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Completed

NCT Number: NCT01186575

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text message

Other

Context-sensitive text messages are sent to men after undergoing circumcision

Other names: SMS, short message service, text messaging

Primary outcomes

  1. Proportion of men failing to return for a post-operative clinic visit at 7 days.

    Time frame: 7 days

    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.

  2. Proportion of men who report resumption of sexual activity before 42 days post-circumcision.

    Time frame: 42 days

    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.'

Secondary outcomes

  1. Time to resumption of sex by study arm

    Time frame: 42 days

  2. Correlates of failure to attend the scheduled 7-day post-operative visit

    Time frame: 42 days

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Kenya Medical Research Institute
  • University of Illinois at Chicago

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 23, 2010
Registry last updated
Jan 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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