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
  Purpose

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 Intervention
HIV Infections
Acquired Immunodeficiency Syndrome
Circumcision, Male
Patient Compliance
Cellular Phone
Other: Text Message

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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.'


Secondary Outcome Measures:
  • 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 ]

Enrollment: 1200
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
Responsible Party: Thomas Odeny, Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01186575     History of Changes
Other Study ID Numbers: 38465-E/G
Study First Received: August 19, 2010
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board
Kenya: Ethical Review Committee

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

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

ClinicalTrials.gov processed this record on August 20, 2014