Text Messaging to Improve Adherence to Clinic Visits and Reduce Early Resumption of Sexual Intercourse After Male Circumcision
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ClinicalTrials.gov Identifier: NCT01186575 |
Recruitment Status
:
Completed
First Posted
: August 23, 2010
Last Update Posted
: January 16, 2015
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- No Results Posted
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Acquired Immunodeficiency Syndrome Circumcision, Male Patient Compliance Cellular Phone | Other: Text Message | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
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 |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Text Message
Context-sensitive text messages are sent to men after undergoing circumcision
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Other: Text Message
Context-sensitive text messages are sent to men after undergoing circumcision
Other Name: SMS, short message service, text messaging
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No Intervention: Usual Care
Usual care after adult male circumcision (no text messages)
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- Proportion of men failing to return for a post-operative clinic visit at 7 days. [ Time Frame: 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.
- Proportion of men who report resumption of sexual activity before 42 days post-circumcision. [ Time Frame: 42 days ]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.'
- Time to resumption of sex by study arm [ Time Frame: 42 days ]
- Correlates of failure to attend the scheduled 7-day post-operative visit [ Time Frame: 42 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186575
Kenya | |
Nyanza Reproductive Health Society | |
Kisumu, Nyanza, Kenya |
Principal Investigator: | Thomas A Odeny, MBChB, MPH | University of Washington | |
Study Chair: | 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 |
Publications of Results:
Responsible Party: | Thomas Odeny, Investigator, University of Washington |
ClinicalTrials.gov Identifier: | NCT01186575 History of Changes |
Other Study ID Numbers: |
38465-E/G |
First Posted: | August 23, 2010 Key Record Dates |
Last Update Posted: | January 16, 2015 |
Last Verified: | January 2015 |
Keywords provided by Thomas Odeny, University of Washington:
HIV Infections Acquired Immunodeficiency Syndrome Circumcision, Male |
Coitus Patient Compliance Cellular Phone |
Additional relevant MeSH terms:
HIV Infections Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases |