Text Messaging to Improve Adherence to Clinic Visits and Reduce Early Resumption of Sexual Intercourse After Male Circumcision
Primary Purpose
HIV Infections, Acquired Immunodeficiency Syndrome, Circumcision, Male
Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Text Message
Sponsored by
About this trial
This is an interventional supportive care trial for HIV Infections focused on measuring HIV Infections, Acquired Immunodeficiency Syndrome, Circumcision, Male, Coitus, Patient Compliance, Cellular Phone
Eligibility 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
Sites / Locations
- Nyanza Reproductive Health Society
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Text Message
Usual Care
Arm Description
Context-sensitive text messages are sent to men after undergoing circumcision
Usual care after adult male circumcision (no text messages)
Outcomes
Primary Outcome Measures
Proportion of men failing to return for a post-operative clinic visit at 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.
Proportion of men who report resumption of sexual activity before 42 days post-circumcision.
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
Correlates of failure to attend the scheduled 7-day post-operative visit
Full Information
NCT ID
NCT01186575
First Posted
August 19, 2010
Last Updated
January 15, 2015
Sponsor
University of Washington
Collaborators
University of Illinois at Chicago, Kenya Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01186575
Brief Title
Text Messaging to Improve Adherence to Clinic Visits and Reduce Early Resumption of Sexual Intercourse After Male Circumcision
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 Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
University of Illinois at Chicago, Kenya Medical Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Acquired Immunodeficiency Syndrome, Circumcision, Male, Patient Compliance, Cellular Phone
Keywords
HIV Infections, Acquired Immunodeficiency Syndrome, Circumcision, Male, Coitus, Patient Compliance, Cellular Phone
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Text Message
Arm Type
Experimental
Arm Description
Context-sensitive text messages are sent to men after undergoing circumcision
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care after adult male circumcision (no text messages)
Intervention Type
Other
Intervention Name(s)
Text Message
Other Intervention Name(s)
SMS, short message service, text messaging
Intervention Description
Context-sensitive text messages are sent to men after undergoing circumcision
Primary Outcome Measure Information:
Title
Proportion of men failing to return for a post-operative clinic visit at 7 days.
Description
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.
Time Frame
7 days
Title
Proportion of men who report resumption of sexual activity before 42 days post-circumcision.
Description
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.'
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Time to resumption of sex by study arm
Time Frame
42 days
Title
Correlates of failure to attend the scheduled 7-day post-operative visit
Time Frame
42 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas A Odeny, MBChB, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
R S McClelland, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elizabeth A Bukusi, MBChB, MMed, MPH, PhD
Organizational Affiliation
Kenya Medical Research Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jane Simoni, PhD
Organizational Affiliation
University of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
King K Holmes, MD, PhD
Organizational Affiliation
University of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Robert C Bailey, PhD, MPH
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
Nyanza Reproductive Health Society
City
Kisumu
State/Province
Nyanza
Country
Kenya
12. IPD Sharing Statement
Citations:
PubMed Identifier
22957034
Citation
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.
Results Reference
result
PubMed Identifier
23846561
Citation
Odeny TA, Bailey RC, Bukusi EA, Simoni JM, Tapia KA, Yuhas K, Holmes KK, McClelland RS. Effect of text messaging to deter early resumption of sexual activity after male circumcision for HIV prevention: a randomized controlled trial. J Acquir Immune Defic Syndr. 2014 Feb 1;65(2):e50-7. doi: 10.1097/QAI.0b013e3182a0a050.
Results Reference
result
Learn more about this trial
Text Messaging to Improve Adherence to Clinic Visits and Reduce Early Resumption of Sexual Intercourse After Male Circumcision
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