title: Evaluation of short message service and peer navigation to improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized controlled trial.
abstract: BACKGROUND
  In countries with a high burden of HIV, such as South Africa, where the epidemic remains the world's largest, improving early uptake of and consistent adherence to antiretroviral therapy could bring substantial HIV prevention gains. However, patients are not linked to or retained in care at rates needed to curtail the epidemic. Two strategies that have demonstrated a potential to stem losses along the HIV care cascade in the sub-Saharan African context are use of text messaging or short message service (SMS) and peer-navigation services.
  
  
  METHODS
  We designed a cluster randomized trial to assess the efficacy of an SMS intervention and a peer-navigation intervention to improve retention in care and treatment, timely linkage to care and treatment, medication adherence, and prevention behaviors in South Africa. Eighteen primary and community healthcare clinics in Rustenburg and Moses Kotane Sub-districts in the North West Province were randomized to one of three conditions: SMS intervention (n = 7), peer navigation intervention (n = 7), or standard of care (n = 4). Approximately 42 participants are being recruited at each clinic, which will result in a target of 750 participants. Eligible participants include patients accessing HIV testing or care in a study clinic, recently diagnosed with HIV, aged 18 years or older, and with access to a cellular telephone where they are willing to receive automated SMS with HIV-related messaging. Data collection includes extraction of visit information from clinical files and participant surveys at baseline, 6 months, and 12 months. Intent-to-treat (ITT) analysis will explore differences between randomization arms and the primary outcome of patient retention in care at 12 months following enrollment. We will also explore secondary outcomes including participants' a) timely linkage to care (within 3 months of HIV diagnosis), b) adherence to treatment based on self-report and clinic's medication dispensation dates, and c) condom-use behaviors.
  
  
  CONCLUSIONS
  The findings will allow us to compare the efficacy of two complementary interventions, one that requires fewer resources to implement (SMS) and one (peer navigation) that offers more flexibility in terms of the patient barriers to care that it can address.
  
  
  BACKGROUND
  NCT02417233, registered 12 December 2014.
authors: Center for AIDS Prevention Studies, Department of Medicine, University of California, San Francisco, UCSF Box 0886, 550 16th Street, 3rd Floor, San Francisco, CA, 94143, USA. sheri.lippman@ucsf.edu.
authors: Sheri A
authors: SA
authors: Lippman
authors: Center for AIDS Prevention Studies, Department of Medicine, University of California, San Francisco, UCSF Box 0886, 550 16th Street, 3rd Floor, San Francisco, CA, 94143, USA. starley.shade@ucsf.edu.
authors: Starley B
authors: SB
authors: Shade
authors: International Training and Education Center for Health South Africa, University of Washington, 232 Bronkhorst Street, Pretoria, Republic of South Africa. jsumitani@itech-southafrica.org.
authors: Jeri
authors: J
authors: Sumitani
authors: International Training and Education Center for Health South Africa, University of Washington, 232 Bronkhorst Street, Pretoria, Republic of South Africa. jdekadt@itech-southafrica.org.
authors: Julia
authors: J
authors: DeKadt
authors: Department of Global Health, University of Washington, Seattle, USA. jmas@uw.edu.
authors: Jennifer M
authors: JM
authors: Gilvydis
authors: International Training and Education Center for Health South Africa, University of Washington, 232 Bronkhorst Street, Pretoria, Republic of South Africa. MRatlhagana@itech-southafrica.org.
authors: Mary Jane
authors: MJ
authors: Ratlhagana
authors: International Training and Education Center for Health South Africa, University of Washington, 232 Bronkhorst Street, Pretoria, Republic of South Africa. jgrignon@uw.edu.|Department of Global Health, University of Washington, Seattle, USA. jgrignon@uw.edu.
authors: Jessica
authors: J
authors: Grignon
authors: Department of Family Medicine and Primary Health Care, University of Limpopo - Medical University of Southern Africa campus, Pretoria, South Africa. tumbo@lantic.net.
authors: John
authors: J
authors: Tumbo
authors: Center for AIDS Prevention Studies, Department of Medicine, University of California, San Francisco, UCSF Box 0886, 550 16th Street, 3rd Floor, San Francisco, CA, 94143, USA. hailey.gilmore@ucsf.edu.
authors: Hailey
authors: H
authors: Gilmore
authors: Center for AIDS Prevention Studies, Department of Medicine, University of California, San Francisco, UCSF Box 0886, 550 16th Street, 3rd Floor, San Francisco, CA, 94143, USA. emily.agnew@ucsf.edu.
authors: Emily
authors: E
authors: Agnew
authors: Center for AIDS Prevention Studies, Department of Medicine, University of California, San Francisco, UCSF Box 0886, 550 16th Street, 3rd Floor, San Francisco, CA, 94143, USA. parya.saberi@ucsf.edu.
authors: Parya
authors: P
authors: Saberi
authors: Departments of Medicine and Global Health, University of Washington, Seattle, WA, USA. sbht@uw.edu.
authors: Scott
authors: S
authors: Barnhart
authors: Center for AIDS Prevention Studies, Department of Medicine, University of California, San Francisco, UCSF Box 0886, 550 16th Street, 3rd Floor, San Francisco, CA, 94143, USA. wayne.steward@ucsf.edu.
authors: Wayne T
authors: WT
authors: Steward
mesh_terms: D002985:Clinical Protocols; D003365:Costs and Cost Analysis; D003625:Data Collection; D015658:HIV Infections / Q000628:therapy*; D006801:Humans; D017063:Outcome Assessment, Health Care; D018401:Sample Size; D013019:South Africa; D060145:Text Messaging