Clinical trial NCT01186575: Text Messaging to Improve Adherence to Clinic Visits and Reduce Early Resumption of Sexual Intercourse After Male Circumcision
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: Kenya Medical Research Institute
First posted: 2010-08-23
Enrollment: 1200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of men failing to return for a post-operative clinic visit at 7 days.
timeFrame: 7 days
measure: Proportion of men who report resumption of sexual activity before 42 days post-circumcision.
timeFrame: 42 days
Secondary outcomes:
measure: Time to resumption of sex by study arm
timeFrame: 42 days
measure: Correlates of failure to attend the scheduled 7-day post-operative visit
timeFrame: 42 days
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Nyanza Reproductive Health Society
state: Nyanza
Study officials:
affiliation: University of Washington
name: Thomas A Odeny, MBChB, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: R S McClelland, MD, MPH
role: STUDY_CHAIR
affiliation: Kenya Medical Research Institute
name: Elizabeth A Bukusi, MBChB, MMed, MPH, PhD
role: STUDY_CHAIR
affiliation: University of Washington
name: Jane Simoni, PhD
role: STUDY_CHAIR
affiliation: University of Washington
name: King K Holmes, MD, PhD
role: STUDY_CHAIR
affiliation: University of Illinois at Chicago
name: Robert C Bailey, PhD, MPH
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.