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      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

      , MA, MPH, PhD 1 , , , MA (Clin Psych), MPH, PhD 2 , , MA, MSc 1 , 2 , , MSc 3 , , MSc 3 , , MSc, PhD 4 , , MPH, PhD, MD 1
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      protocol, RCT, male circumcision, HIV, mHealth, VMMC

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          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.


          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.


          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.


          Enrollment is completed. Follow-up is ongoing. Loss to follow-up is under 10%. No interim analyses have been conducted.


          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.

          Trial Registration

          Pan-African Clinical Trial Registry: PACTR201506001182385

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          Most cited references26

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          The gap report

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            A review of the use of mobile phone text messaging in clinical and healthy behaviour interventions.

            We reviewed the literature on the use of text messaging for clinical and healthy behaviour interventions. Electronic databases were searched in December 2009 using keywords related to text messaging and health interventions. The final review included 24 articles. Of those, seven covered medication adherence, eight discussed clinical management and nine reported on health-related behaviour modification. Sixteen were randomized controlled trials (RCT), five were non-controlled pre-post comparison studies and three were feasibility pilots not reporting a behavioural outcome. The frequency of messaging ranged from multiple messages daily to one message per month. Among the 16 RCTs, 10 reported significant improvement with interventions and six reported differences suggesting positive trends. Text messaging received good acceptance and showed early efficacy in most studies. However, the evidence base is compromised by methodological limitations and is not yet conclusive.
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              Circumcision in HIV-infected men and its effect on HIV transmission to female partners in Rakai, Uganda: a randomised controlled trial.

              Observational studies have reported an association between male circumcision and reduced risk of HIV infection in female partners. We assessed whether circumcision in HIV-infected men would reduce transmission of the virus to female sexual partners. 922 uncircumcised, HIV-infected, asymptomatic men aged 15-49 years with CD4-cell counts 350 cells per microL or more were enrolled in this unblinded, randomised controlled trial in Rakai District, Uganda. Men were randomly assigned by computer-generated randomisation sequence to receive immediate circumcision (intervention; n=474) or circumcision delayed for 24 months (control; n=448). HIV-uninfected female partners of the randomised men were concurrently enrolled (intervention, n=93; control, n=70) and followed up at 6, 12, and 24 months, to assess HIV acquisition by male treatment assignment (primary outcome). A modified intention-to-treat (ITT) analysis, which included all concurrently enrolled couples in which the female partner had at least one follow-up visit over 24 months, assessed female HIV acquisition by use of survival analysis and Cox proportional hazards modelling. This trial is registered with ClinicalTrials.gov, number NCT00124878. The trial was stopped early because of futility. 92 couples in the intervention group and 67 couples in the control group were included in the modified ITT analysis. 17 (18%) women in the intervention group and eight (12%) women in the control group acquired HIV during follow-up (p=0.36). Cumulative probabilities of female HIV infection at 24 months were 21.7% (95% CI 12.7-33.4) in the intervention group and 13.4% (6.7-25.8) in the control group (adjusted hazard ratio 1.49, 95% CI 0.62-3.57; p=0.368). Circumcision of HIV-infected men did not reduce HIV transmission to female partners over 24 months; longer-term effects could not be assessed. Condom use after male circumcision is essential for HIV prevention. Bill & Melinda Gates Foundation with additional laboratory and training support from the National Institutes of Health and the Fogarty International Center.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                Jul-Sep 2016
                26 July 2016
                : 5
                : 3
                : e155
                [1] 1Global Health Department of Public Health Sciences Karolinska Institutet SolnaSweden
                [2] 2Department of Interdisciplinary Sciences Faculty of Medicine and Health Sciences University of Stellenbosch TygerbergSouth Africa
                [3] 3Centre for Evidence-based Health Care Faculty of Medicine and Health Sciences Stellenbosch University TygerbergSouth Africa
                [4] 4Health Metrics Unit Sahlgrenska Academy Gothenburg University GothenburgSweden
                Author notes
                Corresponding Author: Sarah C Thomsen sarah.thomsen@ 123456ki.se
                Author information
                ©Sarah C Thomsen, Donald Skinner, Yoesrie Toefy, Tonya Esterhuizen, Michael McCaul, Max Petzold, Vinod Diwan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 26.07.2016.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 10 May 2016
                : 29 June 2016
                : 2 July 2016
                : 4 July 2016
                Original Paper
                Original Paper

                protocol,rct,male circumcision,hiv,mhealth,vmmc
                protocol, rct, male circumcision, hiv, mhealth, vmmc


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