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

Status Completed

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.

Clinical Trial Description

n/a

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

• NCT number: NCT01186575
• Study type: Interventional
• Source: University of Washington
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Completion date: June 2011