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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186575
• Other study ID #: 38465-E/G
• Status: Completed
• Phase: N/A
• First received: August 19, 2010
• Last updated: January 15, 2015
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardKenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cellular Phone
• Circumcision, Male
• HIV Infections
• Immunologic Deficiency Syndromes
• Patient Compliance

Intervention

Other:
• Text Message
Context-sensitive text messages are sent to men after undergoing circumcision

Locations

Country	Name	City	State
Kenya	Nyanza Reproductive Health Society	Kisumu	Nyanza

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Kenya Medical Research Institute, University of Illinois at Chicago

Country where clinical trial is conducted

Kenya, 

References & Publications (2)

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 — View 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days	No
Primary	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.'	42 days	No
Secondary	Time to resumption of sex by study arm		42 days	No
Secondary	Correlates of failure to attend the scheduled 7-day post-operative visit		42 days	No