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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01186575
Other study ID # 38465-E/G
Secondary ID
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


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
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