Text Messaging to Improve Adherence to Clinic Visits and Reduce Early Resumption of Sexual Intercourse After Male Circumcision

This study has been completed.
Sponsor:
Collaborators:
University of Illinois at Chicago
Kenya Medical Research Institute
Information provided by (Responsible Party):
Thomas Odeny, University of Washington
ClinicalTrials.gov Identifier:
NCT01186575
First received: August 19, 2010
Last updated: January 31, 2013
Last verified: January 2013

August 19, 2010
January 31, 2013
August 2010
March 2011   (final data collection date for primary outcome measure)
  • Proportion of men failing to return for a post-operative clinic visit at 7 days. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    This proportion will be determined by examining each participant's clinic records after their 7th post-operative day. Adherence to this clinic visit will be analyzed as a dichotomous variable.
  • Proportion of men who report resumption of sexual activity before 42 days post-circumcision. [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    This proportion will be determined by self-report using a brief questionnaire delivered via phone call. The analysis will be as a dichotomous variable, with participants considered as having either 'resumed' or 'not resumed.'
Same as current
Complete list of historical versions of study NCT01186575 on ClinicalTrials.gov Archive Site
  • Time to resumption of sex by study arm [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • Correlates of failure to attend the scheduled 7-day post-operative visit [ Time Frame: 42 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Text Messaging to Improve Adherence to Clinic Visits and Reduce Early Resumption of Sexual Intercourse After Male Circumcision
Text Messaging to Improve Adherence to Post-Operative Clinic Appointments and Reduce Early Resumption of Sexual Intercourse After Adult Male Circumcision: A Randomized Controlled Trial

Male circumcision (MC) reduces, by more than half, the risk of HIV-1 acquisition. WHO and UNAIDS recommend that "male circumcision should be recognized as an efficacious intervention for HIV prevention especially in countries and regions with heterosexual HIV epidemics and low male circumcision prevalence." As a result, programs have been introduced and scaled up for voluntary medical male circumcision. Kenya leads with the largest expansion of services.

Early resumption of sexual intercourse after MC may have deleterious effects, including higher rates of post-operative surgical complications, and higher HIV acquisition among females in couples that resume sexual activity before certified wound healing. In the context of rapid scale-up of MC, adherence to post-operative clinic appointments allows clinicians to assess wound healing and to deliver risk reduction counseling. Abstinence from sexual intercourse before complete wound healing would reduce the rate of post-operative adverse events and minimize the risk of HIV transmission from HIV-infected men to their uninfected female partners.

To the investigators knowledge, the effect of reminders delivered via text messaging to promote adherence to clinic visits and abstinence after MC has not been investigated. The investigators propose a randomized controlled trial in which men who will have undergone voluntary medical male circumcision at selected sites in Kisumu will be randomized to receive either the intervention (context-sensitive text messages after circumcision) or the control condition (usual care). This study seeks to determine (a) the effect of regular text messages sent to men after circumcision on attendance of the scheduled 7-day post-operative clinic visit versus usual care; (b) the proportion of men who resume sexual activity before 42 days post-procedure after receiving regular text messages versus usual care within the 42 days post-circumcision; and (c) to identify potential predictors of failure to attend the scheduled 7-day post-operative visit and early resumption of sexual intercourse.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Circumcision, Male
  • Patient Compliance
  • Cellular Phone
Other: Text Message
Context-sensitive text messages are sent to men after undergoing circumcision
Other Name: SMS, short message service, text messaging
  • Experimental: Text Message
    Context-sensitive text messages are sent to men after undergoing circumcision
    Intervention: Other: Text Message
  • No Intervention: Usual Care
    Usual care after adult male circumcision (no text messages)
Odeny TA, Bailey RC, Bukusi EA, Simoni JM, Tapia KA, Yuhas K, Holmes KK, McClelland RS. Text messaging to improve attendance at post-operative clinic visits after adult male circumcision for HIV prevention: a randomized controlled trial. PLoS One. 2012;7(9):e43832. doi: 10.1371/journal.pone.0043832. Epub 2012 Sep 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
June 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male
  • 18 years or older
  • Have undergone circumcision on the day they are screened for the study
  • Currently own a mobile phone with text-messaging capability, and
  • Have the mobile phone in their possession at the time of enrollment
  • Able and willing to respond to a questionnaire administered via a phone call

Exclusion Criteria:

  • Prior participation in a study on male circumcision
  • Currently participating in other ongoing research studies
  • Any medical condition or situation exists such that study participation would not be in the man's best interest, as determined by the investigator
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01186575
38465-E/G
No
Thomas Odeny, University of Washington
University of Washington
  • University of Illinois at Chicago
  • Kenya Medical Research Institute
Principal Investigator: Thomas A Odeny, MBChB, MPH University of Washington
Study Chair: R S McClelland, MD, MPH University of Washington
Study Chair: Elizabeth A Bukusi, MBChB, MMed, MPH, PhD Kenya Medical Research Institute
Study Chair: Jane Simoni, PhD University of Washington
Study Chair: King K Holmes, MD, PhD University of Washington
Study Chair: Robert C Bailey, PhD, MPH University of Illinois at Chicago
University of Washington
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP