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

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ClinicalTrials.gov Identifier: NCT01186575
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : January 16, 2015
Sponsor:
Collaborators:
University of Illinois at Chicago
Kenya Medical Research Institute
Information provided by (Responsible Party):
Thomas Odeny, University of Washington

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
HIV Infections Acquired Immunodeficiency Syndrome Circumcision, Male Patient Compliance Cellular Phone Other: Text Message Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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
Study Start Date : August 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Text Message
Context-sensitive text messages are sent to men after undergoing circumcision
 Other: Text Message
Context-sensitive text messages are sent to men after undergoing circumcision
Other Name: SMS, short message service, text messaging
No Intervention: Usual Care
Usual care after adult male circumcision (no text messages)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186575


Locations
Kenya
Nyanza Reproductive Health Society
Kisumu, Nyanza, Kenya
Sponsors and Collaborators
University of Washington
University of Illinois at Chicago
Kenya Medical Research Institute
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Thomas Odeny, Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01186575     History of Changes
Other Study ID Numbers: 38465-E/G
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: January 2015

Keywords provided by Thomas Odeny, University of Washington:
HIV Infections
Acquired Immunodeficiency Syndrome
Circumcision, Male
 Coitus
Patient Compliance
Cellular Phone

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases