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

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT01186575

Collaborator

University of Illinois at Chicago (Other), Kenya Medical Research Institute (Other)

1,200

Enrollment

Location

Arms

Duration (Months)

120.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Acquired Immunodeficiency Syndrome Circumcision, Male Patient Compliance Cellular Phone	Other: Text Message	N/A

Study Design

Study Type:

Interventional

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 :

Aug 1, 2010

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

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 Names: SMS, short message service, text messaging
No Intervention: Usual Care Usual care after adult male circumcision (no text messages)

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 Names:

SMS, short message service, text messaging

No Intervention: Usual Care

Usual care after adult male circumcision (no text messages)

Outcome Measures

Primary Outcome Measures

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

Time to resumption of sex by study arm [42 days]
Correlates of failure to attend the scheduled 7-day post-operative visit [42 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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