå Centre for Global Health Research, Division of Epidemiology and Global Health, Department of Public Health and Clinical Medicine, Umeå University, 90187, Umeå, Sweden.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Kahn
mesh_terms: D000293:Adolescent; D000328:Adult; D016000:Cluster Analysis; D042241:Early Diagnosis; D005260:Female; D015658:HIV Infections / Q000175:diagnosis* / Q000453:epidemiology / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data; D010349:Patient Compliance / Q000706:statistics & numerical data; D012423:Rural Health; D013019:South Africa / Q000453:epidemiology; D055815:Young Adult
keywords: Cluster randomized trial; Community mobilization; Engagement in care; HIV testing; Retention in care; South Africa; Treatment as prevention