title: Voice-Message-Based mHealth Intervention to Reduce Postoperative Penetrative Sex in Recipients of Voluntary Medical Male Circumcision in the Western Cape, South Africa: Protocol of a Randomized Controlled Trial.
abstract: BACKGROUND
  There is an increased risk of transmission of sexually transmitted infections (STIs), including HIV, in the postoperative period after receiving voluntary medical male circumcision (VMMC). In South Africa, over 4 million men are being targeted with VMMC services but the health system is not able to offer quality counseling. More innovative strategies for communicating with and altering behavior in men and their partners in the postoperative period after VMMC are needed.
  
  
  OBJECTIVE
  This paper presents a study protocol to test the effectiveness of an mHealth intervention designed to task-shift behavior change communication from health care personnel to an automated phone message system, encouraging self-care.
  
  
  METHODS
  A single-blind, randomized controlled trial will be used. A total of 1188 participants will be recruited by nurses or clinicians at clinics in the study districts that have a high turnover of VMMC clients. The population will consist of men aged 18 years and older who indicate at the precounseling session that they possess a mobile phone and consent to participating in the study. Consenting participants will be randomized into either the control or intervention arm before undergoing VMMC. The control arm will receive the standard of care (pre- and postcounseling). The intervention arm will received standard of care and will be sent 38 messages over the 6-week recovery period. Patients will be followed up after 42 days. The primary outcome is self-reported sexual intercourse during the recovery period. Secondary outcomes include nonpenetrative sexual activity, STI symptoms, and perceived risk of acquiring HIV. Analysis will be by intention-to-treat.
  
  
  RESULTS
  Enrollment is completed. Follow-up is ongoing. Loss to follow-up is under 10%. No interim analyses have been conducted.
  
  
  CONCLUSIONS
  The intervention has the potential of reducing risky sexual behavior after VMMC. The platform itself can be used for many other areas of health that require task shifting to patients for better efficiency and access.
  
  
  BACKGROUND
  Pan-African Clinical Trial Registry: PACTR201506001182385.
authors.affiliation: Global Health, Department of Public Health Sciences, Karolinska Institutet, Solna, Sweden. sarah.thomsen@ki.se.
authors.forename: Sarah C
authors.identifier: http://orcid.org/0000-0002-4047-0280
authors.initials: SC
authors.lastname: Thomsen
authors.forename: Donald
authors.identifier: http://orcid.org/0000-0002-4567-0601
authors.initials: D
authors.lastname: Skinner
authors.forename: Yoesrie
authors.identifier: http://orcid.org/0000-0002-5805-8665
authors.initials: Y
authors.lastname: Toefy
authors.forename: Tonya
authors.identifier: http://orcid.org/0000-0002-8703-1664
authors.initials: T
authors.lastname: Esterhuizen
authors.forename: Michael
authors.identifier: http://orcid.org/0000-0002-2730-6478
authors.initials: M
authors.lastname: McCaul
authors.forename: Max
authors.identifier: http://orcid.org/0000-0003-4908-2169
authors.initials: M
authors.lastname: Petzold
authors.forename: Vinod
authors.identifier: http://orcid.org/0000-0002-5831-2037
authors.initials: V
authors.lastname: Diwan
keywords: HIV; RCT; VMMC; mHealth; male circumcision; protocol