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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01186575
Enrollment
1200
Registered
2010-08-23
Start date
2010-08-31
Completion date
2011-06-30
Last updated
2015-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Immunodeficiency Syndrome, Cellular Phone, Circumcision, Male, HIV Infections, Patient Compliance

Keywords

HIV Infections, Acquired Immunodeficiency Syndrome, Circumcision, Male, Coitus, Patient Compliance, Cellular Phone

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.

Interventions

OTHERText Message

Context-sensitive text messages are sent to men after undergoing circumcision

Sponsors

University of Illinois at Chicago
CollaboratorOTHER
Kenya Medical Research Institute
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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

Design outcomes

Primary

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

MeasureTime frame
Time to resumption of sex by study arm42 days
Correlates of failure to attend the scheduled 7-day post-operative visit42 days

Countries

Kenya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026