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

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.

Conditions

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

Interventions

OTHER

Text Message

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

Sponsors & Collaborators

• University of Illinois at Chicago

  collaborator OTHER

• Kenya Medical Research Institute

  collaborator OTHER

• University of Washington

  lead OTHER

Principal Investigators

• Thomas A Odeny, MBChB, MPH · University of Washington

• R S McClelland, MD, MPH · University of Washington

• Elizabeth A Bukusi, MBChB, MMed, MPH, PhD · Kenya Medical Research Institute

• Jane Simoni, PhD · University of Washington

• King K Holmes, MD, PhD · University of Washington

• Robert C Bailey, PhD, MPH · University of Illinois at Chicago

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2011-03-31

Completion

2011-06-30

Countries

• Kenya

Study Locations