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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Text Message

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

Group Type EXPERIMENTAL

Text Message

Intervention Type OTHER

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

Usual Care

Usual care after adult male circumcision (no text messages)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Text Message

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

Intervention Type OTHER

Other Intervention Names

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SMS, short message service, text messaging

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes