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

NCT01186575 | Completed

• 1 other identifier: 38465-E/G
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Time to resumption of sex by study arm

  42 days

• Correlates of failure to attend the scheduled 7-day post-operative visit

  42 days

Study Arms (2)

Text Message

EXPERIMENTAL

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

Other: Text Message

Usual Care

NO INTERVENTION

Usual care after adult male circumcision (no text messages)

Interventions

Text Message OTHER

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

Also known as: SMS, short message service, text messaging

Text Message

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• University of Illinois at Chicago: collaborator
• Kenya Medical Research Institute: collaborator

Study Sites (1)

Nyanza Reproductive Health Society

Kisumu, Nyanza, Kenya

Location

Related Publications (2)

• 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(9):e43832. doi: 10.1371/journal.pone.0043832. Epub 2012 Sep 5.

  PMID: 22957034 RESULT

• 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 Syndr. 2014 Feb 1;65(2):e50-7. doi: 10.1097/QAI.0b013e3182a0a050.

  PMID: 23846561 RESULT

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Patient Compliance; Coitus

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Sexual Behavior

Intervention Hierarchy (Ancestors)

Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Thomas A Odeny, MBChB, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• R S McClelland, MD, MPH

  University of Washington

  STUDY CHAIR

• Elizabeth A Bukusi, MBChB, MMed, MPH, PhD

  Kenya Medical Research Institute

  STUDY CHAIR

• Jane Simoni, PhD

  University of Washington

  STUDY CHAIR

• King K Holmes, MD, PhD

  University of Washington

  STUDY CHAIR

• Robert C Bailey, PhD, MPH

  University of Illinois at Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 16, 2015

Record last verified: 2015-01

Locations

KE (1)